Sygnature Discovery has appointed Kieron Hall as Chief Commercial Officer Sygnature Discovery has announced the appointment of Kieron Hall as its new Chief Commercial Officer (CCO) and Board member. Kieron will play a key role in driving Sygnature Discovery’s strategic vision forward. His leadership will be instrumental in steering the group towards its ambitious growth goals and building upon the company’s…
Nuclera has appointed Seth Benson as Chief Financial Officer Nuclera, the biotechnology company accelerating protein expression and optimisation through its benchtop eProtein Discovery system, has announced that it has appointed Seth Benson as Chief Financial Officer. Seth’s appointment comes after Nuclera strengthened its leadership team with three key appointments as the company continues to scale during this next phase…
iOnctura has appointed Elizabeth Holt as Chief Business Officer iOnctura has announced the appointment of Elizabeth Holt, former Co-Founder of Aiolos Bio, as its Chief Business Officer. Holt brings extensive biopharmaceutical experience to the role. In addition to being part of the founding team for Aiolos Bio, which was acquired by GSK in February last…
Pfizer’s Abrysvo is designed to prevent RSV-associated disease in infants The World Health Organization (WHO) has announced that it has added Pfizer’s maternal respiratory syncytial virus (RSV) vaccine to its list of prequalified vaccines. Abrysvo, which is now the first maternal RSV vaccine to be prequalified by the organisation, aims to prevent RSV-associated lower respiratory…
Collaboration brings remote care to cancer patients Careology and Entia have announced a partnership to enhance cancer care through innovative digital and at-home solutions. The collaboration aims to empower patients to self-manage aspects of their treatment and reduce hospital reliance. Entia’s Liberty, an at-home blood monitoring solution, will integrate with Careology’s platform. This allows patients…
VIDAR-1 trial marks company’s clinical-stage debut Anocca has achieved regulatory approval for its first clinical trial, VIDAR-1, a major milestone in the company’s transition to a clinical-stage organisation. The trial will evaluate advanced pancreatic cancer treatments and begins in Q2, 2025, at leading university hospitals in Sweden, Denmark, Germany and The Netherlands. The VIDAR-1 programme,…
Aragen has appointed Manjunath Ramarao as Chief Scientific Officer Aragen has announced the appointment of Manjunath Ramarao as Chief Scientific Officer (CSO) and Executive Vice President of Integrated Drug Discovery. Ramarao has more than 25 years of experience in global biopharmaceutical research and development (R&D) and joins Aragen from Atomic AI, where he served as…
The update is aimed at strengthening local and national surveillance The UK Health Security Agency (UKHSA) has announced that it has expanded the list of diseases and pathogens that medical professionals and diagnostic laboratories in England are required to report. The update, which follows a public consultation and assessment conducted by the UKHSA and Department…
Elekta has appointed Jonas Bolander as Acting President and CEO Elekta has announcement the appointment of Jonas Bolander as Acting President and Chief Executive Officer (CEO). Bolander has been with Elekta for more than two decades and has most recently been serving as its Executive Vice President, General Counsel and Head of Group Functions. During…
The company is preparing to submit the results to the FDA this year Orca Bio has shared promising results from a late-stage study of its investigational allogeneic T-cell immunotherapy in patients with haematological malignancies. The phase 3 Precision-T trial has been evaluating the candidate, Orca-T, in patients with acute myeloid leukaemia, acute lymphoblastic leukaemia, high-risk…
Abzena has appointed Taylor Boyd as Chief Business Officer Abzena has announced the appointment of Taylor Boyd to the newly created role of Chief Business Officer. Boyd joins the company from Longboard Pharmaceuticals, where he most recently served as Head of Business Development. Prior to this, he was Vice President of Investor Relations at Oxford…
The agency has launched a whole genome sequencing service to monitor the virus The UK Health Security Agency (UKHSA) has announced the launch of a whole genome sequencing service to tackle hepatitis C virus (HCV). The service is aimed at monitoring drug resistance, detecting outbreaks sooner and improving efforts against harder to treat viral strains.…
Top 5 platforms for measurement-based care in 2025 Measurement-based care (MBC) enhances clinical and therapeutic outcomes through client-reported data and evidence collection. MBC systems empower clients to report and interact with their data, giving them ownership over their healing process. This method can improve interactions between clients and health care providers, leading to increased revenue…
How to choose the best telemedicine provider for neurology As hospitals navigate the evolving landscape of healthcare, telemedicine has emerged as a viable solution for extending care to patients regardless of location. Hospitals can navigate the increasing demand for virtual consultations and remote diagnostic capabilities by partnering with a telemedicine provider. Here’s how to select…
Scottish Medicines Consortium approves new option for mCRPC patients Pfizer Ltd has announced that the Scottish Medicines Consortium (SMC) has accepted Talzenna (talazoparib) in combination with enzalutamide for the treatment of adult patients with metastatic castration-resistant prostate cancer (mCRPC) in whom chemotherapy is not clinically indicated. Oliver Kemp, CEO of Prostate Cancer Research, said: “We…
Immunoglobulin therapy improves mobility in phase 2/3 study Grifols has announced positive results from its phase 2/3 clinical trial evaluating the efficacy and safety of intravenous immunoglobulin (IVIG) to treat post-polio syndrome (PPS). The study showed significant improvement in mobility for patients receiving IVIG compared to placebo. The trial, conducted over one year, met its…
EC extends brexpiprazole indication to include adolescents Otsuka Pharmaceutical Europe and Lundbeck have announced that the European Commission has approved Rxulti (brexpiprazole) for the treatment of schizophrenia in adolescents aged 13 years and older. The approval follows a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency…
Company seeks new direction after negative CHMP opinion on KIZFIZO Orphelia Pharma is exploring alternative regulatory pathways for KIZFIZO after receiving a negative opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) on 27 February 2025. The company is determined to secure access to this treatment for…
Phase 2a TREE study assesses safety and efficacy of leriglitazone Minoryx Therapeutics has dosed the first patient in its phase 2a TREE study, which evaluates the safety and efficacy of leriglitazone in treating Rett syndrome. The trial involves 24 female patients aged 5-12 years, receiving leriglitazone or placebo for 36 weeks. Conducted at the Neurometabolic…
Oxford Medical Products targets overweight individuals Oxford Medical Products has announced positive three-month clinical trial results for Sirona, a weight-loss treatment aimed at overweight individuals and those transitioning off GLP-1 medications. The trial, conducted across three NHS hospitals, showed participants experienced sustained weight loss. People with class 1 obesity lost on average 6.3% of their…
CervoMed’s therapy demonstrates significant improvement in patients CervoMed has announced positive results from the extension phase 2b RewinD-LB study of neflamapimod for dementia with Lewy bodies (DLB). A new batch of neflamapimod capsules led to increased plasma drug concentrations and demonstrated improvement on the Clinical Dementia Rating Sum of Boxes (CDR-SB). Improvement was also shown…
FSCD therapy meets all endpoints in interim analysis Agomab Therapeutics NV (Agomab) has announced positive interim results from 44 patients completing treatment in the ongoing STENOVA phase 2a clinical trial for AGMB-129. AGMB-129 is an oral gastro-intestinal (GI)-restricted small molecule inhibitor of ALK5 for the potential treatment of fibrostenosing Crohn’s disease (FSCD). STENOVA is a…
Innovative digital transformation leads to significant improvements To reduce waiting lists and enhance patient communication, Rotherham NHS Foundation Trust has adopted Netcall’s Liberty for Health platform. Since its introduction, the Trust has rapidly validated waiting lists, supported patients to wait well, digitised diagnostic appointments, and engaged with patients through next-generation contact centre technology. As a…
Octapharma supports NHS in building resilient supply chain Octapharma has announced that, for the first time in almost 30 years, NHS patients are receiving medicines made from UK-donated plasma. These plasma-derived medicinal products (PDMPs), including immunoglobulins and albumin, are essential for thousands of UK patients with chronic diseases, immune deficiencies, and critically ill patients following…
NICE convenes third committee meeting for additional appraisal consideration Eisai Europe Ltd. and Biogen Idec Ltd. announced that NICE will convene a third appraisal committee meeting for the ongoing evaluation of Leqembi® (lecanemab). Lecanemab was authorised by the MHRA for treating mild cognitive impairment and mild dementia due to Alzheimer’s disease (AD) in adult patients…
Cohort expansion phase commences with promising results The Safety Review Committee (SRC) has confirmed the end of the Dose Escalation phase and the start of the cohort expansion phase (phase 2) of the SECuRE trial. Based on efficacy and safety assessments, the SRC recommended expanding the dose level to 8 GBq and increasing the number…
Lead candidate for lung infections moves to human trials Centauri Therapeutics Limited has announced the selection of its first clinical candidate for the ABX-01 programme. The compound is designed to target serious Gram-negative bacterial lung infections. This drug candidate will be developed ahead of first in-human clinical studies. The compound is based on the company’s…
Kenvue appoints Bas Vorsteveld as Managing Director for Northern Europe Kenvue has appointed Bas Vorsteveld as Area Managing Director for Northern Europe. He will oversee Kenvue’s business in the UK, Ireland, Norway, Sweden, Denmark and Finland. Bas will manage a portfolio of iconic brands including Nicorette, Aveeno, Johnson’s Baby, Listerine, Neutrogena, Calpol, OGX and Imodium. Carlton Lawson, Group President for…
New research highlights NHS approval gap compared to other cancers Research from the Blood Cancer Alliance reveals a significant disparity in access to new blood cancer treatments on the NHS. Between 2019 and 2024, only 56% of new blood cancer treatments gained NICE approval, compared to 74% for other cancer types. A key factor is…
Grünenthal has appointed Professor Dr Uli Brödl as CSO Grünenthal has announced that Professor Dr Uli Brödl will assume the role of Chief Scientific Officer (CSO) and Member of the Corporate Executive Board. Uli has more than 15 years of industry experience. He joins Grünenthal from Boehringer Ingelheim, where he served as Corporate Senior Vice President, Head of Global Clinical Development…
Pharmaceutical manufacturers in the UK have been navigating complex supply chains for the longest time, balancing the dual pressures of meeting patient needs and maintaining regulatory compliance. However, the introduction of the European Clinical Trials Regulation (CTR) adds a new layer of complexity, placing unprecedented demands on upstream and downstream supply chain processes. These regulations…
The critical step of navigating post-approval phase
New collaboration aims to integrate AI solutions for treatment Brainomix, a leader in stroke AI imaging software, has announced a strategic partnership with Medtronic Neurovascular to improve stroke care across Western Europe. The collaboration seeks to integrate advanced AI solutions into clinical practice, expanding access to life-saving treatments and improving patient outcomes. Brainomix’s 360 Stroke…
New partnership to integrate SRD search technology Datapharm, a UK-based provider of medicines information, has announced its expansion into Europe through a strategic partnership with VIDAL. This collaboration will make Datapharm’s Scientific Response Document (SRD) Search technology accessible to healthcare professionals (HCPs) in France via VIDAL’s platform, with interest from 11 global pharmaceutical companies. To…
Updated data from phase 2 study reveals survival benefit Alligator Bioscience has announced updated results from its phase 2 OPTIMIZE-1 study, showing the survival benefits of mitazalimab in combination with standard chemotherapy (mFOLFIRINOX) for metastatic pancreatic cancer. The 24-month analysis of the 900 µg/kg dose demonstrates a significant survival benefit. The data shows a 24-month…
Data presented in Los Angeles showcases therapy’s potential Microbiotica, a clinical-stage biopharma company, has presented new data on MB097 at the AACR IO meeting held in Los Angeles. MB097 is an oral precision microbiome medicine, currently in development as a co-therapy with KEYTRUDA (pembrolizumab) for advanced melanoma patients. Dr Mat Robinson, Microbiotica’s Senior Vice-President of…
Awareness of interstitial lung disease raised at Miracle Garden Boehringer Ingelheim, a leading biopharmaceutical company, has teamed up with the Emirates Thoracic Society (ETS) and social media influencer Ghaith Marwan to raise awareness of Interstitial Lung Disease (ILD). The campaign reached its crescendo on 22 February 2025 with a grand unveiling at the Dubai Miracle…
Former UK PM advocates for national screening programme Rishi Sunak has joined Prostate Cancer Research as an ambassador to champion the charity’s campaign for a national screening programme for high-risk men. The announcement follows his visit to Oxford BioDynamics’ labs, where he learned about the new EpiSwitch PSE blood test. This test detects prostate cancer…
BC Platforms has appointed Mukhtar Ahmed as CEO BC Platforms has announced that it has appointed Mukhtar Ahmed as its new Chief Executive Officer (CEO). Ahmed brings over three decades of industry experience to the role. He previously served as President of the Science Group at Clarivate, President of eHealth at Bioclinica and Global Vice…
It is hoped that the approach will lead to more targeted treatments for childhood cancers Researchers from the Institute of Cancer Research (ICR) have developed a simple blood test that could be used to improve our understanding of childhood cancers. The findings of the Stratified Medicine Paediatrics (SMPaeds1) programme, published in the journal Cancer Discovery,…
Carbogen Amcis has appointed Stephan Fritschi as CEO Carbogen Amcis has appointed Stephan Fritschi, who is currently serving as the company’s Chief Alliance Officer and Deputy CEO, as Chief Executive Officer (CEO). Fritschi will take on his new role at the pharmaceutical process development and active pharmaceutical ingredient manufacturing company in April, following the departure…
Tenosynovial giant cell tumours can cause pain, stiffness, swelling and movement limitations The US Food and Drug Administration (FDA) has approved Deciphera Pharmaceuticals’ Romvimza (vimseltinib) to treat adults with symptomatic tenosynovial giant cell tumours (TGCTs). The drug has been specifically authorised for cases where surgical resection may potentially lead to worsening functional limitations or severe…
Baxter has appointed Brent Shafer as Chair and Interim CEO Baxter International has appointed Brent Shafer, who has been serving as the company’s Lead Independent Director, as Chair and Interim Chief Executive Officer (CEO). Shafer will be stepping down from his current role at Baxter and brings over four decades of healthcare industry experience to…
The common heart condition affects approximately 1.5 million people in the UK A new UK study has highlighted the critical role of GP data in understanding atrial fibrillation (AF), the most common form of abnormal heart rhythm. The research led by Oxford Population Health and published in the journal Europace demonstrates how communication across NHS…
Baxter has appointed Heather Knight as Executive Vice President and COO Baxter International has appointed Heather Knight, who has been leading the company’s Medical Products and Therapies unit, as Executive Vice President and Chief Operating Officer (COO). Knight holds over three decades of healthcare industry experience and previously served as President of Baxter’s Americas region…
New data has shown that around a third of women do not attend screenings after being invited NHS England has launched its first-ever breast cancer awareness campaign aimed at highlighting the benefits of screening for the disease. The drive, supported by Breast Cancer Now, comes as a new NHS survey of 2,000 women revealed that…
New funding to investigate cognitive decline and brain ageing The University of Bath has received a £3.5 million Wellcome grant to study cognitive decline and premature brain ageing in psychotic disorders like schizophrenia. Led by Professor Esther Walton from the Department of Psychology, the five-year project aims to develop new treatments with fewer side effects…
New test aims to revolutionise prostate cancer screening Scientists in Cambridge have developed a new ‘super test’ for prostate cancer to improve screening, diagnosis and personalised treatment. The test identifies cancerous cells, signs of early and late-stage cancer, whether it is slow or aggressive and genetic risks in the patient. The test involves studying a…
Imaging agent to improve prostate cancer detection Telix Pharmaceuticals has announced that the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) has approved the Marketing Authorization Application for its prostate cancer PET imaging agent, Illuccix. The agent is designed for detecting and localizing prostate-specific membrane antigen (PSMA)-positive lesions in adults with prostate cancer using PET.…
Significant progress for hereditary angioedema condition Global biotechnology leader CSL has announced that the European Commission (EC) has approved ANDEMBRY (garadacimab), the first once-monthly treatment targeting factor XIIa to prevent hereditary angioedema (HAE) attacks in patients aged 12 and older. ANDEMBRY inhibits plasma protein factor XIIa, which starts the cascade of events leading to angioedema…
UCB’s BIMZELX reveals promising two-year data at EHSF 2025 UCB has announced impressive two-year data for BIMZELX (bimekizumab) at the 2025 EHSF. The data from the BE HEARD trials highlight sustained disease control in moderate to severe hidradenitis suppurativa (HS). After two years of treatment with bimekizumab, 53.1% of patients experienced mild disease compared to…
Potential treatment for multiple system atrophy shows promise Lundbeck’s investigational drug, amlenetug, has been granted Fast Track Designation by the US Food and Drug Administration (FDA) as a potential treatment for multiple system atrophy (MSA). This decision follows promising results from the AMULET phase 2 trial presented in March 2024. Amlenetug, a human monoclonal antibody,…
Treatment expands options for HER2-negative metastatic breast cancer AstraZeneca announced that its drug Lynparza (olaparib) has been approved for use in Scotland. The approval by the Scottish Medicines Consortium (SMC) is for treating adults with HER2-negative, locally advanced or metastatic breast cancer with germline BRCA1 or BRCA2 mutations after chemotherapy. Breast cancer is the most…
New immunotherapy offers hope for recurrent cervical cancer Regeneron UK Limited has announced that the Scottish Medicines Consortium (SMC) has accepted Libtayo (cemiplimab) for use on the National Health Service. This approval is for second-line monotherapy treatment of adults with recurrent or metastatic cervical cancer and disease progression after platinum-based chemotherapy. Although cervical cancer is…
CSL Behring’s study reveals significant long-term benefits New data from CSL Behring’s HOPE-B study demonstrates that Hemgenix (etranacogene dezaparvovec-drlb) gene therapy provides sustained efficacy and safety in adults with hemophilia B. The study shows that 94% of patients eliminated factor IX prophylaxis and maintained near-normal factor IX levels through four years. This suggests that Hemgenix…
New methodology may boost innovation in protein engineering Capgemini has introduced a pioneering generative AI-driven methodology for protein engineering, utilising a specialised protein large language model (pLLM) to predict the most effective protein variants. With a patent pending, this groundbreaking approach is set to accelerate the global bioeconomy and drive key scientific breakthroughs across various…
Designation follows promising preclinical data and FDA clearance Ariceum Therapeutics, a private biotech company based in Berlin, has announced that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to its proprietary radiopharmaceutical, 225Ac-satoreotide, for treating patients with Small Cell Lung Cancer (SCLC). SCLC is a severe condition with a poor…
Partnership aims to leverage cutting-edge technology in clinical trials Qureight Ltd and Avalyn Pharma Inc have announced a strategic partnership in progressive pulmonary fibrosis (PPF). The partnership begins with the MIST study, a phase 2b clinical trial evaluating the safety and efficacy of AP01 (inhaled pirfenidone) in PPF patients. This partnership marks the first time…
Breast cancer therapy offers hope for patients at risk of recurrence Novartis UK announced the Medicines and Healthcare products Regulatory Agency (MHRA) has authorised ribociclib for adjuvant treatment in combination with an aromatase inhibitor (AI) for patients with HR+/HER2- early breast cancer at high risk of recurrence. Previously, this treatment was only licensed for advanced…
Sanofi’s Rippon Ubhi appointed new Chair of European Medicines Group Sanofi has announced that Rippon Ubhi has been appointed as the new Chair of the European Medicines Group (EMG). She will continue her role as Country Lead for Sanofi UK & Ireland alongside this new appointment. Rippon has extensive experience of shaping healthcare systems to support better patient…
Study shows AP-325 offers lasting pain relief without central side effects Algiax Pharmaceuticals, a company committed to developing innovative treatments for chronic neuropathic pain, has released positive topline data from its phase 2a clinical trial of AP-325. The trial results suggest that AP-325, an allosteric GABAA-receptor modulator, rapidly reduces neuropathic pain and provides long-term benefits.…
Partnership aims to create recombinant nanobodies to treat immune disorders Grifols, a global healthcare company and leading manufacturer of plasma-derived medicines, has announced a collaboration with biotechnology startup FcR Therapeutics to develop recombinant nanobodies for treating autoimmune diseases. These nanobodies are specialised antibody fragments designed to inhibit the activity of Fc receptors on immune cells.…
Positive opinion issued for marketing authorisation extension The Committee for Medicinal Products for Human Use (CHMP) has recommended extending marketing authorisation for a subcutaneous (SC) formulation of Rybrevant for treating non-small cell lung cancer (NSCLC). The Janssen-Cilag International NV announcement stated: “The SC formulation of amivantamab offers an improved treatment experience, reducing administration time from…
Funding led by new investors FSG and EIC Fund Helsinki-based Aplagon has raised EUR 7 million to advance its APAC therapeutic for thrombo-inflammatory diseases into phase 2a clinical trials. Aki Prihti, CEO of Aplagon, said: “We’re delighted to secure this fund-raising, and to bring on board FSG and EIC Fund as highly experienced VC investors…
Comparison shows improved survival rates for pancreatic cancer treatment Alligator Bioscience has announced positive outcomes from indirect treatment comparison studies, showing that mitazalimab combined with mFOLFIRINOX significantly improves overall survival (OS) for metastatic pancreatic adenocarcinoma cancer (mPDAC) patients. The OPTIMIZE-1 trial, which lacked a control group, used published literature from Phase 2/3 studies for this…
How the emc supports the accessibility of medicines information Distributing reliable information about medicines is challenging for the pharma industry and the healthcare professionals (HCPs) who depend on it to provide patient care. While digitalisation has improved accessibility to this information, it has also led to unregulated information online. PharmaTimes caught up with Rich Cooper, CEO…
Diversity remains high on the agenda for those designing and delivering clinical trials with the aim of bringing new treatments and medicines to market. Laura Bousfield, interim National Research Delivery Director with the National Institute for Health and Care Research (NIHR), reflects on how the narrative is changing around study planning and site selection to…
Commit Biologics has appointed Janine Schuurman to its board Commit Biologics has announced the appointment of Janine Schuurman to its Board of Directors. Janine is a widely recognised scientific leader with over 25 years’ experience in antibody research, discovery and development. She is the co-inventor of several FDA-approved drugs, including amivantamab and epcoritamab. Janine also played a key role in…
Alliance Healthcare has appointed Paula Sutherland as Sales Director Alliance Healthcare UK has announced that Paula Sutherland has been appointed to the position of Sales Director. Paula will lead sales teams in delivering products and services to community pharmacies. She will lead Alliance Healthcare’s UK sales teams. Her leadership will ensure that Alliance Healthcare offerings align with the unique needs…
Patients and care partners may find once every four weeks maintenance dosing easier The US Food and Drug Administration (FDA) has approved a new dosing regimen for LEQEMBI, a treatment for early Alzheimer’s disease, according to Eisai and Biogen Inc. The maintenance dosing will now be administered once every four weeks, a change that may…
Phase 3 trial of Descartes-08 in myasthenia gravis to start in 1H25 Cartesian Therapeutics has secured an agreement from the US Food and Drug Administration (FDA) under the Special Protocol Assessment (SPA) process for its phase 3 AURORA trial of Descartes-08, an mRNA cell therapy candidate for myasthenia gravis (MG). This approval means the FDA…
Study highlights VE303’s potential in reducing recurrent CDI Vedanta Biosciences has published additional results from its Phase 2 CONSORTIUM study for VE303, a potential first-in-class Live Biotherapeutic Product for preventing recurrent Clostridioides difficile infection (rCDI). The study showed VE303 was well tolerated and significantly reduced CDI recurrence odds. VE303, consisting of a defined consortium of…
NICE endorses Imfinzi and Tagrisso for enhanced lung cancer care AstraZeneca has received two positive recommendations from the National Institute for Health and Care Excellence (NICE) for its lung cancer treatments, Imfinzi and Tagrisso, benefiting patients across England and Wales. Imfinzi (durvalumab) in combination with etoposide plus either carboplatin or cisplatin has been endorsed for…
Phase 3 trial shows promising pain relief for acute pain patients Tris Pharma, Inc. has announced positive results from its ALLEVIATE-1 phase 3 clinical trial evaluating cebranopadol for treating moderate-to-severe acute pain following abdominoplasty surgery. The trial achieved its primary endpoint of significantly reducing pain intensity compared to placebo. The study’s results demonstrated a strong…
Orphan drug designation offers development incentives and potential market exclusivity Zydus has announced that the USFDA has granted Orphan Drug Designation (ODD) to Usnoflast, a novel oral NLRP3 inhibitor, for the treatment of amyotrophic lateral sclerosis (ALS). The designation provides eligibility for development incentives, including tax credits, user fee exemptions, and potential seven-year marketing exclusivity…
Europe’s first biomarker trial seeks to prevent Crohn’s Disease onset In a landmark effort, the INTERCEPT project has launched Europe’s first biomarker trial aimed at preventing Crohn’s Disease before symptoms start. This initiative, funded by the Innovative Health Initiative Joint Undertaking (IHI JU) with over EUR 38 million, aims to transform Crohn’s Disease from an…
Combination therapy shows superior survival benefit over standard treatment The European Commission (EC) has approved the marketing authorisation for LAZCLUZE (lazertinib) in combination with RYBREVANT (amivantamab) for the first-line treatment of adult patients with advanced non-small cell lung cancer (NSCLC) with EGFR mutations. Janssen-Cilag International NV announced this approval, marking a significant advancement in NSCLC…
Preclinical data highlights potential in treating Alzheimer’s disease AlzeCure Pharma AB announced that its abstract on NeuroRestore ACD856 has been accepted for presentation at the AD/PD 2025 conference. The abstract will be presented by Gunnar Nordvall, Head of Chemistry at AlzeCure, in Vienna from April 1-5. The abstract, titled ‘Further investigation on the immunomodulatory and…
Collaboration aims to enhance accessibility of medicines information Datapharm has announced its expansion into the United States through a new partnership with phactMI. The collaboration aims to improve the quality and accessibility of medicines information for healthcare professionals (HCPs) and patients across the US via the phactMI search tool, The Drug Information Database. Datapharm operates…
Cell and Gene Therapy Catapult reveals significant growth in UK trials The UK experienced a notable increase in advanced therapy clinical trials in 2024, reaching 187 ongoing trials. This marks a 7% rise from the previous year. Particularly, phase I trials saw an approximate 70% increase, growing from 24 to 41. The Cell and Gene…
Companies aim to provide new treatments for inflammatory conditions Gilead Sciences and LEO Pharma have announced a strategic partnership to advance LEO Pharma’s oral STAT6 program. This collaboration aims to develop treatments for patients suffering from inflammatory diseases such as atopic dermatitis, asthma, and COPD. Gilead will gain exclusive global rights to develop and commercialize…
Partnership aims to advance Alzheimer’s research with innovative tools Cambridge Cognition Holdings plc has expanded its partnership with Actinogen Medical Limited for the phase 2b/3 XanaMIA Alzheimer’s disease trial. Building on the successful integration of Cambridge Cognition’s digital tools during the first phase of this study, Actinogen will continue to use the company’s validated tools…
New partnership to advance precision medicine in lung cancer diagnosis Biofidelity and CellCarta have announced a strategic partnership to utilise Biofidelity’s Aspyre® Lung in global clinical trials. Aspyre Lung simplifies the detection of non-small cell lung cancer (NSCLC) biomarkers by analysing both DNA and RNA from tissue and blood using a streamlined four-step workflow. The…
Promising results from mouse study lead to expanded trials Oxford Drug Design, the Oxford-based AI drug discovery company, has announced further in vivo validation for its first-in-class cancer treatment approach. The company is developing novel treatments using its pioneering AI platform for oncology and other major diseases with unmet needs. A recent in vivo mouse…
Funds to accelerate commercialisation and clinical trials of diagnostic tests Owlstone Medical has announced a first close of $27 million (circa £22 million) in its Series E financing round. The round was led by Ventura Capital, with participation from Aviva Ventures, Horizons Ventures, and the Gates Foundation. The funds will support the development and commercialisation…
Initiative aims to identify plasma-based biomarkers for early detection Grifols has received a grant from The Michael J. Fox Foundation for Parkinson’s Research (MJFF) to identify plasma-based biomarkers that could indicate a person’s likelihood of developing Parkinson’s disease (PD) years before clinical diagnosis. The initiative, named Chronos-PD, could lead to the discovery of new diagnostic…
First-in-human trial of PTD802 to commence following UK MHRA approval Pheno Therapeutics Limited has received clinical trial authorisation (CTA) from the UK’s MHRA for its lead candidate, PTD802. The small molecule therapeutic is designed to promote remyelination in neurological diseases, including multiple sclerosis (MS). PTD802 is a selective GPR17 antagonist developed under an exclusive worldwide…
Companies aim to provide new treatments for inflammatory conditions Gilead Sciences and LEO Pharma have announced a strategic partnership to advance LEO Pharma’s oral STAT6 program. This collaboration aims to develop treatments for patients suffering from inflammatory diseases such as atopic dermatitis, asthma, and COPD. Gilead will gain exclusive global rights to develop and commercialize…
Survey finds AI to enhance productivity and cut costs in the next 12 months AI is poised to significantly lower pharmaceutical R&D costs through efficient drug discovery, optimised clinical trials, and predictive data analysis, according to a GlobalData survey. The leading data and analytics company’s report, “The State of the Biopharmaceutical Industry – 2025,” highlights…
Debra is late getting up for work again. In her heart of hearts, she’s not really enjoying her job as a teaching assistant in the local primary school. There’s a lot of stress, but it’s a job. She was in such a rush this morning that she forgot to take her tablets, again. But if…
Groundbreaking approval provides new hope for patients in England and Wales The National Institute for Health and Care Excellence (NICE) has given a positive recommendation for Lynparza (olaparib) for NHS use in England and Wales. This treatment targets adults with HER2-negative, locally advanced or metastatic breast cancer who have germline BRCA1 or BRCA2 mutations, following…
CR-discovered NXP800 shows promise in clinical trials Prostate cancer resistant to hormone therapy could soon have a new treatment option. The Institute of Cancer Research (ICR), London, found that the drug NXP800, currently in trials for ovarian and bile duct cancer, can slow prostate tumour growth and overcome hormone therapy resistance. Dr Adam Sharp, Leader…
Investment to support RNA therapeutics for epilepsy and neurological disorders Angelini Ventures has co-led a €20 million Series A financing round in Neumirna Therapeutics. The financing, also led by Invivo Partners, saw participation from Innovestor’s Life Science Fund and other existing investors. The funds will support clinical development of Neumirna’s lead asset, NMT.001. This potential…
New FDA-approved schizophrenia treatment shows promise in clinical trials Cambridge Cognition has praised Bristol Myers Squibb for the FDA approval of Cobenfy (KarXT), a new treatment for schizophrenia. Recent research published in The American Journal of Psychiatry showcases the use of Cambridge Cognition’s Cantab product in two phase 3 clinical trials involving patients with schizophrenia.…
M-Trust set to improve product safety and counterfeiting solutions Merck has launched the beta version of M-Trust, a pioneering cyber-physical trust platform, at CES 2025 to tackle product safety, traceability, and counterfeiting issues. The M-Trust platform provides enhanced product quality and authenticity assurances by creating digital twins and linking the physical and digital worlds. Laura…
OAV101 IT expands potential for type II SMA patients Novartis has announced that its intrathecal (IT) formulation of onasemnogene abeparvovec (OAV101 IT) achieved the primary endpoint in a phase 3 STEER study. This success could broaden the eligible patient population for the gene transfer therapy, according to GlobalData. The study involved paediatric patients aged 2–17…
IMDYLLTRA offers new hope for patients with extensive-stage small cell lung cancer The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has granted a conditional marketing authorisation for IMDYLLTRA (tarlatamab), a new treatment for extensive-stage small cell lung cancer (ES-SCLC). This decision marks a significant step forward for patients whose disease has progressed after at…
EpiSwitch PSE shows promise in reducing unnecessary procedures Kearney Urology Center has reported a 50% reduction in biopsies since adopting EpiSwitch PSE, a new accurate blood test for prostate cancer. The reduction is due to the test’s marked improvement over the high false positive rate of the standard prostate-specific antigen (PSA) test. In the UK,…
FDA gives green light to innovative device for liver conditions Sequana Medical NV has announced the US FDA approval of its Alfapump system for treating recurrent or refractory ascites due to liver cirrhosis. This approval marks Alfapump as the first active implantable medical device for this condition in the US. Professor H.E. Vargas of the…
Government announces independent commission on social care The government has announced the creation of an independent commission on social care. The NHS Confederation has responded positively to this news, highlighting the crucial need for support in the sector. Matthew Taylor, chief executive of the NHS Confederation, stated, “This announcement sets out a range of welcome…
MHRA urges caution over illegal medicines from beauty salons and social media The Medicines and Healthcare products Regulatory Agency (MHRA) is reminding the public not to buy weight-loss medicines without a prescription from healthcare professionals. This New Year, people are warned against purchasing such medicines from beauty salons or social media platforms, as it poses…
New chemotherapy-free treatment shows promise for EGFR-mutated NSCLC Janssen-Cilag International NV, a Johnson & Johnson company, announced that the European Commission has approved Rybrevant (amivantamab) in combination with Lazcluze (lazertinib) for first-line treatment of advanced non-small cell lung cancer (NSCLC) with specific EGFR mutations. This approval marks a significant milestone in the treatment of EGFR-mutated…
Phase 2a study shows promising antidepressant effects Beckley Psytech has announced positive topline results from its phase 2a study of ELE-101, a synthetic intravenous (IV) formulation of psilocin benzoate, for patients with Major Depressive Disorder (MDD). The study demonstrated that a single dose of ELE-101 can deliver rapid, robust, and lasting antidepressant effects for up…
New CT-guided radiotherapy system offers personalised cancer treatment Berlin’s Diagnostisch Therapeutisches Zentrum (DTZ) has become the first in the world to treat a patient using Elekta Evo, an AI-powered adaptive CT-Linac. The 62-year-old male patient is receiving curative treatment for bladder cancer, marking a significant advancement in personalised cancer care. “With Iris, CBCT image quality…
First patient dosed in landmark trial for GAD treatment MindMed has announced the dosing of the first patient in its phase 3 Voyage study of MM120 ODT, a pharmaceutically optimised form of lysergide D-tartrate (LSD) for treating Generalised Anxiety Disorder (GAD). The study aims to evaluate the efficacy and safety of MM120 ODT compared to…
New treatment could revolutionise care for HAE patients Global biotechnology leader CSL has announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion on garadacimab, recommending its marketing authorisation as a once-monthly prophylactic treatment for hereditary angioedema (HAE). If approved, garadacimab will be the first…
Promising trial results support marketing authorisation application Minoryx Therapeutics and Neuraxpharm Group have announced that leriglitazone has met the primary endpoint in the NEXUS trial for paediatric patients with cerebral adrenoleukodystrophy (cALD). The companies plan to file for European Marketing Authorization by mid-2025. “Cerebral ALD in boys is a devastating disease both for the patients…
Trial explores potential of therapy in treating multiple cancer types Bayer has begun a phase 1 clinical trial for BAY3498264, an investigational oral selective SOS1 inhibitor, to assess its safety and efficacy in patients with advanced KRAS G12C-mutated solid tumours. This study represents a significant advancement in targeting a variety of KRAS-mutated cancers, including non-small…
Promising results set stage for European marketing authorization Minoryx Therapeutics and Neuraxpharm Group have announced that leriglitazone met the primary endpoint in the NEXUS trial for paediatric patients with cerebral adrenoleukodystrophy (cALD). The companies plan to file for European Marketing Authorization by mid-2025. “Cerebral ALD in boys is a devastating disease for both patients and…
Successful phase 1 study highlights potential of roginolisib iOnctura has announced promising results from the phase 1 DIONE-01 study, showcasing the clinical activity and long-term safety of roginolisib in patients with uveal melanoma. The data will be presented at the European Society for Medical Oncology Immuno-Oncology congress tomorrow. “Roginolisib’s unique allosteric binding mechanism offers a…
New findings presented at international SCWD conference CatalYm has announced promising new data on its lead drug candidate, visugromab, at the 17th International Conference on Sarcopenia, Cachexia & Wasting Disorders (SCWD). The data from the ongoing phase 1/2a GDFATHER trial and preclinical research show visugromab effectively alleviates cancer-induced cachexia, a condition causing severe weight and…
New cell therapy shows potential in treating advanced blood disorder Cellenkos has unveiled new phase 1b data for its T-regulatory cell therapy candidate, CK0804, at the 66th Annual Meeting & Exposition of the American Society of Hematology (ASH). The results highlighted safety and efficacy in patients with myelofibrosis who did not respond to standard treatments.…
promising pre-clinical data on preventing cytokine release syndrome Poolbeg Pharma has unveiled encouraging pre-clinical study data for POLB 001 at the 66th American Society of Hematology (ASH) Annual Meeting. The study showed that all doses of POLB 001 significantly reduced clinically observed Cytokine Release Syndrome (CRS) scores, reinforcing its potential in preventing and treating cancer…
Trial results lead to new treatment option for lung cancer AstraZeneca’s Imfinzi (durvalumab) in combination with chemotherapy has been recommended by NICE for treating adults with resectable non-small cell lung cancer (NSCLC). This decision is based on positive results from the AEGEAN phase 3 trial, making Imfinzi available on the NHS across England and Wales.…
New antibody therapy shows promise in managing condition Neuraxpharm Group has announced that the National Institute for Health and Care Excellence (NICE) has recommended ublituximab (BRIUMVI®) for the treatment of relapsing-remitting multiple sclerosis (RRMS). This approval marks a significant milestone for the European specialty pharmaceutical company. “Today’s milestone reflects our commitment to improving the lives…
Phase 3 trial indicates significant efficacy and safety for children and adolescents Teva Pharmaceutical Industries has presented positive data from its Phase 3 SPACE study, demonstrating the efficacy and safety of AJOVY (fremanezumab) in preventing episodic migraines in children and adolescents aged 6-17 years. The trial showed that fremanezumab significantly reduced monthly migraine and headache…
Data highlights effectiveness of EVER001 in treating pMN Everest Medicines has announced promising results from the Phase 1b/2a clinical trial of EVER001, a novel Bruton’s tyrosine kinase (BTK) inhibitor, for treating primary membranous nephropathy (pMN). The data, available as of September 13, 2024, shows that 81.8% of patients in the low-dose cohort and 85.7% in…
Versant Ventures leads investment round to advance drug Antag Therapeutics has announced the closing of an €80 million Series A financing round to develop AT-7687, a novel therapy targeting obesity. The round was led by Versant Ventures, with Novo Holdings, SR One, Dawn Biopharma, and Pictet also participating. “The backing of such a strong syndicate…
Partnership aims to develop new radiopharmaceuticals for cancer treatment Orbit Discovery, based in Oxford, UK, and Evergreen Theragnostics, headquartered in Springfield, NJ, USA, have announced the expansion of their collaborative research agreement. This partnership seeks to discover new targeting peptides for radiopharmaceutical delivery, building on their initial agreement from April 2023. Through this extended collaboration,…
Immunocore has announced that Kimmtrak (tebentafusp) has been recommended for funding in England by the National Institute for Health and Care Excellence (NICE) and is now available through the NHS. This marks a significant reversal of last year’s negative decision, allowing the first treatment shown to prolong survival in HLA-A*02:01-positive adults with metastatic or unresectable…
Race to create first oral drug for obesity intensifies The competition to gain approval for the first oral GLP-1R drug for obesity is heating up, with four phase 3 trials currently in progress, according to GlobalData. Obesity, defined as an excessive accumulation of body fat, has reached epidemic levels. Predictions suggest that by 2030, half…
New SureSeq CLL + CNV V3 panel improves understanding of CLL OGT has announced the launch of its enhanced SureSeq CLL + CNV V3 Panel, which offers more comprehensive genetic profiling for chronic lymphocytic leukaemia (CLL) samples. This new panel includes advanced proprietary bait designs for better gene coverage and improved CNV detection. Giulia Poloni,…
Therapy for autoimmune disorder shows potential Argenx’s investigational therapy, subcutaneous efgartigimod alfa, has been granted Promising Innovative Medicine (PIM) status by the UK Medicines and Healthcare products Regulatory Agency (MHRA) for treating chronic inflammatory demyelinating polyneuropathy (CIDP). This designation signals its potential for the UK’s Early Access to Medicines Scheme (EAMS). David Knechtel, General Manager…
Injection significantly reduces need for further treatment A new treatment for asthma and COPD attacks could revolutionise patient care, scientists say. An injection given during attacks is more effective than the current steroid tablet treatment, reducing the need for further care by 30%. Findings published today in The Lancet Respiratory Medicine suggest this could be…
2024 ABPI Code update has launched – what’s next for pharma and QR codes? The long-anticipated update to the ABPI Code of Practice has launched, with the real game changer landing in Clause 12.1, which reads: ‘In printed material, prescribing information must be provided within the promotional material either: by inclusion as text, or through…
Curve Therapeutics has appointed Rab Prinjha as Chief R&D Officer Curve Therapeutics has appointed Rab Prinjha as Chief Research and Development (R&D) Officer. Rab is a proven R&D leader with a more than 20-year track record of success leading drug discovery programmes and collaborations pioneering research across immunology, oncology, neuroscience and epigenetics using small molecule, nucleic acid and biologic modalities. He…
How industry and the NHS can work together to bridge the diagnostic gap in COPD
How oncology therapies can stand out in a diverse, uncertain landscape The oncology field is rapidly evolving, particularly with the rise of precision medicines and new targeted treatments. As the field becomes more crowded, many drug developers are diversifying their pipelines, pursuing various emerging therapies to mitigate the uncertainty surrounding the future success of any…
Commit Biologics has appointed Mikkel Wandahl Pedersen as CSO Commit Biologics has announced the appointment of Mikkel Wandahl Pedersen as Chief Scientific Officer (CSO). Mikkel is a seasoned R&D executive and scientific leader with over two decades of experience in immuno-oncology, and autoimmune disease drug discovery and development. Most recently, he served as the CSO…
Tessellate BIO has appointed Dr Lara Boyd as CBO Tessellate BIO has appointed Dr Lara Boyd as Chief Business Officer. Lara joins Tessellate BIO from F-star Therapeutics, an innovation-focused biotech company dedicated to delivering next-generation multispecific antibody therapeutics, where she held a number of senior roles, most recently VP Head of BD and Corporate Strategy, responsible for…
There’s no denying it; pharma is in its innovation era. The life sciences industry is already undergoing a massive revolution, thanks to the rapid integration of artificial intelligence (AI). We’re experiencing a transformation that will likely redefine every aspect of the medical field, from research and drug development to patient care — and beyond. AI…
Mahony will continue as the UK government’s Life Sciences Investment Envoy The Department for Science, Innovation and Technology has announced that Dr Daniel Mahony will continue as the UK government’s Life Sciences Investment Envoy. Mahony has more than 25 years of experience in global healthcare investment and has served as the government’s Envoy since 2022,…
The biotech will use the funding to drive sales of its first commercial product Cytomos has announced that it has raised $5m in an oversubscribed funding round to scale up production of its cell analysis technology. The Edinburgh-based biotech said it will use the investment to drive sales of its first commercial product, Celledonia, which…
The MHRA has appointed Anthony Harnden as Chair The Medicine and Healthcare products Regulatory Agency (MHRA) has appointed Anthony Harnden, Professor of Primary Care in the Nuffield Department of Primary Care Health Sciences at the University of Oxford, as its new Chair. Harnden worked for the NHS for 40 years and brings to the role…
The Netherlands facility is designed to handle a wide range of nanomedicines, including lipid-based nanoparticles Ardena has announced the full Good Manufacturing Practice (GMP) approval of its expanded nanomedicine facility in the Netherlands by the Dutch Healthcare Authority. The Oss facility is designed to handle a wide range of nanomedicines, including polymeric nanoparticles, lipid-based nanoparticles,…
The King’s Fund has appointed Siva Anandaciva as Director of Policy, Events and Partnerships The King’s Fund has appointed Siva Anandaciva, its current Chief Analyst, as Director of Policy, Events and Partnerships. Anandaciva, who is expected to take up the role in the coming months, was previously Head of Analysis at NHS Providers, the membership…
The census found that 56% of people visit their GP for a UTI and 27% for thrush New research from PAGB has revealed that 22% of people do not think of self-care as their first option for easy-to-treat conditions. This Self-Care Week (18 to 24 November), the consumer healthcare association has highlighted the importance of…
Somerset NHS Foundation Trust has appointed Dr Rima Makarem as Chair Somerset NHS Foundation Trust has appointed Dr Rima Makarem, who has 15 years of experience working at board level in the NHS, as its new Chair. Makarem initially trained as a scientist before going on to hold a variety of senior roles within the…
The companies will focus on mechanisms of action, dose selection and biomarker analyses Teva Pharmaceuticals and artificial intelligence (AI)-driven Immunai have entered into a partnership aimed at optimising clinical trials in immunology and immuno-oncology. The multi-year collaboration will utilise Immunai’s proprietary immune cell atlas, AMICA, as well as its AI model, the Immunodynamics Engine (IDE),…
Therapy shows high efficacy in initial trial phase AC Immune SA has reported encouraging interim results from its phase 2 VacSYn clinical trial of ACI-7104.056, an anti-alpha-synuclein (a-syn) active immunotherapy for early Parkinson’s disease (PD). The trial, involving over 30 patients, showed that ACI-7104.056 induced high levels of anti-a-synuclein antibodies, averaging 16-fold higher than those…
First participant vaccinated in study of ovx836 booster dose Osivax, a biopharmaceutical company developing vaccines for broad-spectrum protection against infectious viruses, has vaccinated the first participant in its phase 2a clinical trial of OVX836. This broad-spectrum influenza vaccine candidate is being evaluated as a booster for participants who received OVX836 three to five years ago.…
New long-term partnership to address neurological disorder treatments Vivolta, a specialist in medical electrospinning solutions, has entered a long-term partnership with UK-based Neurochase to manufacture electrospun micro-catheters for advanced brain therapies. This partnership aims to enhance the treatment of neurological disorders, which affect nearly a billion people in the US and Europe. Neurochase is developing…
First patient dosed in phase 1b trial of MB310 therapy Microbiotica, a clinical-stage biopharma company, has announced the dosing of the first patient in its Phase 1b First-in-Human trial, COMPOSER-1, for MB310 in ulcerative colitis (UC) patients. This international trial aims to recruit up to 30 adult patients across the UK, Austria, Bulgaria, Poland, and…
Insight into double-blind, phase i/ii clinical trial for oesophageal cancer Infinitopes, an integrated cancer biotech firm, will present its pioneering cancer vaccine development at the Society for Immunotherapy of Cancer (SITC) 2024 in Houston, US, from 6-10 November. The Oxford-based company will showcase three posters, including one recognised as a ‘top 100’ presentation. Jonathan Kwok,…
Eco-friendly inhalers aim to reduce environmental impact Lupin Healthcare UK Ltd has announced plans to reformulate its pMDI inhalers with a near-zero global warming potential propellant as part of their commitment to achieving net-zero status by 2045. This development aligns with European and UK regulatory requirements and aims to reduce the environmental impact of inhalers…
First car t-cell therapy accepted for second-line treatment in Scotland The Scottish Medicines Consortium (SMC) has approved Kite’s CAR T-cell therapy, Yescarta (axi-cel), for treating adult patients with diffuse large B cell lymphoma (DLBCL) and high-grade B-cell lymphoma (HGBL). This marks the first time a CAR T-cell therapy has been accepted for second-line treatment in…
New treatment option approved for women in Scotland The Scottish Medicines Consortium (SMC) has recommended Yselty (linzagolix) for treating moderate to severe symptoms of uterine fibroids (UFs) in women of reproductive age. This decision means eligible women across Scotland can now access this treatment through the NHS. Uterine fibroids affect approximately 70% of women of…
AstronauTx has appointed Dr Jane Rhodes as Chief Executive Officer AstronauTx has appointed Dr Jane Rhodes as Chief Executive Officer (CEO) and member of the Board, and Magnus Ivarsson as Chief Translation and Early Development Officer. Jane is an accomplished leader with 25 years of experience in the biotech industry. She was previously President and Chief Business Officer at Verge Genomics, and has…
New initiatives to tackle AI-related challenges in life sciences Elsevier, a leader in information and analytics, has announced its support for The Pistoia Alliance in promoting safe and responsible AI adoption in drug discovery. This effort aims to address key AI challenges, including the need for trustworthy data and AI transparency, through industry workshops, webinars,…
Trial to evaluate safety and efficacy of MVA-BN vaccine A new scientific trial evaluating Bavarian Nordic’s mpox vaccine in pregnant and breastfeeding women and infants is set to launch in the Democratic Republic of Congo (DRC). This research could expand access to Bavarian Nordic’s MVA-BN mpox vaccine, currently the only WHO prequalified vaccine for healthy…
New therapy targets specific genetic alterations, promises extended survival Johnson & Johnson has announced that the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has approved BALVERSA (erdafitinib) for treating adults with unresectable or metastatic urothelial carcinoma (UC) harbouring FGFR3 genetic alterations. This approval offers a new option for patients who have already undergone at…
Phase 1 and 2 studies show promising results for anito-cel therapy Arcellx Inc, a biotechnology firm focused on cell therapy innovations, has announced impressive results from its studies on anitocabtagene autoleucel (anito-cel) for treating relapsed or refractory multiple myeloma. These findings will be showcased at the 66th American Society of Haematology (ASH) Annual Meeting in…
Importance of continuous collaboration with rare disease communities At Blueprint Medicines, we aim to make a significant difference in patients’ lives by solving critical medical problems. Since the company’s inception, we have focused on addressing the burden faced by people impacted by systemic mastocytosis (SM), a rare haematologic disorder. SM is caused by the abnormal…
Building strong partnerships with sites for more effective clinical trials When I first entered the clinical research industry more than 20 years ago, trials were focused mainly on recruitment goals and data collection, with less attention to the challenges faced by research sites. While working at a site, I saw firsthand the administrative and operational…
Walgreens Boots Alliance appoints Anthony Hemmerdinger as MD, UK and Ireland Walgreens Boots Alliance has announced the appointment of Anthony Hemmerdinger as Managing Director of Boots UK and Ireland. This follows the announcement in July that Seb James would be stepping down in November, after six years, to pursue a new role in the healthcare sector. Anthony’s appointment follows a…
The new Dementia Trials Accelerator is set to receive £20m of government funding The Dementia Trials Accelerator, led by the UK Dementia Research Institute and Health Data Research UK and funded by the Medical Research Council, will receive £20m of government funding to increase UK participation in dementia clinical trials from 61 in 2021 to…
Heart failure accounted for approximately 90,000 hospital admissions in England in 2019 to 2020 The National Institute for Health and Care Excellence (NICE) has announced that people with heart failure can now stay healthier remotely through advanced remote monitoring technology designed to reduce hospital visits. NICE has approved two algorithm-based technologies, HeartLogic and TriageHF, for…
Approximately 8.2 million people were diagnosed with the infectious disease in 2023 The World Health Organization’s (WHO) newly published report has placed tuberculosis (TB) as the leading infectious disease killer in 2023, surpassing COVID-19. Newly identified TB cases climbed to 8.2 million last year, with the illness disproportionately impacting people in 30 high-burden countries, marking…
danicopan shown to improve haemoglobin levels and reduce anaemia Alexion, AstraZeneca Rare Disease, announced that the National Institute for Health and Care Excellence (NICE) has given a positive recommendation for Voydeya (danicopan). This first-in-class, oral Factor D inhibitor can now be used as an add-on to ravulizumab or eculizumab for treating paroxysmal nocturnal haemoglobinuria (PNH)…
Chiesi Group has appointed Laura Vergani as SVP of Global Communications Chiesi Group has announced that Laura Vergani has joined as Senior Vice President of Global Communications & Public Affairs. Laura brings a proven track record of successful experience from her international career; she was based in London for the last 20 years, where she…
CAL101 shows promising results and is set to enter phase 2 development Calluna Pharma AS has announced the successful completion of Phase 1 clinical trials for its lead drug candidate, CAL101, a first-in-class monoclonal antibody (mAb) targeting fibrotic and fibro-inflammatory diseases. The study, conducted at the Medicines Evaluation Unit in Manchester, showed CAL101 to have…
New treatment option for patients with newly diagnosed multiple myeloma The European Commission has approved the subcutaneous (SC) formulation of DARZALEX (daratumumab) in combination with bortezomib, lenalidomide, and dexamethasone (daratumumab-VRd) for patients with newly diagnosed multiple myeloma (NDMM) who are eligible for an autologous stem cell transplant (ASCT). This approval allows patients to receive this…
Innovative Trials has appointed Ian Keith as Finance and Business Services Director Innovative Trials has appointed Ian Keith, who has been supporting the company as a Business Consultant since the beginning of 2024, as its new Finance and Business Services Director. Keith brings extensive experience to the role and joins Innovative Trials’ senior leadership team…
The company’s workforce will volunteer and fundraise for Team Jak throughout the year Valneva Scotland has partnered with Team Jak, a West Lothian-headquartered charity focused on supporting children and young people with cancer. The Livingston-based vaccine producer will provide year-long support to Team Jak, which offers emotional, social and practical support to patients aged zero…
The five new programmes are designed to fit alongside full-time work and clinical practice Learna and the University of Wolverhampton have partnered to launch five new master’s and postgraduate diploma healthcare programmes. The flexible, online courses are designed to allow students to balance their studies with full-time work and clinical practice, and will cover acute…
Primary open-angle glaucoma affects around 2% of adults aged 40 years and older in the UK The National Institute for Health and Care Excellence (NICE) has issued guidance recommending Santen’s Roclanda for use in patients with primary open-angle glaucoma (POAG) or ocular hypertension (OHT). The health technology assessment agency has specifically recommended that Roclanda be…
Phase 2 study of TG4001 shows promise in cervical cancer patients Transgene, a biotech company specializing in virus-based immunotherapies for cancer, has announced that its phase 2 trial of TG4001 in combination with avelumab did not meet its primary objective of improving progression-free survival in patients with recurrent or metastatic HPV16-positive cervical and anogenital cancers.…
The London hub is home to life sciences companies including Novartis, Engitix and invoX Pharma Vivan Therapeutics has signed a new five-year lease at White City Place, a biotech hub in London home to life sciences companies including Novartis and Engitix. The lease renewal for the mixed-use office and laboratory space in the WestWorks building…
The two-year programme will use virtual reality technology to teach essential skills A £4.5m initiative has been launched to address the growing skills shortage in the UK’s medicines manufacturing industry. The Resilience Centre of Excellence for UK Medicines Manufacturing Skills will serve as a central, coordinated hub for workforce skills, training and outreach. It has…
Partnership to harness AI for DUB-focused preclinical programmes
NK:IO has appointed Richard Hopkins as Chief Executive Officer NK:IO has appointed Richard Hopkins, an experienced biologics developer, as its new Chief Executive Officer. Hopkins has more than 14 years of experience spanning industry, government and academia. He joins the Imperial College spinout after serving as Vice President of Pre-Clinical and Clinical Translation at bit.bio,…
There are around 55,100 new prostate cancer cases in the UK every year HBC Immunology (HBCI) has announced that an oral formulation of its lead peptide “significantly augmented” the anti-tumour activity of Pfizer/Astellas’ androgen receptor inhibitor Xtandi (enzalutamide) in prostate cancer models. The company said the xenograft studies of FT-002a have been successfully completed and…
Study reveals potential new strategy for managing inflammatory bowel disease
Acquisition to enhance Lundbeck’s neuroscience pipeline Lundbeck has announced a significant step forward in its Focused Innovator strategy with the acquisition of Longboard Pharmaceuticals. This strategic deal, valued at approximately USD 2.6 billion, aims to enhance Lundbeck’s capabilities in treating neuro-rare conditions, particularly Developmental and Epileptic Encephalopathies (DEEs). The acquisition includes Longboard’s lead asset, bexicaserin,…
New vaccine aims to protect older adults from severe flu complications Sanofi has announced the launch of its high-dose egg-based quadrivalent influenza vaccine (QIV-HD) in the UK. This vaccine is designed for people aged 65 and older, as well as clinically at-risk individuals aged 60 to 64. The Joint Committee on Vaccination and Immunisation (JCVI)…
Teclistamab offers hope for patients exhausting treatment options Teclistamab (Tecvayli), a drug manufactured by Johnson & Johnson, has received a positive recommendation from NICE for fourth-line use on the NHS in England and Wales. This new treatment is for myeloma, a type of blood cancer affecting plasma cells. While most myeloma patients are men over…
Sheffield cardiologists demonstrate cutting-edge TAVI procedure Cardiologists at Sheffield Teaching Hospitals NHS Foundation Trust have performed a cutting-edge heart valve replacement procedure live to an international audience. The streamlined transcatheter aortic valve implantation (TAVI) highlighted Sheffield’s leading role in cardiovascular research and allowed Christopher Wild, 80, to go home within hours of having his faulty…
New investment to advance gene therapies for kidney diseases Purespring Therapeutics has raised £80m in an oversubscribed Series B financing round. Syncona Ltd, a leading life science investor, committed £19.9m as part of a syndicate led by Sofinnova, alongside Gilde Healthcare, Forbion and British Patient Capital. The funds will be used to advance Purespring’s pipeline…
AviadoBio to receive up to £1.8 billion in potential payments AviadoBio and Astellas Pharma have entered into an exclusive option and licence agreement for AVB-101, an investigational gene therapy targeting frontotemporal dementia (FTD). The deal, announced today, could see AviadoBio receive up to £1.8 billion in licence fees and milestone payments, plus royalties. Under the…
Real-world studies show effectiveness of mogamulizumab in routine practice Kyowa Kirin International (KKI) has announced positive interim findings from three real-world studies on mogamulizumab (Poteligeo) for cutaneous T-cell lymphoma (CTCL). The data will be presented at the European Organisation for Research and Treatment of Cancer’s Cutaneous Lymphoma Tumour Group (EORTC-CLTG) meeting in Lausanne, Switzerland, from…
Scottish Medicines Consortium recommends pembrolizumab The Scottish Medicines Consortium (SMC) has recommended MSD’s KEYTRUDA (pembrolizumab) as a monotherapy for adults with non-small cell lung carcinoma (NSCLC) who are at high risk of recurrence following complete resection and platinum-based chemotherapy. This recommendation is restricted to adults whose tumours express programmed death-ligand 1 (PD-L1) with a tumour…
Biotech company moves forward with phase 2 trial for precision cancer surgery Copenhagen-based biotech company FluoGuide A/S has announced the submission of a Clinical Trial Application (CTA) for a phase II trial in head and neck cancer, specifically oral squamous cell carcinoma. This marks a significant step forward for the company, which specialises in precision…
Harnessing vital patient data for precision in clinical trials In clinical research, leveraging patient data has become a critical factor to improve the design, execution and outcome of clinical trials. Collecting data is no longer enough; the true challenge lies in translating that data into actionable insights that guide decision-making throughout the trial. The importance…
Sphere Fluidics has appointed Dr Alex Dickinson to its Board of Directors Sphere Fluidics has announced the appointment of Dr Alex Dickinson to its Board of Directors as a Non-Executive Director (NED). Alex is a seasoned executive bringing substantial experience from the intersection of healthcare, life sciences and information technology to Sphere Fluidics’ leadership team. He joins the…
Largest real-world study demonstrates significant survival advantage In a landmark study, Johnson & Johnson has announced that ERLEADA (apalutamide) significantly reduces the risk of death by 23% at 24 months compared to enzalutamide in patients with metastatic castration-sensitive prostate cancer (mCSPC). The findings were presented at the 6th European Congress of Oncology Pharmacy (ECOP) in…
Phase 1 trial of IRL757 demonstrates good absorption and safety profile IRLAB Therapeutics AB has announced the successful completion of the first part of its Phase I clinical trial for IRL757, a drug candidate aimed at treating apathy in patients with Parkinson’s disease. The results indicate that IRL757 is well absorbed, provides good exposure in…
Preclinical data on NeuroRestore therapy to be showcased at CTAD in Madrid AlzeCure Pharma AB, a company specializing in drugs for nervous system diseases, announced that its abstract on NeuroRestore ACD856 has been accepted for presentation at the Clinical Trials in Alzheimer’s Disease (CTAD) conference. The event will take place in Madrid, Spain, from October…
ISM001-055 shows promise in improving lung function among patients Insilico Medicine, a clinical-stage generative AI-driven drug discovery company, has announced positive preliminary results from its Phase 2a clinical trial of ISM001-055. This first-in-class small molecule targets TNIK (Traf2- and Nck-interacting kinase) and was designed using generative AI to treat idiopathic pulmonary fibrosis (IPF). The study…
Janssen-Cilag therapy becomes the first single tablet combination therapy for PAH in europe The European Commission has approved Yuvanci (macitentan 10 mg and tadalafil 40 mg), a single tablet combination therapy (STCT) for the long-term treatment of pulmonary arterial hypertension (PAH) in adult patients. This approval marks a significant milestone as Yuvanci becomes the only…
ICON celebrates 2024 ‘company of the year’ win ICON continues to celebrate its achievement at the 2024 Clinical Researcher of the Year Awards, where we were honoured to receive the ‘company of the year’ title in the International PharmaTimes competition. With 53 employees reaching the finalist stage across seven categories, including 28 from ICON Biotech,…
minds + assembly has appointed Fabio Gratton as an Advisor minds + assembly welcomes Fabio Gratton as an Advisor to its Board of Directors. Fabio brings 25 years of expertise in founding and scaling healthcare digital agencies to minds + assembly – experience that is a perfect addition as it continues to expand. A serial…
£3m programme to accelerate new antimicrobial treatment Oxford Drug Design has been awarded a share of a £3 million Collaborative Discovery Programme (CDP) by the Cystic Fibrosis Antimicrobial Resistance (CF AMR) Syndicate. This initiative, funded by the not-for-profit medical research charity LifeArc, aims to accelerate the development of new treatments for lung infections in people…
New government scheme to offer routine opt-out blood tests Starting next week, Sheffield’s Northern General Hospital A&E Department will begin routine opt-out testing for HIV, hepatitis B, and hepatitis C for patients aged 16 and over. This initiative, commencing on Tuesday, 1 October 2024, is part of a new Government scheme aimed at early detection…
4basebio has announced Dr Amy Walker as Chief Operating Officer 4basebio has announced the appointment of Dr Amy Walker as Chief Operating Officer of the company. Amy joined 4basebio in November 2020 and has served as the Vice President of Research and Business Development at the company. She has a background in molecular biology and…
International trial marks leap forward in chemotherapy-induced neuropathy care In a landmark announcement from Paris, AlgoTherapeutix (AlgoTx) has heralded the successful completion of its international phase 2 trial for ATX01, a novel therapeutic aimed at treating chemotherapy-induced peripheral neuropathy (CIPN). The trial, named ‘ACT’, reached its ‘Last Patient Last Visit’ milestone, a critical step in…
International think tanks to shape future of cancer research funding Cancer Grand Challenges, a pioneering initiative co-founded by Cancer Research UK and the US National Cancer Institute (NCI), has launched a global search to identify the most pressing challenges in cancer research. This multi-million-pound effort aims to bring together the world’s leading scientists and patient…
Milieu Insight has appointed Sundip Chahal as Chief Executive Officer Milieu Insight has appointed Sundip Chahal (pictured left), former YouGov Global Chief Operating Officer, as Chief Executive Officer. Chahal brings extensive experience to the position, which he takes on after holding roles of increasing responsibility over 18 years at YouGov. He first joined the group…
There is currently no national screening programme for the disease in the UK Oncologica has developed a urine-based screening test for prostate cancer and has launched a funding drive to support its advancement. The technology, ProstateFocus, uses the Cambridge-based company’s proprietary artificial intelligence-based analysis platform to detect the disease at an early, treatable stage. There…
The conference will return to Vienna AirportCity on 23 to 24 October 2024 Samedan has announced that on 23 to 24 October 2024, its FlyPharma Conference will make a welcome return to Office Park 4, Vienna AirportCity, Austria. FlyPharma invites forward-thinking professionals and businesses to enhance their pharmaceutical supply chains and take advantage of key…
It is hoped that the tool will improve the diagnostic pathway and free up radiologists’ time Leeds Teaching Hospitals NHS Trust (LTHT) has announced that it is piloting a new artificial intelligence (AI) and machine learning software system for prostate cancer diagnosis. Working in collaboration with Lucida Medical, LTHT will test the effectiveness of the…