Data from trials highlight long-term disease control and quality of life improvements UCB has announced new three-year data for BIMZELX (bimekizumab) in moderate to severe hidradenitis suppurativa (HS), showing sustained disease control and symptom resolution across the most stringent clinical endpoints. Bimekizumab is the first approved treatment to selectively inhibit interleukin 17A and 17F. It…
Durvalumab becomes first immunotherapy recommended for LS-SCLC patients in England and Wales AstraZeneca’s Imfinzi (durvalumab) has been approved for NHS use in England and Wales for adults with limited-stage small cell lung cancer (LS-SCLC) whose disease has not progressed after platinum-based chemoradiotherapy. This marks the first treatment advancement in LS-SCLC in over 30 years, offering…
Positive orphan drug opinion supports SOM3355’s potential as first-line treatment in Europe SOM Biotech has received a positive opinion from the European Medicines Agency’s Committee for Orphan Medical Products for SOM3355, a candidate therapy for Huntington’s disease (HD). The molecule already holds orphan drug designation in the US. SOM3355 combines mild beta-blocking activity with VMAT1…
Arcinova has appointed Dr Christian Dowdeswell as Managing Director Arcinova, a Quotient Sciences company and UK-based contract research development and manufacturing organisation (CRDMO), has announced the appointment of Dr Christian Dowdeswell as new Managing Director. He takes the reins from co-founder and Managing Director Paul Ryan, who recently announced his retirement. Christian joins the firm at a busy time…
New phase 4 results show sustained symptom relief and improved patient outcomes Lundbeck has presented new clinical data on eptinezumab at the 2025 International Headache Congress in São Paulo, highlighting its long-term preventive effectiveness in patients severely affected by chronic migraine. The company shared six presentations, including three oral sessions on eptinezumab and Lu AG09222.…
Merck presents phase 3 STRIDE-13 trial results at ESCMID conference in Lisbon Merck has announced positive phase 3 results for Capvaxive, its 21-valent pneumococcal conjugate vaccine, in children and adolescents with chronic medical conditions that increase their risk of pneumococcal disease. Findings from the STRIDE-13 trial were presented at the 6th ESCMID Conference on Vaccines…
Abcuro has appointed George Eldridge as chief financial officer Abcuro Inc, a clinical-stage biotechnology company developing therapies for the treatment of autoimmune diseases and cancer through precise modulation of cytotoxic T cells, has announced the appointment of George Eldridge as chief financial officer. George brings more than 30 years of executive leadership experience in finance and business operations…
Early data reveals strong response rates in ovarian cancer cohort PMV Pharma has announced encouraging interim results from the phase 2 portion of its PYNNACLE trial, evaluating rezatapopt monotherapy in patients with advanced solid tumours harbouring a TP53 Y220C mutation. Confirmed responses were observed across eight tumour types, including ovarian, lung, breast, endometrial, head and…
First patient enrolled in AZURE-2 study comparing brelovitug to Hepcludex Bluejay Therapeutics has enrolled the first patient in AZURE-2, a global phase 3 clinical trial evaluating brelovitug (BJT-778) as a monotherapy for chronic hepatitis D (CHD). The study compares brelovitug with Hepcludex (bulevirtide) in adults with CHD. AZURE-2 is a randomised, controlled trial assessing weekly…
New partnership aims to fast-track mRNA therapies from lab to clinic Quotient Sciences and CPI have signed a memorandum of understanding to form a joint venture focused on accelerating RNA-based drug development. The collaboration will integrate both companies’ technologies to streamline the creation of mRNA therapeutics. The venture will combine Quotient’s Translational Pharmaceutics platform with…
Novel orexin receptor agonist shows potential to improve wakefulness Eisai has presented new clinical data for its investigational orexin 2 receptor agonist E2086 at the World Sleep 2025 congress in Singapore. The phase 1b trial showed that once-daily dosing may improve daytime wakefulness in people with narcolepsy type 1. The randomised, double-blind, single-dose, multiple crossover…
Sharon Curran has been appointed Chair of Rosemont’s board Sharon Curran has been appointed as the new chairperson for Rosemont Pharmaceuticals board of directors. The company manufactures and specialises in novel Rx oral liquid medicines for patients who have difficulty swallowing due to conditions such as dysphagia, stroke or dementia. Sharon has held extensive senior and executive leadership roles in…
Trial explores regenerative macrophage therapy for liver disease Resolution Therapeutics has announced that the first patient has been dosed and safety cleared in its phase 1/2 EMERALD study of RTX001, a first-in-class engineered regenerative macrophage therapy (RMT) for end-stage liver disease. The study is now open for enrolment in the UK and Spain. RTX001 is…
Survey reveals lack of awareness need for greater clarity
Topical TRPV1 antagonist shows promise in heat-induced neuropathic pain lzeCure Pharma has presented new clinical data on its lead pain candidate ACD440 at the NeuPSIG 2025 international pain conference. The presentation includes results from the phase 2 study in chronic peripheral neuropathic pain. ACD440 is a first-in-class TRPV1 antagonist developed as a topical gel for…
Blended solutions gain momentum and reveal untapped potential
Collaboration offers end-to-end support from donor sourcing to manufacturing eXmoor Pharma and Anthony Nolan: Cell Therapy & Laboratory Services (CT&LS) have announced a strategic partnership to provide integrated support for developers of autologous and allogeneic cell therapies. The collaboration combines donor material expertise with GMP manufacturing capabilities. The partnership offers a complete service spanning donor…
Deal covers biosimilars for gastroenterology, neurology and dermatology Polpharma Biologics has signed licensing agreements with MS Pharma for the commercialisation of three proposed biosimilars in the Middle East and North Africa. The deal covers vedolizumab (PB016), ocrelizumab (PB018) and guselkumab (PB019), targeting ulcerative colitis, multiple sclerosis and plaque psoriasis respectively. Under the agreements, MS Pharma…
MHRA grants conditional authorisation for treatment targeting mantle cell lymphoma Eli Lilly and Company has received conditional marketing authorisation from the MHRA for pirtobrutinib (Jaypirca ▼) as monotherapy for adults with relapsed or refractory mantle cell lymphoma (MCL) or chronic lymphocytic leukaemia (CLL) previously treated with a Bruton’s tyrosine kinase (BTK) inhibitor. The decision is…
New subcutaneous autoinjector offers at-home treatment option for patients Eisai and Biogen have announced FDA approval of LEQEMBI IQLIK (lecanemab-irmb) for maintenance dosing in early Alzheimer’s disease. The subcutaneous autoinjector delivers a 360 mg dose in approximately 15 seconds and will be launched in the US on 6 October 2025. LEQEMBI IQLIK is indicated for…
The US Food and Drug Administration (FDA) has accepted an Investigational New Drug (IND) application from Coya Therapeutics for COYA 302, enabling the company to begin a phase 2 clinical trial in patients with amyotrophic lateral sclerosis (ALS). The study will assess the safety and efficacy of COYA 302, a biologic therapy designed to regulate…
Swedish biotech company Akiram Therapeutics has announced significant progress in its first clinical trial of AKIR001, a radiopharmaceutical intended to treat aggressive solid tumours. The company confirmed completion of the first patient cohort in its phase 1 study, with no safety concerns reported, allowing the trial to continue to its next stage. The study is…
HUTCHMED has announced that Weiguo Su, CEO of the company, will take a leave of absence from his duties due to health reasons. As a result, the board of directors has appointed Johnny Cheng, an executive director and chief financial officer (CFO) of the company, as acting CEO with immediate effect, in addition to his…
Encare’s ERAS Interactive Audit System (EIAS) has earned qualification on the Mayo Clinic Platform_Solutions Studio – a distinction rarely awarded to European solutions. The recognition positions EIAS for faster adoption across Mayo Clinic Medical Centres and partner health systems worldwide. Developed in collaboration with the Enhanced Recovery After Surgery (ERAS) Society, EIAS enables hospitals to…
Eli Lilly and Company has announced that Anne White, executive vice president and president of Lilly Neuroscience, will retire at the end of 2025 after more than 30 years with the company. White will remain in her role, and as a member of the executive committee, until her retirement on 31 December. A search for…
Novartis has reported that its experimental drug ianalumab met the primary goal in a phase 3 trial for primary immune thrombocytopenia (ITP), a rare autoimmune condition where the immune system destroys platelets, increasing the risk of bleeding and fatigue. The study, VAYHIT2, investigated ianalumab alongside eltrombopag in patients whose disease had not responded to corticosteroids…
Top-rated pharmacies in northern Virginia for personalised fertility care Finding the right pharmacy to support your fertility journey is essential. What are the top-rated pharmacies for personalized fertility care in Northern Virginia? These specialized companies offer services beyond traditional prescription filling, providing customized medications and expert consultations. 1. Hann’s Fertility Pharmacy As the only independent…
Friends of Cancer Research has announced a new collaboration with global clinical research organisation, MMS, to develop decision frameworks that will help interpret interim overall survival (OS) data in oncology trials. Assessing OS – the time from treatment to end of life – is considered the most effective means of determining whether a cancer therapy…
ANGLE has announced a collaboration with Myriad Genetics to assess whether circulating tumour cell (CTC) DNA harvested from blood samples using ANGLE’s Parsortix system can be used alongside Myriad’s existing tissue-based diagnostic assays. The project will see ANGLE’s R&D team process blood samples from cancer patients with Parsortix, which captures intact cancer cells for downstream…
The US Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) to izalontamab brengitecan (iza-bren), an investigational drug developed by SystImmune and Bristol Myers Squibb, for certain patients with advanced non-small cell lung cancer (NSCLC). The designation applies to patients whose tumours have specific epidermal growth factor receptor (EGFR) gene mutations, and whose…
Upperton Pharma Solutions has been awarded funding under the first VaxHub Sustainable Platform Funding Call to support the development of oral formulations for adenovirus-vectored vaccines, in partnership with the University of Oxford’s Pandemic Sciences Institute in Oxford, UK. The project is scheduled to run until summer 2026. Led by Dame Sarah Gilbert, the project seeks…
Project aims to improve global immunisation through needle-free delivery Upperton Pharma Solutions has secured funding from the first VaxHub Sustainable Platform Funding Call to support the development of an oral formulation for Adenovirus-vectored vaccines. The Nottingham-based CDMO is collaborating with the University of Oxford on the initiative. The project is led by Professor Dame Sarah…
Merck’s therapy becomes first authorised option for aggressive soft tissue tumours Merck has announced that the European Commission has granted marketing authorisation for Ogsiveo (nirogacestat) as monotherapy for adults with progressing desmoid tumors requiring systemic treatment. Ogsiveo is now the first and only approved therapy for desmoid tumors in the European Union. Bernd Kasper, Professor…
Promising results support global submissions and priority review by US FDA Genmab has announced that its phase 3 EPCORE FL-1 trial met both primary endpoints in patients with relapsed or refractory follicular lymphoma. The study evaluated epcoritamab, a bispecific antibody, in combination with rituximab and lenalidomide (R2) versus R2 alone. The combination showed a statistically…
Promising results support global submissions and priority review by US FDA Genmab has announced that its phase 3 EPCORE FL-1 trial met both primary endpoints in patients with relapsed or refractory follicular lymphoma. The study evaluated epcoritamab, a bispecific antibody, in combination with rituximab and lenalidomide (R2) versus R2 alone. The combination showed a statistically…
Lilly’s study finds tirzepatide delivers broader health improvements Eli Lilly has announced positive topline results from its phase 3 SURPASS-CVOT trial, comparing Mounjaro (tirzepatide) with Trulicity (dulaglutide) in adults with type 2 diabetes and cardiovascular disease. The study met its primary objective, with Mounjaro showing non-inferiority to Trulicity in reducing major adverse cardiovascular events (MACE-3),…
Company shifts focus to phase 3 VE303 trial in recurrent C. difficile infection Vedanta Biosciences has announced that VE202 failed to meet the primary endpoint in its phase 2 COLLECTiVE202 study for mild-to-moderate ulcerative colitis. The trial assessed endoscopic response at Week 8, but results showed no statistically significant difference between VE202 and placebo. Clinical…
Teva’s CGRP therapy becomes first approved option for children and adolescent Teva Pharmaceuticals has received US FDA approval for AJOVY (fremanezumab-vfrm) as a preventive treatment for episodic migraine in children and adolescents aged 6–17 who weigh at least 45 kilograms. AJOVY is now the first and only calcitonin gene-related peptide (CGRP) antagonist approved for paediatric…
Nationwide competition to pilot new models of obesity support Eli Lilly and Company and the UK Government have announced a joint programme to develop innovative models of care for obesity, backed by up to £85 million in funding. The initiative includes a UK-wide competition inviting NHS organisations to submit proposals for new approaches to obesity…
Pirtobrutinib meets primary endpoint in CLL/SLL study Eli Lilly and Company has announced positive topline results from its phase 3 BRUIN CLL-314 trial of Jaypirca (pirtobrutinib) in patients with chronic lymphocytic leukaemia or small lymphocytic lymphoma. The study compared pirtobrutinib, a non-covalent BTK inhibitor, with Imbruvica (ibrutinib), a covalent BTK inhibitor, in treatment-naïve and previously…
New treatment option now available across all UK nations Patients in Scotland with relapsed or refractory mantle cell lymphoma (MCL) after one line of treatment can now access zanubrutinib through NHS Scotland, following acceptance by the Scottish Medicines Consortium (SMC). The decision aligns Scotland with England, Wales and Northern Ireland, offering access to BRUKINSA ahead…
New phase of development targets chronic pain and fibromyalgia Sever Pharma Solutions has deepened its partnership with Silo Pharma to advance a novel ketamine-based implant designed to treat chronic pain and fibromyalgia. The expanded agreement will see Sever Pharma Solutions scale up extrusion processes and continue analytical testing for Silo’s investigational SP-26 polymer implant. SP-26…
Celltrion’s biosimilar now fully aligned with ACTEMRA IV indications in US Celltrion has received US Food and Drug Administration approval for an expanded indication of AVTOZMA (tocilizumab-anoh) intravenous infusion, now authorised to treat cytokine release syndrome (CRS) in adults and children aged 2 years and older. The decision brings AVTOZMA IV into full alignment with…
New first-line option for patients with pMMR and dMMR tumours in England NICE has recommended KEYTRUDA (pembrolizumab) with carboplatin and paclitaxel chemotherapy as a first-line treatment for adults with untreated primary advanced or recurrent endometrial cancer in England. The decision includes patients with mismatch repair proficient (pMMR) and mismatch repair deficient (dMMR) tumours. Until now,…
FDA validation and AI-designed therapies mark major shift in treatment strategy Porosome Therapeutics has announced major advances in Alzheimer’s disease research, including FDA validation of organoid-based studies and the development of novel Tau-targeting therapies. The company’s platform aims to modify disease progression rather than manage symptoms. Using its “Reprogram, Restore, and Rescue” strategy, Porosome Therapeutics…
New oral GLP-1 agonist aims to reshape chronic weight management Nxera Pharma has launched a broad proprietary pipeline focused on next-generation therapies for obesity and related metabolic conditions. The pipeline is led by a new oral small molecule GLP-1 agonist and six additional programmes targeting GIP, Amylin and Apelin receptors. The company’s approach is designed…
Dydrogesterone-only tablet returns after 17-year absence to support personalised care Gedeon Richter UK has launched Nalvee (10mg dydrogesterone) in the UK, marking the return of a dydrogesterone-only formulation for hormone replacement therapy after more than 17 years. The oral tablet offers clinicians a new progestogen option for non-hysterectomised women receiving oestrogen therapy. Nalvee is a…
New drug delivery system could transform treatment for chronic conditions Scientists at the University of Bath have developed a new technology that could allow protein-based drugs to be taken orally, potentially replacing injections for treatments such as growth hormone, immunotherapy and diabetes medications including Wegovy and Ozempic. Protein-based drugs cannot currently be taken as pills…
MB310 study investigates safety and efficacy of precision microbiome therapy Microbiotica has completed patient recruitment for its phase 1b trial, COMPOSER-1, evaluating MB310 in adults with ulcerative colitis. The study has enrolled 29 patients across sites in the UK, Austria, Bulgaria, Poland and Spain. Initial results are expected by the end of 2025. COMPOSER-1 is…
US$30.9 million strategic equity deal strengthens oncology platform Everest Medicines has announced a strategic equity investment of US$30.9 million in I-Mab, acquiring 15,846,154 newly issued American depositary shares at US$1.95 per share. Following the transaction, Everest will hold approximately 16.1% of I-Mab’s total issued share capital. The investment includes Everest’s existing 6,078,571 ordinary shares in…
Spikevax authorised to target LP.8.1 variant ahead of 2025-2026 season Moderna has received marketing authorisation from the European Commission for its updated COVID-19 vaccine, Spikevax, which targets the SARS-CoV-2 variant LP.8.1. The vaccine is approved for use in individuals aged six months and older. The authorisation follows a positive opinion from the European Medicines Agency’s…
Four-year treatment slows cognitive decline with consistent safety profile Eisai has presented new clinical data showing that patients with early Alzheimer’s disease continue to benefit from four years of treatment with Leqembi (lecanemab). Findings were shared at the Alzheimer’s Association International Conference 2025, held in Toronto and virtually. Results from the Clarity AD open label…
Still time to enter – but not much! Enter The 2025 PharmaTimes Clinical Researcher of the Year – The Americas! Introducing the Clinical Research Associate (CRA) category. With just one week till the 2025 competition closes for entry, you still have time to enter! Enter as a Clinical Trial Manager As the Clinical Trial Manager…
Imfinzi and Imjudo combination recommended as first-line treatment AstraZeneca has received a positive recommendation from NICE for the use of Imfinzi (durvalumab) with Imjudo (tremelimumab) in adults with advanced or unresectable hepatocellular carcinoma (HCC). The decision marks the first NICE approval of a dual immunotherapy for liver cancer in the UK. The recommendation is based…
Alfasigma to seek regulatory approval following OLINGUITO study success Alfasigma has announced positive topline results from its OLINGUITO phase 3 trial evaluating filgotinib in adults with active axial spondyloarthritis (axSpA), including both radiographic and non-radiographic forms. Filgotinib met the primary endpoint, demonstrating efficacy across the full axSpA spectrum. The safety profile was consistent with previous…
CLEAR-DE study to assess topical therapy for non-proliferative diabetic retinopathy Exonate has announced plans to initiate a phase 2b clinical trial of its lead candidate EXN407, a topical SRPK1 inhibitor, for non-proliferative diabetic retinopathy (NPDR). The CLEAR-DE trial is scheduled to begin in early 2026. The study will evaluate efficacy, dosing and safety in 140…
Veranova has appointed Elizabeth Rebeil as VP of Supply Chain Excellence Veranova has appointed Elizabeth Rebeil as Global Vice President of Supply Chain and Operational Excellence. Bringing over 20 years of industry experience, Elizabeth has held senior roles across pharmaceutical, life sciences and manufacturing sectors. She previously served as Vice President of Supply Chain, Procurement and Customer Service at QuVa Pharma.…
CHMP recommends authorization for LP.8.1-targeting vaccine ahead of 2025-2026 season Moderna has received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use for its updated COVID-19 vaccine targeting the SARS-CoV-2 variant LP.8.1. The recommendation supports marketing authorization for use in individuals aged six months and older. A final decision…
Collaboration aims to advance next-generation therapeutics and vaccines Kling Bio has announced a new collaboration and licence option agreement with Sanofi to accelerate the discovery of neutralising antibodies using its proprietary B cell platform, Kling-Select. The partnership will focus on identifying monoclonal antibodies with potent neutralising activity against a clinically relevant human viral pathogen. The…
Akari Therapeutics has reaffirmed its commitment to advancing research on PH1, a novel spliceosome modulator payload used in its antibody drug conjugates (ADCs), which may offer a new approach to treating cancers driven by oncogenic mutations. PH1 modulates RNA splicing to induce cancer cell death and activate the immune system. It generates neoantigens through mis-spliced…
Irish biotech’s germ-free egg platform could help close global shortfall Irish biotech Ovagen has announced a major advance in vaccine manufacturing, with new data showing its germ-free embryonated eggs can produce over 7,600 doses of yellow fever vaccine per egg—18 times more than current industry standards. The study, conducted at the Pirbright Institute in the…
First patient dosed in phase 1b/2a study of procizumab 4TEEN4 Pharmaceuticals has dosed the first patient in a phase 1b/2a trial of procizumab, a monoclonal antibody designed to treat cardiogenic shock by neutralising a key biological driver of the condition. The multicentre PROCARD1 trial will assess safety, dosing and early signs of efficacy in up…
Enter this year’s thrilling competition! Enter The 2025 PharmaTimes Clinical Researcher of the Year – The Americas! Introducing the Clinical Research Associate (CRA) category. With just over two weeks till the 2025 competition closes for entry, you still have time to enter! Enter as a Clinical Trial Manager As the Clinical Trial Manager (CTM), you…
GlueSEEKER enables rational design of targeted protein degraders PhoreMost has published new data validating its GlueSEEKER platform, a high-throughput technology designed to accelerate molecular glue drug discovery. The study outlines a systematic approach to engineering effector proteins, such as E3 ligases, to trigger targeted protein degradation. The paper, released in BioRxiv, details how GlueSEEKER expands…
EC grants conditional marketing authorisation to Merck and SpringWorks Therapeutics The European Commission has approved EZMEKLY (mirdametinib) for treatment of symptomatic, inoperable plexiform neurofibromas in patients with neurofibromatosis type 1 (NF1) aged two and older. It is the first authorised therapy in the EU for both adult and paediatric NF1-PN patients. Merck announced the decision,…
Clinical results from phase 2 study highlight analgesic effects in neuropathic pain patients AlzeCure Pharma will present new clinical data for its drug candidate ACD440 at NeuPSIG 2025, a global pain conference taking place in Berlin from 4 to 6 September. The abstract was accepted for presentation and will be delivered by Dr Märta Segerdal,…
Digital operating rooms and histotripsy therapy combine to improve outcomes Proximie has announced a new partnership with HistoSonics to support the rollout of the Edison Histotripsy System across hospitals and surgical centres in the US, offering a non-invasive treatment option for liver tumours. The collaboration integrates Proximie’s intelligent operating room platform with HistoSonics’ focused ultrasound…
Healthinote rollout aims to improve early detection and patient self-management North East and North Cumbria NHS has begun a year-long rollout of the Healthinote digital health platform to support patients with chronic kidney disease (CKD), a condition affecting one in ten UK adults. The initiative targets early detection and prevention, particularly in deprived areas where…
Funding to accelerate development of AI-driven tumour profiling tool OneMap One Biosciences has secured €15 million in Series A financing to expand its AI-powered single-cell transcriptomic platform, OneMap, aimed at transforming cancer diagnostics and treatment. The round was led by Redmile Group and Blast, with support from Galion.exe, Invus, Adamed Technology, Sofinnova Partners, Polytechnique Ventures…
First patient dosed in BUOY-1 study targeting MDD with or without anxious distress Seaport Therapeutics has dosed the first patient in its phase 2b BUOY-1 trial of GlyphAllo, a novel oral prodrug of allopregnanolone, for major depressive disorder (MDD) with or without anxious distress. GlyphAllo is designed to overcome limitations of allopregnanolone, a molecule known…
Sebetralstat offers injection-free relief for patients aged 12 and over The MHRA has approved sebetralstat (Ekterly) as the first oral, on-demand treatment for hereditary angioedema (HAE) attacks in patients aged 12 and above. Sebetralstat allows patients to treat attacks at the earliest sign of symptoms without injections, offering greater convenience and faster intervention. HAE is…
Vertex’s once-daily triple therapy approved for eligible patients aged six and over Vertex Pharmaceuticals has announced a broad reimbursement agreement with NHS England for ALYFTREK (deutivacaftor/tezacaftor/vanzacaftor), a next-generation treatment for cystic fibrosis (CF). The agreement follows a positive final draft recommendation from NICE and ensures access for all eligible patients in England. ALYFTREK is licensed…
New treatment targets BRAFV600E-mutant mCRC after prior therapy Pierre Fabre Laboratories have received marketing authorisation in China for BRAFTOVI (encorafenib) in combination with cetuximab to treat adult patients with BRAFV600E-mutant metastatic colorectal cancer (mCRC) following prior systemic therapy. The approval is based on results from the phase 3 BEACON CRC trial and the China-based NAUTICAL…
Researchers at Imperial College London have discovered that an unusual DNA structure could be key to reversing chemotherapy resistance in ovarian cancer, one of the deadliest cancers affecting women worldwide. The study, published in Genome Biology, highlights the role of four-stranded DNA formations known as G-quadruplexes in helping cancer cells evade treatment. These structures were…
OVX836 shown to be safe and effective alongside seasonal Fluarix Tetra Osivax has released phase 2a trial data confirming that its broad-spectrum flu vaccine candidate, OVX836, can be safely co-administered with the seasonal inactivated vaccine Fluarix Tetra. The results, now published in Vaccines, show that the combination was well-tolerated with no serious adverse events, and…
New regulations aim to simplify processes and strengthen patient safety The Government is set to amend UK medical devices regulations by adopting EU Common Specifications for high-risk in vitro diagnostic (IVD) devices, including those used for infectious diseases and blood analysis. This change follows strong support for a proposal to repeal the Coronavirus Test Device…
Enter the 2025 PharmaTimes Clinical Researcher of the Year – The Americas Enter The 2025 PharmaTimes Clinical Researcher of the Year – The Americas! Introducing the Clinical Research Associate (CRA) category. Enter as a Novice CRA (less than 18 months of monitoring experience), an Intermediate CRA (18 months to less than 5 years of experience)…
Funding to support lead candidate targeting FAP and pipeline expansion Actithera has secured $75.5 million in an oversubscribed Series A round to support the clinical development of its lead radioligand therapy targeting fibroblast activation protein (FAP) and to expand its drug discovery pipeline. The round was co-led by M Ventures, Hadean Ventures, Sofinnova Partners and…
BX004 achieves 500-fold bacterial reduction with no resistance in phase 1b/2a study BiomX has published promising phase 1b/2a trial results in Nature Communications, demonstrating that its phage cocktail BX004 significantly reduced bacterial levels in patients with cystic fibrosis (CF) and antibiotic-resistant Pseudomonas aeruginosa infections. The study revealed a 2.7 log₁₀, or roughly 500-fold, greater bacterial…
New trial to test VMX-C001’s effectiveness in restoring coagulation in FXa DOAC patients Biotech company VarmX has received clearance from the US FDA to begin a phase 3 trial of its lead candidate, VMX-C001, in patients requiring urgent surgery while on factor Xa direct oral anticoagulants (FXa DOACs). The decision enables the launch of the…
SMC approval provides option for postmenopausal women at risk of fractures The Scottish Medicines Consortium has recommended Eladynos (abaloparatide) for treating osteoporosis in postmenopausal women at very high risk of fracture through the NHS in Scotland, Theramex announced today. Osteoporosis is a condition marked by reduced bone density and tissue degradation, making bones fragile and…
PulseSight begins phase 1 safety study of gene therapy for geographic atrophy PulseSight Therapeutics has announced that the first patient has been dosed in its phase 1 clinical trial evaluating PST-611, a first-in-class non-viral gene therapy for dry age-related macular degeneration (AMD) and geographic atrophy (GA). Dry AMD is the leading cause of central vision…
CSL Behring marks new era in treatment with milestone reimbursement model The first haemophilia B patient in Germany has been treated with the one-time gene therapy HEMGENIX at the Hemophilia Treatment Center at Hannover Medical School, CSL Behring Germany has announced. HEMGENIX® is the first gene therapy of its kind approved in Europe for adults…
Clinigen has appointed Paul Carter as Non-Executive Chair of its Board Clinigen, the global pharmaceutical services Group, has appointed seasoned biopharma executive Paul Carter as Non-Executive Chair of its Board. This move strengthens the Board as Clinigen advances its strategic transformation and expands its role across the full pharmaceutical life cycle. Paul brings nearly 30 years of global…
Pneumagen’s intranasal antiviral demonstrates reduced infection Pneumagen has announced the publication of phase 2 data showing its antiviral therapy, Neumifil, significantly reduced influenza infection and symptoms. The findings appear in the peer-reviewed journal Infectious Diseases and Therapy. Neumifil is a broad-spectrum, intranasal antiviral developed for the prevention and treatment of viral respiratory tract infections. Pneumagen’s…
Enhanced Genomics appoints Dr Dietrich Stephan as Chair of the Board Enhanced Genomics has appointed Dr Dietrich Stephan as Chair of the Board of Directors. In this role, Dietrich will guide strategic initiatives including the expansion of the company’s internal pipeline, initially focused on autoimmune diseases, and the formation of partnerships to accelerate drug discovery and clinical trial stratification.…
Data shows mRNA-1010 could better protect adults aged 50 and above Moderna has reported positive phase 3 results for its seasonal flu vaccine, mRNA-1010, which outperformed a standard-dose licensed influenza vaccine in adults aged 50 and older. The study, known as P304, enrolled over 40,000 participants across 11 countries. The vaccine showed a 26.6% higher…
Closed Loop Medicine has appointed Kate Woolland as CEO Closed Loop Medicine (CLM) has appointed Kate Woolland as Chief Executive Officer. Previously serving as Chief Operating Officer, she will lead the company into a new phase focused on scaling its innovation platform through strategic partnerships and commercialisation of its intellectual property. CLM has built a global IP portfolio…
New data show strong efficacy of CD388 in phase 2b trial Cidara Therapeutics and hVIVO have announced encouraging topline results from a global phase 2b field study evaluating CD388, a drug-Fc conjugate developed as a non-vaccine preventative against seasonal influenza. As part of the trial, 817 healthy participants were recruited and dosed by hVIVO at…
Positive trial results offer hope for those with ultra-rare epileptic disorder UCB has announced that its phase 3 trial evaluating fenfluramine in CDKL5 deficiency disorder (CDD) achieved its primary and key secondary endpoints. The study assessed 87 children and adults aged 1 to 35 with uncontrolled seizures linked to CDD. It evaluated the efficacy, safety,…
Transforming community prescribing through innovation As the NHS places an increasing focus on strengthening primary care and enhancing community-based prescribing, it is up to digital providers to make sure that pharmacists have the tools they need to make their lives easier. CLEO Systems is focused on using the digital prescribing revolution to support pharmacists and…
Why supporting representative trial participation matters
This year’s event took place on 11 to 12 June at Manchester Central This year’s NHS ConfedExpo took place on 11 to 12 June at Manchester Central, bringing together around 9,000 attendees. Among them were over 5,000 health and care leaders, with roughly one in three attendees representing C‑suite roles. The programme featured more than…
VectorY Therapeutics has appointed Jessica Atkinson as Chief Business Officer VectorY Therapeutics has appointed Jessica Atkinson as Chief Business Officer. In this newly created role, she will support the CEO and leadership team in shaping long-term commercial strategy and forging key partnerships. Jessica brings over 20 years’ experience in business development and commercial strategy within biopharma. She has held leadership roles…
Enter this year’s famous competition Enter The 2025 PharmaTimes Clinical Researcher of the Year – The Americas! Introducing the Novice Clinical Research Associate (CRA) category. As a Clinical Research Associate (CRA) working within a Sponsor or CRO company, your role is defined by Good Clinical Practice under ICH/GCP. You perform a variety of clinical operations…
The programme was unveiled at this year’s NHS ConfedExpo in Manchester PMGroup Worldwide and Visions4Health have launched the Excellence in Healthcare Partnerships (EHP) Awards to recognise collaborations that deliver measurable benefits for patients, healthcare organisations and industry partners. The Awards programme was unveiled at this year’s NHS ConfedExpo in Manchester (11 to 12 June), which…
Biocartis has appointed Ben Svarczkopf as Senior Vice President of Global Marketing Biocartis Group of Companies (Biocartis) has announced the appointment of Ben Svarczkopf as its new Senior Vice President (SVP) of Global Marketing. Svarczkopf has over 25 years of experience in clinical laboratory science and joins the molecular diagnostics company from Diasorin Molecular, where…
The pilot will see GP practices look at patient records to identify those most at risk The NHS has announced the launch of a new initiative aimed at identifying pancreatic cancer in its earliest stages. The three-year pilot will see more than 300 GP practices in England look at patient records to identify individuals aged…
Kallikor has appointed Chris Brett as Chief Technology and Product Officer Kallikor has announced the appointment of Chris Brett as its new Chief Technology and Product Officer. Brett holds more than 18 years of experience in developing intelligent automation and simulation systems, and has extensive knowledge of scalable, artificial intelligence-powered technology solutions. He previously held…
Signadori is advancing a platform designed to overcome the challenges of treating solid cancers eXmoor Pharma and Signadori Bio have entered into a partnership aimed at advancing a gene-modified monocyte-derived macrophage cell therapy programme for solid tumours. The collaboration agreement will see eXmoor, an integrated cell and gene therapy contract development and manufacturing organisation, support…
Aravax has appointed Louise Peacock as Chief Regulatory and Quality Officer Aravax has announced the appointment of Louise Peacock as its new Chief Regulatory and Quality Officer. Peacock brings over 35 years of pharmaceutical industry experience to the role, which she takes on after previously serving as Chief Regulatory Affairs and Quality Officer at Vaderis…
The candidate is being evaluated as both a monotherapy and in combination pembrolizumab Teva Pharmaceutical Industries and Shanghai Fosun Pharmaceutical (Fosun Pharma) have announced a strategic partnership focused on developing a drug candidate currently in phase 1 clinical development for various forms of cancer. The alliance, which aims to accelerate clinical data generation, marks a…
iOnctura has appointed Steven Sciuto as Chief Financial Officer iOnctura has announced the appointment Steven Sciuto as its new Chief Financial Officer. Sciuto holds over 15 years of corporate finance leadership and capital markets experience within the life sciences industry. He most recently served as Vice President of Finance at Neurogene, after holding roles of…
Approximately 59,000 LG-IR-NMIBC patients experience recurrent disease every year in the US The US Food and Drug Administration (FDA) has approved UroGen Pharma’s Zusduri (mitomycin intravesical solution) to treat a subset of bladder cancer patients. Zusduri, which is delivered directly into the bladder in an out-patient procedure, is now the first and only medication approved…
Results suggest bispecific antibody combination could improve outcomes A new investigational treatment has shown strong and lasting responses in multiple myeloma patients with extramedullary disease (EMD), a particularly aggressive and difficult-to-treat form of the cancer. Results from the phase 2 RedirecTT-1 study indicate a 78.9 percent overall response rate (ORR) with the combination of TALVEY…
Collaboration aims to improve rapid detection and personalised treatments EDX Medical Group has entered into an agreement with Spire Healthcare Group to advance diagnostic innovations aimed at improving the detection and treatment of major diseases, including cancer, cardiovascular and infectious conditions. EDX Medical is developing a range of ‘super tests’ for prostate, bowel and testicular…
Tozaro has appointed Dr Jason Slingsby as Chief Executive Officer Tozaro has announced the appointment of Dr Jason Slingsby as Chief Executive Officer. Jason will lead the company’s long-term strategy, including commercialisation of its Smart Polymer technology to enhance downstream manufacturing of viral vectors in cell and gene therapy (CGT). A renowned biotech leader, Jason has over 20 years of experience…
Rheumatology studies show promising results for Sjogren’s disease Argenx has presented positive phase 2 results for efgartigimod in myositis and Sjogren’s disease at EULAR 2025. The company also announced the US FDA has granted Fast Track designation for efgartigimod in primary Sjogren’s disease. Data from the ALKIVIA study showed significant improvements in muscle strength and…
EMHA calls for its inclusion in EU neurological health strategy The European Migraine and Headache Alliance (EMHA) has urged EU policymakers to include migraine in the forthcoming Neurological Health Strategy. During a European Parliament event, MEPs, patient advocates and neurologists discussed the disorder’s impact and the need for formal recognition within EU health policy. Migraine…
Biotech firm shares phase 2 findings on novel osteoarthritis treatmen Levicept has presented new data from its phase 2 trial of LEVI-04 at the European Congress of Rheumatology (EULAR 2025). The first-in-class biologic, designed as a non-addictive pain treatment, showed significant and clinically meaningful improvements in knee osteoarthritis patients, including enhanced physical function beyond pain…
Three-year data highlights inflammation control in psoriatic arthritis UCB has announced new three-year data from phase 3 trials and their open-label extensions investigating BIMZELX (bimekizumab) in psoriatic arthritis and axial spondyloarthritis. The results, presented at EULAR 2025, show sustained inflammation control and significant long-term improvements in symptom relief and physical function. In psoriatic arthritis, 53.2%…
Personalisation is the future of cancer care
Biotech firm to collaborate with NHS on early detection study Tagomics has been awarded £860k in funding from Innovate UK’s Biomedical Catalyst programme to develop a novel diagnostic test for colorectal cancer. The grant forms part of a £1.2M project, with additional funding contributed by Tagomics, to customise its Interlace platform for early disease detection.…
Clinigen has appointed Nihad Hasagic as SVP for CLS Clinigen has appointed Nihad Hasagic as Senior Vice President for Clinigen Lifecycle Services (SVP CLS). CLS plays a key role in Clinigen’s growing service portfolio, helping to facilitate accelerated pathways to patients for critical medicines at every stage of their life cycle, even in complex markets. This key appointment is part of…
Enter The 2025 PharmaTimes Clinical Researcher of the Year – The Americas! Enter The 2025 PharmaTimes Clinical Researcher of the Year – The Americas! Introducing the Decentralised Solutions Individual of the Year category. This category is designed to challenge digital and clinical individuals on their understanding of the importance decentralised solutions play in Clinical Research,…
Tozaro has announced the appointment of Dr Jason Slingsby as Chief Executive Officer. Jason will lead the company’s long-term strategy, including commercialisation of its Smart Polymer technology to enhance downstream manufacturing of viral vectors in cell and gene therapy (CGT). A renowned biotech leader, Jason has over 20 years of experience and demonstrated successes in business development, strategic…
New funding supports development of diagnostic platform Birmingham spin-out Linear Diagnostics has secured £1m funding to advance a rapid test for sexually transmitted infections (STIs), working in partnership with the NIHR HealthTech Research Centre (HRC) in Diagnostic and Technology Evaluation and the North East Innovation Lab, part of Newcastle Hospitals. The funding, from the National…
Therapy indicated for children aged 3 to 14 at treatment initiation Santen has announced that the European Commission has granted market authorisation for Ryjunea, a low-dose atropine eye drop (0.1 mg/ml), to slow the progression of paediatric myopia. This approval represents a milestone in childhood eye care and offers a new option for managing myopia…
Treatment provides option for children with growth failure The National Institute for Health and Care Excellence (NICE) has recommended Sogroya (somapacitan injection) for children aged 3 to 17 years with paediatric growth hormone deficiency. The once-weekly treatment, developed by Novo Nordisk, offers an alternative to existing therapies for children experiencing growth failure due to the…
Last month, I had the privilege of hosting a webinar for the National Institute for Health and Care Research (NIHR) on ‘Strategies for Growing Patient Recruitment and Retention through Inclusive Research Design and Delivery’ (watch via the QR code). The discussion reaffirmed something that’s been increasingly clear to many of us working at the intersection…
Richard Condon, CEO Aspire Pharma, discusses successful leadership
Enter The 2025 PharmaTimes Clinical Researcher of the Year – The Americas! Enter The 2025 PharmaTimes Clinical Researcher of the Year – The Americas! Introducing the Clinical Research Co-ordinator category. As a Clinical Research Co-ordinator (CRC) you play an important role in the success of the study. Your primary responsibility, as with all clinical research…
Updated guidance from NICE expands eligibility for dapagliflozin us The National Institute for Health and Care Excellence (NICE) has published updated guidance recommending Forxiga (dapagliflozin) as a treatment option for chronic kidney disease (CKD) in a broader patient population. The decision follows a review of additional clinical data, including real-world evidence and previous trial results,…
New guidance expands treatment options for eligible patients The National Institute for Health and Care Excellence (NICE) has issued final draft guidance recommending mirikizumab (Omvoh) for adults with moderately to severely active Crohn’s disease who have not responded to previous biological treatment or cannot tolerate it. The decision comes less than two months after the…
Worldwide Clinical Trials has appointed Stephen Rayda as Chief Digital and Information Officer Worldwide Clinical Trials has appointed Stephen Rayda as its first Chief Digital and Information Officer, expanding the company’s leadership team to support continued investment in digital transformation. In this newly created role, Rayda will oversee the integration of digital capabilities across the…
The alliance combines Lumanity’s commercial and development strategy capabilities with PICI’s translational research expertise Lumanity and the Parker Institute for Cancer Immunotherapy (PICI) have announced an alliance to accelerate the development and delivery of new cancer immunotherapies. The partnership brings together PICI’s translational research expertise and network of collaborators with Lumanity’s commercial and development strategy…
Global biopharma Eli Lilly will acquire SiteOne Therapeutics, a biotech dedicated to the development of non-opioid medicines to treat pain and other neuronal hyperexcitability disorders, to advance SiteOne’s leading asset STC-004. Lilly will lead STC-004 through phase 2 trials and commercialisation for global markets. In return, SiteOne and its shareholders could receive up to $1bn…
TQ Therapeutics (TQx) has acquired Juno Therapeutics GmbH, the German subsidiary of Juno Therapeutics, through a share purchase agreement. Juno GmbH was previously owned by Bristol Myers Squibb. Financial terms have not been disclosed. The acquisition expands TQx’s access to intellectual property and licensing agreements that will support the development of its decentralised, automated cell…
Company secures regulatory approvals for commercial rollout in UK and US With over 55 million people worldwide living with dementia, Oxford Brain Diagnostics (OBD) is set to revolutionise early diagnosis with its patented Cortical Disarray Measurement (CDM®) technology. The software analyses standard MRI scans to provide an objective measure of neurodegeneration, offering a more precise…
First non-immunosuppressive dual-action therapy approved for eligible patients The National Institute for Health and Care Excellence (NICE) has recommended FILSPARI (sparsentan) for use in the NHS in England as a treatment for primary IgA nephropathy. The decision follows UK regulatory approval and is based on results from the phase 3 PROTECT trial. NICE’s guidance states…
Kelso Pharma has appointed Bee Koen Low as Chief Operating Officer Kelso Pharma has announced the appointment of Bee Koen Low as its first Chief Operating Officer. Low brings more than 20 years of pharmaceutical industry experience to the role, which she takes on after most recently serving as Director of Operations Diligence and Integration…
Strategic collaboration aims to improve early diagnosis Sonrai Analytics and AOA Dx have announced a partnership to accelerate the development of AOA’s multi-omic liquid biopsy test for ovarian cancer. The collaboration will use Sonrai’s AI-powered platform to validate diagnostic biomarkers, improving accuracy and clinical utility. AOA will integrate Sonrai’s cloud-based analytics platform to analyse multi-modal…
The Board of the Medicines and Healthcare products Regulatory Agency (MHRA) has met in Scotland for the first time, marking a significant step in the agency’s approach to delivering health and innovation priorities across the UK. Held at the Royal College of Surgeons in Edinburgh, the world’s oldest surgical college, the meeting gathered key figures…
The drug was recently approved in the US for familial chylomicronaemia syndrome Ionis Pharmaceuticals has shared positive top-line results from a late-stage study of olezarsen in hypertriglyceridaemia. The phase 3 Essence trial, conducted with Ionis’ research partner the TIMI Study Group, has been evaluating the RNA-targeted drug in adults aged 18 years and older with…
Veranova has appointed Elizabeth Rebeil as Global Vice President of Supply Chain and Operational Excellence Veranova has announced the appointment of Elizabeth Rebeil as its new Global Vice President of Supply Chain and Operational Excellence. Rebeil brings extensive experience in supply chain management to the role, which she takes on after most recently serving as…
Brekiya is now the first DHE auto-injector to be approved by the regulator The US Food and Drug Administration (FDA) has approved Amneal Pharmaceuticals’ Brekiya (dihydroergotamine mesylate) injection to treat acute migraine and cluster headaches in adults. The therapy, which is expected to be available for eligible patients in the second half of 2025, is…
Biotech spin-off targets fibrosis, neoplasm and neovascularization Massalia Therapeutics, a biotechnology spin-off from the C2VN Institute, has officially launched with a mission to develop innovative treatments for patients with fibrotic, neoplastic and neovascularized conditions. The company’s sole-in-class therapeutic platform bridges the intersection of these diseases, offering a new approach to tackling their complex interactions. Co-founded…
Regulator confirms safety and efficacy of new treatment option for patient The Medicines and Healthcare products Regulatory Agency (MHRA) has approved guselkumab (Tremfya) for the treatment of Crohn’s disease and ulcerative colitis (UC). Already used for plaque psoriasis and psoriatic arthritis, guselkumab has shown efficacy in adults with moderately to severely active Crohn’s disease and…
Aspire-FTD study aims to stop disease progression with one-time treatment AviadoBio has launched its phase 1/2 Aspire-FTD trial in the UK, assessing AVB-101, a gene therapy targeting frontotemporal dementia (FTD) with GRN mutations (FTD-GRN). Cambridge University Hospitals NHS Foundation Trust (CUH) has begun recruiting patients, with University College London (UCL) expected to follow. The Advanced…
Asgard Therapeutics has appointed Shane Olwill as Chief Development Officer Asgard Therapeutics, a privately held biotech company pioneering in vivo direct cell reprogramming for cancer immunotherapy, has announced the appointment of experienced immunology drug development specialist Shane Olwill as Chief Development Officer (CDO). Shane, who joins Asgard from Pieris Pharmaceuticals, now merged with NASDAQ-listed Palvella Therapeutics, will lead IND-enabling…
FDA recognises KER-0193 as a potential therapy for rare paediatric disease Kaerus Bioscience has received orphan drug and rare paediatric drug designations from the FDA for KER-0193, its lead candidate targeting fragile x syndrome (FXS). The announcement follows a successful phase 1 trial confirming the drug’s safety and promising pharmacokinetics. FXS is the most common…
Trial progresses towards topline data expected later in the year Herantis Pharma has dosed the first patients in the final cohort of its phase 1b clinical trial assessing HER-096, a disease-modifying treatment for Parkinson’s disease. The study aims to evaluate the drug’s safety, tolerability and pharmacokinetics while exploring biomarkers linked to the condition. HER-096 is…
Screening begins for study evaluating LTI-03 in idiopathic pulmonary fibrosi Rein Therapeutics has begun screening and recruiting patients for its renew phase 2 trial, assessing LTI-03 as a potential treatment for idiopathic pulmonary fibrosis (IPF). The study will enrol up to 120 patients across 50 global sites, with topline results expected in the first half…
Ellab has appointed Gergely Sved as its new Chief Executive Officer Ellab, the provider of validation, monitoring and calibration services and solutions, has appointed Gergely Sved as its new Chief Executive Officer (CEO), following the departure of Ludvig Enlund. Gergely is a highly experienced healthcare and life sciences executive. Most recently, he served as Executive Vice President and Group…
Private equity firm Apiary Capital backs rapid growth of performance-i Apiary Capital has completed its investment in performance-io (PIO), a leading life sciences performance marketing and search engine optimization agency, supporting its international expansion and service growth. London-based PIO employs more than 60 people globally, with teams across the UK, US, India, Japan and South…
Fiona Smith-Laittan has been appointed Chair of Cambridge Global Health Partnerships Fiona Smith-Laittan, Vice President of Global Health Strategy and Partnerships at GlaxoSmithKline (GSK), has been appointed Chair of Cambridge Global Health Partnerships (CGHP). Fiona, who has led GSK’s Global Health Strategy and Partnerships team since 2019, said: “CGHP’s purpose, strategy and activity is aligned…
Study explores whether PI3Kδ targeting could combat resistance iOnctura has begun a randomized phase 1/2 study investigating its lead asset, roginolisib, in combination with dostarlimab, with or without docetaxel, in advanced non-small cell lung cancer (NSCLC). The first patient has been dosed in the study, which aims to evaluate the safety of the drug combination…
Teprotumumab approved as first targeted treatment for thyroid eye disease The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorisation for Amgen’s Tepezza (teprotumumab) as the first licensed treatment for adults with moderate-to-severe thyroid eye disease (TED). TED affects around 50,000 people in the UK, causing eye bulging, double vision, pain and…
Demonstrate your skill and prowess by entering this year’s awards! For 2025, The 2025 PharmaTimes Clinical Researcher of the Year – The Americas Awards are excited to introduce a new category, Clinical Trial Administrator. This category is designed to assess the required skills and competencies to be an organised and competent Clinical Trial Administrator (CTA).…
UCB’s developmental treatment may be eligible for patient access UCB has announced that its developmental treatment DoxTM, a combination of doxecitine and doxribtimine, has been granted Promising Innovative Medicine (PIM) designation by the Medicines and Healthcare Products Regulatory Agency (MHRA) in the UK. TK2d is a rare genetic disorder caused by a mutation in the…
Company seeks approval for new schedules to improve patient convenience Janssen-Cilag International NV, a Johnson & Johnson company, has submitted an application to the European Medicines Agency (EMA) to extend the marketing authorisation for RYBREVANT (amivantamab) with additional subcutaneous dosing regimens. The application includes an every-three-week (Q3W) amivantamab regimen in combination with carboplatin and pemetrexed.…
New initiative aims to accelerate diagnosis and ease NHS pressures Chiesi UK and Ireland and Wirral Primary Care Collaborative (WPCC) have launched COMET, a programme designed to enhance early diagnosis and management of chronic obstructive pulmonary disease (COPD) in the Wirral. COPD is a leading cause of emergency hospital admissions, with an estimated 5,000 people…
Cambridge firm in-licenses two oncology programmes Mosaic Therapeutics a UK-based oncology company has announced it has in-licensed two clinical-stage oncology programmes from Astex Pharmaceuticals. The agreement transforms Mosaic from a research-focused entity into a clinical-stage business. Mosaic intends to develop proprietary combination therapies using these assets guided by its own biomarkers. As part of the…
Approval marks milestone for AI use in frontline care NICE has endorsed DERM, an autonomous AI medical device developed by Skin Analytics, for detecting skin cancer. This recognition marks a major step in using AI to free up clinician capacity and improve patient outcomes across the NHS. NICE reviewed various technologies and recommended DERM as…
Application seeks reduced infusion frequency to support patient flexibility Eisai Europe and Biogen Idec have announced the validation of a Marketing Authorisation Variation by the Medicines and Healthcare products Regulatory Agency (MHRA) for lecanemab – marketed as Leqembi®, in the UK. The proposal aims to reduce the intravenous (IV) dosing frequency from every two weeks…
Study paves the way for personalised therapies for osteoarthritis sufferer Groundbreaking research has identified over 900 genetic links to osteoarthritis, including 500 previously undiscovered, in a study involving Sheffield Teaching Hospitals NHS Foundation Trust. Published in the Nature journal, the research represents the largest genome-wide association study ever conducted on osteoarthritis. Using genetic data from…
New therapy offers hope for patients with limited option Regeneron Pharmaceuticals has announced that the European Commission has conditionally approved Lynozyfic (linvoseltamab) for adults with relapsed and refractory multiple myeloma. This approval targets patients who have undergone at least three prior treatments and whose disease has progressed. Lynozyfic is a bispecific antibody that activates T…
Today’s leaders are building a stronger, more inclusive future for the industry
CHMP recommendation brings new hope for patients Takeda has announced a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) recommending European Commission (EC) approval of Adcetris (brentuximab vedotin) in combination with the BrECADD chemotherapy regimen for adults with newly diagnosed stage IIb with risk factors, stage III, or stage IV Hodgkin…
Aspire Pharma has appointed Katharina Pink as Chief Commercial Officer Aspire Pharma has announced the appointment of Katharina Pink as Chief Commercial Officer and Managing Director, Germany (GmbH). Katharina has joined Aspire during a period of significant growth and geographic expansion for the company and will play an important role in delivering Aspire’s strategy and…
VYVGART could be the first CIDP drug with a novel mechanism in 30 years Argenx has announced that the Committee for Medicinal Products for Human Use (CHMP) has recommended European Commission (EC) approval for VYVGART (efgartigimod alfa) as a subcutaneous treatment for adults with progressive or relapsing chronic inflammatory demyelinating polyneuropathy (CIDP). The recommendation is…
Kymera Therapeutics has appointed Noah Goodman as Chief Business Officer Clinical-stage biopharma Kymera Therapeutics has announced the appointment Noah Goodman as its new Chief Business Officer. Goodman brings extensive life sciences industry experience to the role, which he takes on after serving as President and Chief Business Officer of Chroma Medicine and nChroma Bio. Prior…
The university has been awarded a £1m grant from LifeArc and Muscular Dystrophy UK Researchers from University College London (UCL) are aiming to develop potential treatments for congenital muscular dystrophy (CMD) after being awarded a £1m grant from LifeArc and Muscular Dystrophy UK. CMD encompasses a group of inherited muscle diseases that are usually present…
MHRA authorises drug for adults with rare heart muscle damage The Medicines and Healthcare products Regulatory Agency (MHRA) has given the green light to acoramidis (Beyonttra) for adult patients suffering from cardiomyopathy caused by variant or wild-type transthyretin amyloidosis (ATTR-CM). The approval follows a fast-track process after the European Medicines Agency (EMA) gave its nod…
Mosaic Therapeutics a UK-based oncology company has announced it has in-licensed two clinical-stage oncology programmes from Astex Pharmaceuticals. The agreement transforms Mosaic from a research-focused entity into a clinical-stage business. Mosaic intends to develop proprietary combination therapies using these assets guided by its own biomarkers. As part of the deal Astex has acquired a 19%…
Where to purchase reliable pharmacy automation systems Technological advancements propel the pharmaceutical industry into the future. Better equipment makes it easier to fulfill your job as an industry expert while customers get better service. Automation will continue revolutionising accuracy, efficiency and safety measures, but only if you know where to find the leading options. Learning…
Terumo BCT has appointed Patrick Daly as Chief Business Officer Terumo Blood and Cell Technologies (Terumo BCT) has announced the appointment of Patrick Daly as its Chief Business Officer. Daly joins the medical technology company with more than three decades of business and healthcare industry experience. He takes on the role after building the MedTech…
It is hoped that the MAGIC-I study will support earlier diagnosis and personalised treatment A five-year clinical study aiming to optimise childhood cancer care in Ireland has been launched. MAGIC-I, or Molecular and Genomic Interrogation of Childhood Cancer – Ireland, is focused on better understanding how and why cancer develops, and why outcomes and side…
ABPI has appointed Russell Abberley as President-elect The Association of the British Pharmaceutical Industry (ABPI) has appointed Russell Abberley, Vice President and General Manager of Amgen UK and Ireland, as President-elect. Abberley has been serving as Acting ABPI President since September and will formally take up the Presidency on 13 May for a period of…
The SHIELD-Utah study compared Novavax’s vaccine to the Pfizer/BioNTech mRNA 2024-2025 vaccine Novavax has shared positive preliminary results from a real-world study of its JN.1-adapted COVID-19 vaccine. The SHIELD-Utah study has been comparing Novavax’s non-mRNA COVID-19 vaccine, adjuvanted (2024 to 2025 formula) against Pfizer/BioNTech mRNA 2024 to 2025 vaccine in healthcare workers and first responders.…
Oncodesign Services has appointed Aidan Synnott as CEO Oncodesign Services has announced the appointment of Aidan Synnott as its new Chief Executive Officer (CEO). Synnott has more than two decades of experience in biomedical research, as well as extensive knowledge in global contract research organisation operations and management. He most recently served as Corporate Vice…
More than 37 million adults in the US are affected by migraine The US Food and Drug Administration (FDA) has approved Click Therapeutics’ CT-132 as the first prescription digital therapeutic for the prevention of episodic migraine. CT-132, which can now be prescribed for patients aged 18 years and older, is intended for adjunctive use alongside…
New real-world data reinforce treatment benefit Real-world data from the University of Catania, Italy, suggest that Pepaxti, a treatment for relapsed, refractory multiple myeloma (RRMM), is effective and well tolerated in heavily pretreated patients. The retrospective analysis included eight triple-class refractory RRMM patients who had received a median of 3.5 prior lines of therapy. Some…
European Commission grants authorisation for Eisai and Biogen therapy The European Commission has granted marketing authorisation for Leqembi (lecanemab), making it the first therapy in the EU to slow the progression of early Alzheimer’s disease. Lecanemab is indicated for adults with mild cognitive impairment or mild dementia due to Alzheimer’s who are apolipoprotein E ε4…
Studies show improved bone mineral density and healthcare cost reductions New data from multiple countries confirm the effectiveness of romosozumab, the dual-acting osteoporosis treatment that increases bone formation and decreases bone resorption. Findings were presented at WCO-IOF-ESCEO 2025 in Rome. A systematic literature review identified 362 records from 67 studies across 10 countries. Results showed…
Long-term survival projections suggest improved outcomes for patients New data from Janssen-Cilag International NV suggest that subcutaneous DARZALEX (daratumumab) quadruplet therapy could offer a longer progression free survival for patients with newly diagnosed multiple myeloma. Findings were presented at the 6th European Myeloma Network meeting in Athens. Analysis based on the PERSEUS and CEPHEUS trials…
Birmingham researchers to make MGUS monitoring more efficient Birmingham researchers have received £230k from Cancer Research Horizons to develop a prototype test for monitoring people with MGUS (monoclonal gammopathy of unknown significance), a precursor to blood cancer multiple myeloma. Approximately 6,000 people in the UK are diagnosed with myeloma annually. MGUS affects patients with abnormal…
Major update aims to accelerate research and strengthen patient safety New UK clinical trials regulations have been signed into law, with a 12-month rollout starting 11 April. The reforms mark the most significant update in 20 years, aiming to enhance participant safety, expedite approvals, foster innovation, and increase opportunities for people to engage in vital…
The model could lead to more targeted treatments for the disease Cancer Research scientists have developed a new cell-based model of lung squamous cell carcinoma (LUSC), a type of lung cancer, which has the potential to develop more effective treatments for the disease as well as other cancers. Conducted at the Cancer Research Manchester Institute,…
Johnson & Johnson’s Balversa was found to extend the lives of urothelial cancer patients with a genetic alteration Balversa (erdafitinib) has been recommended for use on the NHS as the first and only treatment in the UK for urothelial cancer (UC) involving a fibroblast growth factor receptor (FGFR3) alteration, which affects up to one in…
AI-powered SkyMind is designed to improve efficiency, compliance and decision-making SkyCell has partnered with Microsoft to launch SkyMind, an artificial intelligence (AI)-powered solution designed to enhance pharmaceutical supply chains by improving efficiency, compliance and decision-making. Powered by Azure OpenAI Service and integrated directly into Microsoft Teams and Copilot, SkyMind marks a step forward in the…
An estimated 7.5 million people will be invited to receive the booster The NHS has started delivering its spring COVID-19 vaccine booster to vulnerable individuals across England, with over half a million appointments already booked as of 1 April. Starting from 1 April, eligible groups are being offered an additional dose to increase protection against…
Approximately 55,100 new cases of prostate cancer are diagnosed every year in the UK The Medicines and Healthcare products Regulatory Agency (MHRA) has approved the prostate cancer imaging agent trofolastat (RoTecPSMA). The regulator’s decision makes trofolastat the first prostate-specific membrane antigen (PSMA)-targeting product approved alongside the radioactive tracer technetium-99m to detect cancerous lesions in men…
Angelini Ventures has appointed Regina Hodits as managing director Angelini Ventures has announced the appointment of Regina Hodits as its new managing director. Hodits holds more than two decades of experience in venture capital, company creation and strategic exits across the biotechnology sector. She joins Angelini from Wellington Partners, where she served as managing director…
The Scottish Medicines Consortium (SMC) has approved bimekizumab for adults with active moderate to severe hidradenitis suppurativa (HS) who have not responded to conventional systemic therapies. This approval makes Scotland the first country in the UK to offer bimekizumab for HS patients. HS is a chronic inflammatory skin condition affecting 0.77% of the UK population.…
Research targets lysosomal function restoration for neurodegeneration Endlyz Therapeutics has launched from stealth, unveiling its pipeline of small molecule modulators designed to restore lysosomal function in Parkinson’s disease (PD) and other neurodegenerative conditions. The company also announced a $2.2 million grant from the Michael J. Fox Foundation for Parkinson’s Research and a collaboration with Prof.…
Women are shaping new dimensions throughout industry Having women in the pharmaceutical industry is crucial because it brings diverse perspectives and experiences. It also leads to better healthcare solutions for women, particularly when addressing conditions that disproportionately affect them. Furthermore, including women promotes gender equity in research and decision-making, while also improving a company’s bottom…
Collaboration introduces automation to enhance efficiency Elekta has announced a partnership with Azra AI to improve cancer registry workflows using AI-powered automation. Combining Elekta’s next-generation software with Azra AI’s oncology workflow tools, this collaboration aims to streamline data management and ensure compliance with international standards. Elekta ONE Registry Informatics, hosted on Axis Cloud, offers secure…
Approval extends ustekinumab’s use to younger patients The European Commission (EC) has approved ustekinumab for the treatment of moderately to severely active Crohn’s disease in paediatric patients weighing at least 40 kg. The decision follows evidence of efficacy and safety in patients who did not respond to conventional or biologic therapies. Crohn’s disease, while commonly…
Advancing care for stage 3 or 4 Hodgkin lymphoma patients The National Institute for Health and Care Excellence (NICE) has recommended brentuximab vedotin combined with doxorubicin, vinblastine and dacarbazine (AVD) to treat adult patients with untreated stage 3 or 4 CD30+ Hodgkin lymphoma. The decision is based on findings from the phase 3 ECHELON-1 trial,…
GMP certification enables 4basebio to supply DNA for clinical trials 4basebio PLC has been granted Good Manufacturing Practice (GMP) certification by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA). This licence authorises the supply of GMP-grade synthetic DNA to support clinical programs in cell and gene therapy and vaccine development. The Cambridge-based company’s proprietary…
Women in healthcare and pharma – progress, challenges and outcomes
Are biotechs underestimating regulatory groundwork
Collaboration expands AI-based risk profiling tools Diagnexia has announced a partnership with Stratipath AB to bring Stratipath Breast, an AI-based prognostic risk profiling tool, to healthcare providers across the UK and Europe. This collaboration integrates Stratipath’s technology with Diagnexia’s digital pathology network, providing faster, more precise cancer diagnostics. The partnership aims to improve decision-making for…
When Integrated DNA Technologies (IDT) launched its Collab Network in February 2023, the goal was to speed up the pace of genomics innovation through collaboration. We strongly believed that bringing researchers and industry leaders together to foster learning and teamwork would yield innovations that members of this network might not have achieved on their own…
The vital link between human and animal well-being The next pandemic will require crucial collaboration between veterinarians and medical professionals. Are we ready? Many experts believe that the ‘next global pandemic’ is not a case of if, but when.Factors such as increased urbanisation and travel, reduced biodiversity, and the heat, drought and floods caused by…
Janssen drug combination extends life expectancy during trial Janssen-Cilag International NV has announced results from the phase 3 MARIPOSA study, demonstrating a significant overall survival benefit for patients with EGFR-mutated advanced non-small cell lung cancer (NSCLC). The study compared Rybrevant (amivantamab) plus Lazcluze (lazertinib) to osimertinib as a first-line treatment. The data, presented at the…
New therapy developed to repair GJB2 R75W mutation Scientists from Juntendo University and The University of Tokyo have created an adeno-associated virus (AAV)-based genome editing approach to treat genetic hearing loss caused by the GJB2 R75W mutation. Their findings, published in JCI Insight, demonstrate the potential of this innovative therapy. Hearing loss, when caused by…
NOUS-209 shows potential to intercept cancer in its early stages Nouscom has announced full safety and immunogenicity results from its phase 1b/2 trial of NOUS-209, an off-the-shelf immunotherapy for Lynch Syndrome (LS). These findings will be shared in an oral presentation at the American Academy of Cancer Research (AACR) Annual Meeting in Chicago this April.…
Drug Safety Research Unit appoints Linda Härmark as its Director The Drug Safety Research Unit has announced Linda Härmark as its new Director. She succeeds Professor Saad Shakir who officially steps down from the position after 26 years. Linda joins the DSRU, which is based in Southampton, from the Netherlands Pharmacovigilance Centre, Lareb, where she has been Deputy Director for…