Bluejay begins phase 3 trial of brelovitug for hepatitis D
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…
Quotient Sciences and CPI launch RNA drug development venture
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…
Eisai unveils promising phase 1b data for narcolepsy drug E2086
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…
Sharon Curran – PharmaTimes
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…
Resolution Therapeutics doses first patient in EMERALD study of RTX001
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…
AlzeCure presents phase 2 data on ACD440 at NeuPSIG 2025
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…
eXmoor and Anthony Nolan partner to streamline cell therapy development
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…
Polpharma Biologics and MS Pharma partner to expand biosimilar access
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…
Lilly receives UK approval for pirtobrutinib in relapsed blood cancers
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…
FDA approves LEQEMBI IQLIK for maintenance dosing in early Alzheimer’s disease
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…
Coya Therapeutics to progress trial of ALS treatment upon FDA approval
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…
Akiram advances trial of targeted radiotherapy for solid tumours
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…
Johnny Cheng appointed as interim CEO of HUTCHMED
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…
Encare’s ERAS system gains Mayo Clinic qualification, strengthening global reach
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….
Anne White to retire as head of Lilly Neuroscience after three decades at company
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…
Novartis blood disorder drug shows promise in late-stage trial
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…
Fertile ground – PharmaTimes
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…
Friends of Cancer Research and MMS partner to improve interpretation of cancer trial survival data
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…
ANGLE partners with Myriad Genetics to explore blood-based cancer testing
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…
FDA grants Breakthrough Therapy Designation to lung cancer therapy
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…
Upperton Pharma Solutions awarded grant to develop oral vaccine delivery with University of Oxford
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…
Upperton and Oxford join forces to develop oral vaccine formulation
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…
Ogsiveo approved in EU for treatment of desmoid tumors
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…
Lilly and UK Government launch £85 million obesity care innovation programme
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…
Mounjaro shows cardiovascular benefit in head-to-head diabetes trial
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…
Vedanta’s ulcerative colitis candidate misses phase 2 efficacy target
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…
Genmab’s epcoritamab combination meets key endpoints in phase 3 lymphoma trial
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,…
FDA approves AJOVY for paediatric migraine prevention
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….
Lilly’s Jaypirca shows positive results in phase 3 trial
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,…
Scotland approves zanubrutinib for relapsed mantle cell lymphoma
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)….
Sever Pharma expands work on ketamine implant with Silo Pharma
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…
FDA expands AVTOZMA IV approval to include cytokine release syndrome
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…
NICE backs KEYTRUDA combination for advanced endometrial cancer
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…
Porosome Therapeutics unveils breakthrough Alzheimer’s research
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…
Nxera unveils proprietary pipeline targeting obesity and metabolic disorders
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…
Gedeon Richter launches Nalvee in UK to expand HRT options for menopause
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…
Bath researchers develop pill-based alternative to injections
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…
Microbiotica completes recruitment for phase 1b ulcerative colitis trial
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,…
US$30.9 million strategic equity deal strengthens Everest’s oncology platform
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%…
Moderna wins EU approval for updated COVID-19 vaccine
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…
Eisai data shows sustained benefit of lecanemab in early Alzheimer’s disease
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…
NICE backs AstraZeneca’s dual immunotherapy for advanced liver cancer
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…
Filgotinib meets phase 3 endpoint in axial spondyloarthritis trial
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…
PharmaTimes Clinical Researcher of the Year – The Americas
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…
Exonate to launch phase 2b trial of EXN407 for diabetic eye disease
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…
Elizabeth Rebeil – PharmaTimes
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…
Moderna’s updated COVID-19 vaccine receives positive EMA opinion
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…
Kling Bio partners with Sanofi to accelerate antibody discovery
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…
Akari Therapeutics advances research on novel PH1 payload for targeted cancer therapy
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…
Ovagen breakthrough boosts yellow fever vaccine yields
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…
4TEEN4 begins trial of antibody therapy for cardiogenic shock
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….
PharmaTimes Clinical Researcher of the Year – The Americas
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…
PhoreMost unveils platform to streamline molecular glue drug discovery
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…
Ezmekly becomes first approved EU therapy for NF1-PN in children and adults
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…
AlzeCure to present promising pain therapy ACD440 at NeuPSIG 2025
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…
One Biosciences raises €15 million to advance single-cell oncology platform
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…
Seaport Therapeutics begins phase 2b trial of GlyphAllo for major depression
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…
Proximie and HistoSonics partner to transform liver tumour treatment in US
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…
North East NHS launches digital platform to tackle chronic kidney disease
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…
MHRA approves first oral treatment for hereditary angioedema attacks
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…
NHS England secures access to new cystic fibrosis treatment ALYFTREK
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…
Imperial study reveals DNA structure that could reverse ovarian cancer resistance
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…
Pierre Fabre secures China approval for BRAFTOVI combination in colorectal cancer
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…
Osivax publishes phase 2a results supporting dual flu vaccine approach
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…
Government to adopt EU standards for high-risk diagnostic devices
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…
Actithera closes $75.5m Series A to advance radioligand therapy platform
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…
BiomX phage therapy shows potent effect in cystic fibrosis trial
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…
Clinical Researcher of the Year – The Americas
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…
VarmX secures US approval to begin phase 3 trial of urgent surgery treatment
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…
Eladynos recommended for osteoporosis treatment in Scottish NHS
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…
First patient dosed in trial for novel dry AMD treatment PST-611
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…
First German haemophilia B patient receives gene therapy HEMGENIX
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…
Paul Carter – PharmaTimes
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…
Neumifil shows promise in treating influenza with positive phase 2 dat
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…
Dr Dietrich Stephan – PharmaTimes
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…
Moderna flu vaccine shows superior results in phase 3 study
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…
Kate Woolland – PharmaTimes
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…
Cidara and hVIVO report positive results in flu prevention study
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….
UCB reports success in phase 3 study of fenfluramine for CDD
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…
Future prescribed – PharmaTimes
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…
NHS ConfedExpo 2025: a platform for change in UK health and care
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…
Jessica Atkinson – PharmaTimes
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…
2025 PharmaTimes Clinical Researcher of the Year
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…
Excellence in Healthcare Partnerships Awards launched by PMGroup and Visions4Health
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…
Ben Svarczkopf – PharmaTimes
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…
NHS rolls out new initiative to identify pancreatic cancer earlier
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…
Chris Brett – PharmaTimes
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…
eXmoor and Signadori Bio enter cell therapy partnership
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…
Louise Peacock – PharmaTimes
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…
Teva and Fosun Pharma partner on early-stage oncology drug
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…
Steven Sciuto – PharmaTimes
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….
FDA approves UroGen’s Zusduri to treat recurrent bladder cancer
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…
Investigational treatment shows promise for aggressive multiple myeloma
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…
EDX medical partners with spire healthcare to advance disease diagnostics
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…
Dr Jason Slingsby – PharmaTimes
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…
Argenx presents new efgartigimod data at EULAR 2025
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…
Migraine takes the spotlight at European Parliament
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…
Levicept presents new LEVI-04 data at EULAR
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…
Bimekizumab shows lasting efficacy at EULAR 2025
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…
Tagomics secures £860k grant for colorectal cancer test
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,…
Nihad Hasagic – PharmaTimes
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…
PharmaTimes Clinical Researcher of the Year – The Americas
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…
Dr Jason Slingsby – PharmaTimes
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…
Linear Diagnostics awarded £1m to develop rapid STI test
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…
EC approves Santen’s Ryjunea to slow progression of paediatric myopia
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…
NICE recommends Sogroya for growth hormone deficiency in children
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…
Patient puzzle – PharmaTimes
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…
PharmaTimes Clinical Researcher of the Year – The Americas
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…
AstraZeneca’s Forxiga recommended for chronic kidney disease treatment
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…
NICE recommends mirikizumab for Crohn’s disease treatment
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…
Stephen Rayda – PharmaTimes
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….
Lumanity and Parker Institute partner to support delivery of new immunotherapies
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…
Eli Lilly acquires SiteOne Therapeutics to advance treatment for chronic pain
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…
TQ Therapeutics acquires Juno GmbH to support decentralised cell therapy platform
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…
Oxford Brain Diagnostics to launch groundbreaking dementia diagnosis technology
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…
NICE recommends sparsentan for IgA nephropathy
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…
Sonrai and AOA Dx partner to accelerate ovarian cancer test development
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,…
MHRA Board meets in Scotland for first time, reinforcing UK-wide health priorities
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…
Bee Koen Low – PharmaTimes
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,…
Ionis shares phase 3 results for olezarsen in moderate hypertriglyceridaemia
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…
Elizabeth Rebeil – PharmaTimes
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…
FDA approves Amneal’s self-administered migraine drug Brekiya
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…
Massalia Therapeutics launches to advance novel treatments for complex conditions
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…
MHRA approves guselkumab for Crohn’s disease and ulcerative colitis
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…
AviadoBio opens UK trial for FTD gene therapy
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…
Shane Olwill – PharmaTimes
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,…
Kaerus Bioscience secures orphan drug designation for fragile x syndrome treatment
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…
Herantis Pharma doses final cohort in phase 1b trial of HER-096 for Parkinson’s disease
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…
Rein Therapeutics initiates renew phase 2 trial for IPF treatment
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…
Gergely Sved – PharmaTimes
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…
Apiary invests in life sciences marketing specialist performance-io
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…
Fiona Smith-Laittan – PharmaTimes
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…
iOnctura starts randomised phase 1/2 trial in lung cancer treatment
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…
Amgen’s Tepezza granted marketing authorisation in the UK
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)….
PharmaTimes Clinical Researcher of the Year – The Americas Awards
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…
MHRA grants Promising Innovative Medicine designation to UCB’s DoxTM for TK2d
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)…
Johnson & Johnson submits application for subcutaneous Rybrevant dosing
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…
Chiesi partners with Wirral Primary Care to improve COPD detection
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…
Mosaic therapeutics expands pipeline with Astex deal
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…
Nice recommends first AI medical device for skin cancer diagnosis in the NHS
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…
Leqembi dosing proposal for Alzheimer’s treatment validated by MHRA
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…
Hundreds of genetic links to osteoarthritis unlocked
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…
Lynozyfic receives EU approval for relapsed multiple myeloma treatment
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…
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Takeda’s Adcetris receives positive opinion for Hodgkin lymphoma treatment
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…
Katharina Pink – PharmaTimes
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…
Argenx receives positive CHMP opinion for CIDP treatment
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…
Noah Goodman – PharmaTimes
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…
UCL researchers launch congenital muscular dystrophy research programme
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…
Acoramidis approved for heart condition treatment
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)….
Mosaic therapeutics expands pipeline with Astex deal
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…
All systems go! – PharmaTimes
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…
Patrick Daly – PharmaTimes
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…
Genomics study launches to optimise childhood cancer care in Ireland
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,…
Russell Abberley – PharmaTimes
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…
Novavax shares positive real-world results for JN.1-adapted COVID-19 vaccine
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…
Aidan Synnott – PharmaTimes
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…
FDA approves Click’s digital therapeutic for episodic migraine
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…
Pepaxti shows effectiveness in heavily pretreated multiple myeloma patients
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…
Leqembi approved as first treatment to slow early Alzheimer’s progression
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…
Global data highlights effectiveness of romosozumab
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….
New data reinforce daratumumab as standard of care for multiple myeloma
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…
New test prototype for monitoring MGUS patients funded
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…
UK clinical trials regulations signed into law
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…
Lab-grown lung cancer cells show potential to revolutionise treatment
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…
First treatment for common bladder cancer recommended by NICE
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…
SkyCell and Microsoft partner to improve pharma supply chains
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…
NHS launches spring COVID-19 booster campaign
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…
Regina Hodits – PharmaTimes
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…
MHRA approves prostate cancer imaging agent trofolastat
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…
SMC approves bimekizumab for hidradenitis suppurativa treatment
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…
Endlyz Therapeutics emerges with pipeline for Parkinson’s disease
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…
Aspire and inspire – PharmaTimes
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,…
Elekta and Azra AI partner to advance cancer registry operations with AI
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…
European Commission approves ustekinumab for paediatric Crohn’s disease
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…
NICE recommends brentuximab vedotin plus AVD for Hodgkin lymphoma
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…
4basebio receives MHRA licence for synthetic DNA manufacture
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…
Diagnexia and Stratipath link up brings AI breast cancer diagnostics to UK
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…
One Health – PharmaTimes
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…
Gene team – PharmaTimes
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…
Amivantamab plus lazertinib shows survival benefit in lung cancer
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…
Genome editing offers hope for genetic hearing loss
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…
Nouscom reveals promising results for lynch syndrome immunotherapy
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…
Linda Härmark – PharmaTimes
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…
Kieron Hall – PharmaTimes
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…
Seth Benson – PharmaTimes
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…
Elizabeth Holt – PharmaTimes
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…
WHO adds first maternal RSV vaccine to prequalification list
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…
Careology and Entia join forces to transform cancer care
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….
Head start – PharmaTimes
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…
Manjunath Ramarao – PharmaTimes
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…
UK expands mandatory infectious disease reporting requirements
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….
Jonas Bolander – PharmaTimes
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…