Latest Pharma and Biotech News
Biotechnology
19 May 2025 Adopting a platform approach to designing new therapies will speed the delivery of innovative genomic treatments to patients—but only if developers, regulators, and manufacturers work together to evolve the current drug development paradigm, writes Vanessa Almendro, vice president of science and technology and head of innovation at Danaher Corporation, in an Expert View piece.
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Pharmaceutical
A week after US President Donald Trump signed an executive order to bring back the Most Favored Nation (MFN) idea he introduced at the end of his first term, the US Department of Health and Human Services (HHS announced it is proceeding with implementing the order on prescription drug pricing. 20 May 2025
Pharmaceutical
German drugmaker Grünenthal has named Maren Thurow as its new vice president and head of global communications, stepping into the role at a time of significant business expansion and leadership change. She succeeds Florian Dieckmann, who had led the company’s communications function since 2021. 20 May 2025
Pharmaceutical
Australia’s digital health sector is poised for steady expansion, with the market forecast to grow at a compound annual growth rate of around 8% through 2034, according to research from data and analytics group GlobalData. 20 May 2025
Biotechnology
Shares in Prime Medicine, a US biotech seeking to develop one-time curative genetic therapies, closed 16% lower Monday. 20 May 2025
Pharmaceutical
Cambridge, USA-based Apnimed today announced positive top-line results from its pivotal Phase III SynAIRgy clinical trial evaluating the efficacy and safety of its lead candidate AD109 (aroxybutynin 2.5mg/atomoxetine 75mg) in adults living with mild, moderate and severe OSA, and across all weight classes. 20 May 2025
Biotechnology
German vaccine pioneer BioNTech today revealed that its UK subsidiary has signed a grant agreement with the UK government to broaden the company’s R&D activities for innovative medicines in the UK. 20 May 2025
Biotechnology
Japan’s Ministry of Health, Labor and Welfare (MHLW) has approved UK pharma major GSK’s Blenrep (belantamab mafodotin) combination for the treatment of adults with relapsed or refractory multiple myeloma. 20 May 2025
Biotechnology
Anti–interleukin five (IL-5) biologics such as mepolizumab and benralizumab have shown significant efficacy in reducing moderate and severe exacerbations in both asthma and chronic obstructive pulmonary disease (COPD), according to new real-world data presented at the 2025 American Thoracic Society (ATS) International Conference. 20 May 2025
Biotechnology
US pharma major Pfizer is stepping up its presence in the high-stakes field of bispecific immuno-oncology with a licensing deal worth up to $6 billion for a Chinese-developed drug that targets two key cancer pathways. 20 May 2025
Pharmaceutical
Major progress has been made in delivering a more efficient and adaptable regulatory framework for clinical trials, and Lawrence Tallon, chief executive of the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has reflected on International Clinical Trials Day. 20 May 2025
Pharmaceutical
German drugmaker Boehringer Ingelheim has released full Phase III results for its experimental lung disease drug nerandomilast, showing it met primary endpoints in both idiopathic pulmonary fibrosis (IPF) and progressive pulmonary fibrosis (PPF).
However, while the data were enough to support regulatory filings, analysts remain cautious, viewing the treatment as a marginal improvement over current options. 20 May 2025
Biotechnology
Swiss gene-editing specialist CRISPR Therapeutics and San Diego, USA-based Sirius Therapeutics, which is developing innovative small interfering RNA (siRNA) therapies, announced a strategic partnership to develop and commercialize siRNA therapies. 20 May 2025
Pharmaceutical
Marking International Clinical Trials Day, we bring you a special Q&A with Andrea Manfrin, Deputy Director of Clinical Trials from the UK's Medicines and Healthcare products Regulatory Agency (MHRA). 20 May 2025
Biotechnology
Genetic medicines company Arbor Biotechnologies has announced the appointment of Don Haut as chief business officer. 19 May 2025
Biosimilars
Formycon and its commercialization partner Fresenius Kabi have announced that the US Food and Drug Administration (FDA) has designated FYB202/Otulfi (ustekinumab-aauz) as interchangeable with Johnson & Johnson’s (NYSE: JNJ) reference biologic Stelara (ustekinumab). 19 May 2025
Biotechnology
Cambridge, UK-based CellCentric today announced the completion of a $120 million Series C funding round. 19 May 2025
Pharmaceutical
A US district court judge has found that the Department of Health and Human Services (HHS) must preapprove the use of 340B rebate models before they can be implemented. 19 May 2025
Biotechnology
US human genetics biotech 23andMe today revealed it has entered into a definitive agreement for the sale of the company to Regeneron Pharmaceutical, whose shares climbed 2% following the announcement 19 May 2025
All news
Generics
The US Food and Drug Administration (FDA) has approved the first generics of Xarelto (rivaroxaban), a cardio vascular drug developed by Germany’s Bayer and marketed in the USA by Johnson & Johnson. 11 March 2025
Pharmaceutical
CervoMed has announced encouraging findings from the first 16 weeks of the extension phase of its Phase IIb RewinD-LB study. 11 March 2025
Pharmaceutical
The Russian Ministry of Industry and Trade has developed criteria for including drugs in the list of strategically important medicines – a measure that will provide an opportunity for their manufacturers to apply for new government support measures, reports The Pharma Letter’s local correspondent. 11 March 2025
Biotechnology
Mineralys Therapeutics saw its stock rise by over 40% after reporting positive top-line results from two pivotal trials evaluating lorundrostat, a potentially new option for uncontrolled and resistant hypertension. 11 March 2025
Biotechnology
Sernova Biotherapeutics, a regenerative medicine company based in Canada and the USA, has announced the appointment of Pericles (Perry) Calias as chief development officer (CDO) and head of R&D. 11 March 2025
Pharmaceutical
An Expert View from Rob Abbott, chief executive and executive director of ISPOR — The Professional Society for Health Economics and Outcomes Research (HEOR), a nonprofit advancing HEOR excellence to improve decision-making for health globally. 10 March 2025
Biotechnology
AstraZeneca and Ionis’ Wainzua (eplontersen) has been approved in the European Union (EU) for the treatment of hereditary transthyretin-mediated amyloidosis in adults with stage 1 or stage 2 polyneuropathy, commonly referred to as hATTR-PN or ATTRv-PN. 10 March 2025
Pharmaceutical
The US Food and Drug Administration has received a range of responses to its draft guidance on the Accelerated Approval pathway, with industry groups and advocacy organizations raising concerns about post-approval study requirements. 10 March 2025
Pharmaceutical
Trevi Therapeutics reported promising results from a mid-stage study of its experimental chronic cough treatment, Haduvio (nalbuphine extended-release). Shares in the company are trading around a third higher following the announcement. 10 March 2025
Pharmaceutical
Danish diabetes and obesity giant Novo Nordisk today announced headline results from REDEFINE 2, a Phase III trial in the global REDEFINE program. 10 March 2025
Biotechnology
Finnish drugmaker Orion Corporation has announced that it is establishing a new research and development (R&D) center in Cambridge, UK, during 2025 to accelerate its global growth strategy and the development of innovative medicines. 10 March 2025
Biotechnology
Shares of German biotech BioNTech dipped 2.5% to $105.86 today, after it reported financial results for the three months and full year ended December 31, 2024, and provided an update on its corporate progress. 10 March 2025
Pharmaceutical
Thought leaders from pharma are among the authors of a column tackling one of society’s toughest questions - what we should do to solve society’s obesity epidemic. 10 March 2025
Biotechnology
Indian drug major Sun Pharmaceutical Industries has entered an agreement with Checkpoint Therapeutics to acquire the US immunotherapy and targeted oncology company, with the news sending the latter’s shares rocketing more than 65% to $4.06 this morning. 10 March 2025
Biotechnology
The US Food and Drug Administration (FDA) has approved the biologics license application (BLA) for Encelto (revakinagene taroretcel-lwey; NT-501) for the treatment of macular telangiectasia type 2 (MacTel), submitted by privately-held US biotech Neurotech Pharmaceuticals. 10 March 2025
Biosimilars
US pharma major Bristol Myers Squibb has announced positive data from the pivotal Phase III POETYK PsA-2 trial evaluating the efficacy and safety of Sotyktu (deucravacitinib) in adults with active psoriatic arthritis (PsA). 10 March 2025
Pharmaceutical
Belgian biotech Agomab Therapeutics has reported positive interim results from its Phase IIa STENOVA trial of AGMB-129, an oral gut-restricted small molecule ALK5 inhibitor in development for fibrostenosing Crohn’s disease. The analysis includes data from 44 patients who completed 12 weeks of treatment, with the study meeting both its primary and secondary endpoints. 10 March 2025
Pharmaceutical
US pharma giant Pfizer today announced that James List, has joined the company as chief internal medicine officer. 10 March 2025
Pharmaceutical
Novartis has reported new data showing that its investigational BTK inhibitor, remibrutinib, significantly improves sleep quality for patients with chronic spontaneous urticaria (CSU). The findings, from the Phase III REMIX-1 and REMIX-2 trials, were presented at the American Academy of Dermatology annual meeting in Orlando. 10 March 2025
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