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
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
Pharmaceutical
USA-based rare disease company Applied Therapeutics saw its shares rise nearly 23% to $0.60 on Friday, ahead of a planned presentation on its lead candidate, govorestat, at the Peripheral Nerve Society (PNS) 2025 Annual Meeting, being held May 17-20 in Edinburgh, Scotland. 19 May 2025
Pharmaceutical
A federal judge in Rhode Island has issued a sweeping order preventing the Trump administration from cutting $11 billion in public health grants, a move that preserves critical funding for 23 states and the District of Columbia as legal proceedings continue. 19 May 2025
Biotechnology
GSK’s biologic therapy Nucala (mepolizumab) has demonstrated a consistent reduction in exacerbation rates among patients with eosinophilic chronic obstructive pulmonary disease (COPD), regardless of their history of severe events. 19 May 2025
Biotechnology
Japanese drugmaker Chugai Pharmaceutical today announced that it obtained regulatory approval from the Ministry of Health, Labor and Welfare (MHLW) for anti-VEGF/anti-Ang-2 bispecific antibody Vabysmo intravitreal injection 120mg/mL (aricimab genetical recombination), for an additional indication of the treatment of choroidal neovascularization associated with angioid streaks. Vabysmo is the first approved drug in Japan for the treatment of this disease. 19 May 2025
All news
Pharmaceutical
Last week’s significant research news included positive new Phase III data on Tezspire in nasal polyps from Amgen and AstraZeneca. US pharma major AbbVie became the latest entrant to the weight management sector, striking a deal with Gubra for its obesity candidate GUB14295. On the M&A front, Ireland-headquartered Jazz Pharmaceuticals announced it is acquiring Chimerix for around $935 million to expand its oncology portfolio. USA-based scPharmaceuticals gained US Food and Administration (FDA) approval for its supplemental new drug application (sNDA) for Furoscix in chronic kidney disease (CKD). 9 March 2025
Biosimilars
On Friday, the US Food and Drug Administration (FDA) approved as the first interchangeable biosimilar to Swiss pharma giant Roche's
anti-IgE monoclonal antibody Xolair (omalizumab). 8 March 2025
Pharmaceutical
Following swiftly after US regulatory clearance for the same indication for Odactra tablet brand, Danish allergy expert ALK Abello its Acarizax announced that Health Canada has approved tablet for use in children, aged five to 11, with house dust mite (HDM) allergy. 8 March 2025
Biotechnology
Nona Biosciences has introduced Hu-mAtrIx, an AI-assisted drug discovery platform designed to accelerate the identification and development of antibody-based therapies. 7 March 2025
Pharmaceutical
Marty Makary, nominated by Donald Trump to lead the Food and Drug Administration (FDA), has faced rigorous Senate scrutiny over recent agency job cuts and the abrupt cancellation of a flu vaccine advisory meeting. 7 March 2025
Generics
German generics and consumer healthcare major STADA Arzneimittel today released financial results, which the firm said continued its profitable growth journey in 2024 – supported by its strong commercial network in Europe, and complemented by a growing presence in the MENA, Eurasia and Asia-Pacific regions. 7 March 2025
Biotechnology
US pharma major Bristol Myers Squibb has announced that the European Commission (EC) has approved Opdivo (nivolumab) plus Yervoy (ipilimumab) for the first-line treatment of adult patients with unresectable or advanced hepatocellular carcinoma (HCC). 7 March 2025
Pharmaceutical
French ophthalmic drug specialist Nicox has provided details of a poster presentation highlighting additional pre-planned analysis from the NCX 470 Mont Blanc Phase III clinical trial at the 2025 American Glaucoma Society (AGS) Annual Meeting. 7 March 2025
Pharmaceutical
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has today approved Alyftrek (triple combination medicine deutivacaftor/tezacaftor/vanzacaftor. 7 March 2025
Pharmaceutical
Cardiorenal specialist scPharmaceuticals has won US Food and Drug Administration (FDA) approval for its supplemental New Drug Application (sNDA) for Furoscix (furosemide injection) to expand the indication to include treatment of edema in patients with chronic kidney disease (CKD). 7 March 2025
Biotechnology
US clinical stage biotech Rapport Therapeutics has announced the appointment of Dr Jeffrey Sevigny as chief medical officer (CMO), effective immediately. 7 March 2025
Biotechnology
A recent study by TEConomy Partners, commissioned by industry group PhRMA, has revealed that biopharmaceutical company-sponsored trials generated over $62 billion in economic activity in the USA in 2023. 7 March 2025
Pharmaceutical
US healthcare giant Johnson & Johnson yesterday revealed that it has made the decision to discontinue the Phase III VENTURA development program evaluating aticaprant as an adjunctive treatment for major depressive disorder (aMDD) due to insufficient efficacy in the target patient population. 7 March 2025
Biotechnology
The Medicines and Healthcare products Regulatory Agency (MHRA) has approved Lazcluze (lazertinib) for adults with non-small cell lung cancer (NSCLC) that has spread to other parts of the body and has undergone specific changes in a gene called epidermal growth factor receptor (EGFR). 7 March 2025
Biotechnology
A treatment combining AstraZeneca’s immunotherapy Imfinzi (durvalumab) with chemotherapy has significantly reduced the risk of cancer recurrence in patients with early-stage stomach and gastroesophageal junction cancers, according to results from the MATTERHORN Phase III trial. 7 March 2025
Biotechnology
Tenaya Therapeutics, a clinical-stage biotechnology company based in South San Francisco, has announced plans to raise approximately $52.5 million through a public offering. 6 March 2025
Pharmaceutical
Private equity firms acquiring assets were among the most eye-catching deals in pharma M&A during February. 6 March 2025
Pharmaceutical
China’s Enhua Pharma has announced a $3.5 million investment in NeuroThree Therapeutics, a biotech firm specializing in treatments for central nervous system disorders. The investment secures a 10.4% stake in the company as part of its Pre-A funding round. 6 March 2025
Pharmaceutical
Privately-held US drugmaker Tris Pharma today announced positive top-line results from its ALLEVIATE-2 Phase III pivotal clinical trial evaluating cebranopadol, an investigational therapy, for the treatment of moderate-to-severe acute pain in patients following bunionectomy surgery. 6 March 2025
Pharmaceutical
USA-based Medicus Pharma has announced a positive-trending interim analysis for the SKNJCT-003 Phase II study, which aims to treat non-invasively basal cell carcinoma of the skin (BCC). 6 March 2025
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