Latest Pharma and Biotech News
Pharmaceutical
13 November 2025 Swiss pharma giant Novartis has announced positive results from KALUMA, a Phase III study for new malaria treatment KLU156 (ganaplacide/lumefantrine, or GanLum).
Today's issue
Refine Search
Pharmaceutical
US pharma major Bristol Myers Squibb—in collaboration with Johnson & Johnson—has announced the decision to stop the Phase III Librexia ACS trial evaluating the efficacy and safety of milvexian when added to the standard of care, of conventional antiplatelet therapy, for patients after a recent acute coronary syndrome (ACS) event. 14 November 2025
Pharmaceutical
TandemAI has announced that it has secured a $22 million Series A extension to further develop its drug discovery platform, which combines advanced AI, physics-based computational methods, and wet lab capabilities. 14 November 2025
Biotechnology
US medtech firm Terumo Blood and Cell Technologies has appointed Liza Loidolt as general manager of its cell and gene therapy business, marking a sharper strategic push into advanced therapeutics. Parent company Terumo Corporation recently reported annual revenue of about $6.1 billion, with growth in blood-and-cell technologies. 14 November 2025
Biotechnology
Chinese biotech Biokin Pharmaceutical has postponed its planned Hong Kong share listing, citing prevailing market conditions as analysts point to cooling risk appetite late in the year. 14 November 2025
Pharmaceutical
The race to find a new treatment for hair loss hotted up last month with two mega funding rounds for Pelage Pharmaceuticals and Veradermics. The deals also demonstrated biopharma’s growing interest in consumer-focused prescription products. 14 November 2025
Pharmaceutical
Merck & Co has struck a $9.2 billion deal to acquire biotechnology company Cidara Therapeutics in a move that bolsters the US pharma giant’s respiratory portfolio and pipeline as it braces for the 2028 loss of patent exclusivity for its mega blockbuster cancer drug Keytruda (pembrolizumab). 14 November 2025
Pharmaceutical
Ireland-based Avadel Pharmaceuticals today announced that it has received an unsolicited proposal from Denmark’s Lundbeck to acquire Avadel, whose shares shot up 21.7% to $19.24 in pre-market activity. 14 November 2025
Biotechnology
Mersana Therapeutics, a US biopharma developing antibody-drug conjugates (ADCs) targeting cancers in areas of high unmet medical need, is to be acquired by Day One Biopharmaceuticals. 14 November 2025
Biotechnology
UK-based life sciences venture capital firm Medicxi today announced the closing of Medicxi V, a 500 million-euros ($579.5 million) fund dedicated to building and backing innovative European biotechnology companies with clear product visions to transform patient care. 14 November 2025
Pharmaceutical
Neurvati Neurosciences, the neuroscience development platform of Blackstone Life Sciences, has announced the appointment of Carlos Martin as chief commercial officer (CCO). 14 November 2025
Pharmaceutical
Gate Bioscience has raised $65 million in an oversubscribed series B to advance its first molecular gate candidates, a novel class of oral small molecules designed to eliminate disease-driving proteins before they are secreted. The round was led by Netherlands-based Forbion, with new backing from US pharma major Eli Lilly (NYSE: LLY). 14 November 2025
Pharmaceutical
The pharma trade group the Association of the British Pharmaceutical Industry (ABPI) and the UK government have agreed to a further extension to the deadline by which companies must give notice if they intend to leave the 2024 voluntary scheme for branded medicines pricing, access and growth (VPAG). 14 November 2025
Pharmaceutical
The US Food and Drug Administration approved USA-based Kura Oncology and Japan’s Kyowa Kirin’s ziftomenib (trade name Komzifti), a menin inhibitor, for adults with relapsed or refractory acute myeloid leukemia (AML) with a susceptible nucleophosmin 1 (NPM1) mutation who have no satisfactory alternative treatment options. 14 November 2025
Biotechnology
Danish CNS company Lundbeck has had its new drug application for Vyepti (eptinezumab) accepted by Japan’s health ministry, marking a major step toward expanding its presence in Asia. 14 November 2025
Generics
German generics and consumer healthcare major STADA Arzneimittel has appointed Craig Shaw as its general manager in the UK. 14 November 2025
Biotechnology
Sino-American antibody company Adagene and Third Arc Bio today announced a licensing agreement under which Third Arc Bio will utilize Adagene’s SAFEbody technology platform to generate masked CD3 T cell engagers against unique tumor associated antigens. 13 November 2025
Pharmaceutical
Swiss clinical-stage biotech, which is pioneering fully synthetic vaccines, today announced the completion of a $15 million financing round from existing shareholders. 13 November 2025
Pharmaceutical
German radiopharma company ITM Isotope Technologies Munich SE (ITM) has announced that the US Food and Drug Administration (FDA) has completed its filing review and accepted the company’s New Drug Application (NDA) for n.c.a. 177Lu-edotreotide—also known as ITM-11. 13 November 2025
Biotechnology
Swiss pharma major Roche has welcomed positive final draft guidance from the UK's health technology assessor, NICE, supporting the use of Columvi (glofitamab) with gemcitabine and oxaliplatin as a second-line treatment for adults with relapsed or refractory diffuse large B-cell lymphoma who are ineligible for autologous stem cell transplant after one prior therapy. 13 November 2025
Biotechnology
Eisai has released new 48-month data from a post-hoc analysis of its Clarity AD open-label extension, focusing on adults with early Alzheimer’s disease who are APOE ε4 non-carriers or heterozygotes. The update was presented at the German Society of Neurology meeting in Berlin. 13 November 2025
All news
Biotechnology
Excellergy, a biotech developing a new class of allergy therapeutics, has announced its launch with a $70 million Series A financing to advance its pipeline of first-in-class effector cell response inhibitors (ECRIs). 13 October 2025
Pharmaceutical
Iceland’s budget for licensed medicines should takes into account the rapid development of new medicines, the increasing number of people with serious diseases and their access to the best possible treatment. 13 October 2025
Biotechnology
US biotech Regeneron Pharmaceuticals has announced positive updated data for its investigational gene therapy DB-OTO for profound genetic hearing loss due to variants of the otoferlin (OTOF) gene and revealed plans to progress the product into regulatory filing. 13 October 2025
Biotechnology
Japanese drugmaker Chugai Pharmaceutical has concluded a license agreement with Roche for CT-388, a long-acting GLP-1/GIP receptor agonist, currently in development for obesity and type 2 diabetes. 13 October 2025
Pharmaceutical
The ground shifted under China’s drugmakers when volume-based procurement cut through list prices. Margins tightened, business models wobbled, and strategy decks were rewritten overnight. The domestic market still offers scale, but the old assumption that scale guaranteed profit no longer holds. 13 October 2025
Generics
India-based Natco Pharma has announced the acquisition of a 35.75% stake in Adcock Ingram, a 135-year-old South African pharmaceutical giant, in a deal valued at approximately $226 million. 13 October 2025
Pharmaceutical
Danish CNS specialist Lundbeck has announced that its investigational drug bexicaserin— for the treatment of seizures associated with developmental and epileptic encephalopathies (DEEs)—has been granted Breakthrough Therapy Designation (BTD) by China's Center for Drug Evaluation (CDE). 13 October 2025
Pharmaceutical
German drug delivery specialist LTS Lohmann Therapie-Systeme has agreed to acquire US contract manufacturer Renaissance Lakewood, expanding its reach into nasal sprays and sterile dosage forms. 13 October 2025
Pharmaceutical
Yongyin, South Korea-based biopharma company GC Biopharma has signed an agreement with Seattle, USA-based biotech Curevo Vaccine to secure contract manufacturing (CMO) rights for amezosvatein (CRV-101), a recombinant shingles vaccine currently under clinical development. 13 October 2025
Pharmaceutical
Takeda sits in a peculiar place in global pharma. As Japan’s largest drugmaker, it retains a national heritage and corporate culture rooted in Osaka. Yet since the $62 billion Shire acquisition closed in 2019, Takeda has positioned itself as a global heavyweight. 13 October 2025
Pharmaceutical
The Gulf's leaders have spent years promising to diversify their economies beyond oil. Pharmaceuticals and biotechnology now stand near the top of that agenda, positioned as strategic industries that promise health security, jobs and prestige. 13 October 2025
Biotechnology
Novo Nordisk is exiting cell therapy research as part of a major restructuring led by new chief executive Mike Doustdar. The Danish drugmaker told The Pharma Letter it was “assessing all business areas and regions to simplify structures, reduce duplication, and sharpen focus.” 13 October 2025
Biotechnology
The US Food and Drug Administration (FDA) on Friday revealed it has received reports of immune effector cell-associated enterocolitis (IEC-EC) in patients who received treatment with Carvykti (ciltacabtagene autoleucel), a CAR-T cell therapy from Johnson & Johnson subsidiary Janssen. 13 October 2025
Pharmaceutical
The Irish Pharmaceutical Healthcare Association (IPHA), the representative body for the research-based biopharmaceutical industry in Ireland, welcomes the allocation of 30 million euros ($34.7 million) for new, life-enhancing medicines in Budget 2026. 13 October 2025
Pharmaceutical
European pharmaceutical contract development and manufacturing organisation (CDMO), NextPharma has entered into an agreement with Cencora, a USA-based pharmaceutical solutions organization, to sell NextPharma’s healthcare logistics services business, NextPharma Logistics GmbH. 13 October 2025
Pharmaceutical
Significant research news last week included French biotech Abivax releasing positive new Phase III data on obefazimod for ulcerative colitis. On the regulatory front, the US Food and Drug Administration (FDA) approved German pharma major Boehringer Ingelheim’s Jascayd, making it the first to gain approval for a new idiopathic pulmonary fibrosis treatment in over decade. M&A news saw Denmark’s Novo Nordisk announce plans to expand its metabolic dysfunction-associated steatohepatitis (MASH) portfolio with the buy of US biotech Akero Therapeutics along with its investigational drug efruxifermin for $4.7 billion, as well as US pharma major Bristol Myers Squibb enter a deal worth around $1.5 billion to acquire Orbital Therapeutics, gaining access to its lead asset OTX-201 for autoimmune diseases. 12 October 2025
Pharmaceutical
UK pharma major AstraZeneca on Friday announced an agreement with US President Donald Trump’s administration to lower the cost of prescription medicines for American patients while preserving America’s cutting-edge biopharmaceutical innovation. 11 October 2025
Biosimilars
South Korea-based Celltrion on Friday announced that the US Food and Drug Administration (FDA) has approved Eydenzelt (aflibercept-boav), a biosimilar referencing Bayer’s Eylea (aflibercept). 11 October 2025
Biotechnology
German pharma major Bayer’s gene therapy subsidiary AskBio today announced initial safety data from the first cohort of participants from its Phase I/Phase II LION-CS101 clinical trial of investigational gene therapy AB-1003 in participants with limb-girdle muscular dystrophy (LGMD) 2I/R9. 10 October 2025
Biotechnology
US biotech major Biogen and RNA medicine specialist Stoke Therapeutics have presented longer-term follow-up analyses from the ongoing open-label extension (OLE) studies of zorevunersen supporting its potential as a disease-modifying medicine for Dravet syndrome. 10 October 2025
Sign up to receive email updates
Join industry leaders for a daily roundup of biotech & pharma news
Copyright © The Pharma Letter 2025 | Headless Content Management with Blaze