Latest Pharma and Biotech News
Pharmaceutical
15 October 2026 The US regulator, the Food and Drug Administration (FDA), has launched an initiative to reshape rare disease drug development, aiming to match evidence expectations more closely to patient needs and the data that can realistically be generated in small populations.
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Pharmaceutical
Shares in Swedish biotech Modus Therapeutics fell by half in Stockholm trading on Thursday after the company paused enrollment in part two of its Phase IIa study of sevuparin in chronic kidney disease (CKD) with anemia. Majority owner KD Ventures, which holds 51%, fell about 5%. 15 October 2026
Pharmaceutical
Japan’s largest drugmaker Takeda today announced that Orzeyful (oveporexton) is now available in Japan and China for the treatment of narcolepsy type 1 (NT1), providing first access to clinicians to prescribe treatment with the new class of medicine. 15 October 2026
Biotechnology
German drug discovery and development services company Evotec has appointed Joanna Holbrook as chief scientific officer (CSO) and a member of its management board, effective November 1. She will lead Evotec’s global scientific strategy across its discovery and development services, technology platforms and proprietary programs. 15 October 2026
Pharmaceutical
UK pharma major AstraZeneca today announced a new strategic drug discovery collaboration and licensing agreement with machine learning-enabled drug discovery and development company insitro. 15 October 2026
Pharmaceutical
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) is introducing a series of new measures to strengthen how key risks associated with antidepressant medicines are communicated to patients, carers and healthcare professionals. 15 October 2026
Biotechnology
The UK National Institute of Health and Care Excellence (NICE) has issued negative final guidance for the use of Roche’s Itovebi (inavolisib), in combination with palbociclib and fulvestrant, for the treatment of adult patients with oestrogen receptor (ER) positive. 15 October 2026
Pharmaceutical
French clinical-stage vaccine company Osivax said its Phase IIb field efficacy trial of OVX836, a nucleoprotein-based influenza A vaccine candidate, failed to meet its prespecified primary endpoint of 50% vaccine efficacy, and that it will now develop the candidate in combination with conventional seasonal flu vaccines. 15 October 2026
Biotechnology
Amsterdam-based precision oncology company iOnctura has appointed Paul Sekhri as chair of its board, with immediate effect, as it prepares for late-stage development of its lead drug, roginolisib. He succeeds Mark Velleca. 15 October 2026
Biotechnology
The US Food and Drug Administration (FDA) approved Anktiva (nogapendekin alfa inbakicept-pmln) from Altor BioSciences, an indirect wholly-owned subsidiary of ImmunityBio, with Bacillus Calmette-Guérin (BCG) for adults with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC). 15 October 2026
Pharmaceutical
UK pharma major GSK plans to cut up to 1,217 permanent jobs in Belgium, where it employs about 8,500 people, according to reports of a works council meeting on Wednesday. 15 October 2026
Biotechnology
For someone receiving Casgevy (exagamglogene autotemcel), gene editing involves much more than an infusion. Blood stem cells must be collected, sent for manufacturing and returned after testing. The patient receives chemotherapy to prepare the bone marrow, followed by the edited cells and a period of recovery under specialist care. 15 October 2026
Biotechnology
Life science investor Syncona announces that it has committed $10.1 million (£7.5 million) to a $310 million (£230 million) Series C financing of its portfolio company OMass Therapeutics, a UK based biotechnology company developing small molecule therapeutics against highly validated targets. 15 October 2026
Biotechnology
US biotech company Verastem Oncology has priced a $250 million offering alongside new results for its experimental cancer drug VS-7375, as it prepares to expand development into three Phase III trials. 15 October 2026
Biotechnology
French pharma major Sanofi must correct potentially misleading messages about a rival flu vaccine and restrict its promotional claims in Germany and France after the European Commission made its commitments legally binding on Wednesday. 15 October 2026
Pharmaceutical
The US regulator, the Food and Drug Administration (FDA), has launched an initiative to reshape rare disease drug development, aiming to match evidence expectations more closely to patient needs and the data that can realistically be generated in small populations. 15 October 2026
Biotechnology
Vir Biotechnology shares jumped nearly 10% in pre-market trading following a major licensing agreement with Gilead Sciences valued at up to $1.9 billion. 15 October 2026
Biotechnology
Switzerland's AL-S Pharma, a biotech developing antibodies against misfolded proteins in amyotrophic lateral sclerosis (ALS), has appointed Harry Welten as chief executive, succeeding Michael Salzmann, as it prepares a confirmatory Phase III trial of its lead program AP-101 that it aims to start in 2027. 14 October 2026
Pharmaceutical
Aquestive Therapeutics has announced an exclusive US licensing agreement with Eton Pharmaceuticals for Libervant (diazepam) buccal film, providing $10 million upfront, up to $47.5 million in regulatory and commercial milestones, and mid-teens royalties on net sales. 14 October 2026
Pharmaceutical
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has published its 2030 Strategy, setting out how it plans to keep pace with AI, cell and gene therapies and personalized medicines while speeding patient access to treatments across all four UK nations. 14 October 2026
Biotechnology
Takeda today announced detailed results from the pivotal Phase II/III IgGNITE clinical trial (TAK-881-3001) evaluating investigational TAK-881 (immune globulin subcutaneous [human]), 20% Solution (SCIG 20%) and recombinant human hyaluronidase]. 14 October 2026
All news
Pharmaceutical
Shares in Swedish biotech Modus Therapeutics fell by half in Stockholm trading on Thursday after the company paused enrollment in part two of its Phase IIa study of sevuparin in chronic kidney disease (CKD) with anemia. Majority owner KD Ventures, which holds 51%, fell about 5%. 15 October 2026
Pharmaceutical
Japan’s largest drugmaker Takeda today announced that Orzeyful (oveporexton) is now available in Japan and China for the treatment of narcolepsy type 1 (NT1), providing first access to clinicians to prescribe treatment with the new class of medicine. 15 October 2026
Biotechnology
German drug discovery and development services company Evotec has appointed Joanna Holbrook as chief scientific officer (CSO) and a member of its management board, effective November 1. She will lead Evotec’s global scientific strategy across its discovery and development services, technology platforms and proprietary programs. 15 October 2026
Pharmaceutical
UK pharma major AstraZeneca today announced a new strategic drug discovery collaboration and licensing agreement with machine learning-enabled drug discovery and development company insitro. 15 October 2026
Pharmaceutical
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) is introducing a series of new measures to strengthen how key risks associated with antidepressant medicines are communicated to patients, carers and healthcare professionals. 15 October 2026
Biotechnology
The UK National Institute of Health and Care Excellence (NICE) has issued negative final guidance for the use of Roche’s Itovebi (inavolisib), in combination with palbociclib and fulvestrant, for the treatment of adult patients with oestrogen receptor (ER) positive. 15 October 2026
Pharmaceutical
French clinical-stage vaccine company Osivax said its Phase IIb field efficacy trial of OVX836, a nucleoprotein-based influenza A vaccine candidate, failed to meet its prespecified primary endpoint of 50% vaccine efficacy, and that it will now develop the candidate in combination with conventional seasonal flu vaccines. 15 October 2026
Biotechnology
Amsterdam-based precision oncology company iOnctura has appointed Paul Sekhri as chair of its board, with immediate effect, as it prepares for late-stage development of its lead drug, roginolisib. He succeeds Mark Velleca. 15 October 2026
Biotechnology
The US Food and Drug Administration (FDA) approved Anktiva (nogapendekin alfa inbakicept-pmln) from Altor BioSciences, an indirect wholly-owned subsidiary of ImmunityBio, with Bacillus Calmette-Guérin (BCG) for adults with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC). 15 October 2026
Pharmaceutical
UK pharma major GSK plans to cut up to 1,217 permanent jobs in Belgium, where it employs about 8,500 people, according to reports of a works council meeting on Wednesday. 15 October 2026
Biotechnology
For someone receiving Casgevy (exagamglogene autotemcel), gene editing involves much more than an infusion. Blood stem cells must be collected, sent for manufacturing and returned after testing. The patient receives chemotherapy to prepare the bone marrow, followed by the edited cells and a period of recovery under specialist care. 15 October 2026
Biotechnology
Life science investor Syncona announces that it has committed $10.1 million (£7.5 million) to a $310 million (£230 million) Series C financing of its portfolio company OMass Therapeutics, a UK based biotechnology company developing small molecule therapeutics against highly validated targets. 15 October 2026
Biotechnology
US biotech company Verastem Oncology has priced a $250 million offering alongside new results for its experimental cancer drug VS-7375, as it prepares to expand development into three Phase III trials. 15 October 2026
Biotechnology
French pharma major Sanofi must correct potentially misleading messages about a rival flu vaccine and restrict its promotional claims in Germany and France after the European Commission made its commitments legally binding on Wednesday. 15 October 2026
Pharmaceutical
The US regulator, the Food and Drug Administration (FDA), has launched an initiative to reshape rare disease drug development, aiming to match evidence expectations more closely to patient needs and the data that can realistically be generated in small populations. 15 October 2026
Biotechnology
Vir Biotechnology shares jumped nearly 10% in pre-market trading following a major licensing agreement with Gilead Sciences valued at up to $1.9 billion. 15 October 2026
Biotechnology
Switzerland's AL-S Pharma, a biotech developing antibodies against misfolded proteins in amyotrophic lateral sclerosis (ALS), has appointed Harry Welten as chief executive, succeeding Michael Salzmann, as it prepares a confirmatory Phase III trial of its lead program AP-101 that it aims to start in 2027. 14 October 2026
Pharmaceutical
Aquestive Therapeutics has announced an exclusive US licensing agreement with Eton Pharmaceuticals for Libervant (diazepam) buccal film, providing $10 million upfront, up to $47.5 million in regulatory and commercial milestones, and mid-teens royalties on net sales. 14 October 2026
Pharmaceutical
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has published its 2030 Strategy, setting out how it plans to keep pace with AI, cell and gene therapies and personalized medicines while speeding patient access to treatments across all four UK nations. 14 October 2026
Biotechnology
Takeda today announced detailed results from the pivotal Phase II/III IgGNITE clinical trial (TAK-881-3001) evaluating investigational TAK-881 (immune globulin subcutaneous [human]), 20% Solution (SCIG 20%) and recombinant human hyaluronidase]. 14 October 2026
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Company Spotlight
A US specialty pharma company in Warren, New Jersey, that makes medicines as thin oral films, manufactures Suboxone for Indivior, licensed US rights to its seizure rescue film Libervant to Eton Pharmaceuticals in October 2026 and resubmitted its needle-free epinephrine film Anaphylm to the FDA in September 2026.
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