Latest Pharma and Biotech News
Pharmaceutical
8 October 2026 USA-based companies Viatris and Pacira BioSciences have entered into a definitive agreement under which Viatris has agreed to acquire all of the outstanding shares of common stock of Pacira for $36.50 per share in cash, with the news sending the latter’s shares up 44% to $36.30 in early trading.
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Pharmaceutical
US biopharma company Mineralys Therapeutics today announced the presentation of a new analysis from its pivotal Phase III Launch-HTN trial, showing that at Week 12, 46% of lorundrostat-treated participants achieved the AHA/ACC Guideline recommended office systolic blood pressure (SBP) target of <130 mmHg. 9 October 2026
Pharmaceutical
Given the impact of the illegal medicines trade on public health in Latin America, on confidence in the health system and on patient safety, Colombia’s main pharmaceutical trade associations have signed the Alliance for the Legality of Medicines. 9 October 2026
Biotechnology
US biotech Outlook Therapeutics, which is specializing in the development and commercialization of Lytenava (bevacizumab-vikg), has appointed Greg DiPasquale as its chief commercial officer (CCO). 9 October 2026
Biotechnology
Leading Swiss contract development and manufacturing organization (CDMO) Lonza and Onava, a US biotech building an AI-native platform for biologics discovery, announced today a collaboration to support AI-enabled drug discovery through experimental validation using Lonza’s GS Gene Expression System platform with GS Ori-Go vectors. 9 October 2026
Pharmaceutical
Israel-based Teva Pharmaceutical Industries US subsidiary today revealed that the US Food and Drug Administration (FDA) has approved Weltruza (olanzapine) for extended-release injectable suspension, a new, once-monthly, subcutaneous long-acting injectable (LAI) for the treatment of schizophrenia in adults. 9 October 2026
Pharmaceutical
Data presented at the European Association for the Study of Diabetes (EASD) Annual Meeting 2026 showed that Eli Lilly’s Foundayo (orforglipron) was associated with greater reductions in both body weight and HbA1c than Novo’s Rybelsus (semaglutide) in adults with type 2 diabetes (T2D) who were overweight or had obesity. 9 October 2026
Generics
India's pharmaceutical manufacturing industry is entering a delicate phase in its development. As uncertainty grows over its long-term access to the US market, the country is gaining improved access to other major overseas markets, says pharma intelligence company GlobalData. 9 October 2026
Biotechnology
Iambic Therapeutics, the San Diego-based AI drug discovery company, has set terms for a Nasdaq initial public offering of 9,375,000 shares priced at $15 to $17 each, under the proposed ticker IAM, according to an amended S-1 filed with the SEC Thursday. 9 October 2026
Biotechnology
Belgo-Dutch immunology specialist argenx announced that it will discontinue the Phase III UNITY study of efgartigimod subcutaneous (SC) (efgartigimod alfa and hyaluronidase-qvfc) in adults with moderate-to-severe Sjögren's disease. 9 October 2026
Pharmaceutical
The Accelerating Clinical Trials in the European Union (ACT EU) advice pilot, which helps sponsors prepare clinical trial applications, will become a permanent initiative from January 2027, the European Medicines Agency (EMA) announced today. 9 October 2026
Biotechnology
Privately-held Endeavor BioMedicines said its Phase IIb WHISTLE-PF trial of taladegib (ENV-101) met its primary endpoint in idiopathic pulmonary fibrosis (IPF), with a statistically significant improvement in lung function against placebo. 9 October 2026
Pharmaceutical
For pharmaceutical companies bidding to supply England's National Health Service (NHS), carbon reporting is already part of the procurement process. Suppliers entering medicines tenders run by NHS England's Medicines Value and Access directorate must provide a valid sustainability assessment and a compliant carbon reduction plan alongside their commercial submissions. 9 October 2026
Pharmaceutical
When the World Health Organization (WHO) updates its Model List of Essential Medicines (EML), it gives governments a reference point for deciding which treatments their health systems should prioritize. Its choices can inform public purchasing and insurance coverage, although countries make their own decisions about what to fund. 9 October 2026
Pharmaceutical
Danish biotech Zealand Pharma said petrelintide met the primary endpoint in a Phase IIb study involving people with overweight or obesity and type 2 diabetes, delivering mean weight loss of up to 9.2% after 28 weeks, compared with 2.0% for placebo. 9 October 2026
Biotechnology
Belgian life sciences company SpectaCell has launched with 6 million euros ($6.7 million) in seed financing to develop a cell analysis platform intended to help drugmakers assess immune therapies, from early research through manufacturing. 9 October 2026
Biotechnology
The US Food and Drug Administration (FDA) has approved oche’s Tecentriq atezolizumab) and Tecentriq Hybreza (atezolizumab and hyaluronidase-tqjs) in combination with a fluoropyrimidine and oxaliplatin for the adjuvant treatment of stage III deficient DNA mismatch repair (dMMR) colon cancer, a type of tumor characterized by high mutation rates. 9 October 2026
Pharmaceutical
USA-based companies Viatris and Pacira BioSciences have entered into a definitive agreement under which Viatris has agreed to acquire all of the outstanding shares of common stock of Pacira for $36.50 per share in cash, with the news sending the latter’s shares up 44% to $36.30 in early trading. 8 October 2026
Pharmaceutical
US pharma major Bristol Myers Squibb said its Phase III EXCALIBER-RRMM trial met its progression-free survival (PFS) endpoint, with Zenbexus (iberdomide) plus daratumumab and dexamethasone (ZDd) beating daratumumab, bortezomib and dexamethasone (DVd) in relapsed or refractory multiple myeloma, including patients at first relapse. 8 October 2026
Biotechnology
Japan’s Ono Pharmaceutical today announced that it has entered into an exclusive license agreement with US biopharma Biohaven for the development and commercialization of Biohaven’s IgG degrader portfolio, including BHV-1300, BHV-1310, and BHV-1320, in Japan, South Korea, Taiwan and ASEAN countries. 8 October 2026
Pharmaceutical
Privately-held US biopharma Cerevance said its Phase III ARISE trial of once-daily oral solengepras met its primary endpoint in Parkinson's disease patients with motor fluctuations on levodopa, and that it will meet the US Food and Drug Administration (FDA) to discuss the path to a potential New Drug Application. 8 October 2026
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Pharmaceutical
Shares of Swedish drug-delivery company Nanexa more than doubled their value to 12.08 kroner in early Friday trading after it signed a global licensing deal with Denmark’s Novo worth up to about 1.17 billion euros ($1.33 billion). 25 September 2026
Biotechnology
Biopharma companies are increasingly choosing to manufacture their newer Food and Drug Administration (FDA)-approved innovator and biosimilar products at facilities in China, signaling growing industry confidence in using the country as one of the bases for its manufacturing, according to pharma intelligence and productivity platform GlobalData. 25 September 2026
Biotechnology
Johnson & Johnson has reported new long-term follow-up data from cohort A of the Phase II CARTITUDE-2 trial showing that half of patients with early-line relapsed or refractory multiple myeloma (RRMM) treated with a single infusion of Carvykti (ciltacabtagene autoleucel; cilta-cel) remained alive and progression-free at five years without maintenance therapy. 25 September 2026
Pharmaceutical
German pharma and life sciences major Merck KGaA today announced that the UK National Institute for Health and Care Excellence (NICE) has issued final draft guidance recommending Ogsiveo (nirogacestat) for the treatment of adults with progressing desmoid tumors who require systemic treatment. 25 September 2026
Pharmaceutical
The US Food and Drug Administration has approved a new oncology indication for Welireg (belzutifan). The oral treatment is now cleared for use alongside Lenvima (lenvatinib) in adults with advanced clear cell renal cell carcinoma following prior immunotherapy. 25 September 2026
Pharmaceutical
The US regulator could soon have a permanent commissioner following Heidi Overton's confirmation hearing before the Senate Health, Education, Labor and Pensions (HELP) committee on Thursday (September 24). Nominated by Donald Trump to lead the Food and Drug Administration (FDA), Dr Overton pledged to follow statutory requirements amid questions over her independence. 25 September 2026
Pharmaceutical
On September 21, 2026, the European Commission granted marketing authorization under exceptional circumstances for Nezglyal (leriglitazone) to treat cerebral adrenoleukodystrophy. The regulatory decision covers male patients aged two to 12 years with gadolinium-negative brain lesions, following a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) on July 23. 25 September 2026
Pharmaceutical
Swiss clinical stage pharma company Addex Therapeutics' shares gained more than 13% to 0.028 francs today, after it announced that it has regained full global rights to all GABAB positive allosteric modulator (PAM) assets discovered under its research collaboration with Indivior UK. 25 September 2026
Biotechnology
US immunology company Kyverna Therapeutics has reported positive one-year topline data from its registrational KYSA-8 trial of miv-cel (mivocabtagene autoleucel, KYV-101) in stiff person syndrome (SPS), alongside longer-term Phase II follow-up from its KYSA-6 trial in generalized myasthenia gravis (gMG). 25 September 2026
Pharmaceutical
UK pharma major AstraZeneca has registered a new hypertension drug in Russia, which belongs to a new class of aldosterone synthase inhibitors, The Pharma Letter’s local correspondent reports. 25 September 2026
Pharmaceutical
Eli Lilly has said that the US Food and Drug Administration (FDA) has approved Onswik (insulin efsitora alfa-gobe), a once-weekly basal insulin, as an adjunct to diet and exercise to control high blood sugar in adults with type 2 diabetes. 25 September 2026
Biotechnology
US pharma major AbbVie yesterday announced that Health Canada has issued a Notice of Compliance for Epkinly (epcoritamab) with a new follicular lymphoma (FL) indication. 25 September 2026
Pharmaceutical
Russian patients with spinal muscular atrophy (SMA) have begun experiencing interruptions in getting essential drugs for their treatment, according to experts of the SMA Families charity foundation. 25 September 2026
Biotechnology
US clinical-stage biotech company Tortugas Neuroscience has announced the appointment of Ramzi Benamar as chief financial officer (CFO). 25 September 2026
Pharmaceutical
The US Food and Drug Administration (FDA) established the accelerated approval pathway through regulation in 1992 in direct response to the HIV and AIDS crisis. The program was later written into law in 2012 to provide earlier access to promising novel therapies for severe conditions. 25 September 2026
Biotechnology
The European Investment Bank (EIB), working with the European Commission, has approved a 35 million euros ($40 million) financing package for VaxThera, the Colombian biotech developing and manufacturing vaccines and biopharma products, with a first 15 million euros venture loan tranche announced in New York on the margins of the UN General Assembly. 24 September 2026
Biotechnology
The UK's Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorization for Gazyvaro (obinutuzumab), from Roche, for adults with moderate to severe, active, autoantibody-positive systemic lupus erythematosus (SLE) who are receiving standard therapy. 24 September 2026
Generics
Lantheus Holdings, a leading radiopharmaceutical-focused company, has announced that the US Food and Drug Administration (FDA) has granted final approval for Bravnetsa (lutetium Lu 177 dotatate), a bioequivalent and therapeutically equivalent radiopharmaceutical to Novartis’s Lutathera (lutetium Lu 177 dotatate). 24 September 2026
Biotechnology
California, USA-based clinical-stage, AI-driven biotech BigHat Biosciences today announced the completion of a $75 million Series C financing, bringing its total funding raised to date to $223 million. 24 September 2026
Biotechnology
Finland-based biotech Kasvu Therapeutics today announced its 30 million euros ($34.4 million) Series A financing, aiming to advance is depression program. 24 September 2026
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