Latest Pharma and Biotech News
Pharmaceutical
9 September 2026 At the 2026 European Respiratory Society (ERS) International Congress, Boehringer Ingelheim (BI) presented results from the Phase IIa/IIb trial of BI 1839100, an investigational asset for chronic cough in idiopathic pulmonary fibrosis (IPF).
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Biotechnology
US clinical-stage biotech Tyra Biosciences yesterday announced initial results from SURF302, its Phase II study evaluating oral dabogratinib in patients with FGFR3-altered low-grade intermediate-risk non-muscle invasive bladder cancer (LG IR NMIBC). 10 September 2026
Biotechnology
US biotech Evommune has said its oral MRGPRX2 antagonist EVO756 failed to meet its primary or secondary endpoints in a Phase IIb trial in moderate-to-severe atopic dermatitis (AD), and that it does not plan to advance the candidate further in the indication. 10 September 2026
Biotechnology
Swiss pharma giant Roche today announced that the US Food and Drug Administration (FDA) has granted Priority Review to a supplemental Biologics License Application (sBLA) for Enspryng (satralizumab) for the treatment of myelin oligodendrocyte glycoprotein antibody-associated disease (MOGAD). 10 September 2026
Biotechnology
USA-based Solstice Oncology has launched with a $225 million Series A financing to advance porustobart, a second-generation, Fc-enhanced CTLA-4 antibody, into neoadjuvant treatment of colon cancer. 10 September 2026
Biotechnology
UK clinical-stage biotech Alchemab Therapeutics has appointed experienced pharma and biotech leader Dr Ben Porter-Brown as chief medical officer (CMO) to accelerate the clinical development of the company’s pipeline of highly novel antibody therapeutics. 10 September 2026
Pharmaceutical
The US Food and Drug Administration (FDA) yesterday granted accelerated approval for German pharma major Bayer’s Hyrnuo (sevabertinib), a kinase inhibitor, for adult patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) whose tumors have HER2 (ERBB2) tyrosine kinase domain (TKD) activating mutations, as detected by an FDA-authorized test. 10 September 2026
Biotechnology
Netherlands-based Scenic Biotech, a company developing therapies that restore lysosomal function in neurodegenerative disease, has appointed Judith Walker as chief medical officer, as the firm prepares to move its lead program into the clinic in early 2027. 10 September 2026
Biotechnology
US clinical stage biotech Callio Therapeutics has announced the appointment of Zachary (Zach) Hornby as chief executive (CEO). 10 September 2026
Pharmaceutical
For the past 20 months the European Union has been running a single, shared review of the evidence behind certain new medicines, replacing part of the work that 27 countries used to do separately. The system began operating on 12 January 2025. It published its first finished report in June 2026, and three more have followed since. 10 September 2026
Pharmaceutical
US biotech company TwoStep Therapeutics has secured Food and Drug Administration (FDA) clearance to begin human testing of its lead cancer candidate, TS-104, alongside an oversubscribed $62.5 million series A financing. The San Carlos, California-based firm said patient enrollment in a first-in-human Phase I trial should begin before the end of the year. 10 September 2026
Biotechnology
US biotech company Encoded Therapeutics has closed a $275 million series F financing that will fund pivotal testing of ETX101, a gene therapy for Dravet syndrome, a severe form of childhood epilepsy. The privately held South San Francisco firm announced the round on Wednesday, days after presenting updated trial data at the European Epilepsy Congress. 10 September 2026
Pharmaceutical
The British Association for Sexual Health and HIV (BASHH) is deeply disappointed by the UK’s National Institute for Health and Care Excellence’s (NICE) draft recommendation not to approve lenacapavir for HIV prevention in the National Health Service (NHS) in England. 10 September 2026
Pharmaceutical
US biopharma company MannKind Corp and Rose Pharma today announced that they have entered into a worldwide licensing and collaboration agreement to develop ROSE-010 Technosphere for weight management. 9 September 2026
Biotechnology
The US Food and Drug Administration (FDA) has granted Breakthrough Therapy designation (BTD) to Cimzia (certolizumab pegol) for the prevention of placenta-mediated adverse pregnancy outcomes in pregnant women who have antiphospholipid syndrome (APS) and are positive for lupus anticoagulant (LA). 9 September 2026
Biotechnology
NodThera, the US biotech developing oral NLRP3 inhibitors, has renamed itself Rezera and announced plans to advance its lead candidate, ruvonoflast, into a Phase III trial in peripheral artery disease (PAD) in the first half of 2027, alongside positive topline data from a Phase II study of the drug. 9 September 2026
Biotechnology
US biotech Kura Oncology today announced the launch of Caspian Therapeutics, a separately financed company established to advance small-molecule menin inhibitors for diabetes and cardiometabolic diseases. 9 September 2026
Pharmaceutical
Shionogi today released the results of an additional Phase II clinical trial in patients with dystrophic epidermolysis bullosa and a global Phase II clinical trial in patients with acute ischemic stroke for redasemtide (a peptide drug created from HMGB1; S-005151), a regeneration-inducing medicine candidate in-licensed from fellow Japan-based StemRIM. 9 September 2026
Pharmaceutical
An artificial intelligence reading of lung scans from a mid-stage trial of Endeavor BioMedicines' taladegib has found that the experimental drug improved the physical structure of the lungs in idiopathic pulmonary fibrosis (IPF), an effect its developers argue standard breathing tests capture only in part. 9 September 2026
Biotechnology
Bristol Myers Squibb, the US pharma major, has reported positive topline Phase II results for arlocabtagene autoleucel (arlo-cel; BMS-986393), an investigational GPRC5D-directed CAR T cell therapy, in patients with relapsed and refractory multiple myeloma who had already failed four drug classes. 9 September 2026
Biotechnology
Swedish biologics company Simris Group has settled on amanitin as the basis of its antibody-drug conjugate work, and says it intends to take two proprietary programs into clinical development by late 2027 or early 2028. 9 September 2026
All news
Pharmaceutical
Swedish specialty pharma company Xspray Pharma has been turned away by the US Food and Drug Administration (FDA) for a fourth time, receiving a Complete Response Letter (CRL) for leukemia candidate Dasynoc on August 19, less than a week before a scheduled decision date of August 25. 24 August 2026
Pharmaceutical
New figures from Statistics Denmark show a slowdown in Danish gross domestic product (GDP) growth and a slowing growth in exports. After a strong start to the year, economic progress has slowed down. 24 August 2026
Pharmaceutical
Norway’s pharma trade group the LMI, the Norwegian Cancer Society, the Norwegian Association of the Disabled (FFO) and LHL organized “The Honest Discussion on Priorities in the Health Service” during Arendal Week. 24 August 2026
Pharmaceutical
The chronic kidney disease (CKD) market across the seven major markets (7MM; the USA, France, Germany, Italy, Spain, the UK and Japan) is forecast to grow at a compound annual growth rate (CAGR) of 9.8% from $4.3 billion in 2025 to $10.9 billion in 2035. 24 August 2026
Biotechnology
Significant research news last week included Dutch biotech argenx reporting strong Phase III results for its Vyvgart in autoimmune myositis. Also, Merck & Co and Moderna released positive new Phase III data for their intismeran plus Keytruda as a treatment for melanoma. On the M&A front, USA based BioMarin announced it is acquiring Dutch biotech Alesta Therapeutics and its lead asset ALE1, while US companies Werewolf and Ambros Therapeutics revealed plans to merge. 23 August 2026
Pharmaceutical
Chinese contract development and manufacturing group WuXi Biologics has agreed to sell its 51.1% stake in Bestchrom, a Shanghai-based supplier of chromatography resins and columns, to an unnamed independent third party. The deal is expected to close by December 2026. Financial terms were not disclosed. 21 August 2026
Generics
Today, the US Food and Drug Administration published a new batch of draft product-specific guidances (PSGs) for developing generic drugs and generating evidence for abbreviated new drug applications (ANDAs). 21 August 2026
Biotechnology
US biotech Cabaletta Bio has named ElevateBio as a second contract development and manufacturing organization (CDMO) for its lead cell therapy rese-cel (resecabtagene autoleucel), placing a privately held Massachusetts operator alongside Swiss CDMO major Lonza as the candidate moves toward a regulatory filing. 21 August 2026
Biotechnology
US cancer care biotech Werewolf Therapeutics and Ambros Therapeutics today announced that they entered into a definitive merger agreement to combine the companies in an all-stock transaction. Werewolf’s shares leapt 128% to $0.99 on the news. 21 August 2026
Pharmaceutical
Privately-held Italian drugmaker Alfasigma has entered into a share purchase agreement with SEVER Life Sciences (SEVER) for the sale of 100% of the shares of Nordic Group and its subsidiaries, a privately owned specialty pharmaceutical company with direct operations in Europe, Canada and Japan. 21 August 2026
Biotechnology
Johnson & Johnson has announced that the European Commission (EC) has approved an indication extension for Tecvayli (teclistamab) in combination with daratumumab for adults with relapsed or refractory multiple myeloma (RRMM) who have received at least one prior therapy, introducing the option as early as second line. 21 August 2026
Biotechnology
Boston, USA-based biotech Amplitude Therapeutics has announced a strategic research collaboration and licensing agreement with US pharma major Eli Lilly to discover and develop trans-amplifying RNA (taRNA) vaccine candidates for infectious diseases. 21 August 2026
Biotechnology
Canada-based Edesa Biotech has priced an underwritten public offering expected to generate approximately $25 million in gross proceeds. The company’s shares slumped 17.2% to $4.76 following the announcement. 21 August 2026
Biotechnology
San Francisco-based Chai Discovery, an artificial intelligence (AI) company building computational design tools for molecules, has entered a collaboration with US pharma major Bristol Myers Squibb to advance antibody discovery using AI. 21 August 2026
Pharmaceutical
UK-based specialty CNS-focused pharma company CNX Therapeutics today announced a distribution partnership with Innomar Strategies, a part of Cencora, for Sativex (nabiximols) in Canada. 21 August 2026
Pharmaceutical
Nearly eight years into the artificial intelligence (AI) drug discovery boom, no medicine discovered or designed with AI has been approved by a regulator in any major market. What the field has accumulated by August 2026 is capital, trial starts and a thin first layer of human data. 21 August 2026
Biotechnology
The UK's cost-effectiveness watchdog has recommended US pharma major Eli Lilly's once-weekly basal insulin Onswik (insulin efsitora alfa) for adults with type 2 diabetes on the National Health Service, even though the product has yet to be licensed in the country. 21 August 2026
Pharmaceutical
Charles River Laboratories International and Taiwan’s Medigen Vaccine Biologics (MVC) have announced a strategic collaboration focused on the characterization and validation of the virus seed bank for MVC’s next-generation multivalent enterovirus vaccine. 21 August 2026
Biotechnology
Genentech, Roche’s US biotech subsidiary, announced plans to invest approximately $750 million in a new device fill-finish manufacturing facility at its 75-acre campus in Hillsboro, Oregon. 21 August 2026
Biotechnology
UroGen Pharma, a US biotech focused on treating urothelial and specialty cancers, has entered into a strategic option and research license agreement and a related equity investment agreement with IntraGel Therapeutics. 20 August 2026
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