With more-than-satisfying phase III data in hand, Minneapolis-based Celcuity Inc. is eyeing an NDA submission in the fourth quarter of this year for gedatolisib (geda) in breast cancer. Shares of the company (NASDAQ:CELC) closed July 28 at $36.79, up $23.02, or 167%, after Wall Street learned of stellar top-line results from the PIK3CA wild-type cohort of the phase III Viktoria-1 trial. Read More
Hengrui Pharmaceuticals Co. Ltd. is out-licensing to GSK plc its potential best-in-class phase I phosphodiesterase 3 and 4 inhibitor (HRS-9821) for treating chronic obstructive pulmonary disease along with 11 additional programs in development for $500 million up front and up to $12 billion in potential milestones. Read More
Pharmaceutical exports from the EU to the U.S. are facing a leap in tariffs from zero duty to 15%, following the trade deal between EU Commission President Ursula von der Leyen and U.S. President Donald Trump sealed in Scotland July 27. Read More
After Recognify Life Sciences Inc.’s phase IIb failure in treating the cognitive impairment in those with schizophrenia, the indication is no closer to a U.S. FDA approved therapy. The placebo-controlled study of inidascamine missed its primary endpoint to improve cognition, joining a list of companies that have tried and failed to find a successful treatment. Read More
While U.S. government cost-cutting seems to be the Trump administration’s priority that consumes all others, some Republican senators are pushing back – at least when it comes to the NIH. Fourteen senators wrote to Russell Vought, head of the White House Office of Management and Budget, to voice their concerns about the administration’s slow disbursement rate of the NIH’s fiscal 2025 funds. Read More
Danish vaccines manufacturer Bavarian Nordic A/S is to be taken private in a DKK233 per-share deal valuing the company at DKK19 billion (US$2.97 billion). The deal needs the support of 90% of Bavarian Nordic shareholders to go through, and as things stand may not reach that target because it does not have the support of the largest shareholder, the Danish pension fund ATP, which owns 10.17%. Read More
Chinese financings are picking up, with Everest Medicines Ltd. raising US$200 million and Nanjing-based Leads Bioloabs Co. Ltd. listing on the main board of the Hong Kong Stock Exchange in a $189 million IPO. Read More
Researchers at the Fred Hutchinson Cancer Research Center found that autoantibodies targeting the exoproteome reshaped checkpoint inhibitor responses and opened new avenues to enhance immunotherapy. In the study published in the July 23, 2025, issue of Nature, the authors set out to address a long-standing question in cancer immunotherapy: why patients with the same type of cancer, treated with the same immunotherapy, can experience such drastically different outcomes. Read More
Biopharmas raising money in public or private financings, including: Abivax, Absci, Algernon, Everest, Hemostemix, Omeros, Pharvaris, Targepeutics. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Adocia, Astrazeneca, Biovie, Jeune, Kintor, Memo, Tonghua Dongbao. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Indivior, Klotho, Liminatus, Revolution. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Astrazeneca, Biogen, Biontech, Eli Lilly, Gilead, GSK, Ipsen, Krystal, Moderna, Novo Nordisk, Omeros, Pfizer, Roche, Sanofi, Servier, Sobi. Read More
