After delaying a June PDUFA date, the U.S. FDA has approved Kalvista Pharmaceuticals Inc.’s Ekterly (sebetralstat) for hereditary angioedema (HAE) in those aged 12 and older. The plasma kallikrein inhibitor now joins a market with previously approved drugs for the rare, genetic, life-threatening condition, as well as other companies with HAE drugs in development. Ekterly is the first orally-delivered on-demand treatment, as all others in the U.S. are intravenously or subcutaneously administered. Read More
Jasper Therapeutics Inc.’s otherwise upbeat data with subcutaneous briquilimab was hamstrung by apparent trouble with one lot of drug used in the phase Ib/II Beacon study in chronic spontaneous urticaria. Shares of the Redwood Calif.-based firm (NASDAQ:JSPR) closed July 7 at $3.04, down $3.73, or 55%.
President Donald Trump signed House Resolution 1, the final version of which does not impose a moratorium on state legislation governing the use of AI. The bill does, however, restore the full deductibility of research and development expenses, which will be retroactive to 2022 for businesses that gross $31 million or less per year. Read More
China’s National Medical Products Administration gave the green light to Simcere Pharmaceutical Group Ltd.’s Enzeshu (suvemcitug) for treating recurrent ovarian cancer, fallopian tube cancer, or primary peritoneal cancer in combination with paclitaxel, liposomal doxorubicin, or topotecan in adults who have received at least one systemic therapy after platinum resistance. Read More
Cogent Biosciences Inc. is eyeing an NDA submission to the U.S. FDA by the end of this year in the wake of positive top-line results from the registration-directed second part of the Summit phase II trial testing bezuclastinib in non-advanced systemic mastocytosis (SM). The data show clinically meaningful and highly statistically significant improvements in SM across the primary and all key secondary endpoints, including patient-reported symptoms and objective measures of mast cell burden. Read More
Apogee Therapeutics Inc. plans to enter a crowded atopic dermatitis market with established drugs, such as Dupixent (dupilumab, Regeneron Pharmaceuticals Inc. and Sanofi SA) and Ebglyss (lebrikizumab-lbkz, Eli Lilly and Co.), which are sold by much larger competitors. But the company thinks it can compete with its anti-IL-13 antibody, APG-777, thanks to the drug’s 77 day half-life that may allow it to be dosed only two to four times a year in the maintenance phase, compared to 13 to 26 injections per year for the established competitors. Read More
Biopharma companies raised $7.38 billion across 99 transactions in June 2025, up from $5.55 billion in May and $2.4 billion in April. For the first half of the year (H1), total financings reached $28.74 billion, down 59% from the $70.32 billion raised during the same period in 2024. Although lower than the record-setting levels of 2020 and 2021, the current total aligns more closely with recent years, including $26.57 billion in the first half of 2022 and $30.57 billion in 2023. Read More
The EU is to harness the “silver economy” of its aging population to help drive innovation and growth as part of a new strategy to make Europe “the most attractive place in the world for life sciences by 2030.” Read More
Wuhan Healthgen Biotechnology Co. Ltd. gained clearance from the Shanghai Stock Exchange July 1 to list under a recently reinstated IPO growth tier geared towards supporting “unprofitable” biotechnology firms. Read More
Finding they were “arbitrary and capricious” under the Administrative Procedures Act, the District Court for the District of Columbia vacated a White House Office of Personnel Management memo and a subsequent Department of Health and Human Services’ guidance intended to implement President Donald Trump’s Day 1 executive order pertaining to gender ideology. Read More
Led by the American Academy of Pediatrics, several medical groups went to court July 7 to force Health and Human Services Secretary Robert Kennedy to restore the CDC’s COVID-19 vaccine recommendations for pregnant women and healthy children ages 6 months to 17 years. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Bioatla, Everest, Inventiva, Marengo, Novartis. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: 4DMT, Alera, Boehringer Ingelheim, CB, Clinigen, Maat, Neurizon, Oxford, Theratechnologies. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Apotex, Biocon, Dizal, Johnson & Johnson, OS Therapies, Regeneron. Read More
