Pfizer Inc. said that, in children aged 5 through 11, the COVID-19 vaccine it co-developed with Biontech SE showed 90.7% efficacy against all variants of concern following two doses. The data were included in briefing documents filed ahead of a full discussion at the FDA’s Vaccines and Related Biological Products advisory committee meeting set for Oct. 26. Read More

DUBLIN – Oncopeptides AB has withdrawn its troubled multiple myeloma drug Pepaxto (melphalan flufenamide) from the U.S. market, less than eight months after receiving an accelerated approval from the FDA. The move comes less than a week before the FDA’s Oncologic Drugs Advisory Committee was due to consider the drug’s safety profile because of data anomalies that surfaced over the summer. Read More

Marking September as the second busiest month, 2021 is more than 6% ahead of last year in terms of reported clinical data, although the gap between the two years has narrowed significantly from 26% in April. Read More

Metacrine Inc.’s departure, in the wake of mixed phase IIa results, from the fiercely competitive nonalcoholic steatohepatitis (NASH) space with farnesoid X receptor (FXR) agonist MET-642, put a serious dent in shares and brought implications for other players. The San Diego-based firm’s stock (NASDAQ:MTCR) closed at $1.63, down $2.20, or 57%, as its plans to shift emphasis from NASH to inflammatory bowel disease (IBD) were made known. Read More

Aicuris Anti-Infective Cures AG has expanded an antibacterial collaboration with Lysando AG to focus on a topical treatment for diabetic foot infections, based around technology that attacks bacteria using specially-designed molecules based on phage proteins. Read More

LONDON – A new National Security Act coming into force on Jan. 4, 2022, will extend the U.K. government’s power to scrutinize and intervene in foreign acquisitions and bring a swathe of domestic life sciences companies within the ambit of national security legislation for the first time. Read More

New hires and promotions in the biopharma industry, including: Aprecia, Athira, Dynavax, Landmark, Promis. Read More

Biopharmas raising money in public or private financings, including: Adma, Aeromics, Egle, Gardiner, Iveric, Simcere. Read More

Clinical updates, including trial initiations, enrollment status and data readouts and publications: Alx, Beyondspring, Biocardia, Biontech, Crescendo, Frequency, Genfleet, Karyopharm, Matinas, Morphosys, PDS, Remynd, Revolo, Scynexis, Sio, Sumitomo Dainippon, Zai. Read More

Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Achilles, Agenus, Aslan, Castle Creek, Cel-Sci, Cue, Emergence, Ernest, Generation, I-Mab, Incyte, Kadmon, Longbow, Mablink, Marinomed, Oncodesign, Palisade, Promega, Qiagen, Sanofi, Selecta, Seneca, Shandong, Shenandoah, Sio, Specialized Therapeutics, Theratechnologies, Varmx. Read More

Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Alphamab, BMS, Currax, Glaxosmithkline, Intellia, Merck, Neuren, Regeneron, Sanofi, Sio, Small, Tetra, Tryp, Ultimovacs. Read More

Total raised in public, private and other financings of biopharma companies, comparing 2021 vs. 2020 vs. 2019. Read More

Year-to-date money raised in public, private and other financings of biopharma companies. Read More

The top 10 biopharma stock gainers and losers for the week. Read More