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 was 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. The vaccine is already FDA-approved for people aged 16 and older and has emergency use authorization for those aged 12 through 15. The companies also just released phase III data showing a booster of the vaccine, marketed as Comirnaty (tozinameran), showed 95.6% efficacy in participants aged 16 and older.

Oncopeptides stock craters as it pulls melanoma drug Pepaxto from U.S. market

DUBLIN – Oncopeptides AB has withdrawn its troubled melanoma drug Pepaxto (melphalan flufenamide) from the U.S. market, less than eight months after receiving an accelerated approval from the FDA.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, after data anomalies surfaced over the summer.

NASH exit, IBD shift with FXR prospect sends Metacrine shares into tailspin

Shares of Metacrine Inc. (NASDAQ:MTCR) were trading midday at $1.68, down $2.14, or 56%, after disclosing mixed results from a phase IIa trial in non-alcoholic steatohepatitis with farnesoid X receptor (FXR) agonist MET-642. At the same time, the company made known its plan to shift its efforts with the compound to inflammatory bowel disease (IBD). A phase II study is next in IBD, where FXR-targeting drugs have yet to generate clinical data.

U.K. government gets bigger voice in foreign buyouts of certain domestic firms

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

Clinical activity up 6%; oncology and anti-infectives lead the pack

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. The 3,135 items of clinical news collected by BioWorld this year compare with 2,954 during the same timeframe of 2020. Only about 14% this year involves vaccines or therapeutics for the SARS-CoV-2 virus, compared with 22.5% last year.

Aicuris expands deal with Lysando to develop endolysin-based antibacterial

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. The potential therapy is based around endolysins, enzymes that phages use to break down bacterial cell walls. There’s a pressing need for new approaches to the problem of antimicrobial resistance, with research into new antibiotics sluggish because of the challenging reimbursement environment for such medicines.

Also in the news

Aadi, Achilles, Adma Biologics, Agenus, Akeso, Aslan, Athira, Axalbion, Cel-Sci, Cue, Egle, Endo, Ernest, Gardiner Healthcare Acquisitions, Generation, Helixmith, Horizon, Humanigen, I-Mab, Incyte, Iveric, Johnson & Johnson, Kadmon, Kintor, Leo, Merck, Metacrine, Moderna, Numinus, Ocular, OS Therapies, Palette Life Sciences, Palisade, Promega, Qiagen, Reven, Revolo, Sanofi, Servier, Shenandoah, Shionogi, Sio Gene Therapies, Specialised, Theratechnologies, Vectivbio, Xilio