The FDA’s approval of Genentech Inc.’s Gavreto (pralsetinib) for treating adults with metastatic rearranged during transfection (RET) fusion-positive non-small-cell lung cancer (NSCLC) follows the FDA’s May approval of Eli Lilly and Co.’s Retevmo for patients whose tumors have a RET alteration. Gavreto will be commercialized in the U.S. by Genentech, part of the Roche Group, along with Blueprint Medicines Corp., which developed the once-daily oral therapy. Outside the U.S., Roche will handle commercialization. Read More

Good news from a pivotal phase III trial of Albireo Pharma Inc.'s odevixibat has moved the world one step closer to going from no treatments for the rare genetic liver disease PFIC to possibly having two: Albireo's entrant and another candidate, maralixibat from Mirum Pharmaceuticals Inc. Read More

Corbus Pharmaceuticals Holdings Inc.’s lenabasum having failed its phase III test in diffuse cutaneous systemic sclerosis (SSc), attention turned to prospects with the cannabinoid receptor type 2 agonist for other indications. Read More

DUBLIN – Spybiotech Ltd. has secured a first vaccine deal for its proprietary Spytag/Spycatcher protein conjugation technology. The Serum Institute of India Pvt. Co. Ltd. (SIIPL) is employing the technology in a COVID-19 virus-like-particle (VLP)-based vaccine, which recently entered a phase I/II trial in Australia. An initial data readout is expected in October or November. Read More

In a relatively light news flow for the group last month, the gainers and decliners in the BioWorld Neurological Diseases index canceled themselves out during August, with the result that the price-weighted index closed relatively flat and, despite briefly moving into positive territory in July, its value is down 4% for the year. Read More

BioWorld looks at translational medicine, including: Oxygen grows tumors but shrinks metastasis chances; Prion protein’s positive point. Read More

A quick look back at top stories. Read More

BioWorld's offices were closed in observance of Labor Day in the U.S. No issue was published Monday, Sept. 7. Read More

New hires and promotions in the biopharma industry, including: Advaxis, Cavogene, Fibrogen, Imcyse, Metrion, PMV, Tmunity. Read More

Biopharmas raising money in public or private financings, including: Algenex, Graybug, Immunovant, Inversago, Manifold, PMV, Prelude. Read More

Clinical updates, including trial initiations, enrollment status and data readouts and publications: Albireo, Allena, Astrazeneca, Athenex, Bayer, Bellus, Biomarin, BMS, Calliditas, Celularity, Clene, Compugen, Corbus, Cyclo, Goldfinch, HRA Pharma, Insmed, Kamada, Merck, Novartis, Radius, Sanofi, Savara, Silence, Spero, Strongbridge, Synairgen, Transgene, Translate Bio, Valneva, Verona. Read More

Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Alkahest, Anges, Anheart, Aptorum, Astrazeneca, Auris, Aveo, Avidity, Biodesix, Biomica, Biontech, Briacell, Brickell, Canbridge, Catalent, Cheplapharm, CN, Cymerus, Daiichi Sankyo, Destiny, Exelixis, Exmceuticals, Glaxosmithkline, Grifols, Humanigen, Icanomab, Innovation, Inovio, Intravacc, Johnson & Johnson, Kite, Lineage Cell, Mab, Moderna, Mylan, NBE, Novavax, Pharmacyte, Pharmamar, Phoremost, Protalix, Recce, Redhill, Regenerx, Sanofi, Silence, Sporegen, Takeda, Vaxart, Vaxil, Vyne, Xtalpi, Zyversa. Read More

Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Aft, Arcutis, Aridis, Ascentage, Atara, Athena, Beyondspring, Caribou, Heron, Hyloris, Kadmon, Kleo, LNC, Marinomed, Ocular, Prometic, Protara, Roche, Silence, VBL. Read More

The latest global regulatory news, changes and updates affecting biopharma, including: Abbvie, Allergan, Astrazeneca, Calvin Scott, Gedeon Richter, HRA Pharma, Nestle. Read More