Given the safety and efficacy data presented June 7 for Novavax Inc.’s COVID-19 vaccine, NVX-CoV2373, it came as no surprise when the U.S. FDA’s Vaccines and Related Biologic Products Advisory Committee voted 21-0, with one abstention, to support an emergency use authorization for the vaccine, which is already approved and being used in many other countries, including the EU and Canada. Read More

Immunos Therapeutics AG closed a $74 million series B round to progress its first-in-class, multifunctional immuno-oncology drug candidate, IOS-1002, and to expand further its pipeline of biologic drugs based on immuno-stimulatory human leukocyte antigen molecules. Read More

Code Biotherapeutics Inc. has raised an upsized and oversubscribed series A financing to develop programs for treating rare and genetic diseases that include Duchenne muscular dystrophy and type 1 diabetes. Read More

Wall Street took in stride mixed FDA briefing documents with regard to the upcoming adcom review of Bluebird Bio Inc.’s two gene therapy prospects, and shares of the company (NASDAQ:BLUE) closed at $3.61, up 63 cents, or 21%. Read More

The U.S. FDA’s accelerated approval path is front burner these days, what with Congress looking to modernize the path through provisions added to the must-pass user fee legislation, the controversy still boiling over the FDA’s accelerated approval last year of Biogen Inc.’s Alzheimer’s drug, Aduhelm (aducanumab), and a number of recent withdrawals of drugs granted accelerated approval years ago. Read More

Shanghai Henlius Biotech Inc.’s anti-PD-1 monoclonal antibody serplulimab has generated positive data in a phase III trial as a first-line treatment for extensive-stage small-cell lung cancer (ES-SCLC). Read More

Global regulatory activity has fallen slightly, partially due to a decline in pandemic activity, and U.S. FDA approvals of drugs and biologics are at their lowest levels in five years. Read More

As multidisciplinary care extends survival and improves the quality of life for people with amyotrophic lateral sclerosis (ALS), can a host of new ALS drugs vying to slow its progression make a difference? Join the BioWorld Insider podcast as we discuss what the future of medicine may hold for ALS patients. Read More

New hires and promotions in the biopharma industry, including: Adarx, Alpine Immune, Athira, Awakn, Brooklyn, Cytovia, Emergence, Forte, Immunomic, Inozyme, NLS, Prolacta, Regenxbio, Targimmune. Read More

New and updated preclinical and clinical data presented by biopharma firms at the American Diabetes Association's 82nd Scientific Sessions, including: Lilly, Sernova, Vertex, Zealand. Read More

New and updated preclinical and clinical data presented by biopharma firms at the American Society of Clinical Oncology annual meeting, including: Adicet, Akeso, Alphamab, Amgen, Anheart, Arcellx, Astrazeneca, Atara, Aveo, Ayala, Biontech, BMS, Carsgen, Centessa, Clovis, CG, Corcept, Cstone, Curis, Cyteir, Effector, Eisai, Enterome, Gilead, Henlius, Immunocore, Immutep, In8bio, Innovent, Intensity, Jacobio, Janssen, JW, Kite, Legend, Linnaeus, Mei, Menarini, Merck, Mirati, Nanobiotix. Read More

Biopharmas raising money in public or private financings, including: Cimcure, Concert, Coya, Evaxion, Inmed, Pinetree, Rockwell. Read More

Clinical updates, including trial initiations, enrollment status and data readouts and publications: Assembly, Arbutus, Corcept, Harmony, Innocare, Medexus, Neurocrine, Newamsterdam, Praxis, Verastem. Read More

Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Aslan, Bavarian, Editas, Find, Immatics, Kiromic, Microbion, MRM, SATT. Read More

Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Acer, Amgen, Antengene, Aum, Biocryst, Biondvax, BMS, Clarity, Cstone, Enlivex, GBT, Iaso, Innovent, Lexaria, Pfizer, Revive, Senhwa, Sensorion, Sifi, Veru. Read More