The question wasn’t if, but when and how, someone would challenge the Medicare negotiation provision laid out in the Inflation Reduction Act (IRA) that was signed into U.S. law last year. Read More
Six months after getting accelerated approval from the U.S. FDA without any input from an advisory committee, Eisai Co. Inc. and Biogen Inc.’s Alzheimer’s disease (AD) therapy, Leqembi (lecanemab) will make an appearance June 9 before the Peripheral and Central Nervous System Drugs Advisory Committee (PCNSDAC), set to discuss the supplemental BLA seeking to convert use of the amyloid beta-targeting antibody to traditional approval. Read More
Standing as one of the more prominent among incurable conditions, Parkinson’s disease (PD) still hasn’t met a medicine or surgical intervention that can slow or stop progression, despite efforts of many drug developers testing new strategies. Read More
Since accelerated approvals first began to be granted in 1992, their pace for cancer indications has increased dramatically but a revolution in science has made it tough for the U.S. FDA to find its balance. Read More
Cellusion Inc. raised ¥2.83 billion (US$21 million) in a series C round to progress its lead therapy, CLS-001, an iPS cell-derived therapy to treat bullous keratopathy. Read More
It has been a tough spring for Fibrogen Inc., which reported another phase III miss on June 7, this time for rare disease drug pamrevlumab to treat non-ambulatory patients with Duchenne muscular dystrophy (DMD). Read More
Free, no-prescription-required access to naloxone has reduced deaths from opioid overdoses by 11% in some communities, but they only work if someone with the reversal agent is available when a person overdoses. Resilient Lifescience Inc. hopes to save those lives, too. The company is developing a wearable patch that monitors vital signs and automatically administers naloxone when needed. In this edition of the BioWorld Insider podcast, Brad Holden, CEO of Resilient Lifescience, explained how the device works for overdoses as well as other potential applications for the new technology.
New hires and promotions in the biopharma industry, including: Abivax, Amarna, Chemomab, Entera, Lobe, Mekanistic, Nkilt, Nona, Ring, Satellos, XNK.Read More
New and updated preclinical and clinical data presented by biopharma firms at the American Society of Clinical Oncology annual meeting, including: Agenus, Akeso, Alligator, Arcus, Atara, Bold, Coherus, Dragonfly, Ellipses, Erasca, Fulgent Genetics, Galera, Gilead, Gilead Sciences, Gracell, Iaso, Immunocore, Immunogen, Immutep, Innovent Biologics, Intensity, ISA, Janssen, Kite, Linnaeus, Memgen, NEC, Precigen, Transcenta, Transgene. Read More
Biopharmas raising money in public or private financings, including: Bitterroot, Cogent, Day One, Effector, Hopewell, Ionis, Kiora, Mozart, Newamsterdam, Nrx, Transcode, Vaxart. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Abtherx, Acuitas, Aegis, Alpha, Bayer, Biontech, Chemomab, Gilead, Lucy, Moderna, Nordic Nanovector, Pasithea Pfizer, Promosome, Scisparc and Thor. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Amphera, Brainstorm, Fennec, GSK, Merck & Co., Quralis, Tscan, Vyluma. Read More
