What a difference a U.S. FDA advisory committee meeting can make. In the wake of the Peripheral and Central Nervous System Drugs Advisory Committee voting 7-2 Sept. 7 to recommend approval of Amylyx Pharmaceuticals Inc.’s amyotrophic lateral sclerosis (ALS) candidate, shares of the Cambridge, Mass.-based company (NASDAQ:AMLX) more than regained the value they lost in March when the same committee voted against approval of AMX-0035. Read More
The U.S. FDA’s approval of Revance Therapeutics Inc.’s Daxxify (daxibotulinumtoxinA-lanm) for the temporary improvement of moderate to severe glabellar lines, or frown lines, in adults, positioned the drug to compete with Abbvie Inc.’s blockbuster, Botox (onabotulinumtoxinA), which tallied $678 million in global net revenues for the second quarter of 2022. Read More
Ducentis Biotherapeutics Ltd. has been acquired by Arcutis Biotherapeutics Inc. for up to $400 million, representing a landmark moment for seed investor Lifearc Ventures, which aims to kick-start promising biotechs in the U.K. while giving any investment returns to its parent medical charity. Read More
Shanghai Junshi Biosciences Co. Ltd. plans to raise up to ¥3.969 billion (US$570 million) by issuing no more than 70 million A shares to target subscribers on the Shanghai STAR Market. Read More
Photys Therapeutics Inc. raised a $75 million series A financing to develop phosphorylation-inducing chimeric small-molecule medicines to fix dysfunctional proteins. Photys, of Cambridge, Mass., was founded by the Longwood Fund and Amit Choudhary of Brigham and Women’s Hospital and the Broad Institute of MIT and Harvard University. Read More
Inflarx NV is poised to apply for U.S. FDA emergency use authorization for its complement inhibitor, vilobelimab, in treating seriously ill, mechanically ventilated COVID-19 patients, following a reappraisal of the statistical analysis of the 369-patient placebo-controlled phase III trial. Read More
ESMO late breakers were released Sept. 8, and scientifically at least, a key theme of the meeting will be that cell therapies, at long last, are capable of besting solid tumors. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Basilea, Nodus, Takeda, Tetra, Tikomed, Virogin, Zealand. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Acelink, Advanced Accelerator, Ammax, Edgewise, Eledon, Fresenius, FSD, Gilead, Iecure, Lytix, Moleculin, Myrtelle, Pfizer, Praxis, Rhythm, Sarepta, Seres, Spero, Tarsus, Viracta. Read More
