Investors didn’t respond well to the U.S. FDA’s briefing document for the March 30 advisory committee meeting on Amylyx Pharmaceuticals Inc.’s amyotrophic lateral sclerosis (ALS) candidate. Shortly after the materials for the adcom were posted Monday, Amylyx (NASDAQ:AMLX) dropped from a morning high of $25.68 per share to an all-time low of $10.49 in the heaviest trading since the company went public in January. With share volume exceeding 15 million, Amylyx rebounded somewhat, ending the day at $16.01, down nearly 36% from its March 25 close of $25. Read More
Following another failure in amyotrophic lateral sclerosis (ALS), Biogen Inc. will discontinue its development of antisense oligonucleotide BIIB-078 with partner Ionis Pharmaceuticals Inc. The stumble is part of a mega-collaboration the two companies began 10 years ago that has also yielded a lot of success, including the blockbuster Spinraza (nusinersen). Read More
Zogenix Inc.’s Fintepla (fenfluramine) cleared the U.S. FDA hurdle shortly after its March 25 PDUFA date, expanding the drug’s use in patients with Lennox-Gastaut syndrome (LGS) and validating UCB SA’s $1.9 billion acquisition of Emeryville, Calif.-based firm, which closed earlier this month. Read More
For the first time this year, BioWorld’s Biopharmaceutical Index has entered positive territory, now showing a modest rise of 3.2% as the world limps further away from the worst of the COVID-19 pandemic. Despite the Russian invasion of Ukraine, rising inflation, and skyrocketing gas prices, the biopharma industry remains center-stage when it comes to preparing for another unexpected health crisis and for harnessing the knowledge of the last two years to fight stubborn diseases such as cancer and Alzheimer’s disease. Read More
The Biden administration has floated a budget proposal for fiscal year 2023, which includes $49 billion for the National Institutes of Health (NIH) and an additional FDA budget authority of $356 million over the current fiscal year. However, the budget also includes legislative proposals, such as a virtual inspection requirement for device manufacturing facilities and compulsory studies of drug shelf life to evaluate finished drug stability beyond the labeled expiration. Read More
The challenging financial environment of 2022 will lead to an increase in partnerships, according to representatives of the two big Swiss biopharma companies, Roche Holding AG and Novartis AG. Read More
After securing $70 million in series B funding, Chinese biotech Medilink Therapeutics Co. Ltd. is gearing up to enter the clinic with its next-generation antibody-drug conjugates (ADCs). Read More
China’s NMPA has given a green light for Walvax Biotechnology Co. Ltd.’s human papillomavirus (HPV) bivalent vaccine to be used against HPV types 16 and 18 to prevent cervical cancer. Read More
New and updated preclinical and clinical data presented by biopharma firms at the American Academy of Dermatology annual meeting, including: Arcutis, Dermavant, Janssen, Leo, Nimbus, Sun, Timber. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Alzamend Neuro, Aptatargets, Biogen, Canbridge, Icosavax, In8bio, Ionis, Morphic, Novavax, Pipeline, Prothena, Provention, Stalicla, Tiziana Life Sciences. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Adma, Aquavit, Astrazeneca, Blueprint, Exelixis,
Henlius, Incyte, Janssen, Kyowa Kirin, Mei. Merck, Neuren, Novartis, Roche, Vertex.
