The U.S. FDA has approved the first treatment directly targeting the mites that cause Demodex blepharitis, an eye disease shared by about 25 million people in the U.S. and now a huge market opportunity for the developer. Read More
With the launch of intravenous Leqembi (lecanemab-irmb) for Alzheimer’s disease (AD) underway, Priya Singhal, Biogen Inc.’s head of development and interim head of research, said the firm, along with partner Eisai Co. Ltd., aims to “address the long-term duration question” with a subcutaneous version, recently touted at the Alzheimer's Association International Conference. Read More
Stoke Therapeutics Inc.’s stock tumbled 32% after the company reported phase I/IIa data of its antisense oligonucleotide, STK-001, in Dravet syndrome, showing it reduced convulsive seizures in children most consistently at the highest dose, with benefits increasing as time progressed. Read More
With Aeon Biopharma Inc. listing on the New York Stock Exchange (NYSE) on July 24, South Korea’s Daewoong Pharmaceutical Co. Ltd. is seeking new territory for its beleaguered botulinum toxin (BTX) product, Nabota (Jeuveau or ABP-450 in the U.S). Aeon’s move is expected help expand Nabota beyond aesthetic treatment to include medical conditions such as episodic migraines, cervical dystonia and post-traumatic stress disorder (PTSD). Read More
The identification of new targets in diseases of the central nervous system (CNS) such as Alzheimer’s and Parkinson’s – conditions which continue to have significant unmet needs – has taken a small step forward as one company, Violet Therapeutics Inc., plans to put $10.6 million in seed funding toward building out a pipeline based on technologies that elucidate the way cells interact amongst one another. Read More
The U.S. Court of Appeals for the Federal Circuit declined an invitation in United Therapeutics Corp. v. Liquidia Technologies Inc. to expand the enablement and written description bar for biopharma claims into the realm of regulatory approval. Read More
A lot of biosimilar sponsors and wannabes are watching as the biosimilar competition in the U.S. unfolds to challenge the all-time biggest-selling drug, Humira from Abbvie Inc. In this episode, BioWorld Regulatory Editor Mari Serebrov and Tom Newcomer, vice president and head of U.S. market access at Samsung Bioepis, discuss the biosimilars landscape. Read More
New hires and promotions in the biopharma industry, including: Acadia, Allarity, Atamyo, Aurobac, Bicara, Cabaletta, Capricor, Editas, Fibrogen, Kalvista, Kiromic, Pheon. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Astellas, Bausch, Breye, Dice, Eli Lilly, Golgi, Humanigen, Hvivo, Intelgenx, Oncurious, Oxurion, Peptidream, Roche, SQZ, Stada, Xbrane. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Avencell, Biocon, Hanchorbio, Keros, Mabwell, Molecure, Nectero, Overland, Polpharma, Replay, Verrica. Read More
