Acadia Pharmaceuticals Inc. President Serge Stankovic said the company was “kept completely in [the] dark” by the FDA regarding specifics about what the agency found wrong a month ago with the sNDA for Nuplazid (pimavanserin) – until, that is, the agency’s complete response letter (CRL) landed on the firm’s desk. Read More
Janssen Pharmaceuticals Inc. has agreed to pay up to $780 million in up-front, milestone payments and R&D funding for exclusive rights to antiviral conjugates to be developed by Cidara Therapeutics Inc. for the prevention and treatment of seasonal and pandemic influenza. Read More
Full rights to TAK-169, a CD38-targeted engineered toxin body that Takeda Pharmaceuticals Co. and Molecular Templates Inc. have been developing, are going to Molecular Templates as is the therapy’s clinical development. Read More
LONDON – Phoremost Ltd. has raised $46 million in an oversubscribed series B that will enable it to put clinical heft behind its claim to have developed a novel approach to finding and drugging inscrutable targets. Read More
Citing the limited data for CAR T therapies in treating multiple myeloma, the Institute for Clinical and Economic Review said their cost-effectiveness for some patients will depend on whether a second dose is needed. Read More
The number of venture capital financings completed in March, as well as the total amount they raised for the biopharma industry, are more than any other month in the past 21 years. With 92 rounds worth $6.2 billion, the volume is 35% higher than the September 2020 record of 68, and the total funds are 66% more than the $3.8 billion raised in the next top month of June 2020. Read More
The latest global regulatory news, changes and updates affecting biopharma, including: First thrombosis incident reported in Australia; FDA offers guidance on ANDAs during pandemic; FDA revises Moderna EUA; Fed Circuit’s indefinite ruling stands; BMS settles Medicaid rebate claims; GAO refuses to reconsider VA challenge. Read More
New hires and promotions in the biopharma industry, including: Biorestorative Therapies, Cymabay, DBV, Ichnos, Myovant, NLS, Oyster Point, Psybio. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Aeon, Bio-Path, Corbus, Fibrogen, Innovation, Ionis, Teneobio, Uniqure. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Acea, Advaxis, Amneal, Anixa, Can-Fite, Chinook, Emergent, Johnson & Johnson, Kashiv, Ontochem, Panacea, Sairopa, Sorrento, Teneobio, Vir, Virpax. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: 89bio, Abbvie, Acadia, Exelixis, Eli Lilly, Passage, Supernus, Tetra. Read More
