Two weeks ahead of its Jan. 6, 2023, PDUFA date, the U.S. FDA has approved the bispecific Lunsumio (mosunetuzumab) to treat adults with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy. It’s the first bispecific antibody approved for treating any type of non-Hodgkin lymphoma (NHL). FL is the most common slow-growing form of NHL. Read More
Topping biopharma regulatory news in 2022 was the signing of the Inflation Reduction Act (IRA), as its provisions requiring Medicare to directly negotiate certain prescription drug prices will open the door for the first time to a degree of government price controls in the U.S., affecting the bottom line of drug companies around the world. Read More
South Korea’s Legochem Bioscience Inc. inked a licensing deal with Amgen Inc. on Dec. 23 for five undisclosed antibody drug conjugate (ADC) targets worth up to ₩1.6 trillion (US$1.24 billion). Under the terms of the deal, Legochem will out-license global rights to Amgen for five undisclosed ADC targets and will receive an undisclosed up-front payment as well as development milestones and sales royalties. The companies did not disclose additional details. Read More
As the biopharma industry moves away from the COVID-19 pandemic and expands research in other areas, the amount of money flowing into companies through deals with nonprofit or government entities and grants has plummeted 53% in comparison with 2021. The drop is mainly due to a diminishing number and a lower overall value of bio/nonprofit partnerships. Grants, on the other hand, have risen in both areas. Read More
In 2021, Biogen Inc.’s Aduhelm (aducanumab) became the first amyloid-targeting therapy to win U.S. FDA approval in Alzheimer’s disease. After decades and dozens of failed phase III trials, the drug was granted accelerated approval in June 2021. In January 2022, however, the U.S. Center for Medicare & Medicaid Services said it would only cover use of Alzheimer’s MAbs targeting amyloid in NIH trials or trials it approved, thus appearing to call into question the rigor of FDA-approved trials. Read More
Congress has wrapped up the budget for fiscal year 2023 with yet another significant boost to funds for the National Institutes of Health, but the omnibus legislation also authorizes the U.S. FDA to designate academic research centers as centers of excellence for continuous drug manufacturing. A conspicuous omission from the omnibus was the Verifying Accurate, Leading-edge IVCT Development (VALID) Act for FDA regulation of lab-developed tests (LDTs), an omission that drew both praise and criticism from stakeholders. Read More
Biopharmas raising money in public or private financings, including: AB Science, Acelrx, Advanced Proteome, Biontech, Kalvista, Lipella, Mesoblast, Outlook, Poxel, Relief, Ryvu, Tracon. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Applied Molecular Transport, Atai, Biontech, Cellectis, Dilafor, Immunis, Jiangsu Recbio, Karolinska, Kures, Nanobiotix, Neuren. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Acer, Adaptimmune, Antengene, Basilea, Biogen, Brainstorm, Celltrion, Coherus, Daiichi Sankyo, DBV, Deka, Disc, Eisai, Elpiscience, Immutep, Junshi, Kite, Relief. Read More
