COVID-19 kept its grip on the world in 2021 as one new variant after another created new waves of infection, forcing regulatory officials to face ongoing political and logistical pressures in dealing with drug and vaccine approvals, mergers and acquisitions, manufacturing issues and demands for pricing reforms.
Beyondspring Pharmaceuticals Inc. said it received a complete response letter from the FDA regarding the NDA for plinabulin, the company’s lead asset. The FDA said results of a phase III registrational trial were strong enough to show benefit but a second trial is needed to satisfy the agency.
Following an FDA priority review, Takeda Pharmaceutical Co. Ltd.'s oral antiviral, maribavir, has won U.S. approval as the first drug in the country to treat resistant cytomegalovirus (CMV) infection and disease in adult and pediatric transplant recipients. The drug will be marketed as Livtencity.
With Omicron all the COVID-19 buzz right now, the FDA’s concern that the antiviral drug molnupiravir might enhance SARS-CoV-2 evolution might take on added weight when the Antimicrobial Drugs Advisory Committee meets Nov. 30 to advise on Merck & Co. Inc.-Ridgeback Biotherapeutics Inc.’s emergency use authorization (EUA) request for what could be the first take-at-home oral drug authorized to treat COVID-19 infections.
Constrained by the U.S. FDA’s authorized conditions of use for a booster dose of Pfizer Inc. and Biontech SE’s COVID-19 vaccine, the CDC’s Advisory Committee on Immunization Practices (ACIP) struggled with making recommendations Sept. 23 for the use of the booster, with several members questioning the need for a third dose in some of the populations the FDA identified.
Five days after an FDA advisory committee recommended a booster dose of Pfizer Inc.-Biontech SE’s COVID-19 vaccine, Comirnaty, for people 65 and older or those who are at high risk of a serious infection, the CDC’s Advisory Committee on Immunization Practices (ACIP) struggled Sept. 22 with what a U.S. booster program would look like if only one booster is available when three different COVID-19 vaccines are being used in the country.
Binhui Biopharmaceutical Co. Ltd.’s BS-001, a recombinant human oncolytic herpes simplex virus type-2 expressing GM-CSF for the potential treatment of solid tumors, has gained an IND approval from the FDA.
Ushering in a new era for the U.S. biosimilar marketplace, the FDA, on July 28, approved its first interchangeable biosimilar, which also will be the first to bring biosimilar competition to the U.S. insulin space. The honor went to Viatris Inc.’s Semglee, which the FDA recognized as both biosimilar to and interchangeable with Sanofi SA’s Lantus (insulin glargine).
Statements Cytodyn Inc. made about the potential for its investigational monoclonal antibody, leronlimab, to treat COVID-19 continue to reverberate with U.S. authorities.
The U.S. Department of Justice (DoJ) has settled with two divisions of Abbott Laboratories of Abbott Park, Ill., over violations of the False Claims Act (FCA) in connection with devices alleged to have been defective. While neither claim recites a specific allegation against corporate executives with St. Jude Medical and Alere, the more conspicuous aspect of these agreements is that they are both directed toward activities that ceased in 2016, making clear that federal attorneys have long memories where problematic devices are concerned.
