Archive for December 2021

The FDA has put a clinical hold on Gilead Sciences’ injectable HIV drug lenacapavir because of the risk of glass particles from the vials getting into the medication. Source: Drug Industry Daily

The FDA has declined to approve Takeda Pharamceutical’s new drug application for TAK-721, developed to treat a chronic inflammatory disease of the esophagus known as eosinophilic esophagitis. Source: Drug Industry Daily

A group of 852 hospitals has sent Department of Health and Human Services (HHS) Secretary Xavier Becerra a letter pressing HHS to appeal a federal court ruling that drugmakers have the ability to restrict sales of medicine that’s handled by contract pharmacies as part of the 340B drug discount program. Source: Drug Industry Daily

In its first authorization of a COVID-19 antiviral for home use, the FDA yesterday granted Emergency Use Authorization (EUA) to Pfizer’s COVID-19 oral antiviral Paxlovid for adults and children 12 years of age and older who are at high risk of progressing to severe disease. Source: Drug Industry Daily

CEPI, the Coalition for Epidemic Preparedness Innovations, has joined with Korean biopharma firm SK bioscience (SK) to develop a “variant-proof” vaccine that would protect against a large coronavirus subgenus that includes the SARS-CoV-2 virus that causes COVID-19. Source: Drug Industry Daily

Eli Lilly’s IL-13 inhibitor lebrikizumab significantly improved disease severity when combined with topical corticosteroids in people with moderate-to-severe atopic dermatitis (AD) in the drug’s third pivotal phase 3 trial, the company said. Source: Drug Industry Daily

The FDA has approved Amgen’s blockbuster Otezla (apremilast) as a treatment for adults with plaque psoriasis of any severity, making it the first oral therapy cleared for that indication. Source: Drug Industry Daily

In a purchase aimed at broadening its portfolio of cancer therapies, Sanofi is acquiring San Francisco, Calif.-based Amunix Pharmaceuticals for $1 billion. Source: Drug Industry Daily

A range of drugs critical to patient care are slipping into shortage. Source: Drug Industry Daily

Ligelizumab, Novartis’ investigational anti-IgE antibody, didn’t stand up to the company’s established blockbuster omalizumab in a pair of phase 3 studies in patients with chronic spontaneous urticaria (CSU). Source: Drug Industry Daily