Regeneron (NSDQ:REGN) has announced that the FDA has signed off on a 1,200 mg subcutaneous or intravenous dose of its REGEN-COV antibody cocktail. The quantity is half of the initially authorized dose. The agency had previously authorized a 2,400 mg dose of the vaccine, including a combined dose of 1,200 mg of Casirivimab and 1,200…
Why Lilly’s tirzepatide has blockbuster potential
Tirzepatide from Eli Lilly (NYSE:LLY) continues to show promise for diabetes, outperforming popular diabetes drugs in head-to-head clinical trials, according to GlobalData. In the recent SURPASS-4 study, tirzepatide supported the reduction of hemoglobin A1C (HbA1c) in people with type 2 diabetes while also supporting weight loss. The study pitted tirzepatide against insulin glargine. Tirzepatide is a dual glucose-dependent insulinotropic…
Lilly’s Taltz leads to durable improvement in axial spondyloarthritis in Phase 3 study
Eli Lilly and Company (NYSE:LLY) has announced that recent Phase 3 data suggest Taltz (ixekizumab) was effective in the long-term management of axial spondyloarthritis (axSpA). Taltz, an interleukin-17A antagonist, is currently indicated for plaque psoriasis, psoriatic arthritis and active ankylosing spondylitis. In the COAST-Y study, Taltz demonstrated long-term improvements in patients’ symptoms with the two subtypes of…
HHS pauses use of Lilly’s COVID-19 antibody cocktail in several states
The U.S. Department of Health and Human Services (HHS) has recommended pausing the combination of Eli Lilly’s (NYSE:LLY) bamlanivimab/etesevimab in eight states, including Illinois, Massachusetts, Arizona, California, Florida, Indiana, Oregon and Washington. The agency’s reasoning for the decision is grounded in lab data that found the antibody cocktail is not effective against P.1 (Brazilian) or B.1.351…
25 promising pipeline drugs
The pandemic has heightened interest in COVID-19 therapies, sometimes stealing attention from other pharmaceutical breakthroughs. But the pandemic has also served as a reminder that investment in new drugs can pay dividends while leading to a greater societal appreciation for the industry. A 2019 study published in International Health concluded that pharmaceuticals that have launched…
Pharma’s top 20 R&D spenders in 2020
The past year has been an unprecedented time for the pharmaceutical industry. On the one hand, the pandemic resulted in substantial delays to clinical trials while also forcing sponsors to rethink clinical trial design to protect participants. But on the other hand, the pandemic underscored the importance of the pharma industry in society. While the…
Biogen moves forward with aducanumab launch plans
Biogen’s (NSDQ:BIIB) Alzheimer’s drug aducanumab seemed to be a potential blockbuster until an FDA advisory committee voiced skepticism in November about the drug. FDA reviewers had previously assessed the drug’s prospects more positively. The company is preparing for the event of an FDA approval of the drug in June. Biogen’s CEO Michel Vounatsos said in…
GSK and Vir Biotechnology seek EUA for COVID-19 monoclonal antibody
GlaxoSmithKline and Vir Biotechnology have filed for emergency use authorization (EUA) for VIR-7831 (GSK4182136), a dual-action SARS-CoV-2 monoclonal antibody. VIR-7831 is designed to stop SARS-CoV-2 viral entry into cells and accelerate the clearing of infected cells. VIR-7831 would have a similar indication to other monoclonal antibodies that have won an EUA. It is intended for…