FDA
Analysts called the approval a much-needed win for Novo Nordisk, but warned that the company could struggle to grow sales once rival drugs come to market.
FEATURED STORIES
Representatives of companies including AbbVie, Eli Lilly, Johnson & Johnson and Merck have voiced concerns about the FDA’s approach to pre-approval inspections.
With notable therapies from Biogen, Sarepta and MacroGenics failing to show efficacy in pivotal or confirmatory trials, experts question the use of biomarker evidence for approval while one former regulator insists that a “failed trial is not a failed drug.”
Coming up in the back half of December, the FDA will issue a verdict on Vanda Pharmaceuticals’ gastroparesis drug tradipitant, which it rejected last September, triggering a very public dispute with the company.
Subscribe to ClinicaSpace
Clinical trial results, research news, the latest in cancer and cell and gene therapy, in your inbox every Monday
THE LATEST
After an initial rejection due to safety issues, followed by a dispute and deferred actions, Akebia Therapeutics on Wednesday finally won the FDA’s nod for vadadustat as a treatment for anemia caused by chronic kidney disease.
Global healthcare and life sciences look toward automation, AI and Quantum to protect patient data and save lives.
With several recent approvals in the space and more on the horizon, BioSpace looks at some of the key decisions and their larger significance both for patients and science.
Merck’s Winrevair is the second PAH drug to get the FDA’s green light in the past week, following Johnson & Johnson’s Opsynvi, which won approval on Friday.
Health economics and outcomes research (HEOR) is a critical but sometimes overlooked part of drug development. Decentralized trials now make it easy.
AstraZeneca’s Alexion on Monday secured the fourth indication for Ultomiris, which can now be used to treat the rare autoimmune condition neuromyelitis optica spectrum disorder.
Regeneron’s bispecific antibody odronextamab was hit with Complete Response Letters from the FDA noting issues with the enrollment status of its confirmatory trials.
Esperion bagged broader-than-expected FDA labels for its cholesterol-busting drugs Friday, allowing the biotech to target seven times as many people in the U.S. compared to the old labels.
Johnson & Johnson’s Opsynvi has been approved by the FDA for the treatment of pulmonary arterial hypertension, combining macitentan, which cuts the risk of clinical worsening and hospitalization, while tadalafil boosts patients’ exercise capacity.
AbbVie’s antibody-drug conjugate Elahere on Friday won the FDA’s full approval for the treatment of FRα-positive, platinum-resistant ovarian, fallopian tube and primary peritoneal cancers.