On Monday the U.S. Patent and Trial and Appeal Board (PTAB) ruled that Novo Nordisk, maker of semaglutide, did not choose the “obvious” research road drug, thereby denying Mylan Pharmaceuticals…
Sanofi and Teva Pharmaceuticals announced today a collaboration to co-develop TEV’574 to treat two types of irritable bowel disease (IBD) — ulcerative colitis and Crohn’s Disease. Source: Drug Industry Daily
With no FDA drug approvals to date for stimulant use disorder, the FDA has published draft guidance outlining current recommendations for development programs and trial designs for treatment of moderate-to-severe…
Upcoming events in the coming weeks include four FDA advisory committee meetings as well as the GMP Quality Management vSummit, the WCG MAGI@Home Clinical Research Conference 2023, the 18th Annual…
In a final guidance published by CBER and CDRH, the FDA provides updated standards for premarket notification (510(k)) submissions by electronic format and establishes Oct. 1 as the start date…
A recent study of cardiac patients using a digital health solution found no long term impact on physical activity, demonstrating the difficulty of establishing the value of digital health technology.…
Humira’s biosimilar competitors have overcome the approval and patent fight process, only to run straight into what may be an even bigger challenge: getting the drugs past pharmacy benefits manager…
Eli Lilly and Point Biopharma Global have announced that Lilly will pay $1.4 billion to acquire Point, a radiopharmaceutical company with a pipeline of clinical and preclinical-stage radioligand therapies in…
The FDA has issued a revision to its Manual of Policies and Procedures (MAPP) describing how the Office of Generic Drugs will track and respond to ANDA suitability petitions, consistent…
Citing deficiencies in the Chemistry, Manufacturing, and Controls (CMC) processes, FDA handed Swiss drugmaker Galderma a complete response letter for RelabotulinumtoxinA, the company’s cosmetic neurotoxin intended to treat frown lines…