Drug Approval | December 20, 2023
Briefs: Aurobindo Pharma and Granules Pharmaceuticals
Granules Pharmaceuticals gets 5 observations from USFDA on completion of GMP inspection
Granules Pharmaceuticals gets 5 observations from USFDA on completion of GMP inspection
Laurus Synthesis receives Form 483 with 5 observations from USFDA
The findings of Phase 3 study are in line with Phase 2 study conducted in the US and Europe
The exclusive agreement also includes development, regulatory, and commercialization milestone payments based on the successful outcome
Dr. Reddy's Laboratories has been issued a Form 483 with three observations
Conditional marketing authorization is based on clinically meaningful response rates, duration of response, and safety from the Phase 2 MagnetisMM-3 trial
Approximately 16,000 patients 12 years of age and older with severe sickle cell disease may now be eligible for this one-time treatment
Dr. Reddy's will make a US$ 7.5 million upfront payment to Coya
The agreement includes an upfront payment of US$15 million, regulatory and commercial milestones, and royalties
Carmot Therapeutics’s R&D portfolio of clinical stage incretins has great potential to treat obesity, diabetes and potentially other diseases
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