News | August 29, 2025
Lilly's oral GLP-1 orforglipron succeeds in Phase 3 trial
Triggering global regulatory submissions this year for the treatment of obesity
Triggering global regulatory submissions this year for the treatment of obesity
The updated formula for Spikevax is now approved for individuals 6 months through 64 years of age
With the addition of Phase II (~91 KL) in Q1 FY26, the combined capacity of the block now stands at ~200 KL
Saroglitazar was generally well tolerated, with overall adverse events generally balanced between Saroglitazar-treated and placebo-treated patients
VYVGART was well tolerated, with a safety profile consistent with prior studies in AChR-Ab seropositive gMG and other indications
New manufacturing facility in Mebane to produce at least 40 million laboratory pipette tips per week
This authorization follows FDA approval in June and WHO’s July recommendation adding twice-yearly lenacapavir as a PrEP option
As part of its partnership with Dr. Reddy’s Laboratories (DRL), FDA acceptance also triggers a $4.2 million milestone payment to Coya
The US generic market is crucial for Indian pharma, contributing about 35% to its total revenue, around US$ 10.7 billion
The inspection, conducted from June 23 to June 25, 2025, concluded with zero Form 483 observations
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