Briefs: Sun Pharmaceutical Industries and Biocon Biologics
The US District Court of New Jersey decided to grant a preliminary injunction delaying the launch of LEQSELVI
The US District Court of New Jersey decided to grant a preliminary injunction delaying the launch of LEQSELVI
Clarity in regulatory frameworks and pathways help in preventing delays in accessing quality-assured, affordable medicines
US$ 800 million senior secured notes, the largest high yield debut USD bond issuance from India in the last 10 years
The inspection concluded with the issuance of a form 483 with five observations
The Notes shall not be offered or sold in India
These clinical studies support the interchangeability of adalimumab-fkjp at low-concentration with high-concentration adalimumab and ustekinumab biosimilarity
Glenmark Pharmaceuticals Limited has informed that the USFDA has issued Form 483 with zero observations
The approval further adds to Biocon’s portfolio of complex drug products
Biocon Biologics earlier announced a settlement agreement in the United States for a Bmab 1200 launch no later than February 22, 2025
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