The FDA removed its Boxed Warning regarding asthma-related death from the labels of medicines containing long-acting beta agonists in combination with inhaled corticosteroids, following postmarket studies of possible side effects.…
The FDA is revising its 20-year-old guidance on the appropriate categorization of changes in chemistry, manufacturing and controls information in approved BLAs, based on a tiered reporting system. Source: Drug…
The PTO’s Patent Trials and Appeals Board launched an inter partes review of two patents for Sanofi’s Lantus insulin glargine injection following a challenge from Mylan. Source: Drug Industry Daily
The French Competition Authority fined Johnson & Johnson €25 million ($27 million) for delaying market access to generic copies of its painkiller Durogesic, a fentanyl-based patch for treatment of chronic…
Five Prime and Zai Lab today announced an exclusive license agreement for FPA144 in Greater China and global strategic development collaboration. Source: BioSpace
Forbes recently interviewed Nazli Azimi, the CEO and co-founder of Bioniz Therapeutics. Source: BioSpace
The total capital raised by Flagship to fuel its institutional innovation and venture creation platform now exceeds $2.3B. Source: BioSpace
Millendo Therapeutics announced that it has acquired Alize Pharma SAS in a stock-based transaction. Source: BioSpace
The parent company of JSR Life Sciences snapped up CRO Crown Bioscience International for $400M, the company announced this morning. Source: BioSpace
Under the seven-year nonexclusive licensing and supply agreement, Juno has obtained rights to use CTS Dynabeads CD3/CD28 magnetic beads as part of the clinical and commercial manufacturing processes for its…