Cipla gets FDA warning letter for cleanliness issues by Eric Palmer Thursday, March 5, 2020 An FDA warning letter has been issued to Cipla's sterile injectables plant in Goa after inspectors found big problems with cleanliness.
Harvard-GIRH, GSK-Clover, Vir-WuXi and more—FiercePharmaAsia by Angus Liu Friday, February 28, 2020 Several influential institutions and biopharma companies have joined hands in developing COVID-19 therapies. Takeda's buying PvP for $330 million.
Biocon insulin plant gets 3 FDA observations by Eric Palmer Monday, February 24, 2020 With a new target date approaching for its competitor to Lantus, the FDA has again given Biocon’s insulin manufacturing plant in Malaysia a once over.
Dr. Reddy's sterile plant now meets at least minimal compliance by Eric Palmer Tuesday, February 18, 2020 Dr. Reddy’s says it has been told the FDA will not take regulatory action at its sterile formulations plant in Duvvada, Visakhapatnam.
Remdesivir, Enhertu, Tecentriq and more—FiercePharmaAsia by Angus Liu Friday, February 14, 2020 A Chinese company's producing a remdesivir generic. Daiichi expects $18 million in Enhertu Q1 sales. Tecentriq becomes seventh PD-1/L1 to enter China.
Dr. Reddy's API plant still struggling to satisfy FDA by Eric Palmer Monday, February 10, 2020 Dr. Reddy’s has spent nearly five years trying to get out from under a warning letter for an important API plant in India but has yet to shake it off.
Gilead's remdesivir, Takeda, Glenmark and more—FiercePharmaAsia by Angus Liu Friday, February 7, 2020 Coronavirus leads to remdesivir patent case. Takda's looking to sell a Shire biologics plant. Glenmark spinoff Ichnos recruits Novartis exec.
FDA continues to ride Lupin over plant failings by Eric Palmer Wednesday, February 5, 2020 Lupin, which racked up a warning letter and at least four Form 483s last year, has gotten off to a regulatory running start in 2020.
Coronavirus drugs, Sanofi, Novartis and more—FiercePharmaAsia by Angus Liu Friday, January 31, 2020 China is repurposing existing drugs for coronavirus. South Korea arrested a Sanofi exec for a vaccine case. Novartis outlined ambitious China plan.
Aurobindo receives tough news about FDA inspection by Eric Palmer Thursday, January 30, 2020 Aurobindo Pharma reported that the FDA has more concerns following an inspection of a solids formulation plant in India.
