Topic: Form 483

Amgen pays $2.7 billion for a 20.5% stake in BeiGene. AstraZeneca tightens its ties to China as China approves a controversial Alzheimer's drug.

India’s Aurobindo, which has yet to close its $1 billion deal to buy 300 Sandoz products in the U.S., continues to rack up FDA issues.

Aurobindo and Glenmark are cited by the FDA. Takeda inks IBD discovery pact with Prometheus. Ascletis recruits Novartis veteran as CSO.

India’s Aurobindo, which has been racking up FDA actions right and left, acknowledged Monday a recent agency inspection resulted in a Form 483. 

After some recalls of defective creams, India's Glenmark has received a warning letter for the plant where they were manufactured.

Novartis is putting the quality teams at gene therapy biotech AveXis under parental control after being embarrassed by a data manipulation scandal.

BeiGene rebuffs claims that it inflated drug sales records; Sumitomo Dainippon pays $3 billion upfront for five "vants"; Genentech settles with JHL Biotech.

An Ipca Labs plant savaged in an FDA warning letter three years ago continues to fail manufacturing standards that would assure its drugs are safe.

Biocon's manufacturing problems cost it and Mylan again; CStone's CEO racks up nearly $20 million in 2018 pay; Novartis sells Suzhou plant.

An FDA Form 483 outlined a host of failings at Dr. Reddy's oncology plant in India, a facility hat has repeatedly had quality problems.