The solid-dose API operation of WuXi had its first visit by FDA inspectors at a new plant in Changzhou, China, and the company says it aced it.
Fresenius continues to hammer Akorn with fraud allegations as the company tries to extract itself from a $4.3 billion buyout of the injectables maker.
Portola has won FDA approval of Andexxa, its antidote for some next-gen bloodthinners, but a manufacturing upgrade will limit initial supplies.
Teva said that while it doesn’t expect a sign-off for the drug by mid-June, it does foresee getting approval for a launch by the end of 2018.
Neopharma and ASKA Pharmaceuticals entered a joint venture to build a $53 million pharmaceutical manufacturing facility in India.
Rapid Micro Biosystems secured $60 million in financing to expand its global reach and develop new products.
Samsung BioLogics lost almost $6 billion in market value after South Korean securities regulators said the company broke accounting rules.
The FDA issued a warning letter to Mexican finished-pharmaceutical manufacturer Degasa.
India’s drug regulatory force pulled off a third round of raids on drug facilities that were manufacturing products without approval.
Yinghua Biochemical and Pharmaceutical Co. was issued a warning letter by the FDA for data integrity issues and problems with its quality unit.