Latest From Akriti Seth
The FDA’s generic drug program yearly performance report shows that generic drug approvals declined for the first time in five years in fiscal year 2020, and the agency also reported a lower number of ANDA submissions.
Kodak CEO Jim Continenza is revealing nothing about ongoing investigations, which leave Kodak’s plans to venture into pharmaceuticals – along with a $765m federal loan – uncertain.
To boost the technology used in its digihaler family of inhalers, Teva has partnered with Amazon Web Services and Onica, a Rackspace Technology company. With this collaboration, Teva aims to protect patients’ information and ensure data security.
Catalent has announced the launch of a new technology, OptiGel DR, for the formulation and manufacture of delayed/enteric release softgels, offering advantages such as potentially enhancing bioavailability and reducing gastric reflux effects.
The FDA has opened registration for a public meeting on reauthorizing the Biosimilar User Fee Act, for fiscal years 2023 through 2027.
India’s Shilpa Medicare has received a warning letter from the US FDA for its finished dosage formulation facility in Jadcherla, Telangana. The company has insisted that supplies from the facility will not be disrupted while it engages with the FDA to resolve the issues.