Latest From Akriti Seth
The US FDA’s ‘Purple Book’ which was created “to improve transparency and functionality for stakeholders by providing a complete view of biological product options” has been updated after being recently transitioned into an online database.
After launching a biosimilar to Avastin (bevacizumab) in India, Cadila Pharma has now also launched rituximab and teriparatide biosimilars in its domestic market.
Alvogen’s newly created B2B unit, Adalvo, has partnered with AmbioPharm for the co-development and licensing for the commercialization of several complex pharmaceutical products, including difficult-to-make peptides, in key global markets.
Kodak’s new pharmaceutical unit receives a $765m loan from the US International Development Finance Corporation, through President Trump’s Defense Production Act, to produce critical pharma components that are essential but have lapsed into chronic national shortage, as defined by the FDA.
As the AAM failed to demonstrate a “concrete or imminent” injury to its member companies, a US appeals court has rejected the agency’s challenge to the Californian law banning “pay-for-delay” deals.
The EMA’s CHMP has recommended suspending all marketing authorizations for generics tested by Panexcell Clinical Laboratories at its site in Mumbai over inadequate data. To lift the suspension, companies relying on data from Panexcell must provide alternative data demonstrating bioequivalence.