Front-line Indian companies like Biocon, Ltd. have a lot riding on regulatory inspections going through as scheduled amid pandemic-related travel restrictions to countries where plants are located.
The Wait For Inspections: Biocon Seeks FDA Stance On Mutual Recognition Agreement Route
Biocon is awaiting a scheduled FDA pre-approval inspection for insulin aspart at its facility in Malaysia, amid concerns that the surge in COVID-19 cases in the Southeast Asian nation may cloud timelines. The Indian firm is also pursuing a mutual recognition agreement route with the agency for a generic product approval.
More from Strategy
• By
Industry lobbied for pharmaceuticals to be exempt from Trump’s sweeping US tariffs and the effort appears to have paid off. J&J, Lilly and Merck & Co. even got shout outs.
• By
With new Phase II data, Edgewise asserted that EDG-7500, a sarcomere modulator, could offer better efficacy and safety than cardiac myosin inhibitors in hypertrophic cardiomyopathy.
• By
Strong sales growth for the German group’s SGLT2 inhibitor in 2024
• By
After failing a Phase II monotherapy study in early Parkinson’s, Cerevance will focus on adjunctive therapy without abandoning the monotherapy concept.
More from Business
• By
CEO Kris Elverum told Scrip about the start-up’s platform for editing RNA to correct genetic variants that cause harm and to reproduce healthy variants as a means of treating disease.
• By
Pharma executives and investors are waiting with bated breath to find out if President Trump will include drugs in a new round of tariffs to be announced on 2 April.
• By
After failing a Phase II monotherapy study in early Parkinson’s, Cerevance will focus on adjunctive therapy without abandoning the monotherapy concept.