BALTIMORE – The US FDA's generics program has reached a long-sought milestone: a steady state in its workload.
Office of Generic Drugs Director Kathleen Uhl made the pronouncement Sept. 7 during a presentation at the Association for Accessible...
OGD Director Uhl says program is now in balance between the number of submissions and agency review actions.
BALTIMORE – The US FDA's generics program has reached a long-sought milestone: a steady state in its workload.
Office of Generic Drugs Director Kathleen Uhl made the pronouncement Sept. 7 during a presentation at the Association for Accessible...
Collating data on the global manufacturing network of leading Indian drug makers, the markets serviced and production hubs for active pharmaceutical ingredients. Will ongoing geopolitical tensions and policy shifts have a bearing on some of these down the line?
After pursuing Alchem International for breaches of EU antitrust rules – relating to a cartel over the SNBB pharmaceutical ingredient used in Buscopan and its generics – the European Commission has now hit the firm with a €489,000 fine.
At Medicines for Europe’s legal and annual conferences in Brussels last week, multiple key issues competed for attention, giving the generics and biosimilars industry plenty to think about at a critical time for EU pharma reform.
The US Federal Circuit’s March 2025 decision affirming a lower court’s determination on both induced infringement and non-obviousness concerning a key patent shielding Janssen’s Invega Trinza (paliperidone palmitate) long-acting injectable is set to stand – for now.
At Medicines for Europe’s legal and annual conferences in Brussels last week, multiple key issues competed for attention, giving the generics and biosimilars industry plenty to think about at a critical time for EU pharma reform.
The US Federal Circuit’s March 2025 decision affirming a lower court’s determination on both induced infringement and non-obviousness concerning a key patent shielding Janssen’s Invega Trinza (paliperidone palmitate) long-acting injectable is set to stand – for now.
The FDA has concluded that generic tasimelteon products held by Teva and MSN Labs meet all statutory bioequivalence requirements, and that there was no “mistake” or untrue statement in the original ANDA approvals, as it denied Vanda’s citizen petition.