Demand-related shortages are a relatively new problem, but the FDA maintains their tools can prevent or end them.
Drug shortage staff at the US Food and Drug Administration are asking industry to notify them of demand spikes, even though it’s not required, so supply problems can be prevented.
Valerie Jensen, associate director of the FDA drug shortage staff, said on 1 December during an Alliance for a Stronger...
As a standalone generics and biosimilars company, Sandoz now feels freer to speak out against originator abuses of intellectual property, the firm’s global IP head Julia Pike tells Generics Bulletin, including challenges to Bayer on rivaroxaban and Amgen on etanercept.
Teva seeks a dedicated development program and first-cycle approval metrics for complex generics. Role of artificial intelligence in the generic drug review process is a talking point for both agency and industry at reauthorization kickoff meeting.
Experts discussed the UK government’s commitment to make the country a desirable destination for companies to launch their biosimilars at a recent conference hosted by Medicines UK.
As the European Commission prepares a formal evaluation of the SPC manufacturing waiver, the generics and biosimilars industry is getting ready to provide detailed feedback on what works – and what doesn’t. At Medicines for Europe’s legal affairs conference, delegates heard the latest updates.
At Medicines for Europe’s legal affairs conference last month, divisional patents were once again a major subject of discussion. Attendees heard fresh details of how patentee games are preventing generics from hitting the market and restricting wider access to major medicines.
Concern continues to build in the European generics industry over the threat posed by the EU’s Urban Wastewater Treatment Directive, which was one of the hottest topics of discussion at Medicines for Europe’s legal and annual conferences. And now, the association has intervened in a legal challenge.
Shanghai Henlius Biotech has received EMA GMP certification for its HLX14 and HLX11 biosimilar production lines, paving the way for faster market entry in the EU and reinforcing its global manufacturing credentials.
