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Generic Priority Review Expanded In Senate User Fee Bill

 
• By Derrick Gingery

Amendment added during markup would require eight-month review of ANDAs for shortage drugs and those with limited competition, as well as pre-submission meetings.

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Legislation expanding the US FDA's generic drug priority review pathway beyond sole-source drugs to generics entering markets with "limited competition" was added to the Senate's user fee reauthorization bill.

The Senate Health, Education, Labor and Pensions Committee overwhelmingly approved the amended FDA Reauthorization Act 21-2 on May 11, sending...

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Who’s Hired? Stada Picks Biogen’s Biosimilars Chief Henshaw To Lead Specialty Segment

 
• By Dave Wallace

Stada has appointed former Biogen biosimilars head Ian Henshaw as the new leader of its Specialty segment. Meanwhile, Craig Burton has left the AAM for Fresenius Kabi, Australia's GBMA is looking for a new chief executive, and Speranza, Outlook and EuroAPI have announced new appointments.

Snapshot Of India’s Pharma Manufacturing Network Amid ‘Trumponomics’

 
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Alchem Fined Over Buscopan API Cartel

 
• By Dave Wallace

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.

European Industry Calls For Support As It Juggles Multiple Challenges

 
• By Dave Wallace

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.

More from Products

Alchem Fined Over Buscopan API Cartel

 
• By Dave Wallace

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.

Apotex Follows Biocon With Canadian Biosimilar Aflibercept Launch

 
• By Dean Rudge

Apotex is marking a “key milestone,” introducing its first ophthalmic biosimilar and its fourth biosimilar since 2016 in its native Canada, with the approval and launch of a biosimilar to Eylea 2mg.

European Industry Calls For Support As It Juggles Multiple Challenges

 
• By Dave Wallace

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.