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FDA's Generic Approvals Catch A Bit Of Breath In July But Continue At Fast Pace

 
• By Derrick Gingery

US Generic drug approvals drop in July, but still are above the monthly average for the year, potentially signaling a new expected output.

FDA entrance sign 2016

FDA's July generic drug approvals tally did not repeat its June record-breaking performance, but the agency still is working at an elevated pace.

That's particularly encouraging news for stakeholders as the agency next month marks its first 10-month approval goal deadline under the...

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Patent Settlements Are ‘Critically Necessary’ As AAM Calculates $423bn Savings Since 2013

 
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The US healthcare system saved billions by allowing early market entry for generic and biosimilar medicines through patent settlements. However, long-winded litigations with an expensive price tag and the Senate’s reintroduced pay-for-delay bill are set to make the situation even more dire.

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Corapharm Deal Offers South-East Europe Opportunity For mAbxience

 
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Lupin Concedes To Wakix IP With 2030 Launch Date Agreement

 
• By Dean Rudge

Ahead of a bench trial beginning in February 2026, Lupin has become the latest ANDA sponsor to settle patent-infringement litigation over Harmony Biosciences’ Wakix (pitolisant hydrochloride), which has been touted as a potential blockbuster by the end of the decade.