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Alvogen's bid to force FDA to approve generic to Bausch's Xifaxan shot down by federal court

Fierce Pharma

federal court denied Alvogen's bid to force the FDA to grant full approval to its proposed Xifaxan generic. The agency previously gave the generic a tentative approval before some patents expire in 2029.

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What sets the Drugs to Watch in 2024 apart

Clarivate

Clarivate data indicates a 90% probability that datopotamab deruxtecan will win marketing authorization in the United States, and projects 2029 sales of $2.7 billion in 2029 for CASGEVY alone. FDA accelerated approval in August, Clarivate projects the drug will see $850 million in sales by 2029. billion in 2029 revenues.

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Gilead wins patent battle with US government over HIV PrEP drugs

Pharmaceutical Technology

The FDA approved Truvada as the first PrEP treatment in July 2012, with Descovy receiving a nod for this use in October 2019. Truvada has since gone generic, with Teva Pharmaceuticals launching the first FDA-approved Truvada generic in October 2020. billion in global sales in 2029, while Truvada estimates amount to $30 million.

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NICE recommends AbbVie’s/J&J’s Imbruvica for combo use in untreated CLL

Pharmaceutical Technology

Brukinsa was approved by the US Food and Drug Administration (FDA) in CLL in January 2023. According to GlobalData’s Pharma Intelligence Centre, a sales consensus forecasts Brukinsa to have global sales of $3.98 billion in 2029, while Calquence is expected to make $5.31 billion in 2029. billion in 2029.

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Novel drug approvals declined in 2022 but what are the CMO opportunities in 2023?

Pharmaceutical Technology

In 2022, the US FDA disappointingly approved almost a third fewer of the most innovative drugs than it did in 2021. Veklury is currently a blockbuster drug, but its revenues are predicted to drop by 2029. During 2013–2022, NME approvals were lower only in 2013 and 2016. It has been approved since 2020 in Japan.

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Merck defends blockbuster Januvia franchise from patent challenge

pharmaphorum

7,326,708) was challenged by Mylan Pharma, now Viatris, before the US Patent and Trademark Office (USPTO), which ruled in Merck’s favour last year. Viatris is seeking FDA approval to market generic versions of both Januvia and Janumet in the US. The US patent (No.

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Market cap downturn hits over half of top 20 biopharmaceutical companies in Q1 2023

Pharmaceutical Technology

trillion in Q1 2023, according to GlobalData’s pharma intelligence centre companies database. This growth is expected to continue, with a 62% growth in annual consensus sales forecast from 2023 to 2028, fuelled by the company’s semaglutide portfolio, according to GlobalData’s report, ‘Looking ahead to 2023 – the future of pharma’.