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Blenrep US Withdrawal Is A Big Blow To GSK’s Blockbuster Hopes

But A Comeback Remains Possible

 
• By Andrew McConaghie

Blenrep’s withdrawal will add to GSK’s blockbuster drought, and hopes of separate trial success for the BCMA-targeting drug in earlier stage myeloma may now be harder to achieve.

US FDA entrance sign
The FDA is now enforcing the accelerated approval commitments more strictly, including requests for withdrawals. • Source: Shutterstock, JHVEPhoto

GSK is to withdraw its multiple myeloma therapy Blenrep (belantamab mafodotin) from the US market following a US Food and Drug Administration request, as the drug has failed to show significant benefits for patients in a confirmatory study.

The request reflects a wider clampdown by the US regulator on drugs given accelerated approvals but which then fail to...

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Dr Reddy’s On Semaglutide Prospects, Capacity And There’s An IP Hearing To Watch

 
• By Anju Ghangurde

Dr Reddy’s CEO discusses the growth opportunity for semaglutide, including production capacity and ‘crazy’ demand indications, and a potential 20-plus product GLP-1 portfolio. All eyes are also on an upcoming hearing in India pertaining to Novo Nordisk’s semaglutide patent in the country.

GSK Gains Hengrui’s PDE3/4 Inhibitor, Options For 11 Early Assets In Potential $12bn Deal

 
• By Dexter Jie Yan

Deal Snapshot: The addition of Hengrui's HRS-9821, a China-originated fast-follower of Verona’s Ohtuvayre in chronic obstructive pulmonary disease, should enable GSK’s COPD therapy portfolio to stack up well against increasing competitors in the indication, including biologics and small molecules.

Quick Listen: Scrip’s Five Must-Know Things

 
• By Ian Haydock

In this week's episode: Sanofi’s Vicebio buy; Sarepta halts US Elevidys shipments; Novartis warning over Europe; US CRL for Genentech’s Columvi; and an interview with Novavax.