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Spectrum Sees Potential Path For Poziotinib In NSCLC Despite Expected CRL

 
• By Alaric DeArment

The CRL follows a negative FDA advisory committee vote in September. The company will lay off three-quarters of its R&D force, but sees potential to partner or sell the asset.

The FDA sent a complete response letter to Spectrum for poziotinib in NSCLC • Source: Shutterstock

The US Food and Drug Administration handing a complete response letter (CRL) to Spectrum Pharmaceuticals Inc. for poziotinib in previously treated patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring HER2 exon 20 insertion mutations came as little surprise. But despite the company deprioritizing the program and laying off most of its R&D workforce, it still sees poziotinib as having a potential future, perhaps by partnering or selling it to a company that could take it forward.

Spectrum announced its receipt of the CRL on 25 November, adding that based on the letter, the company would have...

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• By Alexandra Shimmings

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Leo Looks To Grow In US After Hand Eczema Cream Approval

 
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Pipeline Watch: Five Approvals And Twelve Phase III Readouts

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.

Novartis Upbeat Even With Entresto Expiry Looming

 
• By Kevin Grogan

Swiss major confident that new oncology drugs will fill revenue gap.

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Executives On The Move: Three New CEOs Among This Week’s Changes

Recent moves in the industry include changes at the top at Trogenix and Quetzal Therapeutics, plus Synendos Therapeutics gains a new CMO from Roche.

Memo Therapeutics Plans BK Virus Therapy Phase III Despite Trial Miss

 
• By Manas Mishra

Pointing to data that show a benefit in reducing viral load and the histological signs of the infection, Memo says its drug, potravitug, could become the first therapy to treat BK polyomavirus in kidney transplant recipients.

Viking Rapidly Advancing Oral And Injectable VK2735 For Obesity

 
• By Joseph Haas

In its Q2 update, Viking reported that Phase III trials of subcutaneous VK2735 are under way, and that it expects Phase II data for an oral formulation before year’s end.