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Merck Stretches Lead As EU Approves Keytruda In First-Line NSCLC

 
• By Alexandra Shimmings

Merck & Co just keeps clearing the hurdles to checkpoint inhibitor market domination, with EU approval in the key first-line NSCLC indication coming swiftly after the company snuck in an earlier than expected filing in the US for its chemo combination use.

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Merck Sharp & Dohme Ltd. has received an expanded EU approval for its anti-PD1 product Keytruda (pembrolizumab) for first-line use in metastatic non-small cell lung cancer (NSCLC) in adults whose tumors have high PD-L1 expression (tumor proportion score [TPS] ≥50%) with no EGFR or ALK positive tumor mutations. The additional indication brings its EU label into line with that in the US, where it obtained the first-line use approval in October.

It opens up still wider the most important market for the Merck product at a time when its major competitor...

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2025’s Biggest Launches – Half-Year Progress Report

 
• By Andrew McConaghie

Trial setbacks and extra regulatory scrutiny have hit the progress of some new drugs towards expected approvals this year, but early successes have boosted the commercial prospects of others. Fears of disruption from changes at the US FDA are so far unfounded.

Dizal’s Zegfrovy Wins US NSCLC Approval, At Lower Dose Than In China

 
• By Dexter Jie Yan

Dizal's EGFR inhibitor Zegfrovy approved in US as new once-daily oral option for second-line NSCLC with EGFR exon 20 insertion mutations, at lower dose than in China.

Regeneron Wins Long-Sought FDA Nod For Lynozyfic In Myeloma

 
• By Alaric DeArment

The agency gave accelerated approval to the BCMAxCD3-directed bispecific antibody, which had been the subject of an August 2024 CRL.

Pipeline Watch: Eleven Approvals And ADA Readouts Dominate

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.

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Compass Pathways’ Antidepressant Advances In An Increasingly Tough Psychedelic Market

 
• By Manas Mishra

Psychedelics appear to be in vogue after years of being relegated to alternative medicine. But investor pushback after the highly anticipated release of Phase III trial data by Compass Pathways reveals an increasingly high bar for development.

Eolo Pharma Advances In Obesity With Thermogenesis Approach

 
• By Aakash Babu

Emerging Company Profile: Early-stage biotech Eolo will seek cash and deals for its novel obesity drug SANA after positive Phase I results for weight loss, lean muscle mass preservation and fat mass reduction.

BioMarin’s Roctavian Continues to Shine In Hemophilia A Despite Commercial Woes

 
• By Sushmita Panda

Roctavian shows durable bleed control and safety over five years, but high costs and access hurdles limit its commercial outlook.