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Keytruda Cements Cervical Cancer Leadership With First-Line Nod

 
• By Alaric DeArment

Although the label’s PD-L1 expression requirement could limit the addressable market, there is also potential for future combination with Seagen’s recently approved Tivdak.

Competitive edge and business advantage concept as a group of hot air balloons racing to the top but an individualleader with a small balloon attached giving the winning competitor an extra boost.
Keytruda became the first drug in nearly a decade to get an approval in first-line cervical cancer • Source: Shutterstock

The US Food and Drug Administration’s approval of Merck & Co., Inc.’s Keytruda (pembrolizumab) as a first-line treatment for persistent, recurrent or metastatic cervical cancer makes the PD-1 inhibitor the first new drug in that setting in nearly a decade and raises the possibility of future combination with Seagen Inc. ’s tissue factor-targeting antibody-drug conjugate Tivdak (tisotumab vedotin).

The FDA approved Keytruda combined with chemotherapy, with or without Roche Holding AG’s Avastin (bevacizumab), in first-line cervical cancer...

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Sanofi’s Inhibrx-Acquired Rare Disease Therapy Clears Phase II Hurdle

 
• By Manas Mishra

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Phase III Success For AiCuris’s Herpes Simplex Treatment

 
• By Andrew McConaghie

The German company is now gearing up for a US filing for a product that overcomes drug resistance issues in herpes simplex, and which it believes could transform its business.

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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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How To Score A Win With Real-World Evidence In India

 
• By Vibha Ravi

Bharat Serums showed it’s possible to score a regulatory win with real-world evidence (RWE) studies in India when it ran one leading to a label expansion for its mAb trinbelimab. As cell and gene therapies and rare disease drugs gain currency, sponsors could look at takeaways from the RhYTHM study.

Failing to Clinch Sale, Galapagos To Wind Down Cell Therapy Business

 
• By Manas Mishra

Galapagos is closing its cell therapy business after a prolonged search for buyers, leading to job cuts and site closures in the US, Netherlands, Switzerland and China.

Industry Excellence Celebrated At Citeline Japan Awards

 
• By Ian Haydock

Excellence, innovation and deal-making across the Japanese biopharma sector were celebrated at the Citeline Japan Awards 2025, held in Tokyo on 21 October.