Uncertain About HCV, Vertex Doubles Down On CF, Looks To Sell Off Pipeline Assets

As it nears a crucial inflexion point for its hepatitis C business, Vertex shifts focus to building on its strong early start in cystic fibrosis. The Boston-area firm plans to out-license its mid-stage candidates for autoimmune disease and influenza A.

An R&D focus across diverse therapeutic areas long has been a differentiating factor for Vertex Pharmaceuticals Inc. A recent retrenchment suggests, however, that the Cambridge, Mass.-based biotech soon could be a single-disease specialist, with a leading position globally in cystic fibrosis, similar to Novo Nordisk AS’ status in diabetes.

The company plans to stop detailing Incivek (telaprevir), its fast-rising and only hepatitis C drug, due to a rapid decline...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from United States

US FDA’s CRL Release More Incremental Than ‘Radical’ Transparency

 

The transparency initiative collects CRLs already made public in approval packages on its drugs@fda site to post on the openFDA public portal.

US FDA Asking Questions About Commissioner’s Voucher Program With Details Scarce

 

FDA staff are trying to plan for program implementation in the absence of critical eligibility and other details, although guidance may be coming soon.

Senate Appropriators Give US FDA More Non-User Fee Funds Than House

 

US FDA would receive more funding for fiscal year 2026 in the Senate appropriations bill than its House counterpart, including $10m for unannounced foreign inspections.

Animal Testing: US And EU Regulatory Support Grows For Alternatives, But Validation A Hurdle

 

In this first of a two-part series of articles, US Pharmacopeia CEO Ronald T. Piervincenzi tells the Pink Sheet how the use of alternatives to animal testing in drug development is gaining traction and discusses the challenges that exist.

More from North America

Senate Panel Approves US CDC Director Candidate Monarez With Measles Outbreak Growing

 
• By 

The Senate Health, Education, Labor and Pensions Committee voted to advance Monarez's nomination to lead the CDC as the agency announced the largest US measles outbreak in 22 years.

US FDA Advisory Committee Supports Vaccine Safety, Scrutinizes AE Reporting Quality

 
• By 

The Pediatric Advisory Committee supported routine safety monitoring for three vaccines and 21 drugs, but the panel’s consumer representative said adverse event reporting needs improvement and FDA literature reviews should include lawsuits as well as social media.

US FDA Will Not Pull Teva And MSN Hetlioz ANDAs, Rejects Vanda Citizen Petitions

 
• By 

The FDA concluded that generic tasimelteon products held by Teva and MSN Labs meet all statutory bioequivalence requirements and there was no “mistake” or untrue statement in the original ANDA approvals.