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It’s “Full Speed Ahead” For Merck In HCV After $3.85B Idenix Buyout

 
• By Lisa LaMotta

The company expects to come charging out of the gate with a three-drug combo therapy for hepatitis C now that it has acquired a nucleotide analog to round out its portfolio. Merck is undeterred by the risks associated with the deal.

Any notion that deal-making is dead in hepatitis C was proved false when Merck & Co. Inc. revealed June 9 it will pay $3.85 billion for Idenix Pharmaceuticals Inc. and its portfolio of nucleoside prodrugs. It’s a risky deal in a highly competitive field of drug development where the long-term commercial opportunity remains uncertain.

“We’re moving full-speed ahead,” said Merck’s VP of Infectious Disease Eliav Barr in an interview, indicating the companies are already...

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

 
• By Eliza Slawther

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 Cathy Kelly

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 Sue Sutter

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 Dean Rudge

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.