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Amgen Commits To PCSK9 Phase III, Tightening First-To-Market Race

 
• By Jessica Merrill

The biotech will begin Phase III studies testing the cholesterol treatment in early 2013, about six months after Sanofi/Regeneron initiated Phase III studies of a rival drug.

Amgen Inc. will begin Phase III clinical trials for its PCSK9 antibody AMG 145 for the treatment of high cholesterol in early 2013, positioning the drug about six months behind Sanofi SA/Regeneron Pharmaceuticals Inc.’s PCSK9 antibody, so far the leader in the race to be first to market. Amgen’s management updated investors on the status of the important pipeline drug during a second quarter sales and earnings call July 26.

Few details on the program have been released thus far, but Amgen has studied the drug in approximately 1,300 patients in four Phase II studies: as a monotherapy, in combination...

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EU To Track Decentralized Clinical Trials In CTIS To Support Innovation

 
• By Vibha Sharma

Monitoring the use of decentralized elements in clinical trials is a priority for the European medicines regulatory network.

Pink Sheet Podcast: US FDA’s Big Vaccine Policy Week

 
• By Derrick Gingery, Sarah Karlin-Smith, Sue Sutter, and Nielsen Hobbs

Pink Sheet reporter and editors discuss the new clinical trial requirements that the FDA announced for COVID-19 vaccines, the updated label for Novavax’s newly approved COVID-19 vaccine, and other vaccine-related events that were part of a busy week for policy in the sector.

ICH Targets RWE, Rare Diseases, Biosimilars, ATMPs In New Guideline Push

 
• By Vibha Sharma

The International Council for Harmonisation has identified four new topics that can benefit from global regulatory alignment, with timelines for initiating work to be determined later.

ClinicalTrials.gov Or ISRCTN: Getting Transparency Right For UK Trials

 
• By Vibha Sharma

ISRCTN’s systems are being redesigned to facilitate compliance with upcoming requirements in the UK’s clinical trials legislation.

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