Biogen hopes to submit marketing applications in the U.S. and Europe for both MS therapy BG-12 and its therapies for hemophilia A and B in 2012, with launches possible in early and mid-2013.
Barely a year after new CEO George Scangos restructured the biotech’s pipeline Cambridge, Mass.-based Biogen Inc. is poised to reap benefits, with global filings and provisional launch preparations for MS drug BG-12 and Factors VIII and IX in hemophilia A and B at the top of the list.
“Because of our success in 2011, we have entered 2012 with a lot to do,” Scangos told investors during the company’s full year and fourth quarter earnings call Jan. 31....
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.
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.
ISRCTN’s systems are being redesigned to facilitate compliance with upcoming requirements in the UK’s clinical trials legislation.
The Health and Human Services secretary told a Senate appropriations subcommittee that placebo-controlled trials may not be necessary to ensure vaccine safety as the FDA released a framework requiring them for COVID-19 vaccines.
The Health and Human Services secretary told a Senate appropriations subcommittee that placebo-controlled trials may not be necessary to ensure vaccine safety as the FDA released a framework requiring them for COVID-19 vaccines.
A report by the European pharmaceutical industry criticizes the EU’s clinical trials framework, highlighting regulatory fragmentation, inefficiencies and the need for targeted reforms.
In light of the UK’s MHRA announcing a major overhaul of its clinical trial legislation, the agency’s deputy director for clinical investigations and trials Andrea Manfrin tells the Pink Sheet what sponsors can expect from the new regulation.
