The drugmaker announced in its earnings call Wednesday that the FDA has rescinded the company’s Breakthrough Therapy designation, which could delay Merck’s HCV doublet therapy launch from early to mid-2016.
Pfizer urges parents to take the pledge against meningitis
Pfizer has kicked off a disease-awareness campaign, “Take Action Against Meningitis,” urging parents to discuss vaccinations with their healthcare providers with paralympic snowboarder Amy Purdy.
The regulator noted in its early 2014 retrospective that it set a high mark for the number of approved rare disease drugs this year, and that insufficient information is the reason many breakthrough status requests get bounced.
FDA approves Amgen leukemia immunotherapy
December 3, 2014
6:30 pm
Amgen’s Blincyto was approved for a rare form of leukemia after receiving Breakthrough Therapy designation and a Priority Review.
Five things for pharma marketers to know: Monday, November 24
BioMarin to acquire Dutch biotech Prosensa; Woodcock says significant efficacy key to Breakthrough Therapy designation; Stryker considers $16 billion bid for UK devicemaker Smith and Nephew.
Regeneron’s Eylea scores Breakthrough label
September 16, 2014
6:00 pm
The designation is for diabetic retinopathy for patients with diabetic macular edema.
Imbruvica lassoes CLL indication
July 28, 2014
5:57 pm
The FDA slapped a Breakthrough Therapy label on the CLL indication pursuit in February.
FDA labels AbbVie hep C drug Breakthrough
June 16, 2014
5:08 pm
The all-oral genotype 1 medication got the Breakthrough Therapy designation Friday.