Breakthrough Therapy Designation
The FDA granted the drug Priority Review status just last week.
BMS loses breakthrough therapy status, Gilead's pricing comes under fire in Europe, and pharma fights Italy's off-label Avastin use.
The drugmaker announced in its earnings call Wednesday that the FDA has rescinded the company's Breakthrough Therapy designation, which could delay Merck's HCV doublet therapy launch from early to mid-2016.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 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.
Amgen's Blincyto was approved for a rare form of leukemia after receiving Breakthrough Therapy designation and a Priority Review.
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.
The designation is for diabetic retinopathy for patients with diabetic macular edema.
The FDA slapped a Breakthrough Therapy label on the CLL indication pursuit in February.
The all-oral genotype 1 medication got the Breakthrough Therapy designation Friday.
The FDA granted Breakthrough Therapy status to the duo's multiple myeloma treatment.
The FDA announced Tuesday its approval of lung cancer drug Zykadia for patients with metastatic ALK-positive non-small cell lung cancer.
The experimental Breakthrough Therapy treatment is for acute myeloid leukemia.
The FDA granted Breakthrough status to the daclatasvir + asunaprevir combo for hepatitis C patients with genotype 1b.
Researchers say it's too early to declare the 2012 program a success but that the label will benefit drugs beyond those with orphan status.
Reports are that the UK wants an expedited process that will mirror the FDA's.
It was granted based on data among patients with BRAF V600E mutation-positive non-small lung cancer who have undergone chemo.
The FDA's Center for Drug Evaluation and Research released a preliminary year-in-review report that says the agency has cleared 26 new molecular entities this year.
The drug is priced at $28,000 a month, before add-ons like ribavirin and (possibly) interferon.
The company also has breakthrough therapy designations for CLL and Waldenstrom's macroglobulinemia.
The regulator approved the CLL medication Friday, giving the drugmaker time to create a marketing transition before Rituxan goes generic. The approval marks another milestone: the first drug approved with a Breakthrough Designation label, a tag that is now coming under scrutiny.
Complete Response letter slows Merck's suggamedex; AbbVie looks for next Humira; Roche drug gets breakthrough label; FDA effort to better track medical devices
BI cancer drug lands breakthrough therapy designation; Sanofi tallies two European MS drug approvals; GSK terminates testing for a Crohn's drug; and Teva joins cancer collaboration
GlaxoSmithKline heats up the CLL category with its second breakthrough designation therapy of the year, topped off by priority review for a melanoma combo treatment.
FDA is concerned state biosimilar legislation could make consumers uneasy about the category, J&J hands $75 million milestone payment for ibrutinib, Consumer Reports gets into drug apps
Takeda moves an Alzheimer's treatment to Phase III; Sangamo acquires Ceregene; Catalyst gets breakthrough designation for auto-immune disorder drug; study says seniors likely to opt out of health insurance
The drug maker scored its third breakthrough designation label, this time for orphan drug bimagrumab, a possible treatment for a muscle-wasting disease.
Glaxo shakes up China division, Teva and Lonza break up their biosimilars pact, and FDA's breakthrough designation speeds review but not international and payer uptake.
The interim results of a Phase III study augur well for use of Roche's Rituxan successor in more than one type of leukemia, one analyst said.
The FDA's priority review for the Phase III chronic lymphocytic leukemia drug comes on top of Breakthrough Therapy designation, which the agent won in May.
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