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.
Business briefs: Merck, AbbVie, Roche, plus new FDA device rule
September 23, 2013
5:36 pm
Complete Response letter slows Merck’s suggamedex; AbbVie looks for next Humira; Roche drug gets breakthrough label; FDA effort to better track medical devices
Business briefs: Boehringer Ingelheim, Sanofi, GSK, Teva
September 17, 2013
6:40 pm
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.
Business briefs: Biosimilars, Johnson & Johnson, Consumer Reports
August 29, 2013
5:57 pm
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
Business briefs: Takeda, Sangamo, Catalyst, plus seniors and insurance
August 28, 2013
5:44 pm
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.
Business briefs: Glaxo, Teva, Johnson & Johnson
July 25, 2013
6:29 pm
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.
GA101 looks more like a franchise-extender for Roche
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.