Legislation proposed in the House of Representatives would speed up Food and Drug Administration approval of knock-off versions of vaccines and other biologics while requiring the agency to conduct more inspections of drug factories overseas, according to published reports.
The Food and Drug Administration has approved a branded acne drug made by Ranbaxy Labs, the drug maker said. Ranbaxy announced the FDA approval of Absorica (isotretinoin), a drug for treating severe recalcitrant nodular acne.
Faced with the possibility of a critical cutoff in funding for the Food and Drug Administration, Congress moved in late May to reauthorize the Prescription Drug User Fee Act that provides the bulk of the agency’s resources for new-drug review and approval.
Specialty and biologically engineered medicines have been a boon to millions of Americans with life-threatening and life-altering conditions. But their lofty prices are squeezing patients and payers and spawning a growing legislative backlash that threatens insurers and employer-based health plans.
AstraZeneca and Rigel Pharmaceuticals have entered an exclusive worldwide license agreement for the global development and commercialization of an investigational treatment for moderate to severe chronic asthma.
A drug maker and a teaching and research affiliate of Harvard Medical School announced a new collaboration to promote the development of new medicines for the treatment of diabetes and related disorders.
GlaxoSmithKline has received regulatory approval from the Food and Drug Administration for a vaccine designed to prevent invasive disease caused by Neisseria meningitidis serogroups C and Y and Haemophilus influenzae type B.
Cellceutix on Wednesday reported that the Food and Drug Administration granted a section 505(b) designation for its Prurisol treatment for psoriasis, which would allow the company to forgo early-stage trials and advance Prurisol into latter-stage clinical trials.
Kadmon Pharmaceuticals earlier this month announced that it has launched a new 600 mg/day dose pack of Ribasphere RibaPak (ribavirin, USP), Kadmon's proprietary ribavirin regimen available in a daily, two-pill compliance package for enhanced therapy adherence.
Novo Nordisk and the Juvenile Diabetes Research Foundation on Wednesday announced the creation of a joint research and development team to discover and develop novel immunotherapies to prevent, treat and help cure Type 1 diabetes.
Bayer on Tuesday announced that on July 1, Philip Blake will become senior Bayer representative USA, following a common company practice of assigning this oversight role to a senior executive already holding a significant business role or roles within the region.