Topic:

Regulatory

Latest Headlines

Latest Headlines

Sanofi and Regeneron line up for second place in EU cardio race

Sanofi and Regeneron may be on pace to win the first U.S. approval for a new type of cholesterol treatment, but the pair trails rival Amgen in Europe in a race to make good on blockbuster sales predictions.

Oxford Performance Materials gets FDA nod for 3-D printed spinal implant

Oxford Performance Materials snagged an FDA OK for its 3-D printed spinal implant device, a win for the company as it adds to a string of regulatory approvals and builds out its offerings past skull and facial implants.

Novartis' newly acquired melanoma combo wins EU recommendation

Novartis' recently acquired melanoma duo, Tafinlar and Mekinist, has won a recommendation from the European Medicines Agency's Committee for Medicinal Products for Human Use as a combo treatment for BRAF V600 mutation-positive melanoma

Triage the plan as India's Sun moves on troubled Ranbaxy plants

India's Sun Pharmaceutical Industries has decided that a triage strategy is needed to address the poor state of four Ranbaxy Laboratories manufacturing plants banned by the U.S. FDA in the past 5 years. And that may mean one unit may not make it, the Economic Times reports.

Roche loses appeal on Valcyte patent in India

India has denied an appeal by Roche on a patent claim for eye infection treatment Valcyte for AIDS patients, the Economic Times reports.

Bard hit with FDA warning letter affecting its vena cava filters

C.R. Bard revealed in an SEC filing that its facilities in Glens Falls, NY, and Tempe, AZ, are under an FDA warning letter for misfiling customer complaints--including the report of a patient death, manufacturing the Recovery Cone Removal System without the required clearance or approval, and failing to inform the agency of serious device malfunctions.

Industry groups lobby against Japan reimbursement price cuts

Japan's efforts to trim drug and device costs while spurring innovation has led six drug industry groups to call for a review of a biennial National Health Insurance exercise to assess reimbursement prices that usually leads to cuts. 

India's drug and CRO manufacturing travails gather pace as New Delhi calls on diplomats to help

Repeated quality violations by Indian drug manufacturing and contract research firms are casting a long shadow on the country's hopes to be a key global supplier of medicines and services. And they come at a particularly acute time for Biocon, which opens an initial public offering for its Syngene unit next week.

China state-owned drug firms move to direct consumer sales, prescriptions next?

China's Shandong Freda Pharmaceutical Group has obtained a license to sell direct to consumers, China Daily reports, highlighting a trend that has gathered pace across over-the-counter and healthcare products as companies also eye Beijing for a nod on ethical drugs.

UPDATED: Propeller Health gets FDA nod to sell app, sensor with GSK inhalers

Smart inhaler company Propeller Health received FDA clearance to sell its sensor and digital health platform in association with GlaxoSmithKline's Diskus dry powder inhaler for asthma and COPD.