Topic:

Regulatory

Latest Headlines

Latest Headlines

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.

Bristol-Myers' next-gen HIV med gets FDA 'breakthrough' designation

Bristol-Myers Squibb nabbed a "breakthrough" tag from the FDA for its next-gen HIV therapy aimed at patients who become resistant to the drugs now in use.

'Cures' bill, designed to speed drug approvals, could be too much of a good thing, dissenters say

The FDA has made strides in shortening review times and accelerating the path for breakthrough treatments, but a new bill designed to break down even more regulatory barriers has attracted a chorus of critics worried that it could go too far at the expense of patients.

UPDATED: Amgen beats Regeneron, Sanofi to world's first big PCSK9 drug OK

Amgen may be running a beat or two behind Regeneron and Sanofi in search of the first FDA approval for a PCSK9 drug, but the Big Biotech scooped up the very first approval in Europe today for Repatha (evolocumab), giving the company boasting rights as first mover in what is widely seen as a new blockbuster market in the making.

Medidata's de Vries on disruption in Asia drug research with Japan a focus

Medidata President Glen de Vries said he is a firm believer in putting talent in place on the ground in Asia. The company began with Japan in the region and that existing footprint, he said, has opened up opportunities as technology and biologics combine to disrupt drug discovery in the country.