Topic:

Regulatory

Latest Headlines

Latest Headlines

India's Lee Pharma turned down on CL challenge to AZ's Onglyza

India's Controller of Patents has turned down a compulsory license application by Lee Pharma to make a version of AstraZeneca's Onglyza, citing competing substitutes already in the market and patent terms, the  Economic Times  reported.

Esperion surges after FDA offers a shot at quick approval for LDL-lowering drug

Shares of Esperion Therapeutics shot up more than 10% after the market closed on Monday--after the biotech tipped off investors that the FDA is not going to require a long-term outcomes study of its cholesterol-lowering drug ahead of a possible approval.

UPDATED: FDA slaps three duodenoscope manufacturers with warning letters over related devices

The FDA has taken some steps to address duodenoscopes' role in spreading potentially deadly infections after superbug outbreaks surfaced earlier this year. But in it's latest move the agency is cracking down on three companies manufacturing duodenoscope devices, adding to the hotbed of scrutiny surrounding the products.

GE gets FDA nod for low-dose CT lung cancer screening device

GE Healthcare got an FDA green light for its low-dose computer tomography (CT) lung cancer screening device, a feather in the company's cap as it deepens its dive into diagnostics imaging.

Retrophin goes after Shkreli with a $65M suit, claims of flagrant mismanagement

Retrophin, a biotech founded by former hedge fund manager Martin Shkreli, is suing its former CEO for more than $65 million in damages, alleging he mismanaged the company's funds to settle personal debts, reward his friends and keep afloat his flailing investment firm.

FDA: International regs don't protect patients from contaminated intraocular lenses

The FDA said international standards were insufficient, and put forth a stricter standard in order to ensure that intraocular lenses and other intraocular ophthalmic devices are free of bacteria upon manufacturing.

FDA touts faster approval times in report on initiatives at its device arm

The FDA touted faster approval times in a report on policies and initiatives at its device arm (CDRH). In addition, the agency outlined some of its new regulatory initiatives.

FDA approves Purdue's OxyContin for use in youth aged 11 to 16

The addictive qualities of the powerful pain drug OxyContin have made it controversial, but the FDA has now approved it for youth 11 to 16 after asking maker Purdue Pharma to study its use in that age group.

NICE plots takeover of England's Cancer Drugs Fund

England's Cancer Drugs Fund has been dealing with budget overruns and backlash from drugmakers and patients unhappy with the fund's decision to ax certain meds from its list. Now, the country's cost watchdogs are planning to take the reins and give the fund a much-needed makeover.

India cardiac stent price caps closer after advisory review

An advisory body to India's health ministry has made a recommendation that favors price caps on cardiac stents based on price lists sent by manufacturers, the Economic Times reports.