Topic:

Regulatory

Latest Headlines

Latest Headlines

India considers standalone pharmaceutical ministry

Government officials in India are reportedly giving serious consideration to creating a standalone pharmaceuticals ministry, bringing all of the regulatory bodies under one tent.

China guidelines on stem cell research, treatments possible by summer

China could have guidelines governing stem cell and similar research and treatments by midsummer, the China FDA said in a meeting with local experts in the field.

Singapore extends subsidized drug sales by widening care provider sale points

Singapore's Ministry of Health said that since the beginning of the year, it has been phasing in an extension of drug subsidies for intermediate and long-term care patients that allows them to buy their treatments at any approved point of care.

FDA calls for panel meeting to discuss devices linked to superbug outbreak

Facing increased scrutiny for recent superbug outbreaks tied to duodenoscopes, the FDA is planning to convene an advisory panel to discuss the spread of potentially deadly bacteria through the devices.

Cost watchdogs back Novartis' Xolair for big new market in chronic hives

England's cost-effectiveness watchdogs have changed their mind on Xolair. The National Institute for Health and Care Excellence decided to back the Novartis asthma drug as a treatment for chronic hives, after sending the drugmaker back for more data last year.

Watchdog groups decry FDA's move to let reps hand out journal articles

The FDA rolled out some guidelines last June that would allow drugmakers to hand out medical-journal articles to doctors. And now, the consumer watchdogs at Public Citizen, along with a bevy of patient groups, are in full protest mode.

U.K. looks to FDA 'breakthrough' status for inspiration in regulatory revamp

The United Kingdom government has established the scope of the hotly anticipated review into the development and reimbursement of drugs. And the independent panel is being tasked with looking beyond the U.K.'s borders for inspiration, with an analysis of what can be learnt from the U.S. FDA's "breakthrough" designation on its to-do list.

First off the blocks, Natco gets India's regulatory nod for hep C copy

India's Natco Pharma said that it has received Indian regulatory approval to locally sell its generic version of Sovaldi, the hepatitis C treatment that costs $1,000 a day in the U.S., making it the first Indian license holder to do so and allowing it to set a bar on pricing in India and onto emerging markets.

Biotech in China is built brick-by-brick, but more money would help, BeiGene's Oyler says

Chemistry and biology are joining hands in China in ways that will have a profound impact on biotechnology startups and more established companies, but it is still early days for many companies and more money from venture capitalists or other funding sources is welcome.

Japan a lucrative market for endocrine sales, report says

The makers of new endocrine drugs might be well-advised to look to Japan as a possible lucrative market, according to a research outfit. Evaluate Pharma said those drugs have the highest peak sales potential in Japan, with drugs for the central nervous system second.