Head of FDA's device arm says agency aims to be first in the world to improve devices
12 May 2015
The head of the FDA's device arm (CDRH) acknowledged that the division is failing to live up to its vision that "patients in the U.S. have access to high-quality, safe, and effective medical devices of public health importance first in the world" because advanced devices like trans aortic valve replacements are regularly approved in Europe 5 years earlier than the U.S.
Marinus Pharmaceuticals Provides Business Update and Reports First Quarter 2015 Financial Results
11 May 2015
Marinus Pharmaceuticals, Inc. (Nasdaq:MRNS), a biopharmaceutical company dedicated to the development of innovative epilepsy and other neuropsychiatric therapeutics, today provided a business update and announced its financial results for the first quarter ended March 31, 2015.
Australia budget is a showdown on cancer drug funding, safety net reach
08 May 2015
An Australia government proposal to trim the national drug-coverage budget for innovative drugs by 5%, or U.S.$2.36 billion, has invited a juggernaut of industry opposition already descending on the parliament. The reductions are aimed at the nation's leading drugs, including those for cancer.
China plans first-ever rules on animal testing in medical research by year end
08 May 2015
Chinese authorities are drafting a national standard expected to be implemented by the end of the year to cover humane treatment of animals used in medical research, including for drug testing. The nation currently has no general rules governing animals in clinical research.
EU drugs agency tightens rules on experts moving to industry jobs
08 May 2015
Europe's medicines regulator said on Wednesday it would restrict experts and committee members who intend to work for a pharmaceutical company from participating in the evaluation of medicines, in a move to reduce conflict of interests.
FDA makes strides in inspection effort but challenges persist
07 May 2015
Before a generic drug can make it to market in the U.S., the facility where it will be manufactured must be inspected and approved by the FDA. But with generic drug applications piling up, the agency is having trouble getting to many of those, although it is making progress in catching up.
China kicks press into high gear to knock down talk on higher drug prices
07 May 2015
Within days after China announced an upcoming end to controls on most drug prices, whispers were heard of concerns the move set for June 1 would lead to higher prices at the consumer level. Government information outlets went into high gear to dampen the doubts.
Big new launches rocket cancer drug spending to $100B: IMS report
07 May 2015
Cancer drug pricing is turning more and more heads, especially as critical payers threaten a crackdown in the oncology field. And there's a reason for all the hullaballoo: Spending on oncology meds is increasing rapidly, new IMS numbers show.
Drug Discovery and Development in India
07 May 2015
Indian pharmaceutical companies’ entry into the drug discovery and development field dates back to the early 1990s when India announced the signing of the World Trade Organization (WTO) agreement that introduced a product patent system from Jan. 1, 2005. Changes in the regulatory environment in the same year led to other developments with the emergence of the country as a favorite destination for “chemistry” outsourcing followed by “collaborative drug discovery as contract agencies where in-house strengths in chemistry of local companies was augmented with focus biology”.
New devices test drugs where they will need to work: inside tumors
06 May 2015
Two independent teams of scientists have described microtechnologies that could allow the testing of multiple drugs and drug combinations directly within tumors – both xenografted tumors in animals and tumors that are still within the patients themselves.
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