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NIH announces $100M for new HIV research initiativ...

The Obama administration announced Monday afternoon that the National Institutes of Health will redirect $100 million in funding to establish a new, three-year program to find better treatments–and eventually, a cure–for HIV and AIDS. Dubbed the HIV Cure Initiative, the new investment is meant to spark basic research in this area, which is expected to benefit AIDS research in general, as well as research on other...

Key hep C protein revealed

In a discovery that could put a vaccine for hepatitis C closer in sight, researchers have been able to characterize a key protein in the virus that aids infection in the liver. The structure of the protein, known as E2 envelope glycoprotein, has up until now evaded scientists. But the new, detailed picture of the protein obtained by investigators at The Scripps Research Institute in La Jolla, CA, is an important development...

FDA stops 23andMe from selling genetic kits

The Food and Drug Administration issued a warning letter to 23andMe CEO Ann Wojcicki on Friday, saying the company was selling its spit kits and Personal Genome Service without marketing clearance or approval in violation of the Federal Food, Drug and Cosmetic Act (the FD&C Act). The direct-to-consumer personalized genomics test is “intended for use in the diagnosis of disease or other conditions or in the cure,...

Myriad Releases Three New Tests

Myriad Genetics got their fair share of press this summer when the Supreme Court ruled that Myriad’s gene patents were invalid. But in the past three months, the company has released three diagnostic and prognostic tests. Patent or no patent, they’ve been busy. In the latest addition to their flurry of activity, this week Myriad launched myPath Melanoma, a diagnostic test meant to effectively differentiate malignant...

Early FDA approval for Portola

South San Francisco-based Portola Pharmaceuticals ($PTLA) has nabbed boasting rights to the FDA’s new breakthrough drug designation for andexanet alfa (PRT4445), its Factor Xa inhibitor antidote designed to hit the brake on blood thinners when they turn dangerous. And the biotech says that the BTD helps set the stage for its campaign to win an accelerated approval while pursuing a 2014 launch of a registration...

FDA says new cholesterol drugs may not need outcom...

Members of an experimental class of cholesterol-lowering drugs could get U.S. regulatory approval based on their ability to lower “bad” cholesterol, and may not need to show that they reduce the risk of heart attack and stroke, the Food and Drug Administration said on Thursday. The statement eased industry concerns that the agency would require more onerous “outcome” studies before approving the drugs,...
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