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EU agency lifts lid on drug data secrets

(Reuters) – Europe’s medicines regulator, criticised in the past for excessive secrecy, is opening its data vaults to systematic scrutiny in a move that will let independent researchers trawl through millions of pages of clinical trial information.The change is a landmark in transparency that puts E

GSK in weekend talks to buy Human Genome: sources

(Reuters) – GlaxoSmithKline is holding talks this weekend with Human Genome Sciences to agree a deal to acquire it for some $2.6 billion, after pursuing the U.S. biotech company for three months, sources familiar with the situation said on Sunday.The British pharmaceutical giant could sweeten its pr

Vast F.D.A. Effort Tracked E-Mails of Its Scientists

WASHINGTON — A wide-ranging surveillance operation by the Food and Drug Administration against a group of its own scientists used an enemies list of sorts as it secretly captured thousands of e-mails that the disgruntled scientists sent privately to members of Congress, lawyers, labor officials, jou

Watson sues FDA on generic diabetes drug ruling

Watson said that the FDA improperly denied the company’s shared exclusivity on the generic version despite Watson directly following directions received from the regulator.As a result of the FDA’s decision, approval could be delayed for up to six months, Watson said.Watson planned to launch its gene

Drug Approved to Fight H.I.V. Infection

The Food and Drug Administration on Monday approved the first drug shown to reduce the risk of H.I.V. infection, a milestone in the 30-year battle against the virus that causes AIDS. The agency approved Truvada, a pill made by Gilead Sciences, as a preventive measure for people who are at high risk

Genetically modified rice a good vitamin A source

(Reuters Health) – Genetically modified rice could be a good source of vitamin A for children in countries where deficiency in the vitamin is common, a new study suggests.The study tested so-called Golden Rice against both spinach and supplements in providing vitamin A to 68 six- to eight-year-olds

HIV-prevention drug Truvada approved by US

US health regulators have for the first time approved a drug to prevent HIV infection.Truvada can be used by those at high risk of infection and anyone who may engage in sexual activity with HIV-infected partners, said the Food and Drug Administration (FDA).Studies showed the drug reduced the risk o

Polypill ‘could save thousands’ of lives

“polypill” combining a statin with blood pressure drugs could prevent thousands of heart attacks and strokes every year, according to researchers. A UK study of 84 over-50s, published in the journal PLoS One, showed the pill could cut blood pressure and levels of “bad” cholestero

Lesley Griffiths defends civil servants on NHS report

Wales’ health minister says it was “entirely appropriate” for her civil servants to be in contact with the author of a report into the NHS.Lesley Griffiths defended emails between senior officials and the academic behind the report.Officials were also challenged about why local health boards thought

High Doses of Hormones Faulted in Fertility Care

Two days after Debra Demidon underwent in vitro fertilization, she gained more than 30 pounds in fluid and suddenly was struggling to breathe.Doctors diagnosed severe ovarian hyperstimulation syndrome (OHSS), a complication seen in some women who undergo fertility treatment. It landed Ms. Demidon in
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