To learn how best to prescribe powerful drugs to children, Congress passed a law in the 1990s that rewarded drug makers for conducting clinical studies involving children. Among the incentives for cooperating companies was a possible six-month extension of protection from generic competition after a

The Food and Drug Administration has agreed to give priority status to its review of three new uses for the anticlotting drug Xarelto, Johnson & Johnson announced Monday.The company is asking the agency to approve the drug to treat deep vein thrombosis and pulmonary embolism, and to prevent recu

In the largest settlement involving a pharmaceutical company, the British drugmaker GlaxoSmithKline agreed to plead guilty to criminal charges and pay $3 billion in fines for promoting its best-selling antidepressants for unapproved uses and failing to report safety data about a top diabetes drug, f

Merck, the second-biggest U.S. drugmaker, on Wednesday said outside monitors recommended that its late-stage study of odanacatib, a new type of treatment, be stopped early because data has already shown it reduces fractures. Shares of Merck rose 4.2 percent on Thursday, on boosted hopes for the medi

(Reuters) – Republican governors bent on rejecting the healthcare law’s expanded insurance coverage for millions of low-income Americans may see their gambit backfire if their party fails to sweep the November elections.Five governors have vowed to opt out of the Medicaid expansion for low-income pe

(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

(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

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

(Reuters) – AstraZeneca is to conduct a new global clinical trial of key new heart drug Brilinta involving 11,500 patients with peripheral artery disease, Britain’s second biggest drugmaker said on Tuesday.Peripheral artery disease affects around 27 million people in Europe and North America, with s

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