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FDA bans imports from Sun Pharma plant in India crackdown

By Zeba Siddiqui and Sumeet Chatterjee MUMBAI (Reuters) - The U.S. Food and Drug Administration (FDA) has banned imports from Indian generic drugmaker Sun Pharmaceutical Industries Ltd's plant at Karkhadi in the western state of Gujarat, in the latest quality blow for India's drug sector.

U.S. cattle deaths linked to Zilmax far exceed company reports: study

By Tom Polansek and P.J. Huffstutter (Reuters) - The number of U.S. cattle deaths that may be linked to the Merck & Co Inc feed additive Zilmax are much higher than the figures reported by the drug company to the federal government, according to a research study published on Wednesday.

Pfizer to appeal loss of Celebrex patent

Pharmaceutical giant Pfizer said on Wednesday it will appeal a US federal court's refusal to extend patent protection for its blockbuster Celebrex drug used to treat arthritis. Pfizer said the US District Court for the Eastern District of Virginia invalidated the reissue patent covering methods of treating osteoarthritis and other approved conditions with celecoxib, the active ingredient in Celebrex. The ruling means that Pfizer will be exposed to competition from generic drug makers earlier than the company expected.

U.S. drugmaker to give unapproved medicine to dying Virginia boy

By Eric M. Johnson (Reuters) - A dying seven-year-old boy who is suffering from a viral infection could receive an unapproved treatment as early as Wednesday after a drugmaker struck a deal with U.S. regulators to provide the medicine. Pharmaceutical company Chimerix Inc, lobbied by supporters of Josh Hardy in a campaign that has gained national attention, will make him the first patient in a 20-patient pilot trial of open-label brincidofovir (CMX001).

Geron says FDA halts testing of lead drug

(Reuters) - Geron Corp said the U.S. Food and Drug Administration had ordered to halt the trials of its cancer drug imetelstat due to concerns of liver damage. The company said the FDA verbally notified them about the hold, which will affect all trials of the treatment, including its thrombocythemia and multiple myeloma mid-stage studies. The experimental blood cancer drug was touted as a saviour for the company in November, after a number of trial patients were cured.

Geron says FDA halts testing of lead drug

(Reuters) - Geron Corp said the U.S. Food and Drug Administration had ordered to halt the trials of its cancer drug imetelstat due to concerns of liver damage. The company said the FDA verbally notified them about the hold, which will affect all trials of the treatment, including its thrombocythemia and multiple myeloma mid-stage studies. The experimental blood cancer drug was touted as a saviour for the company in November, after a number of trial patients were cured.

Ranbaxy scrambles for ingredients to make generic Nexium

By Sumeet Chatterjee and Ben Hirschler MUMBAI/LONDON (Reuters) - Indian drugmaker Ranbaxy Laboratories Ltd is in talks with at least two companies on sourcing ingredients for a generic version of AstraZeneca Plc's heartburn drug Nexium, a source said, to ensure the pills can be sold in the United States. Washington in January prohibited Ranbaxy, India's top drugmaker by revenue, from selling drugs in the United States using ingredients from one of its plants in northern India due to poor manufacturing practices.

Experts call for additions to strengthen act amending drug legislation

TORONTO - Several experts say the federal government's attempt to strengthen the powers of the Food and Drug Act haven't gone far enough. They applaud some of the provisions in Bill C-17, but say additional powers are needed to protect the public. They make their argument in a commentary published in this week's issue of the Canadian Medical Association Journal. The act, which was introduced in Parliament in early December, gives the federal health minister long-overdue powers to order the recall of a drug for safety reasons.

West Virginia senator seeks to reverse approval of new painkiller, citing risk of abuse

WASHINGTON - U.S. Sen. Joe Manchin is calling on the government's top health official to overturn the approval of a powerful painkiller, arguing that the pill Zohydro could add to the national epidemic of prescription drug abuse. The West Virginia Democrat joins a chorus of lawmakers, state prosecutors and medical groups seeking a reversal of the Food and Drug Administration's October approval. In a letter Monday, Manchin asks Health and Human Services Secretary Kathleen Sebelius to overrule the agency's decision.

Proteus picks UK for 'smart pill' production and testing

By Ben Hirschler LONDON (Reuters) - A U.S. biotech company pioneering tablets containing edible embedded microchips that can tell if patients have taken their medication is to establish its first international manufacturing site in Britain. Privately held Proteus Digital Health, which is working with drugmakers including Novartis and Otsuka, said on Monday the new site would employ some 200 skilled staff and serve as a hub for the emerging digital medicine industry.
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