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French plan to push copycat biotech drugs worries Big Pharma

By Natalie Huet and Noëlle Mennella PARIS (Reuters) - France is going out on a limb with a plan to push the use of cheap copies of biotech drugs, triggering alarm among companies in Europe's second-biggest pharmaceutical market behind Germany. The government quietly introduced the measure allowing pharmacists to substitute prescribed brand-name biotech drugs with cheaper, similar versions in its 2014 healthcare budget.

Study shows Glaxo heart drug which failed trial has potential benefit

WASHINGTON (Reuters) - An experimental heart drug being developed by GlaxoSmithKline, which failed the main goal of a Phase III study of patients with chronic but well-treated heart disease, showed signs of potential benefit, the trial's co-leader said Sunday. The results presented at the American College of Cardiology scientific meeting in Washington provided a glimmer of hope that the medicine may have value.

Geron says FDA halts patient enrollment in another cancer trial

(Reuters) - Geron Corp said the U.S. Food and Drug Administration ordered a halt to new patient enrollments in an early-stage trial of its blood cancer drug, imetelstat, over concerns about liver damage. The halt announced on Thursday was for enrollments in a trial sponsored by Mayo Clinic, and comes a week after the FDA ordered Geron to cease company-sponsored trials of the drug over similar concerns.

Geron says FDA halts patient enrollment in another cancer trial

(Reuters) - Geron Corp said the U.S. Food and Drug Administration ordered a halt to new patient enrollments in an early-stage trial of its blood cancer drug, imetelstat, over concerns about liver damage. The halt announced on Thursday was for enrollments in a trial sponsored by Mayo Clinic, and comes a week after the FDA ordered Geron to cease company-sponsored trials of the drug over similar concerns.

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.

Hispanics largely left out of clinical trials

Washington, Mar 12 (EFE).- Doctors connected with the research and development of new medications said Wednesday that despite the fact that Hispanics make up 16 percent of the U.S. population, they account for only 1 percent of the people taking part in clinical trials. The low participation rate of minorities in general in medical trials is a negative factor affecting the general long-term health of U.S. society.

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.
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