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Anger over East German medical 'human guinea pigs'

Germany is confronting another chapter from its past -- allegations that Western drug companies used more than 50,000 people in the former communist East as "human guinea pigs" in 1980s medical trials. News magazine Spiegel this week reported that a who's who of big German, Swiss and US pharmaceutical companies made deals with the dictatorship to test medicines, sometimes without the knowledge of the patients.

Senators move ahead with bill to federally oversee large compounding pharmacies

WASHINGTON - Senate lawmakers are pushing ahead with a bill that would bring new federal oversight to large specialty pharmacies like the one that triggered a deadly meningitis outbreak last year. The bill introduced Tuesday by Democrats and Republicans would subject such large compounding operations to direct federal oversight by the Food and Drug Administration, rather than the state pharmacy boards that have traditionally overseen them.

Arena withdraws diet drug application in Europe; shares fall

By Adithya Venkatesan (Reuters) - Arena Pharmaceuticals Inc withdrew an application to market its anti-obesity drug in the European Union, sending its shares down 15 percent in after-hours trading. The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) said certain "major objections" remain outstanding that preclude the recommendation of approval of the drug, according to the company.

FDA panel votes against Aveo's kidney cancer drug

By Toni Clarke (Reuters) - An advisory panel to the Food and Drug Administration recommended that the agency reject a kidney cancer drug made by Aveo Pharmaceuticals Inc and Astellas Pharma Inc, saying data from the clinical trial were inconsistent. In a 13-1 vote on Thursday, the panel said Aveo had not shown that the drug's benefits outweighed its risks in a well-controlled study, and said a second trial would be needed before the drug, tivozanib, should be approved.

California high court affirms local right to ban medical pot shops

By Ronnie Cohen SAN FRANCISCO (Reuters) - The California Supreme Court dealt a blow to the state's faltering medical-marijuana industry on Monday by ruling that local governments may outlaw dispensaries that sell the federally banned drug. The unanimous opinion, which comes as elected officials across the nation grapple with regulating a growing medical pot industry, upheld a ban the southern California city of Riverside enacted on pot shops in 2010.

India's Ranbaxy shares climb as US legal battle ends

Shares in Ranbaxy climbed on Tuesday after US authorities slapped a $500 million fine on India's biggest drugmaker to settle a lengthy lawsuit over the sale of adulterated drugs in the United States. The case -- the largest-ever US drug safety settlement with a generic manufacturer -- ended eight years of criminal and civil investigations into the company, which is now majority-owned by Japan's Daiichi Sankyo. After opening down over four percent, Ranbaxy shares closed up 3.63 percent at 455.5 rupees as analysts said the decision would allow the firm to focus on the future.

Germany's Merck KGaA sees profit rise 54 per cent in Q1 helped by higher prices for key drug

FRANKFURT - Higher prices for its multiple sclerosis drug Rebif helped German pharmaceutical and high-tech materials company Merck KGaA post a 54 per cent rise in first-quarter profit. Merck also saw stronger sales of materials for liquid-crystal displays and raised its profit forecast, saying it would achieve its 2014 goals this year. Its optimism came after it reported net profit of 266 million euros ($345 million) in the first three months of the year, up from 172.7 euros a year earlier. Total revenues rose 4.4 per cent to 2.76 billion.

Ranbaxy pleads guilty, to pay $500 million in U.S. settlement

(Reuters) - Indian generic drugmaker Ranbaxy Laboratories Ltd pleaded guilty on Monday to felony charges related to drug safety and will pay $500 million in civil and criminal fines under the settlement agreement with the U.S. Department of Justice. The settlement is its largest-ever with a generic drugmaker over drug safety, according to the U.S. government. It includes $150 million in payments for a criminal fine and forfeiture and $350 million in payments for civil claims.

Subsidiary of Indian drug maker agrees to pay record $500 million US penalty for impure drugs

WASHINGTON - A subsidiary of India's largest pharmaceutical company has agreed to pay a record $500 million in fines and penalties for selling adulterated drugs and lying to federal regulators in a case that is part of an ongoing crackdown on the quality of generic drugs flowing into the U.S. Federal prosecutors said Monday the guilty plea by Ranbaxy USA Inc. represents the largest financial penalty against a generic drug company for violations of the Federal Food, Drug and Cosmetic Act, which prohibits the sale of impure drugs.

Elan enters $1 billion royalty deal with Theravance over potential respiratory drug sales

Irish drugmaker Elan Corp. PLC plans to pay $1 billion for the right to future royalties from four respiratory treatments being developed by Theravance Inc. and GlaxoSmithKline. The deal announced Monday will give Elan 21 per cent of the future royalties that South San Francisco, Calif.-based Theravance receives from Glaxo, a British drugmaker. Theravance shares soared almost 14 per cent in premarket trading 45 minutes before the market opening.
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