Pharmaceutical sciences

Senate committee advances drug compounding bill

Thomson ReutersMay 22, 2013 19:31

By Jessica Dye NEW YORK (Reuters) - A U.S. Senate committee on Wednesday unanimously approved legislation that would increase federal oversight for companies that compound and sell sterile drugs across state lines. The proposed legislation was introduced in response to a meningitis outbreak last fall that killed more than 50 people and sickened more than 700. The outbreak was traced to contamination found in steroid injections made by the New England Compounding Center.

Merck's insomnia drug moves a step closer to U.S. approval

Thomson ReutersMay 22, 2013 19:31

By Toni Clarke WASHINGTON (Reuters) - Merck & Co's experimental insomnia drug moved a step closer to U.S. approval on Wednesday after a panel of medical experts said it is effective and safe at lower doses. The advisory panel was convened to help the U.S. Food and Drug Administration decide whether to approve the drug, suvorexant, which would be the first in a new class of sedatives that block chemicals in the brain called orexins that help keep people awake. The drugs are designed to help people fall asleep and stay asleep.

Los Angeles voters approve limiting medical marijuana shops

Thomson ReutersMay 22, 2013 07:34

By Alex Dobuzinskis LOS ANGELES (Reuters) - Los Angeles, which has more storefront medical marijuana shops than any other U.S. city, will close hundreds of the dispensaries and hike taxes on those that will be allowed to remain under a ballot measure approved by a wide margin of voters. Nearly 63 percent of voters supported Proposition D, which will cap the number of medical pot dispensaries at 135, compared with 37 percent opposed, according to preliminary results released on Wednesday, the day after the vote.

Peregrine Pharma agrees with FDA on lung cancer trial design

Thomson ReutersMay 20, 2013 10:15

(Reuters) - Peregrine Pharmaceuticals said it reached an agreement with the U.S. Food and Drug Administration on the design of a late-stage trial for its experimental lung cancer drug. The late-stage trial will compare a combination of chemotherapy and the drug, bavituximab, with chemotherapy alone. The main goal of the trial would be to show an improvement in overall survival of patients. Peregrine shares were up 19 percent at $1.83 in early trade on Monday on the Nasdaq.

Anger over East German medical 'human guinea pigs'

Agence France-PresseMay 16, 2013 07:01

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

The Canadian PressMay 15, 2013 14:39

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

Thomson ReutersMay 15, 2013 14:35

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

Thomson ReutersMay 15, 2013 14:34

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

Thomson ReutersMay 15, 2013 14:33

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

Agence France-PresseMay 14, 2013 09:01

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.