Author Archive
Published by Alexis Pellek on February 17, 2011
under Biotech, Trends
Sanofi aventis and Genzyme have finally agreed on a deal for Sanofi’s acquisition of the Cambridge, MA-based biotechnology company. The agreement values Genzyme at roughly $20.1 billion, or $74 per share, according to a joint statement by the companies. Read more »
Published by Alexis Pellek on February 3, 2011
under Regulation, Trends
A recent poll on PharmTech.com asked readers whether FDA should have the authority to issue recalls for pharmaceutical products, and 86% of readers were in favor of allowing the agency to do so. Read more »
Published by Alexis Pellek on January 27, 2011
under Regulation
On Jan. 4, President Obama signed the FDA Food Safety Modernization Act. The bill expands FDA’s oversight of the food industry and grants the agency, among other things, the authority to issue mandatory food recalls (see back story).
PharmTech is asking readers in our current poll whether FDA should have the same power over pharmaceutical recalls. Right now, nearly 90% of respondents have said “Yes.” Read more »
Published by Alexis Pellek on January 6, 2011
under Trends
For the past few years, Pharmaceutical Technology has asked its readers what they think is in store for the pharmaceutical industry for the coming year. Read more »
Published by Alexis Pellek on December 30, 2010
under Regulation
FDA is close to receiving the authority to mandate recalls of food under a new food-safety bill. Efforts are underway in the House to grant the agency this power for pharmaceuticals as well. Read more »
Published by Alexis Pellek on December 23, 2010
under Products, Regulation
After rejecting two obesity-drug candidates in recent months, FDA’s Endocrinologic and Metabolic Drugs Advisory Committee recommended two weeks ago that the agency approve a third drug, Contrave (naltrexone sustained release [SR]/bupropion SR) by Orexigen Therapeutics (San Diego). Members of the expert panel voted 13–7 to approve the drug, but recommended that additional studies be conducted to investigate potential heart risks. Read more »
Published by Alexis Pellek on December 16, 2010
under Products, Regulation
McNeil Consumer Healthcare, a business unit of Johnson & Johnson (New Brunswick, NJ), failed to ensure the quality of over-the-counter consumer products, according to the Form 483 report released by the US Food and Drug Administration on Wednesday. Read more »
Published by Alexis Pellek on December 2, 2010
under Asia News, Products
China said it will work to crack down on counterfeit products such as software, music, organic corn, and pharmaceuticals, according to an article from the Associated Press. The government will launch a six-month campaign focused on eradicating sales of illegally copied and fake goods, said Jiang Zengwei, a deputy commerce minister, at a news conference earlier this week. Read more »
Published by Alexis Pellek on November 20, 2010
under Products, R&D, Regulation
The wait for the release of a new weight-loss drug got longer recently as regulatory decisions were not in favor of fat-fighting treatments. The US Food and Drug Administration decided in October not to approve two anti-obesity treatments, sending complete response letters (CRLs) to the drugs’ sponsors. Read more »
Published by Alexis Pellek on November 11, 2010
under Africa News, Regulation
Improving drug quality and combating the threat of counterfeit and substandard medications were the goals of recent efforts by regulators and leaders across Africa, where fake drugs are a particularly serious problem. Read more »
Next Page »