Author Archive

Sanofi Aventis to Acquire Genzyme for $20.1 Billion

Alexis Brekke Pellek PharmTech editorSanofi 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 »

PharmTech Poll Shows Readers Favor Expanding FDA’s Recall Power

Alexis Brekke Pellek PharmTech editorA recent poll on 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 »

Should FDA Have Drug-Recall Authority?

Alexis Brekke Pellek PharmTech editorOn 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 »

Reader Predictions for Industry in 2011

Alexis Brekke Pellek PharmTech editorFor 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 »

FDA to Gain Food Recall Authority, Drugs Could be Next

Alexis Brekke Pellek PharmTech editorFDA 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 »

Positive Steps Toward the Next Obesity Drug Approval

Alexis Brekke Pellek PharmTech editorAfter 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 »

J&J’s Fort Washington Plant Cited for Quality Problems; Two Vice-Chairmen Appointed

Alexis Brekke Pellek PharmTech editorMcNeil 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 »

China and India Beef Up Anticounterfeiting Initiatives

Alexis Brekke Pellek PharmTech editorChina 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 »

Safety Concerns Prompted FDA’s Rejection of Qnexa and Lorcaserin

Alexis Brekke Pellek PharmTech editorThe 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 »

Recent Regulatory Efforts in Africa Aim to Fight Counterfeit Drugs

Alexis Brekke Pellek PharmTech editorImproving 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 »

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