FDA
Digital Pharma: Byte-sized roundup
November 13, 2009Medical Communications FDA, Merck Serono, Solvay, digital pharma, google, social media
Solvay Pharma has joined the ranks of pharma companies using Twitter, setting up a Russian language account for its Moscow-based …
Digital Pharma: Counting down to the FDA’s social media hearing
November 9, 2009Medical Communications FDA, digi, social media
Later this week the FDA will hold its hotly anticipated hearing on pharma’s use of social media.The ‘Public Hearing on …
Digital Pharma: Counting down to the FDA’s social media hearing
November 9, 2009Medical Communications FDA, digi, digital pharma, industry, social media
Later this week the FDA will hold its hotly anticipated hearing on pharma’s use of social media.The ‘Public Hearing
FDA streamlines GMP for combination products
October 2, 2009Manufacturing and Production FDA, US, reg
The US Food and Drug Administration has said it will draw up new rules on Good Manufacturing Practices (GMP) for …
FDA warns Bayer over German API facility
September 17, 2009Manufacturing and Production Bayer, FDA, reg
The US regulator has sent a warning letter to Bayer indicating it found "significant deviations from US current good manufacturing …
New FDA head aims for aggressive enforcement
August 11, 2009Research and Development, Sales and Marketing FDA, US, drug safety
The new head of US regulator the FDA has set out a vision to support public health, through tighter laws …
TNF blockers must carry children’s cancer warning
August 7, 2009Research and Development, Sales and Marketing FDA, RA, TNF
The FDA has ruled that TNF blocker drugs should carry new warnings of the increased risk of certain cancers for …
FDA blocks Teva from selling vet drugs and warns Apotex
August 6, 2009Manufacturing and Production Apotex, FDA, Teva
The FDA’s clampdown on quality standards continues apace, with Teva’s animal health unit in Missouri and an Apotex plant in …
US approval boosts Plavix competitor
July 14, 2009Research and Development, Sales and Marketing Effient, FDA, US, lilly
US regulator the FDA has approved Lilly and Daiichi Sankyo's Effient, a rival treatment to the world's best-selling blood-thinning drug …
Writing on the wall for ‘pay to delay’ generics deals
July 9, 2009Research and Development, Sales and Marketing FDA, US, generics
Deals allowing US pharma companies to pay generics competitors to delay the launch of rival products should be ended, according …
Genzyme’s woes are a boost for Shire and Protalix
July 9, 2009Research and Development, Sales and Marketing FDA, Genzyme, US
The contamination problems at a plant used by Genzyme to manufacture a drug for Gaucher disease have prompted the US …
Depression warnings for Chantix and Zyban
July 7, 2009Research and Development, Sales and Marketing Chantix, FDA, US, drug safety
Pfizer and GSK's smoking cessations drugs will have to carry strong warnings of depression and other mental health adverse events …
FDA to improve transparency
June 3, 2009Research and Development FDA, US
The US medicines regulator is to boost the transparency around its decision-making, in connection with President Obama's aim to make …
Coast first casualty in US overhaul of IRB system
May 5, 2009Research and Development FDA, US
A US company offering institutional review board services to sponsors of clinical trials has been forced to close its doors …
Sanofi boosted by Multaq vote of approval
March 19, 2009Research and Development, Sales and Marketing FDA, Multaq, Sanofi, US
An FDA committee has recommended Sanofi-Aventis' new atrial fibrillation treatment Multaq, the company's most important late-stage drug. The FDA cardiovascular …
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