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J&J faces multiple recall inquiries from US state attorneys general
18 August 2010
Johnson & Johnson has received requests for information about recent product recalls from "multiple" state attorneys general, it admitted in a recent regulatory filing with the Securities and Exchange Commission. The company said it had received ...
GSK/Valeant's Potiga gets unanimous support from US FDA advisory panel
12 August 2010
The US FDA's peripheral and central nervous system drugs advisory committee on 11 August smoothed the way for approval of the anti-epileptic Potiga (ezogabine, previously known as retigabine), which is being developed under an agreement between ...
US activists petition NIH to break patent on Genzyme's Fabrazyme
05 August 2010
Three US Fabry's disease patients are trying to force the licensing of patents for Genzyme's Fabrazyme (agalsidase beta) to other manufacturers to help alleviate shortages of the drug caused by the company's manufacturing problems. They have ...
FDA sees GMP lapses at a third J&J plant
30 July 2010
Details have emerged on how US FDA inspectors observed a number of good manufacturing practice (GMP) deficiencies at a third Johnson & Johnson plant. This time they relate to Johnson & Johnson Merck Consumer in Lancaster, Pennsylvania, which is ...
FDA advisors "hesitantly" vote no to Vivus's Qnexa
16 July 2010
The US FDA's advisory committee on endocrinologic and metabolic drugs voted 10 to six on 15 July that Vivus's weight-loss drug Qnexa (phentermine plus topiramate) should not be allowed on the market. The company's share price tumbled by 55% in ...
 
2010 Scrip 100 - Changes pharma can believe in?
23 August 2010
Ian Schofield picks some of the most significant developments in the health policy and regulation circles in the first half of 2010 and explains their likely impacts on pharma. Barack Obama signed ...
Are we near a telehealth tipping point?
30 June 2010
Telehealth is the use of IT to diagnose, treat and/or monitor a patient in a different physical location from the expert providing the care. At present, it is only targeted towards a segment of acute ...
Scrip Asia 100 - Attracting brains and the big bucks
29 June 2010
Singapore is kicking off free trade discussions with the EU that promise a fillip to ASEAN business. Phil Greenfield assesses the climate for foreign direct investment in the city-state and another ...
 
Interview: European Medicines Agency gets serious about its global strategy
29 January 2010
Developing relationships with medicine regulators in China and India is just one of the challenges facing Emer Cooke, the international face of the European Medicines Agency (EMA), Scrip's Elizabeth ...
 
Commentary: US CDC should protest against Gardasil fear-mongering
20 July 2009
Merck & Co and the US Centers for Disease Control and Prevention ( CDC ) face a challenge – how to counter emotionally charged reports in the US lay media questioning the safety of the cervical ...
Commentary: Ebullient over Effient, depressed over Daschle
04 February 2009
The atmosphere after a US FDA advisory panel meeting can be sedate and gloomy for sponsor pharmaceutical companies if the agency's outside experts take a negative view on their drug applications. But ...
US post-election buzz: a tale of stem cells, trade agreements and power struggles
12 November 2008
One week after US voters elected Illinois Democratic senator Barack Obama as their next president, we offer a few interesting post-election titbits on which Scrip's Washington bureau is keeping an ...
 
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