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  The Pink Sheet
Sizing Up Medicare's Donut Hole Discounts - from The Pink Sheet
Mon, 14 Nov 2011 00:00:00 -0500
Now that the shouting about health care reform has died down... what exactly does it mean for you and your company in cold, hard cash? Here’s a compelling call to action!
Beijing Publicizes 77 Drugs With Exaggerated Efficacies
Fri, 11 Nov 2011 00:00:00 -0500
Beijing’s health bureau exposed 77 drugs with false ads in which the products’ efficacy was exaggerated Nov. 6. Among them, 30 cases including Zhenzhu Huoluo, Ershijiuwei Wan, and Nuo Lisha were found to be particularly serious.
Drug Company Sues Hanzhou Health Bureau Over Unfair Penalties
Fri, 11 Nov 2011 00:00:00 -0500
A state-run drug company took Hanzhou city’s Health Bureau to court Nov. 8, alleging the bureau’s earlier penalties to be unfair. In mid-November, the Zhejiang FDA revealed that the company’s products contained a popular gum posing as propolis.
Born In The U.S.? Advisory Panel To Weigh U.S. Applicability Of Data On Watson’s Prochieve
Fri, 11 Nov 2011 00:00:00 -0500
Pivotal trial of Columbia Laboratories, Inc. and Watson Laboratories, Inc.'s Prochieve (progesterone vaginal gel 8%) was designed to be global, but can the sponsor convince an FDA advisory panel that the results have domestic relevance?
Fri, 11 Nov 2011 00:00:00 -0500
Former FDA Office of Compliance Director Tim Ulatowski joins Becker Consulting, while former compliance office official Larry Spears jumps from Becker to Deloitte; AAMI continues to address ldquo;alarm fatigue.rdquo;
China Pressure On Drug Prices Added Concern For All Pharmas
Fri, 11 Nov 2011 00:00:00 -0500
China’s pressure on lowering prices for basic drugs is becoming an increasing concern for multinational pharmaceutical companies marketing their drugs in the country. The national policy has led nearly all of China’s provinces to begin buying essential drugs through programs intended to make the treatments more affordable.
Beijing Launches Crackdown On Hospital Over-Use Of Antibiotics
Fri, 11 Nov 2011 00:00:00 -0500
China’s capital city plans a crackdown on over-use of antibiotics in treating patients in 165 hospitals. A spokesperson for the Beijing Municipal Health Bureau said the campaign set to last through the end of the year will evaluate use of the drugs, whose over-use is known to lead to development of resistant infections.
Novo Nordisk CEO Lars Sorensen On Novo’s Vision For China (Part 2 of 2)
Fri, 11 Nov 2011 00:00:00 -0500
Every quarter, Novo Nordisk AS CEO Lars Sorensen flies around the world for meetings with his global team. This quarter, Novo reported an unexpected 3% sales drop in China due to regulatory headwinds and increasing competition from both local and multinational players.
Korea Unveils Financial Tool To Boost New Drug Development
Fri, 11 Nov 2011 00:00:00 -0500
SEOUL - In a follow up action to its Columbus Project, announced in March, South Korea's Ministry of Health and Welfare is moving forward with a plan to provide up to KRW 100 billion ($90 million) to select local pharma trying to expand to global markets, particularly the U.S. market. The Columbus Project is designed to help Korean companies develop globally competitive drugs by offering fast-track consultations for clinical trials and U.S.
Expect Stricter Device Clinical Trial Requirements Across The Globe
Fri, 11 Nov 2011 00:00:00 -0500
Although much angst in industry has focused on escalating data requirements from U.S. FDA, clinical trial requirements for medical devices may be ratcheting up across the globe, trial experts and international regulators say. “We are on the brink of a quite substantial change,” Sabina Hoekstra-van den Bosch, a senior advisor on drug and device matters in The Netherlands’ Ministry of Health, Welfare and Sport, said of requirements in the European Union, Oct. 25 at the Regulatory Affairs Professionals Society meeting in Indianapolis. “We’re very much in an environment with greater regu...
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