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Teva and AstraZeneca want a consolidated class action lawsuit alleging they conspired to delay generic entry of AstraZeneca’s acid-reflux drug Nexium dismissed, arguing that Teva couldn’t have marketed its version sooner due to approval delays plaguing Ranbaxy, which has 180 days of generic exclusivity on the product. Read More
Teva Pharmaceutical is pulling 3,881 bottles of a generic combination drug to treat Parkinson’s disease because the tablets are potentially “superpotent,” marking another recall for the company this year. Read More
More than a year after being warned by the FDA for poor quality, Alexion Pharmaceuticals received a fresh Form 483 for problems surrounding gowning procedures and other quality issues. Read More
Australia’s main pharma lobby is proposing changes in how its members report gifts to healthcare professionals, but at least one industry expert says the plan’s fine print would allow doctors to opt out. Read More
Drugmakers should consider the effects of price harmonization in the Persian Gulf region when deciding where to launch their products in the global marketplace, a new report concludes. Read More
India’s National Pharmaceutical Pricing Authority asked six manufacturers of generic cancer drugs to submit pricing data in advance of its setting price caps on the products, a move that one industry observer says was expected. Read More
In an effort to dispel a perception that Indian drugs are poorly made, the government is offering whistleblowers a hefty reward for providing information on spurious, adulterated and misbranded products. Read More
Recent media reports of GlaxoSmithKline’s decision to dismiss staff in China for bribes that occurred more than a decade ago are raising new questions about the drugmaker’s involvement in alleged corruption that surfaced last year. Read More
Starting next year, drug companies seeking to market products in Canada will need to provide the regulatory authority with information on proposed names, labels and packages.
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A public-private partnership in the EU plans to spend $4.5 billion over the next decade to boost, by 30 percent, the success of clinical trials on high-priority drugs. Read More