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Drugmakers are pushing back against an FDA plan to implement tough restrictions on distributing information about new, off-label benefits of a drug, while loosening restrictions on disseminating journal articles that present new risk information about their products. Read More
European and Canadian trade negotiators reportedly have finalized the text of an historic deal that will bring Canada’s intellectual property regulations for pharmaceuticals closer to those of the EU, although it may take another two years before the agreement is actually implemented. Read More
Canadian generics maker Apotex has lost a $520 million lawsuit the company brought in front of an international arbitration board against the FDA over import alerts on two of its facilities. Read More
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