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Regulators in Canada are revising the dispute resolution process for drugmakers appealing rulings on drug applications, eliminating some available appeals categories and changing what body is responsible for reviewing the disputes. Read More
Rigel Pharmaceuticals said Wednesday it will not initiate any new studies of R348 for the treatment of dry eye disease, after the compound failed to meet its primary and secondary endpoints in a recently completed Phase II trial. Read More
Endo Pharmaceuticals and Impax Laboratories are facing a second proposed class action lawsuit over an alleged pay-to-delay deal that put off a generic launch of Endo’s pain medication Opana ER. Read More
The FDA’s newly created four-point sliding scale of comparability between original biologic products and their biosimilars does not belong in guidance on data to demonstrate that similarity, PhRMA says. Read More
Drugmakers should add microbiology and pharmacogenomics subsections to their prescription drug and biologic product labels when necessary, according to FDA draft guidance released Wednesday. Read More
Impax received its second Form 483 in less than a week for a poor inspection of its U.S. manufacturing facility, igniting fresh doubts about the company’s plan to win approval of its Parkinson’s drug Rytary. Read More
AstraZeneca is suing India-based generics firm Zydus Cadila to block its bid for a version of the brand manufacturer’s acid-reflux drug Nexium. Read More
New Jersey-based Mutual Pharmaceutical and two other generics firms are suing brand manufacturer Reckitt Benckisser for breach of contract, alleging that RB reneged on a license agreement to provide generic supplies of its cold and flu medicine Mucinex for sale. Read More
Boehringer Ingelheim is suing Amneal Pharmaceuticals over its bid to make a generic version of the brand manufacturer’s anti-stroke drug Aggrenox. Read More