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Manufacturers developing biosimilars in Europe want regulators to go back to comparing their therapies with the reference product, based on the actual amount of active ingredient in a dose, rather than a proposed standard that compares dosages and routes of administration. Read More
European regulators have granted Astellas’ oncology drug Xtandi a new indication for men with pre-chemotherapy prostate cancer who have failed androgen deprivation therapy, putting it in direct competition with Johnson & Johnson’s Zytiga. Read More
Specialty and generic drug maker Actavis has agreed to buy botox manufacturer Allergan for $66 billion in a move analysts say could help transform Actavis into a major pharma giant. Read More
Generics maker Apotex has sued Health Canada over its ban of the company’s products from India, alleging the agency is enforcing the ban to blunt criticism against it by leaders in parliament and a national newspaper rather than in response to any legitimate quality manufacturing issues. Read More
Baxter International has filed a lawsuit against generics maker Mylan over its patent challenge to the brandmaker’s heart rate control drug Brevibloc. Read More
Generics firm Pliva has asked the U.S. Supreme Court to throw out a decision by Iowa’s highest court that potentially paves the way for the company and other generics makers to be held liable in failure-to-update-label claims. Read More
Ranbaxy is fighting to reclaim its first-filer generic exclusivity on AstraZeneca’s blockbuster heartburn drug Nexium with a lawsuit challenging the FDA’s recent decision to rescind tentative ANDA approval for the therapy over manufacturing violations. Read More
British generic drugmakers want branded generics to be exempt from any further price cuts on brand pharmaceuticals, arguing their products already deliver greater savings than what can be achieved from government intervention. Read More
Australia’s supreme court has struck a victory for brandmakers in the country with a finding that extends the time they have to seek an extension on their drug patents. Read More