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With drugmakers facing a Jan. 1 deadline to begin complying with new product track-and-trace requirements, the FDA has announced a wide range of options that companies can choose from to satisfy the new law in a short guidance that contains no surprises for industry. Read More
The FDA is requiring drugmakers to revamp their product labeling to include clearer information on the safe use of drugs and biologicals in pregnant women and nursing mothers, marking the first labeling requirement of its kind since the late 1970s. Read More
Compounding pharmacies are warning that a federal drug safety law is starting to hamper their ability to supply needed therapies to patients, and that a strict reading of the law could cause even greater hurdles to producing the products. Read More
The FDA is considering a new inspection scoring system that would for the first time recognize drugmakers that go beyond normal compliance with good manufacturing practices. Read More
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