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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
The FDA has approved an expanded indication for Genzyme’s leukemia drug Lemtrada to treat relapsing multiple sclerosis, 11 months after it initially turned down the company’s sBLA due to safety concerns. 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
FDA investigators will be able to photograph most areas of a facility during an inspection, including product labels and visible contamination of materials, according to a final guidance issued last month. Read More
The FDA has slapped another Indian active pharmaceutical ingredient maker with a warning for data integrity weaknesses, including printing batch records from personal computers over which the company lacked adequate controls. Read More
The FDA chided drugmaker Sciecure Pharma for distributing a sales aid that touted overblown superiority claims and disregarded risk information surrounding its insomnia treatment Doral.
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The FDA has cited Cadila Pharmaceuticals for poor data integrity practices and sloppy investigations into foul smelling batches of active pharmaceutical ingredients (APIs), violations that the agency threatened could result in an import alert. Read More
The FDA is fleshing out its expectations for drugmakers that want to participate in the agency’s rare pediatric disease voucher program, offering new details on requirements for seeking the designation, a five-year post approval reporting schedule and procedures for transferring the vouchers. Read More
The head of the European Medicines Agency was forced to resign after a tribunal found he was improperly selected in 2011, a move agency officials characterized as a procedural issue. Read More