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The Federal Circuit Court of Appeals has ruled that two of The Medicines Company’s patents for its anticlotting drug Angiomax are invalid — a win for Hospira, which is planning a generic version of the treatment. Read More
The European Commission says it does not have the authority to issue compulsory licenses to allow the manufacture of generic drugs during a health emergency, noting those decisions are made by member states on an individual basis. Read More
Lawmakers in the House introduced a bipartisan bill that would prevent brand drugmakers from thwarting competition by using restricted distribution networks to deny generics and biosimilars makers access to product samples they need to obtain FDA marketing approval. Read More
In its latest study of direct-to-consumer ads, the FDA wants to know if the inclusion of efficacy information in drug advertisements affects how patients perceive the drug. Read More
The FDA is calling for increased focus on the underlying biology of diseases like Alzheimer’s and diabetes, noting that the discovery of biomarkers has led to important breakthroughs for cancer and HIV/AIDS. Read More
In a document released Friday, the Senate Appropriations Committee calls for fiscal year 2016 user fee amounts totaling nearly $1.2 billion for drugs and biologics — figures that are in line with those proposed by its counterpart in the House. Read More
Excipient makers preparing for the new GMP standard NSF/IPEC/ANSI 363 should be aware they are expected to police themselves to determine if they are meeting manufacturing requirements for their products. Read More