With the FDA already reviewing its first biosimilar applications, several patient advocacy groups are banding together to ensure the agency listens to the patient voice as it makes approval decisions and develops future biosimilar guidance.
Although it's still in an embryonic stage, an international neonatal consortium was birthed Wednesday to accelerate the development of much-needed drugs and devices for neonates.
Another local government is considering forcing drugmakers into the waste management business. San Francisco's Board of Supervisors is proposing an ordinance that would make biopharma companies responsible for collecting and disposing of unused prescription and nonprescription drugs used by city residents.
Recognizing that good science can be used for bad purposes or lead to harmful accidents, the National Science Advisory Board for Biosecurity (NSABB) debated the merits of an administration-imposed moratorium on government funding for so-called "gain-of-function" (GOF) research involving influenza, MERS and SARS viruses.
Not even the Federal Circuit can agree on whether it set a new standard for obviousness when it tossed a patent for Bristol-Myers Squibb Co.'s (BMS) hepatitis B drug.
With nearly 10,000 confirmed cases of Ebola and the World Health Organization (WHO) expecting up to another 10,000 new Ebola infections per week in West Africa, the need for a vaccine has never been more apparent.
At the end of the day, does it really matter whether the Federal Circuit takes a fresh look at the construction of patent claims or defers to a lower court's interpretation of issues of fact?
In its ongoing scrutiny of heparin producers, the FDA has added a Beijing firm to a growing list of companies that are on import alert due to concerns about the potential for contamination.
