The FDA has approved a second-generation Medtronic device to treat gastroparesis patients who are not able to control nausea and vomiting using drugs. The Enterra II System has been approved under a humanitarian device exemption, which is used by the agency to approve devices intended for a population of fewer than 4,000 people in the U.S.
SINGAPORE-- India is not a member of the 12-nation Trans-Pacific Partnership, but its intellectual property rules governing pharmaceutical patents lie at the core of a dispute ginning up this year to reach a final agreement. India's resistance to relaxing its rules has been a model for the emerging-market members of the TPP to seek similar compulsory licensing arrangements for generic drugs.
Recent med tech IPO success story Nevro has garnered an approvable letter from the FDA for its Senza spinal cord stimulation system to treat chronic pain, according to the company. Nevro said it needs to address manufacturing and product labeling issues in order to attain FDA approval.
European regulators are recommending approval for The Medicines Company's cangrelor, setting up an overseas nod for a blood-thinning drug rejected by the FDA last year.
President Obama has pushed precision medicine and cybersecurity into the national consciousness and toward the top of the legislative agenda. Obama referred to both topics in his State of the Union address, but at this stage more is known about the cybersecurity plan.
The Taiwan Food and Drug Administration has reclassified 13 commonly prescribed drugs to be available over-the-counter as of June as rising medical costs strain the country's reimbursement policies and threaten support for chronic care therapies that are more expensive.
A group of independent FDA advisers voted in favor of a new anti-infective from Astellas Pharma, setting the stage for a likely approval.
The European Medicines Agency accepted Pfizer's application to expand its label for blockbuster vaccine Prevenar 13 back in August, and so far, an advisory committee likes what it sees.
AstraZeneca's gout treatment lesinurad may have a checkered efficacy record, but the European Medicines Agency has accepted the company's application for the drug--meaning it still has a chance to become the blockbuster the British pharma giant had hoped for.
The FDA's device arm (CDRH) just issued its strategic goals. They are: to strengthen the clinical trial enterprise, to strike the right balance between premarket and postmarket data collection and to provide excellent customer service.