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Regulatory

Latest Headlines

Latest Headlines

FDA approves next-gen Medtronic device to treat drug-refractory gastroparesis

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.

Trans-Pacific Partnership push waits on cue from Obama's India visit

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.

Nevro gains on FDA pending approval with the resolution of manufacturing, labeling issues

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.

The Medicines Co.'s FDA-rejected cardio drug finds EU success

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.

Obama talks up precision meds, cybersecurity in SOTU speech

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.

Taiwan moves to cut reimbursement costs by switching 13 drugs to OTC

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.

Astellas' new antibiotic marches toward FDA approval with panel nod

A group of independent FDA advisers voted in favor of a new anti-infective from Astellas Pharma, setting the stage for a likely approval.

Pfizer wins recommendation for Prevenar expansion in Europe

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.

Europe accepts AstraZeneca's gout drug app, keeping blockbuster hopes alive

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.

FDA's device arm issues strategic priorities for 2015

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.