Topic:

Regulatory

Latest Headlines

Latest Headlines

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.

AstraZeneca's $1.3B gout drug comes under EU scrutiny

The European Medicines Agency has accepted AstraZeneca's application for lesinurad, a gout treatment with a checkered efficacy record, stoking the company's hopes that it can make the drug into a blockbuster.

Roche's Ventana inches closer to FDA approval for lung cancer companion Dx

Roche's Ventana Medical Systems has submitted its companion diagnostic test for ALK1-positive lung cancer for FDA approval, inching the company closer to full regulatory approval for the product and helping it gain ground in a fiercely competitive cancer diagnostics market.

K2M to cash out shareholders, raise $40M on FDA nod for next-gen spinal system

K2M Group Holdings got FDA clearance for the second generation of its top product, the Mesa Deformity Spinal System. The company is now planning to capitalize on that milestone. It's slated to raise $40 million, as well as to sell 4.9 million on behalf of existing shareholders including its majority owner, private equity group Welsh, Carson, Anderson & Stowe.

Novartis eyes psoriasis dominance with new approvals for Cosentyx

Novartis scored FDA and European approvals this week for its blockbuster contender Cosentyx. But rival companies are developing their own therapies, and existing drugs challenge its market share.