Topic:

Regulatory

Latest Headlines

Latest Headlines

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.

Hospira gets FDA nod for wireless infusion pump, finishing up two-year plan to reinvigorate devices

Hospira hopes to get back on track with its infusion pump business this year. The latest bit of good news for the company is FDA clearance for the Plum 360 Infusion System, which adds the capability to wirelessly stream data to an electronic medical record and access an expanded drug library for information to maintain patient safety.

U.K. expands Wockhardt ban

In 2013, U.K. and European regulators banned most products from a Wockhardt plant in India that was found faking data, but the U.K. allowed it to continue shipping a few that were required for essential medicines. This week, the U.K. stiffened the action to include all active ingredients from Wockhardt's plant in Chikalthana, a facility the FDA has also banned from shipping to the U.S.

Celator's delivery platform results in FDA's fast-track designation for its cancer candidate

Celator Pharmaceuticals received fast-track designation for its candidate for the treatment of secondary acute myeloid leukemia in elderly patients. CPX-351 is designed to achieve sustained release of the anticancer drugs cytarabine and daunorubicin in a precise ratio.