Topic:

Regulatory

Latest Headlines

Latest Headlines

Gore's endovascular graft-repair device gains wider FDA nod

W.L. Gore's has achieved a broader FDA approval for its endovascular graft-repair device.

Roche lung cancer Dx achieves Chinese approval

Roche's Ventana Medical Systems arm gained pivotal Chinese regulatory approval for a companion diagnostic that pairs with Pfizer's targeted lung cancer drug Xalkori.

UPDATED: Syndax scores a coveted 'breakthrough' designation for PhIII cancer drug

The Waltham, MA-based biotech won the BTD for entinostat, an experimental histone deacetylase inhibitor (HDACi) set to begin Phase III testing in early 2014 in combination with exemestane in postmenopausal women with metastatic ER-positive breast cancer who have progressed on hormonal therapy.

Quest, LabCorp defrauded Medicaid, lawsuit says

Testing giants Quest Diagnostics and LabCorp have been gouging Virginia's Medicaid system, according to a lawsuit, inflating prices by as much as 1,000% of what they charged private insurers.

Industry Voices: Breakthrough designation Q&A

By Michelle Rohrer, Vice President, U.S. Regulatory Affairs, Genentech In August I had the pleasure of participating in Fierce's "Understanding Major Regulatory Change" webinar. This...

Dako gets FDA warning letter tied to Roche companion Dx

Diagnostics giant Dako got an earful from the FDA over how it manufactures test kits at a Denmark plant, including the company's high-profile companion diagnostic for Roche's blockbuster Herceptin breast cancer treatment.

OvaScience shares blitzed after FDA steps in to supervise lead product

When OvaScience went public last year, the management laid out the tantalizing prospect that their lead fertility program could deliver a marketable product by the end of this year. And they could do it, according to their S-1, without the risk associated with FDA oversight for a new drug by developing it as a cellular and tissue-based product.

FDA cites Dx maker Dako for quality system violations

Dako got hit with an FDA citation over what the agency says are quality system manufacturing violations involving one of its signature breast cancer diagnostic kits and other related products.

UPDATED: FDA experts endorse new COPD blockbuster from GlaxoSmithKline, Theravance

GlaxoSmithKline and Theravance have nailed down a solid majority of FDA panel votes in favor of marketing their new COPD therapy Anoro Ellipta. The outside experts voted 11 to 2 this afternoon to endorse the therapy, opening the door to the first of several new drug that will likely wind up duking it out in a tough fight for market share.

Hospira, Celltrion achieve milestone in EU with OK for Remicade biosimilar

Hospira, which jumped early into the the biosimilar market in Europe, has seen its efforts pay off with the approval of Inflectra, a biosimilar of Johnson & Johnson's Remicade.