Topic:

Regulatory

Latest Headlines

Latest Headlines

Exact Sciences bags FDA approval and proposed CMS coverage for colorectal cancer screening test

Exact Sciences won FDA approval for its stool-based colorectal cancer diagnostic, charting a regulatory milestone and picking up proposed national coverage for its product along the way.

Celltrion targets J&J's Remicade as biosimilars loom in the U.S.

South Korea's Celltrion is aiming to be second in line when biosimilars make their U.S. landfall, filing an FDA application to market a knockoff of Johnson & Johnson's blockbuster Remicade.

NICE says social values, along with cost, need to be factored into decisions

The U.K.'s National Institute for Health and Care Excellence wants to know what "societal values" should be considered, along with cost and efficiency, when making decisions. Now an appointed group of 30 people have given it that feedback, PMLive reports.

Exact Sciences wins FDA approval and more for next-gen colon cancer test

Exact Sciences gained FDA premarket approval for its new, cutting-edge colorectal cancer screening test. It is also well ahead in the insurance reimbursement battle.

Wockhardt's earnings devastated by FDA bans

With FDA bans in place on two plants, India's Wockhardt saw its profits slip in the first part of this year. But with access to its largest market still severely curtailed, Wockhardt has been unable to get its financial footing and profits went crashing in its last quarter, off 94%.

How much would you pay for FDA special treatment?

Knight Therapeutics intends to find out how much drugmakers are willing to pay for the FDA's attention, putting its priority review voucher up for sale and shining a light on a program designed to encourage neglected disease R&D.

Syria broadens corruption accusations against GlaxoSmithKline

Last month, a whistleblower sent a letter to GlaxoSmithKline alleging "multiple corrupt and illegal practices" in the company's Syrian consumer health operation before it was shut down in 2012. Now it appears the problems may have extended to GSK's prescription drug business in Syria, which is still in operation.

Lenox MacLaren's grinding court battle with Medtronic will continue

A federal appeals court panel ruled that Lenox MacLaren Surgical has sufficient grounds to take Medtronic ($MDT) back to court over monopolization claims against the Minnesota-based medical device giant.

Pakistan indicts 76 customs officers in fake drug probe

The spotlight is back on Pakistani customs officials. With the force having previously been accused of accepting bribes to facilitate global counterfeiting operations, the Pakistani Federal Investigation Agency (FIA) has now indicted 76 customs officials as part of an investigation into the unlawful clearance of raw materials.

Recalls overseen by FDA soar in 2013, 2014

The number of recalls overseen by the FDA has surged over the past two years, Regulatory Focus reports.