Topic:

Regulatory

Latest Headlines

Latest Headlines

Merck wins breakthrough FDA approval for blockbuster cancer contender pembrolizumab

Merck has won the frenzied race to secure the first FDA approval for a new breed of cancer treatment, clearing the way for a U.S. launch and a scramble for dominance in a field expected to peak at nearly $35 billion a year.

Merck's new antibiotic hops on the FDA fast track

Merck has secured the FDA's fast-track designation for its latest antibiotic candidate, a mid-stage treatment for complicated infections.

NICE slaps unusual rules on Alexion's pricey Soliris after atypical cost review

Despite its well-publicized rejections of several high-priced cancer drugs, the U.K.'s National Institute for Health and Care Excellence has just recommended what's widely considered to be the most expensive drug in the world--Alexion's Soliris. 

Wockhardt expects to resolve most FDA concerns within the year

Wockhardt has been in a world of hurt since the FDA last year banned two of the plants that made drugs for the U.S. market. But the Indian drugmaker has said that with the help of outside consultants it can get most of its problems with the FDA resolved within the year, and that has the M&A handicappers suggesting it is prime takeover target.

AdvaMed says FDA proposed rule would result in more PMAs, device reclassifications

The device industry is awaiting the finalization of the FDA's rule on medical device classification procedures, and will be combing it for the requested changes from the March 2014 proposed rule. More comments asking for an easing of the regulatory burden may be forthcoming, for the FDA extended the public comment period to Sept. 22, according to a notice in the June 12  Federal Register. 

Abbott glucose monitor eliminates finger sticks, receives CE mark

Getting rid of the finger stick for diabetics while maintaining sufficient accuracy without calibration is a long-held industry goal and could prove a boon to patients.

USDA gives conditional approval for Zoetis PEDv vaccine

The U.S. Department of Agriculture has given conditional approval for use of Zoetis' vaccine to combat the porcine epidemic diarrhea virus, or PEDv, that has caused havoc in global swine herds, killing an estimated 8 million piglets in the U.S. alone since it was first reported more than a year ago.

Kentucky Horse Racing Commission looking into regulating compounders

The commissioner of the Kentucky Horse Racing Commission announced that the organization is looking into ways it can add regulatory oversight of drug compounders.

GE wins approval of 3-D imaging tech for breast screening

GE today announced the approval of its SenoClaire breast tomosynthesis device that employs 3-D imaging, developed in collaboration with Massachusetts General Hospital. 

Governors to HHS secretary: Nix that FDA nod for controversial painkiller Zohydro

Count five U.S. governors among the lobbyists for a turnabout on the powerful painkiller Zohydro. The New England politicians wrote Health and Human Services Secretary Sylvia Burwell last week, urging her to yank the drug's FDA approval.