Topic:

Regulatory

Latest Headlines

Latest Headlines

FDA, DOJ arrest NECC pharmacist about to leave the country

Federal authorities have arrested a pharmacist that worked for the now bankrupt New England Compounding Center. The compounder's manufacturing failures are believed to be responsible for a fungal meningitis outbreak in 2012 that killed 64 people and sickened 751. 

FDA clears Otoharmonic's iPad/iPod app to treat tinnitus

The FDA has given clearance to startup Otoharmonics for its iPad and iPod Touch application that uses sound therapy to teach the brain to ignore persistent ringing caused by tinnitus.

FDA warning dampens Keryx's parade for newly approved kidney drug

When the FDA came through with their expected approval for Keryx's ferric citrate (formerly Zerenex), a new treatment to deal with complications of kidney disease, on Friday, a label warning that the drug could wind up triggering iron overload dampened analysts' enthusiasm for this treatment considerably, with Keryx's stock price ending Friday down 5%.

GSK, Pfizer partnership wins EU nod for HIV pill weeks after FDA approval

Hot on the heels of its FDA approval, a new combo pill from the HIV-focused partnership of GlaxoSmithKline and Pfizer, has won approval in Europe. ViiV Healthcare said that the EU had given a green light to its once daily combo pill Triumeq, an approval that will help it reach the $5 billion in peak sales it has been forecast to capture.

OncoMed gets back on track as FDA clears another clinical hold

OncoMed is moving on from tandem setbacks in its cancer pipeline now that the FDA has removed its final clinical hold on one of the company's oncology candidates, clearing it to resume enrollment in a Phase I study.

Feds intercept pharmacist linked to meningitis outbreak as he headed to Hong Kong

It is not often that drug company employees get hauled off an airplane leaving the country and arrested. But it is not often that a drug company's products are tied to the deaths of dozens of people, like the compounded steroids that are believed to have given more than 750 people fungal meningitis in 2012.

OncoMed gets back on track as FDA clears another clinical hold

OncoMed is moving on from tandem setbacks in its cancer pipeline now that the FDA has removed its final clinical hold on one of the biotech's oncology candidates, clearing it to resume enrollment in a Phase I study.

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.