Topic:

Regulatory

Latest Headlines

Latest Headlines

First Dx for kidney failure approved by FDA

The FDA cleared the first and only diagnostic for acute kidney injury today, Astute Medical announced. A recent study found that hospitalized patients who got AKI had a 30% mortality rate at one year, twice that of a heart attack.

FDA faces pressure to green-light generic versions of AZ's pricey Nexium

Back in 2008, Indian generics maker Ranbaxy made a deal with AstraZeneca to launch its Nexium copycat in May of this year. So why are Americans still unable to buy cheap versions of the blockbuster heartburn pill, which brought in more than $2 billion in U.S. sales last year?

J&J ordered to fork over $3M in vaginal mesh case

Johnson & Johnson's Ethicon unit lost a battle in its ongoing vaginal mesh litigation as a federal jury in West Virginia ordered the company to pay $3.27 million to a woman who claimed the device caused undue pain and serious side effects.

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.