Topic:

Regulatory

Latest Headlines

Latest Headlines

More FDA issues arise for Hospira in India

About three months before Hospira closed on its acquisition of an API plant from India's Orchid Chemicals & Pharmaceuticals, FDA inspectors made a visit to the facility in Waluj. They had concerns with what they found.

Can AstraZeneca turn its Movantik constipation pill into a blockbuster?

AstraZeneca's brand-new Movantik has an edge on rivals in the opioid-induced constipation (OIC) market, which is expected to near $2 billion by 2017. It's the first mu-opioid approved for OIC, and the first mu-opioid pill, period.

Regeneron nabs FDA 'breakthrough' tag for new Eylea use in diabetics

Plenty of drugmakers are chasing opportunity in diabetes. The fast-growing epidemic means new therapies are sorely needed. But dealing with diabetes directly isn't the only strategy. Regeneron figures it can score by treating some of the disease's long-term complications.

AZ faces market-making task to capitalize on Movantik's edge in OIC

Congratulate AstraZeneca and Nektar Therapeutics. Their oral therapy for opioid-related constipation, Movantek, beat all rival pills to market. And if analysts are correct, that market lead will pay off big time.

FDA greenlights first human study of Wearable Artificial Kidney

Months after clearing the Wearable Artificial Kidney for human clinical trials, the FDA gave medical researchers a green light to begin the first human study of the device in the United States.

Pension fund sues AbbVie over expected high taxes from Shire deal

As if the merger-happy pharmaceutical industry didn't have enough to worry about, what with the federal government threatening to crack down on companies that flee overseas to lower their taxes, now there's another set of stakeholders protesting these so-called tax inversions: pension funds.

UPDATED: FDA takes step toward standardized medical device labeling

Tucked away in the Federal Register are the FDA's intentions to test its own labeling format to "inform FDA's planned regulatory approach to standardizing medical device labeling across the United States."

AstraZeneca and Nektar win FDA OK for blockbuster-hopeful constipation drug

The FDA approved a new opioid-induced constipation treatment from partners AstraZeneca and Nektar Therapeutics, shaking off some safety concerns and green-lighting a drug the two hope can bring in billions.

UPDATED: With FDA confab looming, Chantix experts can't persuade court to unseal Pfizer records

Next month, the FDA's expert advisers will take another look at Pfizer's stop-smoking drug Chantix. The official agenda: Weigh new data on Chantix's links to psychiatric side effects, and consider changing the black-box warning about those risks.

Smallpox biotech Siga files for bankruptcy over PharmAthene spat

A court ruling has saddled biodefense specialist Siga Technologies with debts it cannot pay, the company said, and the biotech is filing for bankruptcy in an effort to keep its doors open long enough for an appeal.