Topic:

Regulatory

Latest Headlines

Latest Headlines

Natco India plant gets Form 483 from FDA

Indian drug maker Natco has joined a long list of compatriots facing FDA concerns over manufacturing issues. According to The Financial Express, the company received an FDA Form 483 for a finished dosage plant in Telangana after an inspection in May.

Put a lid on 'Low-T' drug use, FDA panel advises, threatening AbbVie, Lilly meds

An FDA advisory panel wants to limit the use of testosterone drugs for safety reasons--and the proposed restrictions would shrink sales significantly. That's not good news for AbbVie, the market leader, and other drugmakers that have been riding a surge of testosterone growth.

UPDATED: Oral low-T drugs in the pipeline face a showdown with the FDA

An expert panel assembled by the FDA has taken a big step toward blunting the fast-growing market for low-testosterone drugs, raising a thorny issue not just for the companies that sell such remedies, but also for two biotechs trying to gain approvals for new ones.

FDA procedural delay on Rytary gives Impax breathing room

The FDA has put off reconsideration of Impax Laboratories' Parkinson drug Rytary. The delay will give the California company some additional time to work on the latest in a series of FDA concerns over its manufacturing that have kept the drug sidelined.

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.