Topic:

Regulatory

Latest Headlines

Latest Headlines

UPDATED: Europe approves Gilead's cancer drug Zydelig amid challenging pricing environment

The approval puts Gilead well on track to meet analyst expectations that Zydelig (idelalisib) will be hauling in $1.2 billion in annual sales by 2020, though there's little doubt Gilead will face pressure from European health agencies to keep a lid on the new drug's price.

Novo Nordisk wins EU approval for a diabetes combo with billion-dollar potential

Novo Nordisk picked up European approval for a combination of a long-acting insulin and its own Victoza, pioneering a once-a-day approach to Type 2 diabetes that could bring in blockbuster sales.

Court ruling against FDA enables more combination products to be classified as devices

The U.S. District Court for the District of Columbia rejected the FDA's attempt to classify Prevor's Diphoterine Skin Wash as a drug rather than a device for the second time, dealing industry a victory in the sometimes contentious arena of product classification decisions.

FDA advisers shoot down Clarus' pitch for a new low-T drug

Amid widespread safety concerns surrounding testosterone drugs, an FDA panel has recommended against Clarus Therapeutics' oral treatment, dimming the future for the company's sole product.

FDA backs ED upstart Stendra as a fast-acting alternative to Viagra

Companies have been studying Stendra for some sort of competitive edge. Now, they may have found one: The FDA backed the ED pill as a fast-acting treatment, taken 15 minutes before sex. Previously, the directions prescribed a 30-minute lead time.

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.