Topic:

Regulatory

Latest Headlines

Latest Headlines

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.

NY sues Actavis and Forest for 'monopoly' on Alzheimer's drug

Some analysts called it a cheap trick when Forest Laboratories said it would stop making the Alzheimer's drug Namenda this fall so it could push patients to switch to their new long-acting version as generic rivals to the original loom. New York attorney general Eric Schneiderman calls the tactic something else: illegal.

Novo's next-gen insulin clears a pediatric hurdle amid renewed U.S. hope

Novo Nordisk bolstered its better-late-than-never case to win FDA approval for a new long-acting insulin, as the drug, Tresiba, met its main goals in a study on children with Type 1 diabetes.

U.K. picks a controversial brain cancer vaccine as its first new 'innovative medicine'

Anxious to prove that U.K. drug regulators aren't as slow and stodgy as they're often accused of being, British officials today announced the first in a new category of experimental drugs to earn the title of "Promising Innovative Medicine."

Baxter and Halozyme sway the FDA after a painful rejection

Two years after safety concerns torpedoed their first pitch, partners Baxter and Halozyme Therapeutics have locked up FDA approval for HyQvia, a treatment for immunodeficiency.

NPS slides as faint panel praise puts FDA approval in jeopardy

NPS Pharmaceuticals walked away from an FDA panel meeting with a recommendation to approve its orphan drug, but a lukewarm reception and nagging safety concerns have investors fearing the worst.

FDA seeks input on conditional approvals for new animal health products

The FDA last week issued two separate notices that it is looking for public comment on how the regulatory agency decides conditional approvals for new animal drugs as well as how it proceeds on giving its okay for combination drugs in medicated feeds.

Application of regulatory handbrake to 23andMe offers cautionary tale to Silicon Valley

Observers tipped the arrival of Apple's long-awaited Watch to bring the worlds of health and tech closer than ever, but this week's announcement was notably light on medical uses. The failure to even mention HealthKit in the presentation has sparked discussion of Silicon Valley's wariness of healthcare regulators in the wake of 23andMe's run-in with the FDA.