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Regulatory

Latest Headlines

Latest Headlines

Pfizer preps its case for FDA pulling Chantix's black-box warning

The FDA polished up the official label on Pfizer's stop-smoking drug Chantix earlier this week. It was a victory for Pfizer, the payoff from several studies testing the drug for psychiatric side effects. Essentially, the new label will include study data suggesting that patients using the drug might not be at a greater risk of psychiatric problems after all.

Hey, Big Pharma: When the feds swoop in, be nice. It worked for Shire

Shire and the U.S. Justice Department have come to terms: The Ireland-based drugmaker agreed to pay $56.5 million to settle a variety of alleged marketing violations. So far, so familiar, given the long list of pharma companies that wrapped up similar investigations.

Analysis: Treasury Department's move designed to create uncertainty

The Treasury Department's issuance of a notice cracking down on inversions was designed to create uncertainty, says Terry Haines, head of political analysis at investment research firm ISI Group. By that count, the move has succeeded. Questions abound. Will one of the affected companies sue to challenge the legal validity of the agency's action? And what's next? The 42-page notice requests comment and says that the Treasury Department and the IRS expect to issue additional guidance.

Little is known about the Sunshine Act site ahead of launch, AdvaMed says

With just a week to go before the expected release of pharma and med tech companies' payments to physicians under the Sunshine Act, stakeholders are still in the dark about what the website will look like, AdvaMed told FierceMedicalDevices.

FDA moves aggressively on low-T drugs, but replacement pill still aims to enter market

Last week the FDA cracked down hard on low-T therapies. Its expert panel voted to advise the agency to restrict the use of such drugs for a specific medical need.

Health Diagnostic CEO resigns as feds start doctor payment investigation

Health Diagnostic Laboratory CEO Tonya Mallory resigned from her position at the same time a federal investigation was launched to look into the company's blood-sample practices.

FDA to weigh in on cybersecurity concerns

Amid growing concern over the cybersecurity of medical devices, the FDA is weighing in on the issue and addressing product safety at an upcoming conference.

Hamburg called on to resign for FDA's approval of Zohydro

The FDA approved opioid painkiller Zohydro nearly a year ago as a med to provide relief for those with chronic pain. But the drug has been nothing but 11 months of aggravation for the agency and its leader, Commissioner Margaret Hamburg, who is now being called on to resign by organized anti-addiction groups who say the FDA has contributed to an epidemic of abuse in the country.

Celgene's Otezla nabs psoriasis approval, launching next-gen showdown

Celgene's anti-inflammatory newcomer Otezla just took another step toward the powerhouse. The drug won FDA approval in a big market important to its sales: psoriasis, the most common autoimmune disease in the U.S. It's the first in a new generation of psoriasis meds to nab that indication.

J&J 'disappointed' U.K. watchdogs nixed Olysio-Sovaldi hep C combo. What next?

Johnson & Johnson pessimists are already worried that Olysio will end up like a mayfly, with a short, happy, busy life and an all-too-sudden end. If the U.K.'s cost-effectiveness gatekeepers offer any indication, they may be correct.