Topic:

Regulatory

Latest Headlines

Latest Headlines

Hillary Clinton hedges on the device tax, says nation must weigh pros and cons

In a speech emphasizing the importance of compromise, likely presidential candidate Hillary Clinton said that there may be room for that dirty word in Washington when it comes to repealing the 2.3% medical device tax. That is a key demand of Republicans, not to mention of the device industry.

Shire's long-delayed ADHD drug hits another FDA speed bump

Shire's plans to squeeze more sales out of its blockbuster Adderall franchise are facing another delay, as the FDA wants more data on a new long-acting ADHD treatment that has languished in agency purgatory for years.

Boston Scientific wins positive recommendation from FDA panel for stroke-fighting Watchman device

Boston Scientific won a positive recommendation from an FDA panel for its stroke-fighting Watchman device, even as panel members expressed doubt that the product would work well in patients who are eligible for traditional drug therapy.

Gerresheimer adjusts earnings forecast lower in wake of FDA crackdown

The FDA's crackdown on manufacturing plants has triggered German drugs packaging firm Gerresheimer AG to trim its financial outlook.

Chantix litigation may be wrapped, but safety debate wears on

Just as a federal judge says it's time to close the books on the Chantix litigation that's been moving through her Alabama court, Pfizer is preparing for another kind of fight over the drug. The company has been building its case for the FDA to clear the black-box warning off the stop-smoking drug's label, but patient groups are now petitioning the agency to add more heft to that warning instead.

Amgen declares a head-to-head PhIII win for Humira biosimilar

Amgen has taken a big stride toward gaining regulatory approval for its biosimilar of Humira, AbbVie's megablockbuster anti-inflammatory. The Big Biotech reports today that its knockoff of Humira--dubbed ABP 501--hit its marks on equivalency for efficacy and safety for treating plaque psoriasis. 

USPTO to review delivery patent in spat between Suboxone and BDSI's Bunavail

MonoSol Rx announced that the U.S. Patent and Trademark Office will decide by August 2015 whether BioDelivery Sciences International's BEMA drug delivery technology infringes on a patent protecting its Suboxone sublingual film.

Bayer insists its probiotic marketing claims aren't full of hot air

Last month, the feds took issue with Bayer's marketing for its Phillips' Colon Health product, saying the company's claims lacked scientific backing. But the way the German pharma sees it, the legal standard the DOJ is holding it to is not only unfair, it's unprecedented.

Balking at marketing slapdown, Galderma declares itself pharma non grata

What's a drugmaker hauled up for marketing violations to do? If you're Galderma, you declare yourself exempt from the rules.

India's IPCA buys plant as it deals with FDA issues

Indian drugmaker IPCA, which has stopped shipping products to the U.S. and Canada from a plant in Bangalore, has acquired a high potency oral solid dosage facility from Alpa Laboratories.