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Regulatory

Latest Headlines

Latest Headlines

Bristol-Myers gets the approval Gilead didn't want: Daklinza + Sovaldi for hep C

Want a window into the future of hepatitis C drug marketing? Keep an eye on Europe. Bristol-Myers Squibb bagged European approval for its hepatitis C fighter Daklinza (daclatasvir) Wednesday, setting the company up for head-to-head competition with Gilead Sciences' upcoming combo drug.

Bristol-Myers gets the approval Gilead didn't want: Daklinza + Sovaldi for hep C

Bristol-Myers Squibb bagged European approval for its hepatitis C fighter Daklinza (daclatasvir) Wednesday, setting the company up for head-to-head competition with Gilead Sciences' upcoming combo drug.

FDA approves next-generation Medtronic pacemaker

Medtronic snagged FDA approval for its next-generation cardiac resynchronization therapy (CRT) pacemaker in patients with heart failure, expanding its cardiovascular portfolio and advancing its proprietary technology for heart rhythm therapy.

Alexion gets new Form 483 in follow-up inspection

Despite the best efforts of Alexion, the FDA has lingering concerns about manufacturing of the drugmaker's orphan drug Soliris at a plant in Rhode Island and presented it with a Form 483 with new observations following a follow-up inspection of the plant last week.

Sources: Ranbaxy's manufacturing problems lead to Texas

Ranbaxy Laboratories last year agreed to pay $500 million to settle litigation with federal authorities over the years that the drugmaker failed to follow good manufacturing practices and sold inferior drugs to the U.S. Now sources say it may ante up a much smaller payment to the state of Texas for many of the same issues.

Mad at NICE's cancer drug rejections? Look to drugmakers, agency chief says

Political shilly-shallying about the cost of drugs has to end, the chief of the U.K.'s cost-effectiveness agency says. Government officials and politicians need to be up front with the public about one stark fact: The country's health service just can't afford every drug that can help patients.

FDA's 'Most Wanted Fugitives': The agency wants your help finding these bad players

You have heard about the FBI Top 10 Most Wanted list, and of the America's Most Wanted television show, but are you familiar with the FDA's list of Most Wanted Fugitives? Yes, the drug oversight agency has bad players who have fled that it would like to bring to justice. And it would like your help to do that.

UPDATED: FDA simplifies approval process for innovative devices lacking a predecessor

Truly innovative devices that do not have a substantially equivalent predecessor are automatically lumped into Class III, reserved for high-risk devices, and need a costly clinical trial to gain approval. But not all new products are high risk. To fix this barrier to innovation, FDA created the de novo approval pathway in 1997, enabling applicants to apply for approval as low- or moderate-risk devices. 

Glaxo's ViiV venture adds $5B combo pill to its HIV-fighting armory

GlaxoSmithKline may be suffering from R&D setbacks, generic competition and corruption investigations in a dozen countries, but its HIV-oriented venture ViiV Healthcare is racking up new OKs. Friday, the company scored the FDA's blessing for a combo drug pegged at $5 billion in peak sales.

Rollout of openFDA continues with drug labeling, medtech adverse event APIs

Having committed to a fast rollout of APIs at the start of the summer, the FDA made good on its promise this week by making data on drug labeling available. And the regulator went beyond its initial commitment by releasing an API for medical device adverse events.