Topic:

Regulatory

Latest Headlines

Latest Headlines

New NICE evals could green-light more drugs, but only at 'the very best price'

The U.K.'s cost watchdog is changing up the way it evaluates drugs. The National Institute for Health and Care Excellence (NICE) will be zooming out to look at the bigger picture when assessing therapies, which could result in more positive recommendations--something drugmakers have been dreaming of for years.

J&J's Ethicon division pays $11M to resolve a vaginal mesh case

It's bad news for Johnson and Johnson's Ethicon division in its ongoing vaginal mesh saga: The company paid out $11.1 million to settle one of the first of many cases to go to court over its transvaginal mesh products, Lawyers and Settlements reported.

FDA takes aim at yet another Indian API maker

The steady string of warning letters issued to Indian drug and ingredient makers as the FDA has added to its staff in India is fueling the perception that the country has issues when it comes to quality. Now another warning letter has been issued.

Drugmakers agree to new FDA rules restricting antibiotic use in livestock

In December, the FDA asked animal health companies to voluntarily stop using antibiotics to promote growth of meatier cows, pigs, and other livestock. Now, the agency says 25 companies have signed on to its new guidelines, including Eli Lilly's Elanco, Novartis' animal health unit, and Zoetis.

Crucial EU compact vote on U.S.-style device approval system raises industry concern

With less than a week before Members of the European Parliament vote on a proposal that would establish a tougher U.S.-style approval system for medical device implants, there remains a wide chasm of concern between member states as the industry grumbles that a new layer of red tape will be added.  

FDA's Woodcock throws cold water on generic drug research

A group of researchers and doctors has been trying to get the attention of Congress for its contention that generic drugs made outside the U.S. are more likely to be tainted and ineffective. But FDA CDER Director Janet Woodcock says the research was flawed and their conclusions faulty.

Novartis fuels drive for fast OK of LDK378 with new lung cancer data

Novartis has taken another step forward in its quest to win a fast approval for its lung cancer drug LDK378. The pharma giant says the ALK inhibitor demonstrated clear signs of activity in a majority of the non-small cell lung cancer patients enrolled in an early study, including a group already treated by the ALK inhibitor Xalkori (crizotinib).

Medtronic is expected to publicly detail its failed renal denervation pivotal study on March 29

In January, Medtronic revealed that its Symplicity renal denervation device failed to significantly lower blood pressure in patients with drug-resistant hypertension during a pivotal U.S. trial. Now the company is expected to reveal details about what went wrong on Saturday, March 29.

GlaxoSmithKline yanks European app for Tafinlar-Mekinist combo in melanoma

The FDA may have given its blessing to GlaxoSmithKline's melanoma combo Tafinlar and Mekinist. But not so fast, says its counterpart across the pond. The European Medicines Agency (EMA) wants more information, and that has prompted GSK to withdraw its application--for now.

FDA accepts Avanir's inhaled migraine treatment application

California drugmaker Avanir Pharmaceuticals touted the FDA's acceptance of its application for an inhaled migraine treatment after a pivotal trial.