Topic:

Regulatory

Latest Headlines

Latest Headlines

FDA grants priority review status in first-line glioblastoma for Medtronic, J&J-backed startup Novocure

The FDA has granted priority review status to Novocure's supplemental PMA application for its Optune to treat newly diagnosed glioblastoma in combination with temozolomide chemotherapy. The tumor-treating-fields device is already approved to treat recurrent glioblastoma in adults.

33 indicted for selling BMS' Abilify, Novartis' Gleevec in massive diversion scheme

Federal authorities have rounded up nearly three dozen people indicted in a far-ranging scheme in which they allegedly sold $200 million worth of diverted drugs that included blockbusters like Bristol-Myers Squibb's antipsychotic Abilify, Gilead Sciences' HIV med Truvada and Novartis' cancer drug Gleevec.

Teva recalls generic Prozac made by Croatian subsidiary Pliva

Teva Pharmaceutical Industries' Croatia-based operating unit Pliva manufactures in Eastern Europe but supplies some of Teva's drugs for the U.S. market. Among those drugs is fluoxetine, a generic version of the antidepressants Sarafem and Prozac, and Teva is having to recall three lots of the product made by Pliva because of contamination.

Roche scores FDA approval for colorectal cancer test

Roche snagged FDA approval for its KRAS mutation test for metastatic colorectal cancer (mCRC), chalking up a regulatory win as the company continues to gain ground in cancer R&D and expand its diagnostic offerings.

FDA lawsuit in hand, Amarin plots a new Vascepa marketing strategy

Amarin styled its lawsuit against the FDA looking to lift the restrictions in place on its marketing case for the prescription-strength fish oil Vascepa as a First Amendment issue regarding free speech.

Secret doctor letter shows Amarin's true 'free speech' leanings

In case you're in doubt about why pharma is suddenly all about the First Amendment, here's some illuminating evidence. In a letter obtained by  CardioBrief 's Larry Husten, Amarin makes very clear that it sued FDA last week for marketing reasons, not out of love for the Bill of Rights.

FDA approves Nevro device that eliminates side effect of spinal stimulation

The FDA approved Nevro's novel spinal cord stimulation system Friday, saying it is the only device in the class that does not produce a tingling sensation known as paresthesia.

That Namenda hard switch Actavis wants? It could cost HHS $6B

Actavis said last month it stood to lose $200 million in sales if an appeals court didn't let it force patients over to a new, patent-protected version of Alzheimer's treatment Namenda before generics hit. But if it does? The Department of Health and Human Services (HHS) predicts it'll cost the federal government $6 billion at the least.

Japan's Oncolys begins PhI trial of cancer drug licensed from Astellas

Japan's Oncolys BioPharma has started a U.S.-based Phase I trial of cancer drug candidate OBP-801 licensed from Astellas Pharma in 2009.

Push to use big data in Japan gets help from industry, academia

The pharmaceutical industry's producers and academic researchers in Japan are actively engaged, despite setbacks experienced by others such as Google, in building a big-data pipeline, this one now including 10 drugmakers and 30 medical institutions.