Takeda Development Center Americas, a unit of Japan's Takeda Pharmaceutical, and Orexigen Therapeutics have ended a cardiovascular outcomes trial that compared the obesity drug Contrave to a placebo in addition to diet and exercise counselling, in 8,909 overweight and obese patients with certain CV risk factors, the companies said.
Regardless of what the national government does in the way of fixing drug prices, the India state of Punjab said it would fix its own prices for essential and generic drugs. The state prices apparently would piggy-back the National Pharmaceutical Pricing Authority system.
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.
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 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 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.
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.
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.
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.
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.