Topic:

Regulatory

Latest Headlines

Latest Headlines

FDA warns Lilly to stop marketing antibiotic for weight gain in pigs

When Eli Lilly bought Novartis Animal Health last year, it picked up a product that the FDA had in its crosshairs: Denagard (tiamulin hydrogen fumarate) plus CTC (chlortetracycline hydrochloride), a medicated feed product for pigs. The product is an antibiotic, and the FDA wants Lilly to stop marketing it for weight gain.

Takeda, Orexigen end CV study for obesity drug Contrave

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.

India's Punjab state goes its own way on drug price caps

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.

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.