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Regulatory

Latest Headlines

Latest Headlines

Indian industry asks Modi to press for access to China's drug market

Just ahead of a visit by Prime Minister Narendra Modi later this week, a major India business organization urged him to press his China counterpart to make it easier for drugmakers to enter the country's vast market.

New legal woes in U.S., Europe, for Olympus duodenoscope device

The Olympus problem with one of its duodenoscopes has cropped up again with another major suit in the United States and new assertions the device also was linked to hospital superbugs in Europe.

Vertex clears an FDA hurdle with its cystic fibrosis combo

A panel of FDA advisers voted in favor of Vertex Pharmaceuticals' closely watched combination treatment for cystic fibrosis, looking past some efficacy doubts and setting the stage for a likely approval.

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.