Topic:

Regulatory

Latest Headlines

Latest Headlines

Novartis accused again of kickback tactics in new whistleblower suit

Kickback accusations have yet again been raised against Novartis, a company that four years ago promised to live by a new integrity code. A former exec now suggests she was fired for suggesting similar methods in the way Novartis planned to award a contract to wholesaler and health services company McKesson.

Ulthera device clears FDA for décolleté on heels of Merz acquisition plans

Merz already committed to buying Ulthera for up to $600 million in cash and milestones. Now it will get another FDA-cleared indication as part of the bargain. The company's system has cleared the FDA to improve the lines and wrinkles of the décolleté.

Novartis' leading CAR-T cancer therapy gains breakthrough status at the FDA

The FDA has provided its special 'breakthrough' status for Novartis' closely-watched development program for a personalized CAR-T cancer therapy, promising to help speed development for engineered T cells.

Bristol-Myers' hep C combo wins Japanese OK, leading the pack

Bristol-Myers Squibb has become the first drugmaker to win regulatory approval for a combination hepatitis C treatment that doesn't require painful injections, picking up a Japanese nod for its all-oral cocktail.

FDA lowers regulatory bar for neurostimulators to treat headache

Soon, transcutaneous electrical nerve stimulation to treat headache will only require a 510(k), the FDA said in a July 3 final order published in the  Federal Register.

EU approves GSK's Mekinist and Novartis will reap the rewards

GlaxoSmithKline has notched another approval for its novel melanoma med Mekinist, and Novartis gets to celebrate. The drug, which the EU has approved for use there, is among those GSK is selling to the Swiss drugmaker in a $16 billion deal.

FDA unveils HeartWare warning letter for company's ventricular assist device

The FDA slapped HeartWare International with a formal warning letter one month after citing the company for safety issues related to its HeartWare Ventricular Assist Device system.

Senators call on White House to release FDA guidance on lab-developed tests

Five senate Democrats called for the White House Office of Management and Budget to release a long-sequestered FDA draft guidance on laboratory developed tests for public comment. In a letter to OMB acting director Brian Deese, they urged him to release the proposed regulation "to ensure appropriate and efficient oversight of diagnostic tools can move forward in an open and transparent manner."

U.S. voices concern over closed trial of American linked to GSK scandal

Until now, the widening soap opera that has left GlaxoSmithKline facing bribery charges in China seemed to be Britain's problem. But now the United States is stepping in, as China moves to try an American in a secret courtroom procedure starting August 7.

FDA begins to guide nanotechnology in animal feed

The FDA's new draft industry guidance on the use of nanomaterials in animal feed could ramp up production in drug delivery products for livestock, as companies scramble to find new ways of fattening them up--and faster.