Topic:

Regulatory

Latest Headlines

Latest Headlines

Google releases health and fitness developers' kit

Google released a preview of its software development kit for fitness apps on Aug. 7. The software will interact with wearable devices and enable a variety of apps to benefit from information about a user's fitness history stored on a centralized interface.

Novartis can't convince judge to free it from kickbacks case

Novartis has failed again to convince a federal judge to boot a Department of Justice kickbacks case against it that claims the Swiss drugmaker showered pharmacies with discounts and rebates to boost sales of two drugs.

NICE raises ire of breast cancer patients with rejection of Roche's Kadcyla

The National Institute for Health and Care Excellence has issued its final draft guidance for Kadcyla, which declares the drug is too expensive to cover.

FDA switches course on Tekmira drug as Ebola panic triggers policy review

Shares of Tekmira got a boost Thursday night after the company spread the word that the FDA had switched its full clinical hold on an experimental Ebola drug to a partial hold, clearing the path to its possible use to fight a sudden outbreak in Africa that has been sparking chilling headlines the world over.

Medtronic and Covidien face FTC pushback for pending merger

As the regulatory climate for corporate tax inversions reaches a boiling point, Medtronic is facing heightened government scrutiny for its pending merger with Covidien.

CTI BioPharma gets on the FDA fast track with its cancer drug

Seattle's CTI BioPharma picked up the FDA's fast-track designation for pacritinib, a late-stage treatment for blood cancer.

FDA authorizes emergency use of military-developed Ebola test

A test-tube diagnostic developed by the U.S. military to screen for a specific strain of the Ebola virus has gained FDA authorization for emergency use.

EMA accepts Pfizer app to expand Prevenar in adults

Sales of Pfizer's best-selling vaccine may soon be getting bigger. The European Medicines Agency (EMA) has accepted the company's application to expand the label on Prevenar 13 in adults to include the prevention of pneumonia caused by the 13 pneumococcal serotypes the vaccine contains.

U.K. cost-effectiveness watchdog bars access to AstraZeneca's Iressa

Backtracking on a positive decision it made four years ago, Britain's National Institute for Health and Care Excellence has dealt a blow to AstraZeneca by withdrawing its endorsement of the company's drug Iressa for the treatment of non-small cell lung cancer patients who have failed previous treatments.

Pfizer settles more off-label marketing cases tied to Rapamune

Pfizer has cleared the decks of a marketing scandal that it inherited with its 2009 acquisition of Wyeth. The New York drugmaker will pay $35 million to 41 states and the District of Columbia to settle a case accusing it of pushing a kidney transplant drug for off-label uses.