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Regulatory

Latest Headlines

Latest Headlines

New use for Bayer's Eylea in EU gives it more market power against Novartis' Lucentis

The European Commission has approved Bayer's Eylea (aflibercept) for the treatment of diabetic macular edema, the most common cause of vision loss among people with diabetes.

Sunshine Act payments database offline, rollout of initiative delayed

The Centers for Medicare & Medicaid Services took offline the payments database used by drug and device makers to disclose payments to doctors and teaching hospitals under the Sunshine Act, a part of the Affordable Care Act. CMS's action came in response to complaints that some doctors could see the payments made by other doctors.

Ipca joins list of Indian drugmakers accused of data falsification

When the FDA issued a Form 483 to Ipca Laboratories late last month, the Indian API manufacturer voluntarily suspended shipments to the U.S. Now the release of details about the 483 has shown why Ipca acted swiftly, with the company joining the list of Indian drugmakers accused of data falsification.

Four unanswered questions about the looming LDT regulations

The FDA described the contents of its proposed regulatory framework to Congress, but the details of its plan remain a mystery. Following the July 31 notification to Congress, the agency must wait at least 60 days before the release of its draft guidance on the topic.

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The National Institute for Health and Care Excellence has issued its final draft guidance for Kadcyla, which declares the drug is too expensive to cover.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