Topic:

Regulatory

Latest Headlines

Latest Headlines

Weak Unichem earnings cast shadow on Lupin, Mylan in India

SINGAPORE-- If Unichem Laboratories' third-quarter earnings report of net profits of only $334,316 (converted from Indian rupees) is any indication, Lupin and Mylan's India unit can soon be expected to reveal huge reductions for the period. They, Slovenian Krka and Teva Pharmaceutical were fined a total of $427.7 million last summer by the European Commission for allegedly accepting pay for delay from France's Servier.

China FDA plans to lift ban on online drug sales

The China Food and Drug Administration plans to allow online sales of prescription drugs as early as this month, opening up the market to existing online e-commerce platform operators like Alibaba.com and JD.com.

AbbVie wins quick approval for its hep C treatment in Europe

AbbVie has won European Commission approval for its oral hepatitis C cocktail, offering some positive news after some disappointments for the U.S. drugmaker in recent months. It also sets the stage for the drugmaker to take its marketing battle with Gilead Sciences to another continent.

An inside look at the FDA's approach to speeding new drug approvals

The FDA enjoyed some industry kudos at the end of 2014 after handing out a record number of new drug approvals for the past decade. And now it's crunched the numbers for the year to underscore the kind of trends regulators see in the biopharma world.

New FDA quality office to grade manufacturing operations

The FDA has shared details of plans for its Office of Pharmaceutical Quality. Staffers plan to group drug production operations by category and release an average quality grade for each bucket, allowing manufacturers to see if they are outperforming their peers.

FDA links saline supply chain mixup to patient death

The saline shortage may have claimed a life. The FDA reported that one person has died and many more have taken ill after receiving simulated intravenous products that are intended for training use only.

Obesity devices aim for the U.S. as Obalon gets $30M to complete pivotal trial in 2015, EnteroMedics gains FDA approval

Micro cap EnteroMedics is up 35% in early trading on the news that it has garnered an FDA approval for its Maestro vagal blocking therapy as an obesity treatment. The device was narrowly supported by a June FDA panel due to concerns about efficacy. In addition, another obesity device company, Obalon Therapeutics, has secured $30 million to complete a U.S. pivotal trial in 2015 for its nonsurgical weight loss balloon.

Senate joins House, introduces repeal of medical device tax

A bipartisan group of senators introduced a bill on Tuesday to repeal the 2.3% medical device excise tax, a financial component of the Affordable Care Act.

Indian state hires FDA's online education provider to train inspectors

The Indian state of Gujarat has hit upon a way to bring its inspectors up to international standards: Hire the company that provides online training to the FDA. Officials at the Gujarat Food and Drug Control Authority will have access to training services from UL EduNeering, the company that has helped the FDA develop its educational program since 1999.

German cost gatekeeper spurns Gilead's Zydelig for CLL

Gilead Sciences was dealt a stinging blow from Germany's price watchdog IQWiG over its cancer-fighting drug Zydelig (idealisib), as the cost-effectiveness gatekeeper found the drug has no added benefit for patients with chronic lymphocytic leukemia compared with existing therapies.