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Regulatory

Latest Headlines

Latest Headlines

FDA looks at Baxter Mexico plant for more saline supply

Baxter International is working with the FDA to add a plant in Mexico to the list of providers approved to ship saline to the U.S. as a shortage of the solution plagues healthcare providers. But while the drugmaker is expanding production, it has also had to repeatedly recall lots of saline because of manufacturing missteps. On Friday, it issued yet another.

Suit says CVS manipulated generic drug prices

Pharmacy giant CVS has found itself in the crosshairs of another lawsuit accusing it of inflating the prices of generic drugs. The suit, filed in federal court in San Francisco, says the company pulled off a "massive fraud" through a discount program for patients paying cash for prescriptions,  Bloomberg  reports. 

Romania launches bribery probe into 11 drugmakers

Romanian authorities are investigating 11 drug companies for suspected bribery in the country, echoing an investigation launched in China two years ago that targeted drugmakers such as GlaxoSmithKline for alleged wrongdoing.

CMS expands Medicare coverage of speech-generating devices

The Centers for Medicare & Medicaid Services announced that it is expanding Medicare coverage of speech-generating devices to include devices that generate written messages over email and text. Devices that enable Medicare recipients to electronically interface with a telephone to deliver speech via phone messages are also covered.

In a big week for obesity devices, GI Dynamics terminates U.S. pivotal obesity device trial

One of a handful of obesity devices aiming for the U.S. market has been sidelined. Australian company GI Dynamics has opted, after discussions with the FDA, to terminate its pivotal trial for its EndoBarrier due to safety concerns. The trial had already been placed on hold by the agency in March due to the incidence of hepatic abscess.

Syngene IPO by India's Biocon reaches top of range with no GVK, Quest blowback

India's Biocon easily reached the top end of its offer range for an initial public offering of shares in CRO Syngene, a source said, adding that recent reports of troubles at other Indian companies in the sector had no impact on demand.

India drugs watchdog to look at feasibility of online drug sales

The Drugs Controller General of India has moved to create a subcommittee to study the feasibility of online drug sales even in the face of strong opposition from brick-and-mortar pharmacies and as restrictions on such sales are routinely flouted, DNA India newspaper reports.

Is Asia's IP landscape in for big changes under TPP?

Selling the Trans-Pacific Partnership to a dozen nations after the details are out may prove something of a challenge, as an article in the Japan Times shows.

Regulators in Europe propose bans on plants in China and India

According to reports posted on the EudraGMDP site, regulators from Italy recommended bans on specific products made by Jinan Jinda Pharmaceutical in Shandong Province in China and Wuxi Jida Pharmaceutical in Jiangsu City, China, as well as Parabolic Drugs in Haryana, India.

Edwards ups TAVR guidance on Sapien 3 launch, looks to expand indication in 2016

Edwards Lifesciences bumped up its transcatheter heart valve sales estimate for 2015 due to what it anticipates will be a strong U.S. launch for its third-generation TAVR device, Sapien 3. It was approved in June within a day of an FDA approval for a similar device from Medtronic, so the next quarter's earnings will start to tell the tale on how that U.S. next-gen TAVR competition will play out.