Latest Headlines

Latest Headlines

New India patent chief means Lee Pharma's saxagliptin CL app on hold for now

The appointment of a new Controller-General for Patents, Designs and Trademarks in India has delayed the compulsory license application by Lee Pharma, which wants to produce the diabetes drug saxagliptin developed and patented by London-based AstraZeneca, according to a report by The Hindu.

Novartis says 'remedial action' taken at troubled Indian plants

Swiss drug giant Novartis says it has taken "remedical action" to correct problems at two of its plants in western India that were given a warning letter by the U.S. Food and Drug Administration, according to a report by  NDTV.

BMS gets a leg up in the China hep C race with PhI for Daklinza

China has moved closer to approval of the nation's first state-of-the-art treatment for hepatitis C, according to researchers who presented data from their initial trial at the Liver Meeting conference in San Francisco.

FDA panel to examine 'maternal vaccines' to protect infants

Several manufacturers are already developing vaccines to protect infants via maternal immunization, but the potential of such vaccines has "yet to be fully realized." This Friday, an FDA advisory panel will examine the development and licensing of these "maternal vaccines," MedPage Today reported.

Discounts not enough to sway U.K. gatekeeper to back Roche's Kadcyla

The drug pricing debate is heating up stateside, but across the pond, it's been hot for some time. Adding fuel to the fire--about Roche's breast cancer med Kadcyla, at least--U.K. cost-effectiveness gatekeepers gave a final thumbs-down to the drug, two weeks after England's special oncology drugs fund agreed to cover the med at a discount.

Bristol-Myers nabs FDA priority review for new Opdivo use in kidney cancer

The FDA put Bristol-Myers Squibb's immuno-oncology drug Opdivo on its priority review fast track for a new use in kidney cancer. It would be yet another new indication for Opdivo, which was first approved for melanoma last year and now boasts two indications in lung cancer. 

Registry data shows more than 10% of TAVR patients are being treated off-label

Registry data shows that more than 10% of TAVR recipients are being treated off-label, meaning they do not meet the FDA's recommended criteria for use.

FDA calls for beefed-up oversight of lab-developed tests

The FDA is calling for more oversight of lab-developed tests (LDTs) in the wake of a congressional hearing about the agency's ability to regulate the products, pointing to a new internal report that says certain LDTs "may have caused or have caused" harm to patients by producing incorrect results.

Baxalta Singapore plant gets FDA OK to produce Advate hemophilia product

The hemophilia A treatment Advate is the cornerstone to the future of Baxalta, the company that was created when Baxter International spun off its drug operations in July. Now the newbie will be able to produce more of the product at a plant in Singapore it opened just last year.

FDA approves, Medtronic launches the first remote monitoring pacemaker app

Medtronic has launched the first app-based remote monitoring for implantable pacemakers. Remote monitoring of pacemakers has been the standard of care, but this next-gen version goes beyond a dedicated device to do so.