Novartis is moving toward the U.S. market with a biosimilar of Amgen's Neulasta, awaiting FDA approval for a long-acting treatment designed to boost white blood cell count.
India's generic drugs could face new price controls as early as next year, as the prime minister's office pushes for an investigation of what one official in press reports called "astronomical" markups by drugmakers, suppliers and retailers.
Suggesting that India's chief drug regulator may not be doing enough to protect certain volunteers in clinical trials, the Supreme Court ordered the agency to provide adequate oversight, particularly when drugs to treat the human papillomavirus are concerned.
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.
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.
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.
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.
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.
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 that more than 10% of TAVR recipients are being treated off-label, meaning they do not meet the FDA's recommended criteria for use.