Collegium Pharmaceutical watched the FDA-promised approval date come and go for its abuse-deterrent painkiller, putting an indefinite hold on the company's plans to launch its first product.
The Indian government may be upping the ante for drug makers who fail to follow new guidelines by doubling the penalties it imposes when manufacturing plants attract the ire of international regulators, according to a report in The Hindustan Times.
China FDA has issued four guidance documents to improve its oversight of the country's device industry.
Duties and distribution costs have made top-tier drugs in China among the most expensive in the world. If they can be found cheaper, chances are they are counterfeit. As a result, a thriving gray market in Hong Kong is drawing tourists from the mainland looking to get drugs like Gilead Sciences' hep C med Sovaldi or Roche's breast cancer drug Herceptin, often without a prescription.
Spinal device specialist NuVasive got an FDA nod for its spinal cord surgical product, building out its portfolio as the company fights for dominance in a competitive market.
Many shoebox-sized drugstores in Hong Kong are magnets for mainland Chinese seeking access to cutting-edge oncology and hepatitis C treatments without a prescription because they are either highly expensive or not available at home in the latest twist of cross-border healthcare buying, Bloomberg reports.
Ready for the lung cancer showdown between Merck & Co.'s Keytruda and Bristol-Myers Squibb's Opdivo? It's here, and way ahead of schedule.
On Oct. 10, California Gov. Jerry Brown signed a bill that prohibits the use of antibiotics for fattening up farm animals and that requires the drugs to be prescribed by licensed veterinarians. It is the most restrictive law to date in the U.S. aimed at stemming the rise of antibiotic-resistant infections.
CIMB Equities Research said last week the Trans-Pacific Partnership could negatively impact the Malaysian pharmaceutical sector, but those effects won't be felt any time soon, according to a report in The Nation.
Indian pharmaceutical firms got some good news last week when it was reported that during the period from July to September there was a 50% gain in the number of abbreviated new drug approvals (ANDAs) by the U.S. FDA, Bloomberg TV India reported.