The addictive qualities of the powerful pain drug OxyContin have made it controversial, but the FDA has now approved it for youth 11 to 16 after asking maker Purdue Pharma to study its use in that age group.
England's Cancer Drugs Fund has been dealing with budget overruns and backlash from drugmakers and patients unhappy with the fund's decision to ax certain meds from its list. Now, the country's cost watchdogs are planning to take the reins and give the fund a much-needed makeover.
An advisory body to India's health ministry has made a recommendation that favors price caps on cardiac stents based on price lists sent by manufacturers, the Economic Times reports.
Singapore-based ASLAN Pharmaceuticals has received a U.S. FDA orphan designation for candidate ASLAN001 (varlitinib), a pan-HER inhibitor, as a treatment for cholangiocarcinoma, a rare and very aggressive form of bile duct cancer which has no cure, the company said in a press release.
India approved spending of INR17.5 billion ($270 million) to upgrade its federal and state drug regulation system with the Cabinet Committee on Economic Affairs approval this week, the Economic Times reported.
Amid growing pushback over the FDA's regulation of medical devices, a new study shows that many high-risk therapeutic devices that get the agency's approval have limited studies proving their safety and efficacy.
A pharma industry group in Australia has warned the government that it needs to do something to relieve the high costs of drug manufacturing in the country or continue to lose exports.
An Indian CRO that counts Johnson & Johnson, Novartis and Sanofi among its clients is under fire from the FDA for repeated quality control issues, the latest ding to the country's reputation as a go-to destination for outsourced drug development.
Dentca announced that it received the first FDA clearance for a 3-D printed resin that's used as the base material during the denture repair and fabrication process.
Chinese drugmaker Jinan Jida has turned to a U.S. company to help it resolve plant issues that led the EU to suspend its certificate of suitability for the antibiotic nitrofurantoin last month.