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.
As the fourth market entrant in a hotly contested group of new-age anticoagulants, Daiichi Sankyo's Lixiana (edoxaban) has some ground to make up. Luckily, it got a boost in the U.K. that could help it build momentum.
New Zealand's opposition Labour Party and the Malaysian Medical Association separately urged national negotiators to go slow on the Trans-Pacific Partnership (TPP) trade pact, citing worries over the potential effect on drug costs.
South African health minister Aaron Motsoaledi wants India to hang tough on intellectual property (IP) challenges for pharmaceuticals because the country's role as a major supplier of affordable medicines needs to be lauded, not scolded.
U.S.-based Abbott Laboratories is among a number of companies that hope to leverage acquisitions in Russia into exports, with other players such as India's Lupin among other potential firms to look to ship wider abroad.