Topic:

Regulatory

Latest Headlines

Latest Headlines

India cardiac stent price caps closer after advisory review

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.

ASLAN gets U.S. FDA orphan designation on ASLAN001

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's cabinet approves $270M to upgrade drug regulation

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.

JAMA: High-risk devices come with minimal safety studies

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.

Australian pharma group says high manufacturing costs killing drug exports

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. 

Another Indian CRO draws the ire of Western regulators

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.

In a first, FDA clears a material enabling 3-D printing of dentures

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.

UPDATED: Chinese plant banned by EU, getting compliance help from US company

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.

Daiichi clot-buster wins a NICE green light, but still faces an uphill track

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.

Opposition grows in Malaysia and New Zealand on TPP drug provisions

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.