Topic:

Regulatory

Latest Headlines

Latest Headlines

China scraps 15% drug markup at 100 hospitals, to move nationwide by 2017

China's State Council plans to scrap a 15% markup on drug sales in major hospital nationwide, kicking into gear a pilot that aims to transform cost and quality issues over a two-year horizon.

Shanghai Pharma finds a partner for online drug sales in JD.com

Shanghai Pharmaceuticals has struck a deal with Chinese online retailer JD.com for OTC and other healthcare product sales as the space sees increased competition with rival Alibaba Group Holding, Reuters said, citing a Shanghai Stock Exchange announcement in Chinese by the drug company.

JHL says batch of oncology monoclonal antibody a 'milestone' in CMO efforts

JHL Biotech said it has successfully completed the GMP manufacture and lot release of its first 500-liter scale batch from its Taiwan facility for a privately held Chinese biotech company of its unspecified oncology monoclonal antibody product for use in Phase I clinical trials in Australia.

China, ASEAN to share infectious disease info to monitor for epidemics

China and the Association of Southeast Asian Nations (ASEAN) have agreed to share information about infectious diseases that cross the region's borders, according to the state news service, Xinhua.

Australia, pharmacy body near agreement on budget subsidies for medicines

Australia's government reportedly has reached an agreement with the nation's pharmacists, nearing an end to a long-fought battle over a budget to cover subsidized medicines.

FDA advisory panel recommends sterilization after each use of duodenoscope

In a recommendation often followed by the U.S. FDA, an advisory panel asked that the agency require sterilization after each use of a duodenoscope, directly affecting at least three Japan makers.

India's top court orders temporary halt to Glenmark's production of Merck diabetes drugs

India's Supreme Court has called a temporary halt to Glenmark's production of generics of two Merck diabetes drugs but allowed continued sales of the local drugmaker's inventory through October or November.

AbbVie nabs FDA's orphan drug tag for Humira in HS

AbbVie is working to lessen its reliance on blockbuster Humira, which is already facing biosimilar competition in India. But it's also working to broaden the drug's label, and on that front, it got a boost from the FDA on Friday.

FDA creates openFDA developer challenge

The FDA has challenged developers to create algorithms that identify spikes in adverse event data automatically. The challenge is one of several posted by the regulator to encourage developers to use the data made available through the openFDA initiative and share their work on Reddit.

Wockhardt heart drug and Fujifilm, Mitsubishi Heavy devices in FDA recall notices

India-based Wockhardt's U.S. unit has ordered a national recall of 93,393 bottles of its Captopril heart and hypertension drug for being of the wrong thickness. The U.S. FDA also announced recalls of two Japan-made devices.