US FDA's reorganization of drug reviews splits Keegan's old OHOP division into two.

China's Changchun Changsheng Biotech has been officially declared bankrupt, ending long-running speculation. The major vaccine maker’s dramatic fall has several take-away lessons for health companies operating in China, where several new regulations are taking effect.

Allowing multi-regulator collaboration on oncology application assessment may run into pricing issues if Canada and Australia gain access to novel drugs before European countries, US FDA's Pazdur says.

HHS Secretary Alex Azar says that reshaping Administration’s upcoming proposed rule would drive Medicare Part B drug prices even lower than previously projected. As Part B drug costs are being blamed for higher premiums, the policy revisions are at OMB, but plan would reemerge as "a notice of proposed rulemaking if that comes out,” Azar said.

Following its recent EU approval, moves are under way to make Merck’s Ervebo vaccine available in countries at risk of Ebola.

The European Medicines Agency is this week deciding whether GlaxoSmithKline’s planned EU marketing application for its BCMA-targeting therapy merits an accelerated assessment.

Nine countries are joining forces on horizon scanning with the aim of improving their chances of securing lower prices for high-cost drugs.

House Republicans are eager to keep working on legislation to permit innovative payment models for curative gene and cell therapies. Democrats, for now, are focused on other priorities.

Health technology assessment body NICE has given the thumbs-up to Epidyolex and Sativex, which become the first plant-derived medicinal cannabis products to secure routine NHS funding. It has also issued positive guidance on other products including nabilone, but turned down the use of cannabis-based drugs in chronic pain.

The BioIndustry Association has laid out its wishlist for the next UK administration, including deep regulatory alignment with the EU after Brexit, a more “flexible” approach to health technology assessment appraisals of new drugs, and support for R&D.

India has taken strides towards creating a supportive environment for its nascent gene therapy research, but the R&D and regulatory infrastructure is still evolving amid concerns over potential product costs.

Provention Bio’s teplizumab, a potentially game-changing treatment for preventing or delaying type 1 diabetes, is one of three investigational products to be newly accepted onto the European Medicines Agency’s popular priority medicines scheme.

Filing stays litigation but state attorneys general will be battling company's settlement proposal in US bankruptcy court. Details emerge on Purdue finances, rebate expenditures and litigation costs.

Lead plaintiffs counsel have accepted Purdue's proposed settlement offer to resolve more than 2,000 opioid suits, but more than half of state attorneys general reject the proposal.

Novartis is pioneering the new “living drugs” model. But its present financial performance benefits from regulatory problems that have beset generic competitors to a franchise written off for dead: the antihypertensive brand Diovan (valsartan).

FDA generic drug reviewers often stumble over "hidden facilities" that are listed in drug master files but not the ANDAs; industry official offers some tips to bridge this communications gap with DMF holders.

Nitrosamines taint Mylan’s valsartan API solvent recovery, whether outsourced or in-house; firm mulls US FDA's request for ‘material systems review.’

The head of US FDA’s drug quality office comments on quality-related topics at the GRx-Biosims meeting; sheds more light on facility rating system plan.