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Japan's Ministry of Health, Labour and Welfare received around 50 formal applications and has cleared screening for the "sakigake" fast-track drug and device review process before the Pharmaceuticals and Medical Devices Agency,… The "sakigake designation system" is aimed at expediting the review of innovative drugs, regenerative medicines and devices developed in Japan earlier than the rest of the world. This includes prioritized consultations and priority review status….products considered must display a novel mechanism of action, be scalable commercially, show high efficacy and be developed and planned for approval in Japan ahead of the rest of the world,…

China's much-hyped market for vitamins and supplements is facing a steep challenge from traditional remedies…The vitamins market is…being outstripped by a traditional medicine business…and is growing twice as fast…That's prompted vitamins firms from…Amway to…Pfizer Inc to look for inspiration from traditional medicine recipes going back thousands of years to succeed in China's increasingly pivotal healthcare market…"We've tried to learn the heritage and marry it with modern life sciences,"…."Half of the population still believe in traditional ways and still go to traditional doctors or hospitals. This is a way of life and is passed from generation to generation,"…

U.S. Democratic presidential candidate Hillary Clinton proposed on Tuesday a $250 monthly cap on out-of-pocket prescription drug costs and other measures to stop what she called "price gouging" by pharmaceutical companies….Clinton rolled out a plan to encourage the development and use of generic drugs and to end pharmaceutical companies' ability to write off consumer-directed advertising as a business expense….monthly cap would limit what insurance companies could ask patients to pay for drugs that treat chronic or serious medical conditions.

At least that's the main message from his appearances on various TV news shows…In an interview on "CBS This Morning," Shkreli told reporter…Daraprim, was unprofitable at the old price…. Shkreli didn't do himself or his company any favors over the weekend when the news of the price spike went viral online after an HIV/AIDS group complained of the increase and he took to his Twitter account to admonish anyone who dared to question the business decision

"This is not what we do in the biotech industry," Alnylam's Maraganore…"We're about innovation, patience and 21st century medicines. We're not about repricing drugs from the 1950s to make a profit. It's not how we focus our R&D investments." …"Most Americans get it when people work hard, they take risks and then they get rewarded. But people do tend to hate it and dislike it when people try to cheat the system," he said….Maraganore said prices for new drugs are not too high. "The focus should be on value and access. There's a lot of data that shows that drugs actually reduce overall costs," he contended—claiming money spent on medications can lower health-care expenditures.

Turing Pharmaceuticals, a small company that generated outrage over raising the cost of an old anti-infective drug by more than 5,000 percent, said on Tuesday it would roll back that increase to make sure it remains affordable....Chief Executive Officer Martin Shkreli became the new face of the U.S. drug pricing controversy this week, after the New York Times reported that the company had raised the price of Daraprim, a 62-year-old treatment for a dangerous parasitic infection, to $750 a pill from $13.50 after acquiring it. The medicine once sold for $1 a pill.

Walgreen Co.’s persisting failure to remove expired sales tags from its shelves deceives customers and violates a 2014 settlement that sought to resolve the matter in Missouri, the state’s attorney general argued…in asking a state court to punish the pharmacy chain…Attorney General Chris Koster filed court documents asking a judge to hold the nation’s largest pharmacy retailer in contempt of the settlement and issue steeper fines, including up to $5,000 for each expired tag. Koster said that since July, undercover investigators have found a total of more than 1,300 shelf tags displaying sales prices that had expired...

Drug's (cycloserine) price rose to $360 a capsule after Rodelis acquired it...new owner, the cost will go down to $35 per capsule....A nonprofit in Indiana has dropped the price of a drug for multi-drug resistant tuberculosis roughly 90% after re-acquiring rights to the medicine from Rodelis Therapeutics, the latest sign of a growing outcry over skyrocketing costs for rare disease treatments.

In Europe, uptake of biosimilars has been slowed by safety concerns,low awareness…The introduction of biosimilar drugs in the U.S.,which kicked off this month with Novartis AG ’s version (filgrastim, Zarzio) of an Amgen Inc. blockbuster (filgrastim, Neupogen),hands health-care payers a new weapon against rising drug prices. But it could be a duller blade than they had hoped...

Gilead Sciences' decision to slap Sovaldi,…with an $84,000 price tag was widely considered a turning point for payers and pharmacy benefit managers…the months leading up to the approvals this summer…negotiations were already under way between those drugmakers and Express Scripts,…PBMs are becoming increasingly savvy and hard-nosed about which drugs they will cover and what they are willing to pay for them… PBMs want to position [themselves] so they are advocating on behalf of their customers. Their customers are worried...