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 •  October 11

HONG KONG – China's State Council released a set of guidelines for innovation in new drug and medical device development. The new regulations round up some recent regulatory updates, providing substantial and practical guidance to further push the innovation in China's health care industry.

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 •  June 21

SAN DIEGO – Buzzing through the halls, amid private discussions and public panels, a technology that some say could dramatically transform therapeutic development teeters at the forefront of many BIO 2017 discussions.

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 •  May 31

SHANGHAI – The hot topic at the 9th DIA China annual meeting was China's proposed entry into the ICH, a global body that facilitates the harmonizing of drug regulations across countries. Acceptance into the ICH (International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use) would be a major milestone for...

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 •  April 7

With the off-label/intended use controversy still simmering, a bill has debuted in the U.S. House of Representatives that would restrict the federal government's ability to pursue charges against manufacturers of drugs and devices based merely on "actual or constructive knowledge" on the part of the manufacturer that the drug, device or biologic...

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 •  March 22

TOKYO – Though Japan's drug sector will maintain a pro-innovation policy with the aim to maximize patient value, discussions between the country's Ministry of Health, Labour and Welfare (MHLW) and the Pharmaceutical Research and Manufacturers of America (PHRMA) showed stark differences in opinions. To continue reading subscribe now to BioWorld Asia...

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 •  March 10

Staff Writer Drugmakers looking to the FDA's 505(b)(2) pathway for shorter approval times may want to think again. A new report says the filings, generally expected to streamline development and review, instead took an average of about five months longer than those for new molecular entities (NMEs) in recent years. Created by the Hatch-Waxman Act...

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 •  February 14

Contributing Writer SAN DIEGO – To stimulate innovation, pharmaceutical companies have to reinvent themselves, looking outside their walls for early stage compounds. “We made the naïve conclusion that, if you just invest more money into the same thing, the correlation of innovation will still be linear, and we’ll just get more output. We did the...

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 •  February 14

Staff Writer Nearly 18 months after its launch by the FDA, the breakthrough therapy designation (BTD) is showing the potential to meet the agency’s stated goal of speeding the development and review of drugs that show early evidence of offering substantial improvement over existing therapies on a clinically significant endpoint. By approving only...

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 •  February 14

Staff Writer Despite strong economic and logistical arguments to be made for conducting clinical trials in Brazil, Russia, India and China (the BRIC countries), increasingly complex regulation, corruption and patent challenges are forcing drugmakers to up their game to succeed, according to a new report from Thomson Reuters Life Sciences. Those...

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 •  February 14

Washington Editor While the biopharma industry once again wants Canada placed on the U.S. Trade Representative’s priority watch list because of its policies that erode the value of drug patents, Eli Lilly and Co. has taken the matter into its own hands. A few months ago, the Indianapolis-based company began the two- to four-year process of seeking...