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Japanese regulators are hoping to halve drug review times and speed up patient access to novel therapies by encouraging companies to file NDAs first in Japan, or in tandem with U.S. and EU submissions, under an approval pathway approved in April. Read More
With a growing number of biologics set to lose patent protection in coming years, a leading industry group is calling for regulatory reforms to encourage the development and approval of biosimilars. Read More
The European Medicines Agency’s EudraVigilance system for monitoring drug side effects and adverse events is about to undergo an overhaul, and regulators are readying drugmakers and national authorities with a new change plan. Read More
French drugmaker Sanofi is looking to future-proof its diabetes franchise by in-licensing rights to a trio of next-generation diabetes medicines from South Korea’s Hanmi in a deal worth up to $4.2 billion. Read More
The European Commission released new guidelines clarifying the responsibilities of qualified persons overseeing global, multisite manufacturing operations and the data they need to collect. Read More
Starting next June, drugmakers must use a new centralized database to file product safety update reports, the European Medicines Agency says. Read More
Manufacturers of new biologics could receive up to eight years of exclusivity in 12 countries under the Trans Pacific Partnership, a close reading of the deal shows. The specific terms of the contentious trade pact, which President Barack Obama inked with 11 other countries in October, were publicly released Nov. 6. Read More
Drugmakers submitting an NDA or BLA with a tropical disease priority review voucher in the U.S. will now pay a $2.7 million fee — a $165,000 increase over fiscal year 2015, which ended Sept. 30. Read More
Despite its lucrative promise, the U.S. Food and Drug Administration’s priority review voucher program has done little to spur development of novel treatments for tropical and rare pediatric diseases, a new study in JAMA concludes. Read More
Delegates from more than 20 countries in Latin America and the Caribbean are calling for comprehensive health and medicines policies and strategies that provide long-term, sustainable and effective solutions for ensuring access to life-saving drugs. Read More