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Ebola vaccine manufacturers Janssen, GlaxoSmithKline and NewLink Genetics will be sheltered from legal liability under a law that protects companies that produce treatments to combat public health emergencies, the U.S. government says. Read More
Brand drugmakers in Europe are calling on the European Commission to implement a system to facilitate the resolution of patent disputes before a generic version is launched, a move they say would curb inefficiencies in the current patent litigation system. Read More
India’s drug pricing authority has placed 52 additional drugs under price control, including treatments for cancer, skin disorders and infection, as part of a program to provide life-saving and essential medicines to the public. Read More
India’s Central Drugs Standard Control Organization has proposed accreditation and ethics standards for clinical trial sites, investigators and ethics committees. Read More
Several EU member states suspended marketing authorization for therapies that underwent bioequivalence testing at contract research organization GVK Biosciences’ facility in Hyderabad, India, citing serious concerns about deviations from good clinical practice. Read More
Companies developing biosimilars for the European market want regulators to revert to comparing therapies with the reference product based on the amount of active ingredient in a dose, rather than a proposed standard that compares dose with route of administration. Read More
In a preview of how the U.S. Food and Drug Administration’s new Office of Pharmaceutical Quality will speed generic drug approvals, the office is rolling out a framework for filers of abbreviated new drug applications to respond to minor queries regarding chemistry, manufacturing and control early in the review cycle. Read More
The Brazilian government is providing more clarity around a voluntary program that encourages public-private partnerships to expand access to affordable drugs, but questions remain about the program’s transparency and how the market would be divided among competing partnerships. Read More
Sponsors submitting pediatric study plans should consider whether a product affects adults and children similarly when choosing an approach, the FDA says. Read More
Indian authorities issued a number of clinical trial regulations last month, covering compensation for trial injuries, exemptions for local Phase III trials and penalties for conducting trials without permission. Read More