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The National Pharmaceutical Pricing Authority says 59 of the top 100 companies have failed to register with the system, despite several deadline extensions. Read More
Sponsors seeking approval of new drugs based on published literature or postmarketing data must prove that their drug is comparable to its reference product. Read More
The World Health Organization has added new treatments for hepatitis C to its essential medicines list, including Gilead Sciences’ Sovaldi and Harvoni, but says prices must come down before most people will be able to access them. Read More
The European Medicines Agency has granted orphan medicines designation to Hemispherx Biopharma Europe’s experimental Ebola treatment Ampligen. Read More
British drug giant GlaxoSmithKline hopes to cure HIV/AIDS with a first-of-its-kind partnership with researchers from the University of North Carolina at Chapel Hill. Read More
Vertex Pharmaceuticals’ Kalydeco/lumacaftor combination therapy may be in danger as regulators question whether it will provide significant improvements in lung function for most cystic fibrosis patients. Read More
Actavis plans to immediately relaunch its generic version of AstraZeneca’s inhaled asthma drug Pulmicort Respules following a federal appeals court decision upholding a lower court ruling that invalidated the brandmaker’s patent on the drug. Read More
Sponsors of regenerative drugs can now get a conditional approval in Japan based on limited data, under a new regulatory pathway meant to speed patient access to novel therapies. Read More
An Indian pharmacists group is urging the government to immediately begin requiring detailed instructions on storage temperatures on all drug labels, to prevent improper handling in the supply chain and by end users. Read More