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A public-private partnership in the EU plans to spend $4.5 billion over the next decade to boost, by 30 percent, the success of clinical trials on high-priority drugs. Read More
Pharma is seeking greater clarity around a European Medicines Agency initiative to streamline regulatory approvals of drugs and national coverage decisions via parallel reviews by the EMA and health technology assessment bodies. Read More
Drugmakers are praising a decision by Ireland’s Health Products Regulatory Authority to allow as many as three dozen drugs to be sold through pharmacies without a prescription. Read More
The European Medicines Agency acted properly in rejecting a UK-based pharmaceutical company’s over-the-counter migraine medicine, the European ombudsman says. Read More
Iroko Pharmaceuticals’ low-dose painkiller Zorvolex is now available for patients with osteoarthritis pain, following FDA’s approval for the second indication. Read More
The FDA has shed light on how amendments to an NDA, BLA or supplement may affect review timelines established under the 2012 prescription drug user fee program. Read More
Eli Lilly and Boehringer Ingelheim have won tentative FDA approval for their insulin product Basaglar, which is considered the biosimilar of a Sanofi product in Europe but is being reviewed as its own NDA in the United States. Read More
Hospira has won a temporary restraining order blocking Mylan from marketing a generic version of its sedative Precedex, which the FDA authorized last week under the controversial section viii statement pathway that foregoes a patent challenge and instead allows manufacturers to “carve out” indications not protected by patents. Read More
Argentina recently agreed to open its borders to finished drug products from India, a policy change applauded by Indian manufacturers who now have access to the multi-billion-dollar market. Read More
Drugmaker ViiV Healthcare is set to launch its triple combination HIV therapy Triumeq in the U.S., after receiving a green light from the FDA. Read More