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Mylan may move forward with its proposed hostile takeover bid of Perrigo, as long as it divests seven generic drugs, the FTC has determined. The move is the final regulatory hurdle for Mylan’s bid and eases the FTC’s concerns that the deal would harm competition. Read More
A new EvaluatePharma report projects the orphan drug market will surge over the next five years, doubling the yearly growth of the overall prescription drug market. Read More
WTO Accord Exempts Poorest Nations from Patent Rules for 17 Years Researchers: Competitors Nip at Heels of First-in-Class Drugs Janssen Submits Application to EMA for Expanded Imbruvica Indication Read More
The HHS Office of Inspector General is planning to examine the FDA’s oversight of postmarketing studies of approved drugs and how well information exchange is occurring in the pharmaceutical supply chain as part of its six priorities for the agency in fiscal year 2016. Read More
Taking aim at what they call the “skyrocketing costs of pharmaceuticals,” Democratic members of the House Committee on Oversight & Government Reform are slated to launch the Affordable Drug Pricing Task Force during a press conference today. Read More
Valeant is offering patients access to its dermatology products for zero dollar copay under a program through major pharmacy chains and independent pharmacies. Read More
The pharmaceutical and biologics industries aren’t hiding their displeasure with a decision from the Centers for Medicare & Medicaid Services to treat all biosimilars based on the originator product as identical for billing and reimbursement purposes. Read More
The moment dietary supplement manufacturers start making specific curative claims, supplements are seen as drugs in the eyes of the FDA and require an IND, says a new guidance document. Read More