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The FDA approved GlaxoSmithKline’s injectable drug Nucala Wednesday for use in patients 12 years and older suffering from severe asthma attacks. It is intended to be used in conjunction with other asthma drugs. Read More
Allegations of price gouging within the pharmaceutical industry reached fever pitch in Washington, D.C., yesterday, with House members calling for hearings, a Senate committee opening an investigation into pricing practices and HHS announcing a hearing on the subject. Read More
FDA Names Permanent Deputy Director for Office of Generic Drugs Report: Generic Drugs Saved U.S. $254 Billion Agilis Wins Orphan Drug Designation for Angelman Syndrome Therapy Roche Reaches Deal With NHS England to Keep Kadcyla on Listing FDA Fast Tracks Opioid Addiction Drug Read More
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