May 24, 2017

Vol. 14 No. 100

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In First Address as FDA Commissioner, Gottlieb Highlights Opioids, Drug Pricing

Gottlieb said the agency could take meaningful steps to increase competition and bring low-cost alternatives to the market. Read More

Eleven Senate Democrats Warn Proposed Cuts Would Hurt Cures Act Implementation

Trump’s budget blueprint for the next fiscal year seeks deep cuts to federal agencies. Read More

FDA Issues 21 New Product-Specific Draft Guidances for Generics, 16 Revised

The documents describe the FDA’s recommendations for necessary in vivo and in vitro studies for each drug. Read More

Sage Therapeutics Receives Fast Track Designation for Depression Drug

The neuroactive steroid is a positive allosteric modulator of synaptic and extrasynaptic receptors. Read More

GlycoMimetics’ Leukemia Drug Wins FDA Breakthrough Therapy Designation

The drug is an E-selectin antagonist currently being evaluated in the Phase II clinical trial. Read More