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Emergent BioSolutions Inc.

www.emergentbiosolutions.com

Latest From Emergent BioSolutions Inc.

Yet Another Myeloma CAR-T Therapy Makes It Onto EMA’s PRIME

Only two of seven applications for entry into the European Medicines Agency’s priority medicines scheme for getting treatments for unmet medical need to patients faster were successful last month.

Research and Development Strategies Europe

Purdue's Support For OTC Naloxone Would Continue In Bankruptcy

Bankrupt Purdue proposes continued funding for developing OTC naloxone product through firm to sell ‘millions of doses’ of the emergency opioid overdose product at low or no cost. Harm Reduction Therapeutics, which previously received funding from Purdue, has pushed back target date for NDA until early 2021 for its OTC naloxone nasal spray.
OTC Drugs Drug Approval Standards

OTC Naloxone's Potential Overshadowed As FDA Priortizes Rx Generic Reviews

FDA appears committed to stemming opioid abuse by accelerating reviews of ANDAs for generics of overdose treatments but acceleration for making one of them, naloxone, available OTC is needed, too, says Michael Hufford, Harm Reduction Therapeutics CEO. "Relief that ... FDA is demonstrating its willingness to do everything that it can to accelerate these approvals," but "frustration that the public continues to be denied access to low cost naloxone," he says.
Prescription To Otc Switch OTC Drugs

Amid Hype Over Narcan First Generic, A Plea For A Labeling Change

Naloxone distribution programs ask that the cheaper generic injectable formulation have the same community-use language in its label as the nasal spray and auto-injector so they can maximize their distribution efforts.
FDA Neurology
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