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Emergent BioSolutions Inc.

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Latest From Emergent BioSolutions Inc.

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

Keeping Track: Two Goal Date Extensions, Another Herceptin Biosimilar Approval, And A BLA Withdrawal

The latest drug development news and highlights from our US FDA Performance Tracker.
Drug Review Regulation

US FDA’s Biologics Center Faces Exciting 2019 After Quiet Year For Novel Approvals

CBER’s novel biologic approvals in 2018 were few, long, and with a low level of innovation. But the center’s work to build regulatory framework for emerging technologies is setting the stage for a different story in 2019.
Vaccines Biologics
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