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Anavex Life Sciences Appoints Former FDA Officer as Senior Vice President for Nonclinical Development


Published: May 05, 2021
NEW YORK, May 05, 2021 (GLOBE NEWSWIRE) Anavex Life Sciences Corp.  . (“Anavex” or the “Company”) (Nasdaq: AVXL), a clinical-stage biopharmaceutical company developing differentiated therapeutics for the treatment of neurodegenerative and neurodevelopmental disorders including Alzheimer’s disease, Parkinson’s disease, Rett syndrome and other central nervous system (CNS) diseases, today announced the appointment of Dr. Adebayo (Bayo) Laniyonu, as Senior Vice President for Nonclinical Development. Dr. Laniyonu has over 24 years’ experience with the US Food and Drug Administration (FDA).
“Dr. Laniyonu has an accomplished track record of working within the FDA,” said Christopher U. Missling, PhD, President and Chief Executive Officer of Anavex. “His depth of experience makes him an excellent choice to provide objective perspective and manage the continuous nonclinical projects at Anavex.” ....

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"Buy American" Update: Essential Medicines May Continue to Come From Abroad (For Now) | Sheppard Mullin Richter & Hampton LLP


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The Biden Administration has taken (at least temporarily) the teeth out of a Trump-era Executive Order that directed the government to “Buy American” for essential drugs and medical devices. President Trump’s August 2020 Executive Order on Ensuring Essential Medicines, Medical Countermeasures, and Critical Inputs Are Made in the United States (Executive Order 13944) aimed to reduce dependence on foreign drugs and devices critical to the U.S. public health sector, in part by requiring that the U.S. Trade Representative remove those essential items from the coverage of any international free trade agreement. On April 20, 2021, the Biden Administration withdrew just such a proposal to remove essential drugs and medical devices from coverage under the World Trade Organization Government Procurement Agreement (“WTO GPA”). With the proposal withdrawn, the U.S. government remains free to buy U.S.-made ....

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Buy America Update: Essential Medicines May Come From Abroad


Thursday, April 29, 2021
The Biden Administration has taken (at least temporarily) the teeth out of a Trump-era Executive Order that directed the government to “Buy American” for essential drugs and medical devices. President Trump’s August 2020 Executive Order on Ensuring Essential Medicines, Medical Countermeasures, and Critical Inputs Are Made in the United States (Executive Order 13944) aimed to reduce dependence on foreign drugs and devices critical to the U.S. public health sector, in part by requiring that the U.S. Trade Representative remove those essential items from the coverage of any international free trade agreement. On April 20, 2021, the Biden Administration withdrew just such a proposal to remove essential drugs and medical devices from coverage under the World Trade Organization Government Procurement Agreement (“WTO GPA”). With the proposal withdrawn, the U.S. government remains free to buy U.S.-made  ....

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Enalare Therapeutics Announces Partnership with BARDA to Advance Development of its Lead Product ENA-001


Enalare Therapeutics Announces Partnership with BARDA to Advance Development of its Lead Product ENA-001
Posted Apr 29, 2021
The Funding Will Accelerate Development of an Intramuscular Formulation of a Novel Agnostic  Respiratory Stimulant to Treat Life-threatening Respiratory Depression 
PRINCETON, N.J. - Enalare Therapeutics Inc. announced today that it has received an initial contract from the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services, to support development of the company’s lead product ENA-001. The funding will be used to advance development of an intramuscular (IM) formulation for ENA-001, a New Chemical Entity (NCE) with a novel mechanism of action and potential broad applications as an agnostic respiratory stimulant. The funding is provided via the BARDA Division of Research, Innovation, a ....

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