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FarmaKology Newsletter - Issue #51
NeuroFlow promotes behavioral health access and engagement in all care settings to improve outcomes, overall wellness, and cost of care. Our suite of tools enables remote monitoring and behavioral health integration across the continuum of care, including psychology, primary care, and pain management settings. NeuroFlow’s mission is to be a resource and asset to health care providers in their tireless pursuit to help patients feel better faster.
Allergan, an AbbVie Company, and Molecular Partners Receive Complete Response Letter from FDA on Biologics License Application for Abicipar pegol
Allergan, an AbbVie Company, and Molecular Partners , a clinical-stage biotechnology company developing a new class of custom-built protein therapeutics known as DARPin® therapeutics, today announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter to the Biologics License Application for Abicipar pegol, a novel, investigational DARPin® therapy for patients with neovascular age-related macular degeneration .The letter from the FDA indicates that the rate of intraocular inflammation observed following administration of Abicipar pegol 2 mg/0.05 mL results in an unfavorable benefit-risk ratio in the treatment of neovascular age-related macular degeneration . AbbVie plans to meet with the FDA to discuss their comments and determine next steps.
Moderna and Catalent Announce Collaboration for Fill-Finish Manufacturing of Moderna’s COVID-19 Vaccine Candidate
Moderna, Inc. , a clinical stage biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients, and Catalent, Inc. , the leading global provider of advanced delivery technologies, development, and manufacturing solutions for drugs, biologics, cell and gene therapies, and consumer health products, today announced a collaboration for large-scale, commercial fill-finish manufacturing of Moderna’s mRNA-based COVID-19 vaccine candidate at Catalent’s biologics facility in Bloomington, Indiana.
Celltex Therapeutics Receives Another FDA Approval: Phase II Clinical Trial Using Mesenchymal Stem Cells (MSCs) as a Prophylactic Against COVID-19
Celltex, a Houston, Texas-based biotechnology company, today announced that it has received approval from the U.S. Food and Drug Administration (FDA) to proceed with the Company’s Investigational New Drug application to investigate the Prophylactic Efficacy of Autologous Adipose Tissue-Derived Mesenchymal Stem Cells Against Coronavirus Disease 2019 (COVID-19).
The Saskatchewan Health Authority (SHA) says it is considering joining several clinical trials for COVID-19 medications, but is not currently using or testing any medications during patient treatment.Management of COVID-19 cases in Saskatchewan currently consists of two types of care — supportive and advanced — neither of which involves the use of medication. "Despite lots of interest and activity, no specific medications or interventions have been proven to safely treat COVID-19," said the SHA in a written response to questions.
Research & Study
Listen to Episode 59: Using Tau To Target Alzheimer’s and fifty-eight more episodes by Pharm Exec Podcast, free! No signup or install needed. Episode 59: Using Tau to Target Alzheimer’s. Episode 58: Understanding FDA’s Gene Therapy Guidelines.