ProMIS Neurosciences Offers Perspectives on Recent Progress in the Alzheimer’s/Amyloid Field
Two positive events in January support PMN310 “best in class” positioning
TORONTO and CAMBRIDGE, Mass., Feb. 02, 2021 (GLOBE NEWSWIRE) ProMIS Neurosciences, Inc. (TSX: PMN) (OTCQB: ARFXF), a biotechnology company focused on the discovery and development of antibody therapeutics targeting toxic oligomers implicated in the development of neurodegenerative diseases, announced today its perspectives on recent progress in the Alzheimer’s field.
Two important events occurred in January 2021, both of which we consider very positive for the Alzheimer’s field, for the updated amyloid hypothesis, and for ProMIS Neurosciences. The FDA extended the PDUFA date (Prescription Drug User Fee Act) for review of Biogen’s aducanumab from March 7 to June 7, 2021, as announced on January 29. Lilly announced positive clinical results for their antibody, donanemab, on January 11, making it the
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Below are specific updates on pipeline assets since our previous earnings announcement on October 27, 2020: Abrocitinib (PF-04965842) In November 2020, Pfizer announced positive top-line results from the fifth Phase 3 trial of abrocitinib, JADE REGIMEN, a 52-week study which investigated abrocitinib in patients 12 and older with moderate to severe atopic dermatitis (AD) following response to initial open label induction treatment with abrocitinib 200 mg. Patients were randomized into one of three arms: 200 mg, 100 mg or placebo. Both doses of abrocitinib met the primary endpoint, resulting in significantly fewer patients experiencing a loss of response requiring rescue treatment compared to those randomized to placebo. Both doses also met the key secondary endpoint of a larger percentage of patients maintaining an Investigator’s Global Assessment (IGA) response of clear or almost clear relative to placebo.
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Two positive events in January support PMN310 best in class positioning
TORONTO and CAMBRIDGE, Mass., Feb. 02, 2021 (GLOBE NEWSWIRE) ProMIS Neurosciences, Inc. (TSX: PMN) (OTCQB: ARFXF), a biotechnology company focused on the discovery and development of antibody therapeutics targeting toxic oligomers implicated in the development of neurodegenerative diseases, announced today its perspectives on recent progress in the Alzheimer s field.
Two important events occurred in January 2021, both of which we consider very positive for the Alzheimer s field, for the updated amyloid hypothesis, and for ProMIS Neurosciences. The FDA extended the PDUFA date (Prescription Drug User Fee Act) for review of Biogen s aducanumab from March 7 to June 7, 2021, as announced on January 29. Lilly announced positive clinical results for their antibody, donanemab, on January 11, making it the third antibody with positive clinical results in Alzheimer s disease (AD) due to its targeting of aggr
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MUMBAI, India and BALTIMORE, Feb. 1, 2021 /PRNewswire/ Lupin Pharmaceuticals Inc. (Lupin), global pharmaceutical company, announced today a partnership with Phil, Inc., which helps deliver cost-effective next-generation access solutions for patients who are prescribed Solosec® (secnidazole) 2g oral granules for the treatment of bacterial vaginosis (BV) in adult women.
Solosec® is the only single 2g oral dose therapy for the most common vaginal infection in the U.S. among adult women. This treatment is designed to deliver a full course of therapy in just one packet.
1 In November, Lupin announced that the U.S. Food and Drug Administration (FDA) has accepted its supplemental New Drug Application (sNDA) for Solosec® (secnidazole) for the treatment of trichomoniasis in adults and adolescents. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target date of June 30, 2021.
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Although the Biden-Harris Administration that assumed control of the Executive Branch on January 20, 2021 immediately ordered a regulatory freeze of new or pending rules while the new administration gets its bearings (as reported by our colleagues in this post), several important changes to the laws enforced by the Food and Drug Administration (FDA) were recently enacted by Congress. As legislative actions, those changes are of course unaffected by President Biden’s regulatory freeze and so we thought worth a summary to ensure our readers are up to speed on the large amount of activity that occurred in the final weeks of the 116th Congress and the Trump Administration.