CytoDyn Files FDA-Suggested Modifications to IND and Protocol for Phase 2 Clinical Trial for COVID-19 Patients

VANCOUVER, Washington, March 27, 2020 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTC.QB: CYDY), (“CytoDyn” or the “Company"), a late-stage biotechnology company developing leronlimab (PRO 140), a CCR5 ant

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Atlanta Site Added to NIH Clinical Trial of a Vaccine for COVID-19

March 27, 2020 -- Emory University in Atlanta will begin enrolling healthy adult volunteers ages 18 to 55 years in a Phase 1 clinical trial of an investigational vaccine designed to prevent coronaviru

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Sanofi and Translate Bio Collaborate to Develop Novel mRNA Vaccine Candidate Against COVID-19

PARIS and LEXINGTON, MASS. - March 27, 2020 -- Sanofi Pasteur, the vaccines global business unit of Sanofi, and Translate Bio (NASDAQ: TBIO), a clinical-stage messenger RNA (mRNA) therapeutics company

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FDA Approves Kesimpta (ofatumumab) Targeted B-cell Therapy for Patients with Relapsing Multiple Sclerosis

Basel, August 20, 2020 -- Novartis today announced that the US Food and Drug Administration (FDA) has approved Kesimpta® (ofatumumab, formerly OMB157) as an injection for subcutaneous use for the trea

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Gilead Sciences Statement on Request to Rescind Remdesivir Orphan Drug Designation

March 25, 2020 -- Gilead has submitted a request to the U.S. Food and Drug Administration to rescind the orphan drug designation it was granted for the investigational antiviral remdesivir for the tre

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Aldeyra to Screen Clinical-Stage Compounds for Activity in COVID-19 Infection

LEXINGTON, Mass.--(BUSINESS WIRE)--Mar. 24, 2020 -- Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra) today announced that it will begin screening its library of novel reactive aldehyde species (RAS

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Two Additional Coronavirus Patients Treated at Leading New York Hospital with CytoDyn’s Leronlimab, Bringing the Total to Four Patients

VANCOUVER, Washington, March 23, 2020 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTC.QB: CYDY), (“CytoDyn” or the “Company"), a late-stage biotechnology company developing leronlimab (PRO 140), a CCR5 ant

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Gilead Sciences Statement on Access to Remdesivir Outside of Clinical Trials

March 22, 2020 -- Gilead is working to rapidly assess the safety and efficacy of remdesivir as a potential treatment for COVID-19 through multiple ongoing clinical trials. Enrollment in clinical trial

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U.S. Food and Drug Administration (FDA) Grants Emergency IND for Two Coronavirus Patients Treated in New York with CytoDyn’s Leronlimab

VANCOUVER, Washington, March 19, 2020 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTC.QB: CYDY), (“CytoDyn” or the “Company"), a late-stage biotechnology company developing leronlimab (PRO 140), a CCR5 ant

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Rhythm Pharmaceuticals Receives Orphan Drug Designation from U.S. FDA for Setmelanotide for the Treatment of Alström Syndrome

BOSTON, March 18, 2020 (GLOBE NEWSWIRE) -- Rhythm Pharmaceuticals, Inc. (Nasdaq: RYTM), a late-stage biopharmaceutical company aimed at developing and commercializing therapies for the treatment of ra

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Novartis Announces NEJM Publication of Three Pivotal Trials Showing Durable and Potent Efficacy of Inclisiran, an Investigational First-in-Class siRNA Cholesterol-Lowering Therapy

East Hanover, N.J., March 18, 2020 -- Novartis announced today the publication of three pivotal Phase III clinical trials for inclisiran, a potential first-in-class small interfering RNA (siRNA) inves

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Pfizer Announces Positive Top-Line Results from Third Phase 3 Trial of Abrocitinib for Moderate to Severe Atopic Dermatitis, Which Showed Improvements in Skin Clearance, Disease Extent and Severity, and Itch

March 18, 2020 -- Pfizer Inc. (NYSE:PFE) announced today that JADE COMPARE (B7451029) met its co-primary efficacy endpoints. The Phase 3 study evaluated the safety and efficacy of abrocitinib, an inve

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