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FDA Approves Ziextenzo (pegfilgrastim-bmez), a Biosimilar to Neulasta

Holzkirchen, Nov. 5, 2019 – Sandoz, a Novartis division and a global leader in biosimilars, today announced that the US Food and Drug Administration (FDA) approved its biosimilar Ziextenzo (pegfilgras

FDA Approves Talicia (omeprazole magnesium, amoxicillin and rifabutin) for the Treatment of H. pylori Infection in Adults

TEL-AVIV, Israel and RALEIGH, N.C., Nov. 04, 2019 (GLOBE NEWSWIRE) -- RedHill Biopharma Ltd. (Nasdaq: RDHL) (Tel-Aviv Stock Exchange: RDHL) (“RedHill” or the “Company”), a specialty biopharmaceutical

PellePharm Completes Enrollment Of Pivotal Phase 3 Clinical Trial Of Patidegib Topical Gel In Patients With Gorlin Syndrome

SAN FRANCISCO – December 2, 2019 – PellePharm, Inc., a BridgeBio Pharma, Inc. (Nasdaq: BBIO) company, today announced the completion of enrollment for its pivotal Phase 3 clinical trial of Patidegib T

Positive Phase III Results for Genentech’s Satralizumab in Neuromyelitis Optica Spectrum Disorder Published in the New England Journal of Medicine

South San Francisco, CA -- December 1, 2019 -- Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that data from SAkuraSky, a pivotal Phase III study of the investiga

The Medicines Company Announces that the ORION-9 Study of Inclisiran in HeFH Patients Showed Durable and Potent LDL-C Lowering with Twice-Yearly Dosing

November 18, 2019 -- The Medicines Company (NASDAQ: MDCO) today announced detailed results from ORION-9, the last of three pivotal 18-month low-density lipoprotein cholesterol (LDL-C) lowering Phase 3

New England Journal of Medicine Publishes Results of Ebola Clinical Trial Confirming Superiority of Regeneron's REGN-EB3 to ZMapp in Preventing Ebola Deaths

TARRYTOWN, N.Y., Nov. 27, 2019 /PRNewswire/ -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) announced today that the New England Journal of Medicine(NEJM) published results from the randomized contr

Chi-Med Announces Surufatinib Granted FDA Orphan Drug Designation for Pancreatic Neuroendocrine Tumors

LONDON, Nov. 25, 2019 (GLOBE NEWSWIRE) -- Hutchison China MediTech Limited (“Chi-Med”) (AIM/Nasdaq: HCM) today announces that the U.S. Food and Drug Administration (“FDA”) has granted Orphan Drug desi

FDA Grants Priority Review to Genentech’s Risdiplam for Spinal Muscular Atrophy

South San Francisco, CA -- November 24, 2019 -- Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) has accepted the N

Pivotal Data from Phase 3 Study of Sutimlimab in Cold Agglutinin Disease to be Presented at ASH 2019 Late-Breaking Session

CAMBRIDGE, Mass., Nov. 21, 2019 /PRNewswire/ -- Sanofi, Full data from the pivotal Phase 3 CARDINAL trial evaluating the safety and efficacy of sutimlimab in people with primary cold agglutinin diseas

Newron Receives FDA Rare Pediatric Disease Designation for Sarizotan for the Treatment of Rett Syndrome

MILAN & MORRISTOWN, N.J. -- November 19, 2019 -- Newron Pharmaceuticals S.p.A. (“Newron”) (SIX: NWRN, XETRA: NP5), a biopharmaceutical company focused on the development of novel therapies for pat

Myovant Sciences Announces 97% Response Rate in Positive Phase 3 HERO Study of Once-Daily, Oral Relugolix in Men with Advanced Prostate Cancer

BASEL, Switzerland, Nov. 19, 2019 (GLOBE NEWSWIRE) -- Myovant Sciences (NYSE: MYOV), a healthcare company focused on developing innovative treatments for women's health and prostate cancer, today

Allergan Announces Positive Phase 3 ACHIEVE II Trial Results for Ubrogepant Published in The Journal of the American Medical Association

DUBLIN, Nov. 19, 2019 /PRNewswire/ -- Allergan plc (NYSE: AGN) today announced that positive results from ACHIEVE II (UBR-MD-02), a pivotal Phase 3 clinical trial evaluating the efficacy, safety and t