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Nicole Watkins

ViiV Submits Fostemsavir NDA to the FDA for Treatment of HIV in Adults with Few Treatment Options Available

LONDON–(BUSINESS WIRE)–ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer Inc. and Shionogi Limited as shareholders, today completed submission of a New Drug Application (NDA) to the US Food and Drug Administration (FDA) seeking approval of fostemsavir, an investigational, first-in-class attachment inhibitor for the treatment of …

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Regeneron Announces Positive Topline Phase 2 Data with Anti-C5 Antibody Pozelimab in Patients with a Rare Blood Disorder

TARRYTOWN, N.Y., Dec. 5, 2019 /PRNewswire/ — Results from initial 6-patient cohort show pozelimab reduced lactate dehydrogenase (LDH) to normal levels at week 8 in patients with paroxysmal nocturnal hemoglobinuria (PNH), utilizing a weekly subcutaneous dosing regimen Second part of Phase 2 trial initiated; plans for Phase 3 program underway …

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Bayer Collaborates with Children’s Hospital of Philadelphia to Research Novel Small Molecule Therapies for Oral Treatment of Hemophilia

WHIPPANY, N.J., Dec. 5, 2019 /PRNewswire/ — Bayer announced today that it has entered into a three-year collaboration agreement with Children’s Hospital of Philadelphia (CHOP) for the discovery and development of small molecules (SMOLs) to develop a first-in-class oral non-replacement therapy (NRT) for the treatment of hemophilia A and B. …

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Sage Therapeutics’ Investigational SAGE-217 Fails to Meet its Primary Endpoint in Pivotal Phase 3 Trial

CAMBRIDGE, Mass.–(BUSINESS WIRE)–Sage Therapeutics (NASDAQ: SAGE), a biopharmaceutical company developing novel therapies for people with debilitating brain disorders, today reported topline results from the pivotal Phase 3 MOUNTAIN Study evaluating the effect of SAGE-217 on depressive symptoms in adults with major depressive disorder (MDD). The MOUNTAIN Study did not meet …

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Takeda and Enzyre to Develop Diagnostic Device Allowing Hemophilia Patients to Determine their Coagulation Status at Home

NIJMEGEN, Netherlands, Dec. 5, 2019 /PRNewswire/ — Enzyre, which is developing breakthrough ambulant diagnostic technology for coagulation testing, today announced that it has entered into a research collaboration agreement with Takeda Pharmaceutical Company Limited (Takeda) to develop a diagnostic device that will enable hemophilia patients to determine their coagulation status …

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Aurinia’s Voclosporin Demonstrates Superiority Over Standard of Care in Phase 3 Lupus Nephritis Trial

VICTORIA, British Columbia–(BUSINESS WIRE)–Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH / TSX:AUP) (“Aurinia” or the “Company”), a late-stage clinical biopharmaceutical company focused on advancing voclosporin across multiple inflammatory and autoimmune conditions, today announced positive efficacy and safety results from its pivotal AURORA Phase 3 trial of voclosporin, in combination with mycophenolate (“MMF”) …

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AstraZeneca Collaborates with Gatehouse Bio to Use its AI-Powered Analytics Platform to Identify Drug Targets in Respiratory and Cardiovascular Diseases

BOSTON–(BUSINESS WIRE)–Gatehouse Bio, a pioneer in next-generation therapeutics, is collaborating with AstraZeneca, a global science-led biopharmaceutical company, to explore the identification of new targets for respiratory and cardiovascular diseases using Gatehouse Bio’s Artificial Intelligence (AI)-powered platform. Gatehouse Bio’s ‘sRNAlytics platform’ identifies novel small RNA (sRNA) signatures and illuminates molecular pathways …

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ImmunityBio Granted FDA Breakthrough Therapy Designation for N-803 IL-15 Superagonist in Non-Muscle Invasive Bladder Cancer

CULVER CITY, Calif.–(BUSINESS WIRE)–ImmunityBio, a privately held immunotherapy company, has received Breakthrough Therapy Designation (BTD) from the U.S. Food and Drug Administration (FDA) for its interleukin-15 (IL-15) agonist complex, N-803, in combination with Bacillus Calmette-Guerin (BCG), for the treatment of patients with BCG-unresponsive non-muscle invasive bladder carcinoma in situ (CIS). This grant …

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Foundation Medicine Expands Indication for FoundationOne CDx as a Companion Diagnostic for Piqray

CAMBRIDGE, Mass.–(BUSINESS WIRE)–Foundation Medicine, Inc. today announced it has received approval from the U.S. Food and Drug Administration (FDA) for FoundationOne®CDx to be used as a companion diagnostic for Piqray® (alpelisib) in combination with fulvestrant for the treatment of postmenopausal women, and men, with hormone receptor (HR)-positive, human epidermal growth factor receptor …

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FDA Grants Breakthrough Therapy Designation to Bristol-Myers Squibb’s Orencia to Help Prevent Acute Graft-Versus-Host Disease

PRINCETON, N.J.–(BUSINESS WIRE)–Bristol-Myers Squibb Company (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for ORENCIA® (abatacept) for the prevention of moderate to severe acute graft-versus-host disease (GvHD) in hematopoietic stem cell transplants from unrelated donors. There are no approved therapies for the prevention of …

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