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Nicole Watkins

Blueprint Medicines Submits NDA to the FDA for Avapritinib for the Treatment of PDGFRA Exon 18 Mutant GIST and Fourth-Line GIST

CAMBRIDGE, Mass., June 14, 2019 /PRNewswire/ — Blueprint Medicines Corporation (NASDAQ: BPMC), a precision therapy company focused on genomically defined cancers, rare diseases and cancer immunotherapy, today announced it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for avapritinib for the treatment of …

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Updated Efficacy Data from GBT’s Phase 3 Study Show Statistically Significant and Sustained Improvements in Hemoglobin with Voxelotor

AMSTERDAM, The Netherlands, June 14, 2019 (GLOBE NEWSWIRE) — Global Blood Therapeutics, Inc. (GBT) (Nasdaq: GBT) today announced new results from its Phase 3 HOPE Study of voxelotor in patients ages 12 and older with sickle cell disease (SCD). The findings from 274 adolescents and adults treated with voxelotor showed the HOPE Study met …

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Janssen Reports Top-Line Phase 3 Results for Tremfya in Adults with Active Psoriatic Arthritis

HORSHAM, Pa.–(BUSINESS WIRE)–The Janssen Pharmaceutical Companies of Johnson & Johnson today announced top-line results from the Phase 3 DISCOVER 1 and 2 studies, which evaluated the efficacy and safety of guselkumab compared to placebo in adult patients with active moderate to severe psoriatic arthritis (PsA). Both studies met their primary …

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Bristol-Myers Squibb Announces Empliciti-Based Combination Showed Improvements Across All Efficacy Endpoints in Phase 2 Trial in Multiple Myeloma

PRINCETON, N.J.–(BUSINESS WIRE)–Bristol-Myers Squibb Company (NYSE: BMY) today announced the presentation of updated data from ELOQUENT-3, the international randomized Phase 2 study evaluating Empliciti  (elotuzumab) plus pomalidomide and dexamethasone (EPd) versus pomalidomide and dexamethasone (Pd) alone in patients with relapsed or refractory multiple myeloma (RRMM). In a non-prespecified analysis conducted …

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Enanta’s EDP-938 Achieved its Primary and Secondary Endpoints in Phase 2a Human Challenge Study in Healthy Adults with Respiratory Syncytial Virus

WATERTOWN, Mass.–(BUSINESS WIRE)–Enanta Pharmaceuticals, Inc. (NASDAQ:ENTA), a research and development-focused biotechnology company dedicated to creating small molecule drugs for viral infections and liver diseases, today announced topline results that demonstrated that EDP-938 achieved highly statistically significant (p<0.001) reductions in viral load and in resolution of clinical symptoms compared to placebo …

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FDA Approves Amgen and Allergan’s Kanjinti, a Biosimilar to Herceptin

THOUSAND OAKS, Calif., June 13, 2019 /PRNewswire/ — Amgen (NASDAQ:AMGN) and Allergan plc (NYSE:AGN) today announced that the U.S. Food and Drug Administration (FDA) has approved KANJINTI™ (trastuzumab-anns) for all approved indications of the reference product, Herceptin® (trastuzumab):  for the treatment of HER2-overexpressing adjuvant and metastatic breast cancer and HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma. “The FDA approval of KANJINTI is …

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GSK Forms Drug Discovery Alliance with University of California CRISPR Researchers

GlaxoSmithKline plc today announced a five-year collaboration with the University of California to establish a state-of-the-art laboratory for CRISPR technologies, the Laboratory for Genomics Research (LGR). The new laboratory will explore how gene mutations cause disease and develop new technologies using CRISPR to rapidly accelerate the discovery of new medicines. …

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AbCellera and Gilead Enter Infectious Disease Therapeutic Antibody Discovery Collaboration

VANCOUVER, British Columbia–(BUSINESS WIRE)–AbCellera, a leader in therapeutic antibody discovery from natural immune systems, today announced it has entered into an agreement with Gilead Sciences to support the discovery of therapeutic antibody candidates for infectious diseases. AbCellera will apply its expertise in single-cell screening of natural immune sources to generate …

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Bone Therapeutics’ Allogeneic Cell Therapy Product Meets Primary Endpoints in Phase 2a Study in Patients Undergoing Lumbar Spinal Fusion

Gosselies, Belgium, 13 June 2019, 7 am CEST – BONE THERAPEUTICS (Euronext Brussels and Paris: BOTHE), the leading biotech company focused on the development of innovative cell and biological therapeutics to address high unmet medical needs in orthopaedics and bone diseases, today announces that its allogeneic cell therapy product, ALLOB, successfully completed …

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Phase 3 Study Showed that Genentech’s Rituxan is Superior to Standard of Care in Achieving Sustained Remission in Pemphigus Vulgaris

SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced positive top line results from the Roche-sponsored Phase III PEMPHIX study evaluating the efficacy and safety of Rituxan® (rituximab) compared to mycophenolate mofetil (MMF) in adults with moderate to severe pemphigus vulgaris (PV). …

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