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Nicole Watkins

GSK Announces Positive Results from the Pivotal DREAMM-2 Study for Multiple Myeloma

GlaxoSmithKline plc (LSE/NYSE: GSK) today announced positive headline results from the pivotal DREAMM-2 open-label, randomized study of two doses of belantamab mafodotin (GSK2857916). The 196 patients in the trial had relapsed multiple myeloma, were refractory to an immunomodulatory drug, a proteasome inhibitor, and to treatment with an anti-CD38 antibody. The …

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Comparison of Three Similar Frontline Breast Cancer Drugs Reveals Important Differences

Every year, more than 250,000 women in the U.S. are diagnosed with breast cancer. When detected early, patients with the most common form–which tests positive for hormone receptors (HR+) and negative for the HER2 receptor–usually respond well to treatment. But for those in advanced stages, few treatment options existed until …

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International Team Discovers Unique Pathway for Treating Deadly Children’s Brain Cancer

PHOENIX, Ariz. — Aug. 22, 2019 — An international team of researchers led by Yale University, University of Iowa, and the Translational Genomics Research Institute (TGen), an affiliate of City of Hope, has discovered a new pathway that may improve success against an incurable type of children’s brain cancer. The …

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Amgen and Allergan Announce Positive Top-Line Results from Comparative Clinical Study of ABP 798, Biosimilar Candidate to Rituxan

THOUSAND OAKS, Calif., Aug. 22, 2019 /PRNewswire/ — Amgen (NASDAQ:AMGN) and Allergan plc. (NYSE:AGN) today announced positive top-line results from a comparative clinical study evaluating the efficacy and safety of ABP 798, a biosimilar candidate to Rituxan® (rituximab), compared to Rituxan in patients with CD20-positive B-cell non-Hodgkin’s lymphoma. The primary endpoint, an assessment of overall response rate (ORR) …

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FDA Grants Regenerative Medicine Advanced Therapy Designation to MB-107 Lentiviral Gene Therapy for X-Linked Severe Combined Immunodeficiency

NEW YORK and MEMPHIS, Tenn., Aug. 22, 2019 (GLOBE NEWSWIRE) — Mustang Bio, Inc. (NASDAQ: MBIO) and St. Jude Children’s Research Hospital have announced that MB-107, a lentiviral gene therapy for the treatment of X-linked severe combined immunodeficiency, also known as bubble boy disease, has been granted the Regenerative Medicine …

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Themis Bioscience Announces Exclusive License and Research Collaboration Agreement with MSD to Develop Vaccine Candidates

VIENNA–(BUSINESS WIRE)–Themis Bioscience announced today a research collaboration and exclusive license agreement with MSD (tradename of Merck & Co., Inc., Kenilworth, N.J., USA) for the discovery and development of undisclosed vaccine candidates using Themis’ measles virus vector-based platform. “Given the versatility of our immune-modulation platform and our proven ability to rapidly …

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Sobi Sells FDA Priority Review Voucher to AstraZeneca for $95 Million

STOCKHOLM, Aug. 22, 2019 /PRNewswire/ — Swedish Orphan Biovitrum AB (publ) (Sobi™) (STO:SOBI) has entered into an agreement to sell a US Food and Drug Administration (FDA) Priority Review Voucher (PRV) to AstraZeneca for a total cash consideration of USD 95 M. A PRV entitles the holder to FDA priority …

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ViiV Reports Positive Phase 3 Results of Investigational, Long-Acting, Injectable HIV-Treatment Regimen Every 2 Months

LONDON–(BUSINESS WIRE)–ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer Inc. and Shionogi Limited as shareholders, today announced positive headline results from its global phase III ATLAS-2M study of the investigational, long-acting, injectable, 2-drug regimen (2DR) of ViiV Healthcare’s cabotegravir and Janssen’s rilpivirine for the treatment …

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FDA Grants Xtandi sNDA Priority Review for the Treatment of Metastatic Hormone-Sensitive Prostate Cancer

TOKYO & NEW YORK–(BUSINESS WIRE)–Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) and Pfizer Inc. (NYSE: PFE) announced today that the U.S. Food and Drug Administration (FDA) has accepted for review the filing of a supplemental New Drug Application (sNDA) for XTANDI® (enzalutamide) to add an indication …

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FDA Accepts and Grants Priority Review to BeiGene’s Zanubrutinib for Relapsed/Refractory Mantle Cell Lymphoma

CAMBRIDGE, Mass. and BEIJING, China, Aug. 21, 2019 (GLOBE NEWSWIRE) — BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160), a commercial-stage biopharmaceutical company focused on developing and commercializing innovative molecularly-targeted and immuno-oncology drugs for the treatment of cancer, today announced that the U.S. Food and Drug Administration (FDA) has accepted the company’s …

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