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Monthly Archives: July 2017

Jazz Pharmaceuticals to Use XL-Protein’s Technology Platform to Develop Long-Acting Asparaginase Product Candidates

DUBLIN, July 26, 2017 /PRNewswire/ — Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced that it has entered into a license agreement with XL-protein GmbH (“XLp”) for the rights to develop, manufacture and commercialize products using XLp’s PASylation® Technology to extend the plasma half-life of selected asparaginase product candidates.  Under the …

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Genentech’s Actemra Demonstrates Positive Results in Phase 3 Study in Patients with Giant Cell Arteritis

SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that data from the Phase III GiACTA study, which evaluated Actemra® (tocilizumab) in adult patients with GCA, were published in the July 27, 2017 issue of the New England Journal of Medicine. The primary …

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AstraZeneca’s Tagrisso Significantly Improves Progression-Free Survival in Late-Stage NSCLC Study

AstraZeneca today announced that the Phase III FLAURA trial showed a statistically-significant and clinically-meaningful progression-free survival (PFS) benefit with Tagrisso (osimertinib) compared to current 1st-line standard-of-care treatment (erlotinib or gefitinib) in previously-untreated patients with locally-advanced or metastatic epidermal growth factor receptor mutation-positive (EGFRm) non-small cell lung cancer (NSCLC). Sean Bohen, Executive Vice …

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Merck’s Investigational Doravirine Meets Primary Efficacy Endpoint in Pivotal Phase 3 Trial for Treatment of HIV-1 Infection

KENILWORTH, N.J.–(BUSINESS WIRE)–Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced the presentation of results from the DRIVE-AHEAD study, the second of two pivotal Phase 3 clinical trials evaluating the efficacy and safety of doravirine, the company’s investigational, non-nucleoside reverse transcriptase inhibitor (NNRTI), for the treatment …

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Adaptive’s ImmunoSEQ Platform to be Used for Immunosequencing-Based Biomarker Discovery in NCI Trials

SEATTLE–(BUSINESS WIRE)–Adaptive Biotechnologies, a pioneer in combining next-generation sequencing and expert bioinformatics to profile T-cell and B-cell receptors (TCRs and BCRs) of the adaptive immune system, today announced a translational collaboration with the Cancer Therapy Evaluation Program (CTEP) of the National Cancer Institute (NCI), part of the National Institutes of …

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Pfizer Announces Positive Top-Line Results from Comparative Study for PF-06439535, a Potential Biosimilar to Avastin

NEW YORK–(BUSINESS WIRE)–Pfizer Inc. (NYSE:PFE) today announced that the REFLECTIONS B7391003 study, a comparative, confirmatory safety and efficacy study of PF-06439535 versus Avastin® (bevacizumab), met its primary objective. PF-06439535 is being developed by Pfizer as a potential biosimilar to Avastin. The trial demonstrated equivalence in the primary endpoint of objective …

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Gilead Announces Late-Stage Results for Investigational Triple-Combo Therapy for Treatment of HIV

FOSTER CITY, Calif.–(BUSINESS WIRE)–Gilead Sciences, Inc. (NASDAQ: GILD) today announced detailed 48-week results from two Phase 3 studies (Studies 1489 and 1490) evaluating the efficacy and safety of a fixed-dose combination of bictegravir (50 mg) (BIC), a novel investigational integrase strand transfer inhibitor (INSTI), and emtricitabine/tenofovir alafenamide (200/25mg) (FTC/TAF), a …

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Mitsubishi Tanabe to Acquire NeuroDerm for $1.1 Billion

REHOVOT, Israel – July 24, 2017 – NeuroDerm Ltd. (Nasdaq: NDRM), a clinical stage pharmaceutical company developing drug-device combinations for central nervous system (CNS) disorders, today announced that it has signed a definitive agreement under which Mitsubishi Tanabe Pharma Corporation (TSE Code: 4508) (“MTPC”), a publicly traded company on the Tokyo Stock Exchange, will …

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Lilly Partners with Nektar for Development of its Autoimmune Candidate NKTR-358

INDIANAPOLIS and SAN FRANCISCO, July 24, 2017 /PRNewswire/ — Eli Lilly and Company (NYSE: LLY) and Nektar Therapeutics (NASDAQ: NKTR) have announced a strategic collaboration to co-develop NKTR-358, a novel immunological therapy discovered by Nektar. NKTR-358, which achieved first human dose in Phase 1 clinical development in March of 2017, …

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FDA Expands Approval of Yervoy to Include Pediatric Patients 12 Years and Older with Unresectable or Metastatic Melanoma

PRINCETON, N.J.–(BUSINESS WIRE)–Bristol-Myers Squibb Company (NYSE:BMY) today announced that the U.S. Food and Drug Administration (FDA) has expanded the indication for Yervoy® (ipilimumab) injection for intravenous use to now include the treatment of unresectable or metastatic melanoma in pediatric patients 12 years of age and older. Yervoy was evaluated in two trials of pediatric patients: …

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