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Monthly Archives: March 2017

Corbus Pharmaceuticals Reports Positive Topline Data from its Cystic Fibrosis Study

NORWORD, MA — (Marketwired) — 03/30/17 — Corbus Pharmaceuticals Holdings, Inc. (NASDAQ: CRBP) (“Corbus” or the “Company”), a clinical stage drug development company targeting rare, chronic, serious inflammatory and fibrotic diseases, today announced positive topline data from its Phase 2 study evaluating multiple doses of anabasum (fka JBT-101 or Resunab) …

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Bristol-Myers to Leverage Foundation Medicine’s Platform to Identify Predictive Biomarkers

NEW YORK & CAMBRIDGE, Mass.–(BUSINESS WIRE)–Bristol-Myers Squibb Company (NYSE:BMY) and Foundation Medicine (NASDAQ:FMI) today announced a collaboration that leverages Foundation Medicine’s comprehensive genomic profiling and molecular information solutions to identify predictive biomarkers such as Tumor Mutational Burden (TMB) and Microsatellite Instability (MSI) in patients enrolled across clinical trials investigating Bristol-Myers …

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Incyte, Merck Provide Details on Collaboration of Epacadostat and Keytruda

WILMINGTON, Del. & KENILWORTH, N.J.–(BUSINESS WIRE)–Incyte Corporation (Nasdaq:INCY) and Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced additional details of their clinical development program investigating the combination of epacadostat, Incyte’s investigational oral selective IDO1 enzyme inhibitor, with KEYTRUDA®(pembrolizumab), Merck’s anti-PD-1 therapy, in patients across five …

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Halozyme’s PEGPH20 Shows No Incremental Survival Benefit in Pancreatic Cancer Study

SAN DIEGO, March 30, 2017 /PRNewswire/ — Halozyme Therapeutics, Inc. (NASDAQ: HALO) today announced it has been informed by SWOG, an independent network of researchers that design and conduct cancer clinical trials, that the SWOG Phase 1b/2 trial evaluating PEGPH20 plus modified FOLFIRINOX chemotherapy versus modified FOLFIRINOX alone in patients …

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FDA Grants Full Approval to AstraZeneca’s NSCLC Drug Tagrisso

AstraZeneca today announced that the US Food and Drug Administration (FDA) has granted full approval for Tagrisso (osimertinib) 80mg once-daily tablets, for the treatment of patients with metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive non-small cell lung cancer (NSCLC), as detected by an FDA-approved test, whose disease has progressed …

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Novartis Gains Priority Review from the FDA for its CAR-T Cell Therapy

Basel, March 29, 2017 – Novartis announced today that the US Food and Drug Administration (FDA) has accepted the company’s Biologics License Application (BLA) filing and granted priority review for CTL019 (tisagenlecleucel-T), an investigational chimeric antigen receptor T cell (CAR-T) therapy, in relapsed and refractory (r/r) pediatric and young adult …

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Genmab Discontinues Mid-Stage Non-Hodgkin’s Lymphoma Study

Copenhagen, Denmark; March 30, 2017 — Genmab A/S (Nasdaq Copenhagen: GEN) announced today that its collaboration partner for daratumumab, Janssen Biotech, Inc., has decided not to initiate stage 2 of the Phase II study (CARINA, LYM2001) of daratumumab in three types of relapsed or refractory non-Hodgkin’s lymphoma (NHL).  The study …

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FDA Grants Priority Review to Amgen’s Blincyto sBLA

THOUSAND OAKS, Calif., March 29, 2017 /PRNewswire/ — Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration (FDA) has accepted for priority review the supplemental Biologics License Application (sBLA) for BLINCYTO® (blinatumomab) to include overall survival (OS) data from the Phase 3 TOWER study. The application also includes new …

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AstraZeneca’s Lynparza Granted FDA Priority Review for Maintenance Setting in Ovarian Cancer Patients

WILMINGTON, Del.–(BUSINESS WIRE)–AstraZeneca today announced that the US Food and Drug Administration (FDA) has accepted the company’s New Drug Application (NDA) for LYNPARZA™ (olaparib) tablets (300mg twice daily) for use in platinum-sensitive, relapsed ovarian cancer patients in the maintenance setting. The FDA has also granted priority review status with a …

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Bristol-Myers Collaborates with Parker Institute and CRI for Immuno-Oncology Research

NEW YORK & SAN FRANCISCO–(BUSINESS WIRE)–The Parker Institute for Cancer Immunotherapy, Bristol-Myers Squibb Company (NYSE: BMY) and the Cancer Research Institute (CRI) today announced a multi-year clinical research collaboration to coordinate and rapidly initiate clinical Immuno-Oncology (I-O) studies across the Parker Institute and CRI networks. Bristol-Myers Squibb will work closely …

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