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Monthly Archives: July 2015

FDA Grants Breakthrough Therapy Designation to Bristol-Myers Squibb’s HIV Candidate

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 to the investigational compound BMS-663068 when used in combination with other antiretroviral (ARV) agents for the treatment of HIV-1 infection in heavily treatment-experienced adult patients. BMS-663068 is an oral …

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Oncobiologics Secures $31 Million to Advance Development of Biosimilars Platform and Pipeline

CRANBURY, N.J., July 27, 2015 /PRNewswire/ — Oncobiologics, Inc., announced the closing of a $31 million financing.  Proceeds will be used to support continued development and expansion of the company’s proprietary BioSymphony™ biosimilar platform and advancement of its preclinical and clinical programs. The investment round was led by new investor, Perceptive …

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FDA Approves Sanofi’s PCSK9 Drug Praluent

PARIS and TARRYTOWN, N.Y., July 24, 2015 /PRNewswire/ — Sanofi and Regeneron Pharmaceuticals, Inc. announced today that the U.S. Food and Drug Administration (FDA) approved Praluent® (alirocumab) Injection, the first FDA-approved treatment in a new class of drugs known as PCSK9 (proprotein convertase subtilisin/kexin type 9) inhibitors. Praluent is indicated as …

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Do Tests Lie?

By: Gina D’Aiello, P.A., Regional Clinical Liaison, BioPlus Specialty Pharmacy Imagine the joy of finally being cured of the life-threatening disease of hepatitis C. Now, imagine that after settling back into “normal” life for the next few months or years, another doctor (erroneously) tells you that you were never cured …

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FDA Approves AstraZeneca’s Iressa for First-Line Use in Patients with Lung Cancer

The U.S. Food and Drug Administration today approved Iressa (gefitinib) for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors harbor specific types of epidermal growth factor receptor (EGFR) gene mutations, as detected by an FDA-approved test. Lung cancer is the leading cause of cancer-related …

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Roche’s Investigational Immunotherapy Meets Primary Endpoint in Bladder Cancer Study

Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that in the IMvigor 210 study, the investigational cancer immunotherapy atezolizumab (MPDL3280A; anti-PDL1) shrank tumours (objective response rate, ORR, the primary end point of this Phase II study) in people with locally advanced or metastatic urothelial bladder cancer (UBC) who had progressed …

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Epirus Enters Biosimilars Collaboration with Polpharma Group

BOSTON, July 14, 2015 (GLOBE NEWSWIRE) —  EPIRUS Biopharmaceuticals, Inc. (Nasdaq:EPRS) and Polpharma Group today announced the signing of a multi-product, multi-region profit-sharing collaboration for select EPIRUS biosimilars, including BOW015 (infliximab, reference biologic Remicade®), BOW050 (adalimumab, reference biologic Humira®) andBOW070 (tocilizumab, reference biologic Actemra®), representing $6 billion in innovator sales in …

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Takeda Submits New Drug Application for Ixazomib for Patients with Relapsed/Refractory Multiple Myeloma

Cambridge, Mass., July 14, 2015 and Osaka, Japan, July 15, 2015 –Takeda Pharmaceutical Company Limited (TSE: 4502) today announced that a New Drug Application (NDA) has been submitted to the United States (U.S.) Food and Drug Administration (FDA) for ixazomib, an investigational oral proteasome inhibitor for the treatment of patients …

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Celgene to Acquire Receptos, Advancing Leadership in Immune-Inflammatory Diseases

SUMMIT, N.J. & SAN DIEGO–(BUSINESS WIRE)– Celgene Corporation (NASDAQ: CELG) and Receptos, Inc. (NASDAQ: RCPT) today announced the signing of a definitive agreement in which Celgene has agreed to acquire Receptos. Under the terms of the merger agreement, Celgene will pay $232.00 per share in cash, or a total of …

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