BioSpace News Archive

Business

InfuSystem Holdings Reports Third Quarter 2017 Financial Results

Net revenues totaled $17.6M, an increase of 2.1%, versus the third quarter of 2016 of $17.2M.

November 10, 2017

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37 min read

Pharm Country

Bristol-Myers Squibb Release: U.S. Food and Drug Administration Expands Approval of Sprycel (Dasatinib) to Include Treatment of Children With Philadelphia Chromosome-Positive Chronic Myeloid Leukemia in Chronic Phase

Bristol-Myers Squibb today announced the U.S. Food and Drug Administration (FDA) has expanded the indication for Sprycel (dasatinib) tablets to include the treatment of children with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (CP).

November 10, 2017

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21 min read

Deals

Valeant Pharmaceuticals Completes Sale of Obagi Medical Products Business to Haitong International Zhongua Finance Acquisition Fund I, L.P.

Valeant will use approximately $180M of the net proceeds from the sale to repay term loan debt under its Senior Credit Facility.

November 10, 2017

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3 min read

Business

U.S. Dept. of Veterans Affairs Renews and Expands Cancer Testing Contract With Personal Genome Diagnostics

The contract includes PDGx’s CancerSELECT 125 tissue and PlasmaSELECT64 liquid biopsy profiling panels.

November 10, 2017

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2 min read

Policy

Zydus Announces Regulatory Approval of Lipaglyn (Saroglitazar Magnesium) in Mexico

Zydus today announced that the Mexico regulatory authority COFEPRIS has granted marketing approval to commercialize Lipaglyn (Saroglitazar Magnesium) in Mexico for the treatment of Dyslipidemia in patients with diabetes mellitus type 2 and Hypertriglyceridemia in patients with diabetes mellitus type 2 not controlled by statins.

November 10, 2017

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2 min read

BioForest

Alpine Immune Sciences Presents Preclinical Data on Novel Immuno-Oncology Molecules at the Society for Immunotherapy of Cancer’s 32nd Annual Meeting

The findings will be presented on Friday, November 10, in a poster session titled “Immune Modulation, Cytokines, and Antibodies” [#P343] at the Society for Immunotherapy of Cancer’s (SITC) 32nd Annual Meeting in National Harbor, MD.

November 10, 2017

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5 min read

Business

Trillium Therapeutics Reports Third Quarter 2017 Financial and Operating Results

As of September 30, 2017, Trillium had cash and marketable securities of $64.3 million compared to $50.5 million at December 31, 2016.

November 10, 2017

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7 min read

Drug Development

Amgen and Allergan Receive Positive CHMP Opinion for ABP 215 (Biosimilar Bevacizumab) for the Treatment of Certain Types of Cancer

ABP 215 has been recommended for approval for the treatment of certain types of cancer, including in combination with fluoropyrimidine-based chemotherapy for metastatic carcinoma of the colon or rectum.

November 10, 2017

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16 min read

Policy

Amgen Receives Positive CHMP Opinion to Expand Use of Nplate (romiplostim) in Pediatric Patients With Chronic Immune Thrombocytopenic Purpura

Positive Opinion Based on Five Studies Demonstrating Nplate Reduces Rates of Bleeding in Children With Rare Blood Disorder [10-November-2017] THOUSAND OAKS, Calif., Nov. 10, 2017 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opini

November 10, 2017

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13 min read

Business

Singapore Volition Signs Memorandum of Understanding With the National Taiwan University to Conduct Two Large Clinical Studies

The studies will be under the supervision of Professor Han-Mo Chiu, Clinical Professor, Department of Internal Medicine of NTU who will be the Principal Investigator for both trials.

November 10, 2017

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6 min read