United States

North Shore InnoVentures receives $1.65M from Massachusetts Life Sciences Center

Monday, March 31, 2014 01:29 PM

North Shore InnoVentures (NSIV), a New England technology incubator and business accelerator, has received a capital grant of $1.65 million from the Massachusetts Life Sciences Center (MLSC). The grant will allow NSIV to expand its current laboratory facilities over the next three years and purchase advanced analytical instrumentation. This grant is part of a larger $5 million award to the Life Sciences Consortium of the North Shore (LSCNS), consisting of Endicott College, Gordon College, North Shore InnoVentures, North Shore Community College and Salem State University, that will fund major lab/facility and equipment upgrade projects at the member institutions and organizations.

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WIRB Copernicus Group

FDA approves long-acting recombinant coagulation Factor IX concentrate for hemophilia B

Monday, March 31, 2014 01:10 PM

The FDA has approved Alprolix, Coagulation Factor IX (Recombinant), Fc Fusion Protein, for use in adults and children who have Hemophilia B. Alprolix is the first Hemophilia B treatment designed to require less frequent injections when used to prevent or reduce the frequency of bleeding.

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Kite Pharma granted FDA Orphan Drug Designation for Anti-CD19

Monday, March 31, 2014 01:06 PM

Kite Pharma, a clinical-stage biotechnology company focused on developing engineered autologous T cell therapy (eACT) products for cancer, has announced that the FDA Office of Orphan Products Development (OOPD) granted Orphan Drug Designation for the company's lead investigational therapy, an autologous engineered T cell product that targets CD19 expression on B cell malignancies, for the treatment of diffuse large B cell lymphoma (DLBCL).

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FDA approves Topamax for migraine prevention in adolescents

Monday, March 31, 2014 12:55 PM

The FDA has approved Topamax (topiramate) for prevention (prophylaxis) of migraine headaches in adolescents ages 12 to 17. This is the first FDA approval of a drug for migraine prevention in this age group. The medication is taken on a dailybasis to reduce the frequency of migraine headaches.

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FDA approves Otezla to treat psoriatic arthritis

Friday, March 28, 2014 12:50 PM

The FDA has approved Otezla (apremilast) to treat adults with active psoriatic arthritis (PsA).

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Avanir Pharmaceuticals receives NDA acceptance for AVP-825 for migraines

Friday, March 28, 2014 12:42 PM

Avanir Pharmaceuticals, a biopharmaceutical company focused on central nervous system disorders, has announced that the FDA has accepted the company's New Drug Application (NDA) of AVP-825, its innovative Breath Powered investigational drug-device combination product for the acute treatment of migraine.

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Frank Sposato, Jr., of CFS Clinical, selected as Top IT Pro finalist

Friday, March 28, 2014 12:35 PM

Philadelphia Business Journal hasannounced the list of finalists for the 2014 Top IT Pros this week, naming Frank Sposato Jr., vice president of information technology at CFS Clinical, as one of the Top 5 IT Pros in a private company.

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Baxter to split into two independent companies, separating biopharmaceutical development and medical products

Thursday, March 27, 2014 02:55 PM

Deerfield, Ill.-based Baxter International plans to create two separate, independent global healthcare companies—one focused on developing and marketing innovative biopharmaceuticals and the other on life-saving medical products.

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Chesapeake IRB acquires Goodwyn IRB

Thursday, March 27, 2014 09:39 AM

Chesapeake IRB has completed the acquisition of Goodwyn IRB.

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BARDA awards SwRI $8.3M to continue developing cyanide poisoning antidote

Wednesday, March 26, 2014 11:45 AM

The U.S. Department of Health and Human Services Biomedical Advanced Research and Development Authority (BARDA) has awarded Southwest Research Institute (SwRI), an independent, nonprofit, applied R&D organization, an $8.3 million contract extension to continue development of a nasal-delivery, first-line treatment system to combat cyanide poisoning using an intranasal formulation of isoamyl nitrite.

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