Clinical Intelligence

KaloBios touts phase I/II results of KB002 in persistent asthma

Thursday, February 28, 2013 08:00 AM

KaloBios Pharmaceuticals reported data from its phase I/II study in persistent asthma for KB002 (precursor chimeric anti-GM-CSF monoclonal antibody to KB003).

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Bayer's Stivarga receives FDA approval for GIST

Tuesday, February 26, 2013 12:27 PM

The FDA has approved Bayer's Stivarga (regorafenib) tablets to treat patients with locally advanced, unresectable or metastatic gastrointestinal stromal tumor (GIST) who have been previously treated with imatinib mesylate and sunitinib malate.

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Neurovance receives patent for EB-1020, initiates ADHD trial

Friday, February 22, 2013 01:59 PM

The United States Patent and Trademark Office (USPTO) has issued Neurovance, a Cambridge, Mass.-based company spun out of Euthymics Bioscience, a notice of allowance for a composition of matter patent for EB-1020, providing proprietary protection for EB-1020 through July 2026.

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FDA approves new treatment for late-stage breast cancer

Friday, February 22, 2013 12:41 PM

The FDA has approved Genentech’s Kadcyla (ado-trastuzumab emtansine), a new therapy for patients with HER2-positive, late-stage (metastatic) breast cancer.

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Lentigen receives Orphan Drug status for gene therapy for glioblastoma multiforme

Thursday, February 14, 2013 08:00 AM

Lentigen, a biotechnology company specializing in the development and manufacture of lentiviral gene delivery products, announced that that the FDA has granted orphan drug status to LG631-CD34, P140K methylguanine methyltransferase (MGMT) transduced human CD34 cells, for bone marrow protection in the treatment of glioblastoma multiforme.

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Critical Pharma completes second trial on CP024 intranasal growth hormone

Wednesday, February 13, 2013 12:13 PM

Critical Pharmaceuticals, a Nottingham, U.K.-based biotechnology company, has successfully completed a second clinical study on its CP024 growth hormone nasal spray.

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Gilead touts positive results in two phase III studies of sofosbuvir for Hep C

Monday, February 4, 2013 02:14 PM

Gilead Sciences, a biopharmaceutical company based in Foster City, Calif., released top line results from two phase III studies, FISSION and NEUTRINO, evaluating a 12-week course of the once-daily nucleotide sofosbuvir in combination with ribavirin (FISSION) and in combination with ribavirin and pegylated interferon (NEUTRINO) among treatment-naïve patients with chronic hepatitis C virus (HCV) infection.

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The CenterWatch Monthly, February 2013

Friday, February 1, 2013 10:48 AM

Sized out of big deals, mid-tier CROs still thriving

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FDA grants Soligenix Fast Track for OrbeShield for gastrointestinal acute radiation syndrome

Thursday, January 31, 2013 02:00 PM

Soligenix, a development-stage biopharmaceutical company, announced today that its OrbeShield (oral beclomethasone 17, 21-dipropionate or oral BDP) development program for the treatment of gastrointestinal acute radiation syndrome (GI ARS) has received Fast Track designation from the FDA.

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FDA approves Gleevec for children with acute lymphoblastic leukemia

Monday, January 28, 2013 11:22 AM

The FDA has approved a new use for Novartis’ Gleevec (imatinib) to treat children newly diagnosed with Philadelphia chromosome positive (Ph+) acute lymphoblastic leukemia (ALL).

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