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The CenterWatch Monthly, February 2014

Monday, February 3, 2014 08:59 AM

Tracking major changes in the R&D pipeline

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Omeros reports positive results from OMS824 phase IIa clinical trial

Friday, January 31, 2014 01:25 PM

Omeros has announced positive results from a phase IIa clinical trial of OMS824, the company's phosphodiesterase 10 (PDE10) inhibitor, in which the drug was well-tolerated and demonstrated comparable systemic pharmacokinetics when administered alone and concomitantly with approved antipsychotic agents in patients with schizophrenia. OMS824 selectively inhibits PDE10, an enzyme expressed in areas of the brain linked to a wide range of diseases that affect cognition, including schizophrenia and Huntington's disease.

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Singapore's influenza vaccines shows favorable immunogenicity, tolerability

Friday, January 31, 2014 01:20 PM

Singapore's Agency for Science, Technology and Research (A*STAR) and Switzerland's Cytos Biotechnology have announced that their influenza vaccine (gH1-Qbeta) met its primary end point for immunogenicity (seroconversion based on haemaglutination inhibition titres according to FDA criteria) in the phase I clinical trial in healthy Asian volunteers. The induced immune response showed good cross-reactivity to recent drifted H1N1 strains. The H1N1 influenza vaccine candidate is based on Cytos' proprietary bacteriophage Qbeta virus-like particle (VLP) technology.

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MJFF highlights promising Parkinson’s research

Friday, January 31, 2014 01:03 PM

Research projects from three biopharmaceutical companies in the U.S. comprise the 2013 second half (2H 2013) of The Michael J. Fox Foundation for Parkinson's Research (MJFF) Partnering Program. Among the most promising in the MJFF portfolio, Partnering Program participants' research projects are presented directly to industry groups who may wish to invest in further development of the project. By connecting industry leaders with those studies ripe for investment, the foundation aims to drive forward promising research in Parkinson's disease (PD) through the pipeline of drug development and eventually into patients' hands.

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PTC Therapeutics, the SMA Foundation and Roche collaborate

Friday, January 24, 2014 10:39 AM

PTC Therapeutics, the SMA Foundation and Roche have announced that their joint research program in Spinal Muscular Atrophy (SMA) has entered the first stage of clinical development aiming to assess safety and tolerability of an oral compound in healthy volunteers. SMA is a genetic neuromuscular disorder that leads to muscle weakness and mobility impairment and is considered the leading genetic cause of death in infants and toddlers.

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BioLineRx receives Orphan Drug designation for stem cell mobilization treatment

Friday, January 24, 2014 10:34 AM

BioLineRx, a clinical-stage biopharmaceutical company dedicated to identifying, in-licensing and developing promising therapeutic candidates, has received notice from the FDA confirming an Orphan Drug Designation of BL-8040 as a treatment for stem cell mobilization, in addition to the Orphan Drug Designation previously granted to BL-8040 as a treatment for Acute Myeloid Leukemia (AML).

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Nektar presents positive data from a phase I study of Etirinotecan Pegol (NKTR-102)

Monday, January 20, 2014 02:12 PM

Nektar Therapeutics presented favorable data today from a phase I study of etirinotecan pegol (EP, NKTR-102) in combination with 5-fluorouracil (5-FU)/Leucovorin (LV) in patients with advanced cancer. NKTR-102 is the first long-acting topoisomerase I-inhibitor designed to concentrate in tumor tissue, provide sustained tumor suppression throughout the entire chemotherapy cycle, and to reduce the peak exposures that are associated with toxicities of other cytotoxics.

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FDA approves first gel for sealing corneal incision after cataract surgery

Wednesday, January 15, 2014 03:56 PM

The FDA has approved the first gel sealant for use in stopping fluid from leaking through the incision in a patient’s cornea after cataract surgery with intraocular lens placement in adults. Prior to the approval, stitches were the only option for closing a leaking corneal incision after cataract surgery.

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Etirinotecan Pegol (NKTR-102) passes interim efficacy analysis for phase III study

Wednesday, January 15, 2014 03:51 PM

Nektar Therapeutics has announced that the Independent Data Monitoring Committee (DMC) created to provide safety oversight for the company's pivotal clinical study for etirinotecan pegol (NKTR-102) has recommended continuation of the BEACON phase III trial, based upon the completion of a planned interim efficacy analysis in accordance with the DMC charter. The BEACON trial is evaluating NKTR-102 versus an agent of physician's choice for the treatment of locally recurrent or metastatic breast cancer, with a primary efficacy endpoint of overall survival. NKTR-102 is the first long-acting topoisomerase I-inhibitor designed to concentrate in tumor tissue, provide sustained tumor suppression throughout the entire chemotherapy cycle and to reduce the peak exposures that are associated with toxicities of other cytotoxics.

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AbbVie initiates phase III study of Veliparib (ABT-888) for breast cancer

Wednesday, January 15, 2014 03:25 PM

AbbVie, a global, research-based biopharmaceutical company, has initiated a phase III clinical trial evaluating the safety and efficacy of its investigational compound, veliparib (ABT-888) when added to carboplatin, a chemotherapy, in women with early-stage, triple-negative breast cancer.  The three-arm trial will compare the addition of veliparib plus carboplatin or placebo plus carboplatin to standard neoadjuvant chemotherapy.

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