Theorem Clinical Research

Clinical Intelligence

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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Scioderm initiates phase IIb study of Epidermolysis Bullosa

Tuesday, January 7, 2014 10:30 AM

Scioderm, a privately-held, clinical-stage pharmaceutical company, has initiated a phase IIb study designed to evaluate the efficacy and safety of SD-101, a novel topical therapy, for the treatment of non-healing wounds in patients with Epidermolysis Bullosa (EB), a rare, genetic connective tissue disorder that typically manifests at birth or early childhood.

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Amgen, UCB release positive phase II data for romosozumab

Tuesday, January 7, 2014 09:00 AM

Amgen and UCB have announced results from a phase II trial evaluating romosozumab (AMG 785/CDP7851) in postmenopausal women with low bone mineral density (BMD). Published in the New England Journal of Medicine (NEJM), the trial demonstrated that, compared with placebo, romosozumab treatment for 12 months significantly increased BMD at the lumbar spine, total hip and femoral neck. Significant increases also were observed in the first BMD assessment at three months. Moreover, in exploratory analyses, increases observed at the lumbar spine and hip were significantly greater than those observed with current treatments FOSAMAX (alendronate sodium) and FORTEO/FORSTEO (teriparatide).

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FDA approves Tretten to treat rare genetic clotting disorder

Tuesday, January 7, 2014 08:00 AM

The FDA has approved Tretten, Coagulation Factor XIII A-Subunit (Recombinant), the first recombinant product for use in the routine prevention of bleeding in adults and children who have a rare clotting disorder, known as congenital Factor XIII A-subunit deficiency.

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