Clinical Intelligence

Pharmacyclics submits NDA for Ibrutinib

Tuesday, July 16, 2013 11:36 AM

Pharmacyclics, a clinical-stage biopharmaceutical company focused on developing and commercializing small-molecule drugs for the treatment of cancer and immune mediated diseases, based in Sunnyvale, Calif., has submitted a New Drug Application (NDA) to the FDA for the investigational oral Bruton's tyrosine kinase (BTK) inhibitor, ibrutinib, for two relapsed/refractory B-cell malignancy indications: mantle cell lymphoma (MCL) and chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL).

More... »

BNA, JPNI among 30 sites in ACADIA clinical trial

Monday, July 15, 2013 01:35 PM

Boulder Neurosurgical & Spine Associates (BNA) and the Justin Parker Neurological Institute (JPNI) are among approximately 30 sites in the U.S. participating in the ACADIA clinical trial. The trial seeks to evaluate the safety and efficacy of the ACADIA Facet Replacement System, an investigational device for treatment of lumbar spinal stenosis (LSS).

More... »

Asubio broadens inclusion criteria for spinal cord injury trial

Thursday, July 11, 2013 10:00 AM

Asubio Pharmaceuticals has expanded enrollment for its ASCENT-ASCI (Asubio Spinal Cord Early Neuro-recovery Treatment for Acute Spinal Cord Injury) trial to include AIS A, B and C injury to the cervical spine. ASCENT-ASCI is a phase II clinical trial evaluating SUN13837, an investigational medication being developed to improve neurological function in patients with newly diagnosed acute spinal cord injury.

More... »

Curetis initiates prospective multicenter Unyver study in Europe

Thursday, July 11, 2013 08:30 AM

Curetis has started an additional prospective, multicenter trial of its marketed Unyver P50 Pneumonia Application to demonstrate its clinical and health economic value.

More... »

Neurocrine completes study enrollment

Tuesday, July 9, 2013 01:37 PM

Biopharmaceutical Neurocrine Biosciences has completed recruitment in the phase IIb clinical trial (Kinect Study) of its proprietary Vesicular Mono-Amine Transporter 2 compound, NBI-98854. The final subject will randomize this week.

More... »

Array BioPharma initiates MILO study

Tuesday, July 9, 2013 12:36 PM

Array BioPharma said a $5 million milestone was achieved after the start of Array's phase III trial in patients with low-grade serous ovarian cancer (LGSOC).

More... »

KaloBios updates pipeline of clinical programs

Wednesday, July 3, 2013 02:19 PM

KaloBios Pharmaceuticals has updated the status of its ongoing clinical programs for KB003, KB001-A and KB004, its pipeline of proprietary monoclonal antibodies in development for severe respiratory diseases and cancer.

More... »

Morphotek announces initiation of phase I study for MORAb-066

Wednesday, July 3, 2013 02:16 PM

Biopharmaceutical Morphotek, a subsidiary of Eisai, has announced that the Sarah Cannon Research Institute in Nashville, Tenn., has opened enrollment in a phase I clinical study with MORAb-066 in patients with advanced or metastatic breast, pancreatic, colorectal or non-small cell lung cancer (adenocarcinoma) malignancies. The open-label, phase I study will assess the safety, tolerability and pharmacokinetics of MORAb-066 administered with weekly intravenous infusions.

More... »

Advanced Clinical Care recruiting for psoriasis trials

Wednesday, July 3, 2013 02:14 PM

Advanced Clinical Care, a Massachusetts clinical trial center, is recruiting patients for two plaque psoriasis clinical trials. Advanced Clinical Care previously has run and completed trials involving rheumatic disease. With these trials the researchers will gain knowledge about the two treatment medications for people suffering with plaque psoriasis. Both trials run for five years, providing patients free care and free medication for the entire duration of the study.

More... »

AtheroNova initiates phase I clinical trial of AHRO-001

Wednesday, July 3, 2013 08:54 AM

AtheroNova, a biotech company focused on the R&D of compounds to safely regress atherosclerotic plaque and improve lipid profiles in humans, has initiated a phase I clinical trial with its compound, AHRO-001, to evaluate the safety, tolerability and pharmacokinetics of AHRO-001 in healthy volunteers. The clinical study is being conducted in Russia with licensing partner OOO CardioNova.

More... »