BioPharm Business News and Perspectives

Thursday, September 04, 2008 Omeros Enters Into Agreement With Affitech for Anti-inflammatory Therapeutics, Awaits Phase III Clinical Trial Results for Agent
Omeros Corp and Affitech AS have entered into an agreement for the discovery and development of fully human antibodies for Omeros’ MASP-2, which mediates activation of the complement system via the lectin pathway...

Tuesday, September 02, 2008 Logical Therapeutics Reports Positive Results from Phase Ib Clinical Study of Naproxen Prodrug; Dosing Well-Tolerated and Plasma Concentrations Achieve Therapeutic Range
In the phase Ib study twice-daily dosing with LT-NS001 for 7 days resulted in plasma concentrations of naproxen within the therapeutic range, with no serious adverse events reported...

Thursday, August 28, 2008 Mesoblast Reports Preclinical Study Shows Allogeneic Stem Cells in Ewes are Safe, Effective for Cervical Spine Fusion; Therapy May Receive Boost From US FDA’s Recent Alert of Life-Threatening Complications Associated With rhBMP in Cervical Spine Fusions
Mesoblast is currently in phase II clinical trials for fusion of the lumbar spine and, based on these new results, will extend its market opportunity to cover the entire spectrum of spinal fusion. Subject to FDA approval, Mesoblast's therapy will eliminate the need for autograft...

Monday, August 25, 2008 Emisphere Reports Full Recruitment of Study Evaluating Eligen^® Technology and Salmon Calcitonin on Vertebral Fractures in Postmenopausal Women
Emisphere Technologies announced that recruitment is finished for a randomized, double-blind, placebo-controlled, multicenter study of oral salmon calcitonin in the treatment of osteoporosis in postmenopausal women taking calcium and vitamin D...

Thursday, August 21, 2008 Mesoblast Reports Stem Cells Regrow Knee Cartilage in Postmenopausal Ewes With OA; Repair Nonhealing Bones in Humans
Mesoblast, a regenerative medicine company developing treatments for orthopaedic conditions, announced successful preclinical trial results showing that its proprietary adult stem cells regenerated and regrew damaged knee cartilage...

Tuesday, August 19, 2008 Centocor Says US FDA Extends Review by 3 Months for Ustekinumab’s (CNTO 1275) Biologic License Application to Treat Plaque Psoriasis
Centocor filed an application with the FDA for ustekinumab in late 2007 seeking approval to market the drug to treat adult patients with chronic moderate-to-severe plaque psoriasis...

Monday, August 18, 2008 MedImmune, Medarex Report Initiation of Phase IIa Clinical Trial of Fully Human Anti-Interferonα Monoclonal Antibody in Lupus Patients
MedImmune has initiated enrollment in a phase IIa trial with a human monoclonal antibody (MEDI-545) targeting interferonα in adult patients with moderate-to-severe active lupus...

Wednesday, August 13, 2008 Tolerx Reports Collaboration Partner, Genentech, has Advanced a Modified Humanized Nondepleting Anti-CD4 Monoclonal Antibody Into Phase I Clinical Trial in RA Patients
The Tolerx and Genentech collaboration has moved a modified version of TRX1 (MTRX1011A), an anti-CD4 monoclonal antibody, into a phase I clinical trial that has begun enrolling RA patients...

Monday, August 11, 2008 Hollis-Eden Initiates Phase I/II Clinical Trial With TRIOLEX™ (HE3286) in RA
Hollis-Eden's investigational, nonimmunosuppressive oral drug candidate Triolex™ (HE3286), a stabilized, synthetic analog of a naturally occurring molecule metabolized by the body, is being tested in patients diagnosed with RA who are receiving a stable dose of MTX...

Wednesday, August 06, 2008 NeoStrata Reports Novel Nonprescription Coal Tar Solution Provides Significant Benefits Versus Calcipotriol for Moderate Psoriasis
Findings from an ongoing 12-week study demonstrate benefits of a novel, nonprescription topically applied LCD (coal tar) solution (Psorent™) versus calcipotriol cream (Dovonex^®) in treatment of moderate plaque psoriasis...