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Ablynx NV, of Ghent, Belgium, initiated preclinical development of next-generation anti-IgE Nanobody ALX-0962 in severe allergic asthma. ALX-0962 consists of a potent anti-IgE Nanobody with a dual mode of action – the ability to bind with high affinity to IgE while also displacing receptor-bound IgE – together with a serum albumin binding Nanobody for in vivo plasma half-life extension. BioAlliance Pharma SA, of Paris, reported the International Independent Board of Experts' data and safety -
Other News To Note
Seattle Genetics Inc., of Bothell, Wash., said the FDA accepted for filing its supplemental biologics license application supporting the use of Adcetris (brentuximab vedotin) for retreatment and extended duration beyond 16 cycles of therapy in relapsed Hodgkin lymphoma (HL) and systemic anaplastic large-cell lymphoma (sALCL -
Pharma: Clinic Roundup
Eli Lilly and Co., of Indianapolis, said the Phase III PRELUDE study of enzastaurin, which explored the molecule as monotherapy in preventing relapse in patients with diffuse large B-cell lymphoma, failed to show a statistically significant increase compared to placebo in disease-free survival in patients at high risk of relapse following rituximab-based chemotherapy -
Receptos Prices Solid IPO, Raises $72.8M for Pipeline
Senesco is advancing its ongoing Phase Ib/IIa study of SNS01-T, an approach to cancer therapy designed to selectively trigger apoptosis in B-cell cancers such as multiple myeloma and mantle cell and diffuse large B-cell lymphomas -
Clinic Roundup
SymBio Pharmaceuticals Ltd., of Tokyo, said it completed patient enrollment in its Phase II study of Treakisym (bendamustine hydrochloride, SyB L-0501) in front-line low-grade non-Hodgkin's lymphoma (NHL) and mantle cell lymphoma (MCL) patients in Japan -
Pharma: Clinic Roundup
The mantle cell lymphoma (MCL) EAP is available to eligible patients with relapsed or refractory MCL, who could benefit from treatment with ibrutinib prior to FDA approval -
Clinic Roundup
Senesco Technologies Inc., of Bridgewater, N.J., said the Data Review Committee (DRC) for its SNS01-T trial in multiple myeloma and non-Hodgkin's B-cell lymphoma approved initiating cohort 3 and escalating the SNS01-T dose level fourfold to 0.2 mg/Kg...The study is an open-label, multiple-dose, dose-escalation study to evaluate the safety and tolerability of SNS01-T when administered by intravenous infusion to approximately 15 relapsed or refractory multiple myeloma, mantle cell (MCL) or diffuse -
Pharma: Other News To Note
The compound previously received breakthrough status for use in patients with relapsed or refractory mantle cell lymphoma and Waldenstrom's macroglobulinemia -
Epizyme Files for IPO, Aims for $69M for Epigenetics Platform
The funding allowed ReXceptor to enter a formal partnership with C2N Diagnostics, which will assist the company with the initiation and coordination of the clinical trial of an AD program licensed from Case Western's Technology Transfer Office and based on discoveries that bexarotene, a medication sold at Targretin for cutaneous T-cell lymphomas, reversed AD symptoms in mice within 72 hours of a single dose of treatment. -
Clinic Roundup
Senesco Technologies Inc., of Bridgewater, N.J., completed the second cohort of its Phase Ib/IIa trial of SNS01-T. Two multiple myeloma patients and one diffuse large B-cell lymphoma patient have completed the study...The study is an open-label, multiple-dose, dose-escalation study that will evaluate the safety and tolerability of SNS01-T when administered by intravenous infusion to approximately 15 relapsed or refractory multiple myeloma, mantle cell or diffuse large B-cell lymphoma patients -
Biotech - Big Pharma Collaborations: Modified And Terminated Agreements: Dec. 1, 2012 - April 18, 2013
cell lymphoma colon cancer and metastatic melanoma The companies first inked the deal in 2006, with Teva exercising an option to invest another $19M in 2011 and agreeing to finance up to $50M of CureTech's R&D program 2/1/13 Orexo AB (Uppsala, Sweden) Novartis AG (Basel, Switzerland) ND Terminated license agreement from August 2009 relating to the OX17 program to treat gastroesophageal reflux disease The program has not progressed according to plans, and Orexo said it will be discontinued 2/26 -
FDA Submissions, Approvals & Other Actions: March 2013
radioactive diagnostic imaging agent Breast cancer or melanoma FDA approved it 3/14/13 Seattle Genetics Inc. (Bothell, Wash.) Adcetris Brentuximab vedotin Hodgkin lymphoma and systemic anaplastic large cell lymphoma Submitted an sBLA to the FDA 3/19/13 CARDIOVASCULAR Biogen Idec Inc. (Weston, Mass.) Protein Recombinant Factor VIII Fc fusion protein Hemophilia A Submitted a BLA 3/13/13 Pozen Inc. (Chapel Hill, N.C.) PA32540/PA8140 A coordinated-delivery tablet combining immediate-release -
Phase I Clinical Trials Update: March 2013
cell lymphoma Started a Phase Ib trial 3/5/13 CARDIOVASCULAR Acorda Therapeutics Inc. (Ardsley, N.Y.) GGF2 Glial growth factor 2, a neuregulin peptide Heart failure Phase I data showed a single dose was generally well tolerated up to 0.75 mg/kg, which higher doses might be associated with reversible hepatotoxic events 3/8/13 BioCryst Pharmaceuticals Inc. (Research Triangle Park, N.C.) BCX4161 A selective inhibitor of plasma kallikrein Hereditary angioedema Started a Phase I trial 3/27/13 -
Phase II Clinical Trials Update: March 2013
cell lymphoma Completed enrollment in a Phase II trial 3/7/13 Telormedix SA (Biggio, Switzerland) TMX-101 A Toll-like receptor 7 agonist Bladder cancer Recruited the first patient in a Phase II trial 3/12/13 Viralytics Ltd. (Sydney, Australia) Cavatak Virotherapy candidate Melanoma Phase II data showed it is well tolerated, and three patients have met the primary endpoint of immune-related progression free survival at six months 3/26/13 Ziopharm Oncology Inc. (New York) Ad-RTS IL-12 Previously -
Other News To Note
Elorac Inc., of Vernon Hills, Ill., said the FDA granted fast-track designation to the company's naloxone topical lotion for the relief of pruritus in patients with cutaneous T-cell lymphoma (CTCL -
Phase III Clinical Trials Update: March 2013
cell lymphoma A registration trial confirmed the drug exceeded the efficacy level defined by the study's primary endpoint, a minimum objective response rate of 20% 3/6/13 Ziopharm Oncology Inc. (New York) Palifosfamide Alkylating agent Metastatic soft tissue sarcoma Failed to meet the primary endpoint of progression-free survival 3/27/13 CARDIOVASCULAR Acasti Pharma Inc. (Laval, Quebec) NKPL66 CaPre Mild-to-high hypertriglyceridemia Preliminary data showed it achieved a statistically significant -
Other News To Note
The compound previously received breakthrough status for use in patients with relapsed or refractory mantle cell lymphoma and Waldenstrom's macroglobulinemia -
Other News To Note
Romidepsin is the active ingredient in Istodax, Celgene's approved drug for cutaneous T-cell lymphoma and peripheral T-cell lymphoma -
Topical HDAC Inhibitor Could 'Shape' CTCL Care
The Cambridge, Mass.-based biotech has the more modest goal of advancing its single asset, topical histone deacetylase (HDAC) inhibitor SHP-141, in cutaneous T-cell lymphoma (CTCL) and, potentially, other inflammatory skin conditions...But Istodax, also approved for peripheral T-cell lymphoma, carries warnings – among them, thrombocytopenia, leucopenia, anemia, severe infections, tumor lysis syndrome and electrocardiographic changes. (See BioWorld Today, Nov. 9, 2009, and Dec. 8, 2009.) With -
Other News To Note
Actinobac Biomed Inc., of New Brunswick, N.J., said it received a $202,000 Small Business Technology Transfer grant from the National Institutes of Health to study its drug candidate, Leukothera, in B-cell lymphomas
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