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GSK, Theravance's Breo Wins Advisory Panel Nod in COPD
I do have some safety concerns about this particular therapy, because I believe the toxicity over a long period of time is going to cause continued exacerbations, as it did in the clinical trials," Mullins saidBy Randy Osborne | BioWorld Today | Thursday, April 18, 2013 -
Other News To Note
Benitec Biopharma Ltd., of Sydney, Australia, said its subsidiary, Tacere Therapeutics Inc., submitted an application to the National Institutes of Health's Recombinant DNA Advisory Committee (RAC), comprising the full clinical trial protocol for its ddRNAi-based therapeutic, TT-034, in hepatitis C virus infection, as well as safety and toxicology dataBioWorld Today | Thursday, April 18, 2013 -
Other News To Note
NeuroDerm Ltd., of Ness Ziona, Israel, said enrollment of patients is ongoing in its Phase IIa clinical trial of ND0612, a treatment for Parkinson's diseaseBioWorld International | Wednesday, April 17, 2013 -
Clinic Roundup
clinical trials, for SMD and dry age-related macular degeneration (dry AMD...NeuroDerm Ltd., of Ness Ziona, Israel, said enrollment of patients is ongoing in its Phase IIa clinical trial of ND0612, a treatment for Parkinson's diseaseBioWorld Today | Tuesday, April 16, 2013 -
Phase I Clinical Trials Update: March 2013
Company (Location) Product Description Indication Status Date AUTOIMMUNE Trophos SA (Marseille, France) Olesoxime A mitochondrial-targeted, cholesterol-like compound Multiple sclerosis Started a Phase Ib study 3/15/13 CANCER Anaeropharma Science Inc. (Tokyo) APS001F A living recombinant bifidobacterium Advanced or metastatic solid tumors Started a Phase I trial 3/29/13 Bio-Path Holdings Inc. (Houston) BP-100-1.01 Liposomal Grb-2 Blood cancers Started enrolling patients in the fifth dosageBioWorld Insight | Monday, April 15, 2013 -
Non-U.S. Clinical Trials & Regulatory Actions: March 2013
Company (Location) Product Description Indication Status Date AUTOIMMUNE Halozyme Therapeutics Inc. (San Diego) and Baxter International Inc. (London) HyQvia Combination of human normal immunoglobulin and recombinant human hyaluronidase designed as a replacement therapy Primary and secondary immunodeficiencies Received a positive opinion from the EMA's CHMP 3/25/13 Biogen Idec Inc. (Weston, Mass.) Tecfidera Dimethyl fumarate Relapsing-remitting multiple sclerosis Received a positive opinionBioWorld Insight | Monday, April 15, 2013 -
Phase II Clinical Trials Update: March 2013
Company (Location) Product Description Indication Status Date AUTOIMMUNE Anacor Pharmaceuticals Inc. (Palo Alto, Calif.) AN2728 Topical boron-based phosphodiesterase-4 inhibitor Mild to moderate atopic dermatitis Phase II data showed it achieved a 71% improvement from baseline 3/22/13 GeNeuro SA (Geneva) GNbAC1 A humanized monoclonal antibody targeting a human endogenous retrovirus Multiple sclerosis Completed a Phase IIa study 3/15/13 CANCER Biothera Inc. (Eagen, Minn.) Imprime PGG ImmunoBioWorld Insight | Monday, April 15, 2013 -
Pharma: Other News To Note
Bristol-Myers Squibb Co., of New York, will invest $250 million to expand its large-scale biologics manufacturing facility in Devens, Mass., introducing biologics development and clinical trial manufacturing capabilities and adding about 350 employeesBioWorld Today | Monday, April 15, 2013 -
Phase III Clinical Trials Update: March 2013
Company (Location) Product Description Indication Status Date AUTOIMMUNE Anthera Pharmaceuticals Inc. (Hayward, Calif.) Blisibimod A peptibody antagonist of BAFF Lupus Started a Phase III trial 3/29/13 Biogen Idec Inc. (Weston, Mass.) Plegridy Peginterferon beta-1a Relapsing-remitting multiple sclerosis Two-year Phase III data showed it significantly reduced MS disease activity, including relapses, disability progression and brain lesions, compared to placebo at one year 3/21/13 Celgene CorpBioWorld Insight | Monday, April 15, 2013 -
Durata Pads Coffers Ahead of NDA; Kamada Files for U.S. IPO
Proceeds from the IPO would be used to fund clinical trials, R&D for additional AAT indications, expanding distribution capabilities to additional territories, expanding its manufacturing infrastructure and for general corporate purposesBy Jennifer Boggs | BioWorld Today | Monday, April 15, 2013 -
Cancer Immunotherapy: 'Living Drugs' Bring High Hopes, Issues
And at the opening press conference, where scientists announced the results of several clinical trials of immunotherapies, discussant Louis Weiner, of Washington University in St. Louis, went so far as to suggest that immunotherapy should be considered a fourth branch of cancer therapy, along with surgery, radiation and drug treatment...And so, Topalian and her team are planning a clinical trial that will explicitly test sequential treatment with epigenetic-targeting drugs and PD-1 blockadeBy Anette Breindl | BioWorld Insight | Monday, April 15, 2013 -
Financings Roundup
Coronado plans to use the proceeds to fund R&D, clinical trials and manufacture of supply as well as other corporate purposesBioWorld Today | Friday, April 12, 2013 -
Oh, Baby: FDA Decision Takes Nine Months off Acadia's Wait
Mills noted that the company has gained "experience with not only the drug for its effects, but also in manufacturing multiple lots for our clinical trials," so Acadia is "very comfortable with the chemical characteristics of the drugBy Randy Osborne | BioWorld Today | Friday, April 12, 2013 -
Activartis in Partnering Talks Armed with Phase II Survival
Alongside the Phase II evidence of safety and efficacy in glioblastoma, Activartis has evidence from academic clinical trials demonstrating the technology is applicable to other tumor typesBio Perspectives | Wednesday, April 10, 2013 -
MedDay Raises $10.5M for Neurological Drug R&D
The company plans to use the funds to move its lead program into clinical trials and to advance a second discovery programBy Cormac Sheridan | BioWorld Today | Wednesday, April 10, 2013 -
S-TARget Seeking $8M for Allergy Vaccine Platform
S-TARget is seeking scientific advice from Germany's Paul-Ehrlich-Institut on clinical trial designBy Cormac Sheridan | BioWorld Today | Wednesday, April 10, 2013 -
Activartis in Partnering Talks Armed with Phase II Survival
Alongside the Phase II evidence of safety and efficacy in glioblastoma, Activartis has evidence from academic clinical trials demonstrating the technology is applicable to other tumor typesBy Nuala Moran | BioWorld Today | Wednesday, April 10, 2013 -
EyeGate Reports Positive Data for Ophthalmic Drug/Device
That program is not yet in clinical trialsBy Catherine Shaffer | BioWorld Today | Wednesday, April 10, 2013 -
S-TARget Seeking $8M for Allergy Vaccine Platform
S-TARget is seeking scientific advice from Germany's Paul-Ehrlich-Institut on clinical trial designBy Cormac Sheridan | BioWorld International | Wednesday, April 10, 2013 -
Activartis in Partnering Talks Armed with Phase II Survival
Alongside the Phase II evidence of safety and efficacy in glioblastoma, Activartis has evidence from academic clinical trials demonstrating the technology is applicable to other tumor typesBy Nuala Moran | BioWorld International | Wednesday, April 10, 2013
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