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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 -
For Model Systems, Is Petri Dish Half Full or Half Empty?
And at a standing-room-only session that explored how mice can be used to improve clinical trials rather than basic science, Genentech's Leisa Johnson enumerated the advantages of GEMMs...Anyone who wants to test each possible combination in clinical trials has "a serious problem – you will run out of patients to accrueBy Anette Breindl | BioWorld Today | Thursday, April 11, 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 -
Epigenetics Now Goes Far Beyond HDAC Inhibitors
For now, the bulk of clinical trials targeting epigenetic mechanisms is still at an early stage...Those clinical trials, he said, will be "the ultimate test of the whole hypothesisBio Perspectives | Tuesday, April 9, 2013 -
Epigenetics Now Goes Far Beyond HDAC Inhibitors
For now, the bulk of clinical trials targeting epigenetic mechanisms is still at an early stage...Those clinical trials, he said, will be "the ultimate test of the whole hypothesisBy Anette Breindl | BioWorld Today | Tuesday, April 9, 2013 -
The Search for Venture Capital Continues to be Challenging
RN-307 was discovered and originally developed by Rinat Neuroscience Corp., a South San Francisco protein therapeutics company that was acquired by Pfizer in 2006. (See BioWorld Today, April 10, 2006.) In a Series C financing Versartis Inc., of Redwood City, Calif., raised $25 million to support clinical trials of its product candidate VRS-317 for growth hormone deficiency in children. (See BioWorld Today, Jan. 16, 2013.) The drug is a once-monthly form of recombinant human growth hormone (HGHBy Peter Winter | BioWorld Insight | Monday, April 8, 2013 -
Geron ESC Assets Regenerate at Asterias Biotherapeutics
The complex asset contribution agreement involves multiple transfers of common stock and warrants, along with patents, regulatory filings and investigational new drug (IND) applications filed with the FDA for Geron's Phase I safety study of oligodendrocyte progenitor (GRNOPC-1) cells in patients with neurologically complete, subacute spinal cord injury – the first FDA-approved ESC clinical trial. (See BioWorld Today, Jan. 26, 2009, and Jan. 27, 2009.) The S-1 represented the first step toBy Marie Powers | BioWorld Today | Friday, April 5, 2013 -
Financings Roundup
Net proceeds will be used to cover costs related to the new drug application for CompleoTRT, making a milestone payment for CompleoTRT, manufacturing scale-up for CompleoTRT and Tefina clinical trialsBioWorld Today | Friday, April 5, 2013 -
AACR Annual Meeting Set to Kick Off in Washington
Jose Baselga, physician-in-chief at Memorial Sloan-Kettering Cancer Center and the chairman of the program committee for the 2013 annual meeting, said in a recorded greeting that the data being presented at the conference span the trajectory from basic biology to clinical trial resultsBy Anette Breindl | BioWorld Today | Friday, April 5, 2013 -
Study Shows Road Taken by Broadly Neutralizing Antibody
Haynes and his colleagues said they hope that by understanding the road traveled by the broadly neutralizing antibody their subject produced, they will be able to develop a series of antigens that can be used to induce broadly neutralizing antibodies via a series of vaccinations – though Haynes' response when asked when such a vaccine might enter clinical trials was succinct: "I don't knowBy Anette Breindl | BioWorld Today | Thursday, April 4, 2013
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