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GSK, Emory Initiatives Address Translational Science Flaws
Two initiatives from different ends of the drug development spectrum are shining a bright light on nagging weaknesses in translational medicine and the urgent need to improve speed and efficiency in moving early stage discoveries into therapeutic candidates. Glaxosmithkline plc's (GSK) Discovery Fast Track competition is designed to serve as a funnel, enabling the London-based pharma to quickly sift a large number of academic discoveries and identify 10 candidates for its Discovery PartnershipsBy Marie Powers | BioWorld Insight | Monday, June 17, 2013 -
Phase III Clinical Trials Update: May 2013
Company (Location) Product Description Indication Status Date AUTOIMMUNE Regeneron Pharmaceuticals Inc. (Tarrytown, N.Y.) and Sanofi SA (Paris) Sarilumab Fully human monoclonal antibody directed against the alpha subunit of the IL-6 receptor complex Moderate to severe rheumatoid arthritis Enrolled their first patients in Phase III trials 5/16/13 Xenoport Inc. (Santa Clara, Calif.) Arbaclofen placarbil A prodrug of the R-isomer of baclofen Spasticity due to multiple sclerosis Terminated theBioWorld Insight | Monday, June 17, 2013 -
Non-U.S. Clinical Trials & Regulatory Actions: May 2013
Company (Location) Product Description Indication Status Date AUTOIMMUNE GW Pharmaceuticals plc (Porton Down, UK) Sativex Cannabinoid product Moderate to severe spasticity in multiple sclerosis Received commercial approval for Sativex in Italy 5/8/13 CANCER Aveo Pharmaceuticals Inc. (Cambridge, Mass.) and Astellas Pharma Inc. (Tokyo) Tivozanib A once-daily, VEGF receptor tyrosine kinase inhibitor Advanced renal cell carcinoma Astellas no longer intends to submit an MAA and will not fund anyBioWorld Insight | Monday, June 17, 2013 -
Impact of Genomics on Economy in U.S. Significant, Study Finds
It has been 10 years since the international human genome project (HGP) was officially declared completed two years ahead of schedule. This monumental undertaking has helped fuel the biopharmaceutical sector to its current lofty heights and one of the reasons that bioscience discoveries in overdrive can be traced back to the completion of the sequencing of the human genome. (See BioWorld Today, April 16, 2003.) This truly remarkable achievement has been the underpinning of a new wave of genomicsBy Peter Winter | BioWorld Insight | Monday, June 17, 2013 -
FDA Submissions, Approvals & Other Actions: May 2013
Company (Location) Product Description Indication Status Date AUTOIMMUNE Biogen Idec Inc. (Weston, Mass.) Plegridy Peginterferon beta-1a Multiple sclerosis Submitted a BLA 5/22/13 CANCER Algeta ASA (Oslo, Norway) and Bayer AG (Leverkusen, Germany) Xofigo Radium Ra 223 dichloride; an alpha particle-emitting radioactive therapeutic agent Castration-resistant prostate cancer FDA approved it 5/16/13 Aveo Oncology Inc. (Cambridge, Mass.) Tivozanib A once-daily, VEGF receptor tyrosine kinaseBioWorld Insight | Monday, June 17, 2013 -
Word on the Street
"There are a lot of situations where people use only an animal model and take a shot at a clinical trial and are disappointed after spending resources that could have been spent elsewhere." – Gene Williams, executive chairman and CEO of DART Therapeutics Inc., discussing its use of Biovista Inc.'s clinical outcomes search space technology to identify potential drug candidates for in-licensing in Duchenne's muscular dystrophy "I think the biggest challenge today for selling into BRIC for globalBioWorld Insight | Monday, June 17, 2013 -
Money Raised By Biotech: Jan. 1 - June 13, 2013
BioWorld Insight | Monday, June 17, 2013 -
Money Raised By Biotech In 2013 vs. 2012
BioWorld Insight | Monday, June 17, 2013 -
Phase II Clinical Trials Update: May 2013
Company (Location) Product Description Indication Status Date AUTOIMMUNE Creabilis SA (Luxembourg) CT327 Topical TrkA kinase inhibitor Chronic pruritis caused by psoriasis Phase IIb data showed a statistically significant and clinically meaningful reduction in pruritus of 60 percent compared to 20 percent for those receiving placebo 5/13/13 Idera Pharmaceuticals Inc. (Cambridge, Mass.) IMO-3100 A selective antagonist of Toll-like receptors 7 and 9 Psoriasis Phase II data showed improvementsBioWorld Insight | Monday, June 17, 2013 -
Pfizer Keeping the ADC Faith: Potential $635M CytomX Deal
By Randy Osborne Staff Writer CytomX Therapeutics Inc.'s oncology deal with Pfizer Inc. to develop Probody-drug conjugates (PDCs) gives the pharma giant rights to develop selected candidates in exchange for a potential $25 million up front, as well as $610 million if regulatory and sales milestones are met, and tiered royalties into the double digits on sales of resulting products. The $25 million "incorporates the up-front research funding and near-term milestone payments, as we move [PDCsBio Perspectives | Wednesday, June 12, 2013 -
Decision Time Looms for Elan, Royalty in Bitter Takeover Battle
By Cormac Sheridan Staff Writer DUBLIN, Ireland – Royalty Pharma's bitter and protracted takeover battle for Elan Corp. plc will, one way or another, reach a climax next Monday when Elan shareholders vote on the company's recent M&A deals. Acceptance of those transactions, which requires a vote representing 50 percent of Elan's equity plus one share, would scupper Royalty's takeover bid. Rejection would signal the end of the road for Dublin, Ireland-based Elan, a company that has, over the yearsBio Perspectives | Wednesday, June 12, 2013 -
A&G Pharmaceutical Inc.
Bioscan | Wednesday, June 12, 2013 -
A.P. Pharma Inc.
Bioscan | Wednesday, June 12, 2013 -
A/F Protein Inc.
Bioscan | Wednesday, June 12, 2013 -
Aarden Pharmaceuticals Inc.
Bioscan | Wednesday, June 12, 2013 -
Aastrom Biosciences Inc.
Bioscan | Wednesday, June 12, 2013 -
AB Enzymes GmbH
Bioscan | Wednesday, June 12, 2013 -
Abbott Diabetes Care
Bioscan | Wednesday, June 12, 2013 -
Abbott
Bioscan | Wednesday, June 12, 2013 -
AbbVie Inc.
Bioscan | Wednesday, June 12, 2013
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