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Phase I Clinical Trials Update: April 2013
Company (Location) Product Description Indication Status Date AUTOIMMUNE Acorda Therapeutics Inc. (Ardsley, N.Y.) rHIgM22 A remyelinating antibody Multiple sclerosis Enrollment began in the first trial 4/24/13 Arena Pharmaceuticals Inc. (San Diego) APD334 An oral drug targeting the sphingosine 1-phosphate subtype 1 receptor Autoimmune diseases Initiated dosing in a Phase I trial 4/8/13 Idera Pharmaceuticals Inc. (Cambridge, Mass.) IMO-8400 An agonist of Toll-like receptors 7, 8 and 9 PsoriasisBioWorld Insight | Monday, May 13, 2013 -
Phase III Clinical Trials Update: April 2013
San Diego) Etarfolatide Molecular imaging agent Osteoarthritis Data showed it may identify and differentiate inflammatory from non-inflammatory diseases states 4/29/13 MISCELLANEOUS BHR Pharma LLC (Herndon, Va.) BHR-100 Intravenous progesterone infusion agent Severe traumatic brain injury The 1,000th patient was enrolled in the global Phase III study 4/16/13 EyeGate Pharma Inc. (Waltham, Mass.) EGP-437 Comprises a formulation of dexamethasone delivered into the eye using an ocular iontophoresisBioWorld Insight | Monday, May 13, 2013 -
Non-U.S. Clinical Trials & Regulatory Actions: April 2013
San Diego) and Eisai Inc. (Woodcliff Lake, N.J.) Belviq Lorcaserin HCl Chronic weight management Submitted an MAA for its use as an adjunct to a reduced-calorie diet and increased physical activity 4/2/13 Avanir Pharmaceuticals Inc. (Aliso Viejo, Calif.) Nuedexta Dextrometh-orphan hydrobromide and quinidine sulfate Pseudobulbar affect CHMP recommended approval 4/29/13 Trigemina Inc. (Moraga, Calif.) TI-001 Intranasal oxytocin Chronic migraine Chile approved the protocol for a Phase II study 4/10BioWorld Insight | Monday, May 13, 2013 -
FDA Submissions, Approvals & Other Actions: April 2013
plc (Bedminster, N.J., and Dublin, Ireland) Vascepa Icosapent ethyl capsules High triglycerides FDA accepted its supplemental NDA for use as an adjunct to diet 4/24/13 Santarus Inc. (San Diego) and Pharming Group (Leiden, the Netherlands) Ruconest Recombinant human C1 esterase inhibitor Hereditary angioedema Submitted a BLA 4/18/13 CENTRAL NERVOUS SYSTEM Acadia Pharmaceuticals Inc. (San Diego) Pimaanserin Oral tablet Parkinson's disease psychosis FDA said the company will not need another PhaseBioWorld Insight | Monday, May 13, 2013 -
Receptos Prices Solid IPO, Raises $72.8M for Pipeline
Receptos Inc., of San Diego, priced its initial public offering (IPO) of 5.2 million shares of common stock at $14 per share, for a total raise of $72.8 millionBy Catherine Shaffer | BioWorld Today | Friday, May 10, 2013 -
Lumena Large: $23M Series A Funds Phase II Cholestatic Bid
These studies should read out in the second half of next year, and the funding will take us through the end of 2014," said Mike Grey, president and CEO of San Diego-based Lumena...said Grey, formerly CEO of SGX Pharmaceuticals Inc., of San Diego, acquired in 2008 by Indianapolis-based Eli Lilly and CoBy Randy Osborne | BioWorld Today | Thursday, May 9, 2013 -
Cardio3 BioSciences Closes $25M Funding Round
and Cytori Therapeutics Inc., of San Diego.By Cormac Sheridan | BioWorld Today | Thursday, May 9, 2013 -
Other News To Note
Institut de Recherches Servier, of Paris, inked a nonexclusive collaboration to use the enhanced spine platform (ESP) technology developed by Afraxis Inc., of San Diego, to discover central nervous system (CNS) drugsBioWorld International | Wednesday, May 8, 2013 -
Other News To Note
Arena Pharmaceuticals Inc., of San Diego, said partner Eisai Inc., of Woodcliff Lake, N.J., will be able to launch obesity drug Belviq (lorcaserin) next month, following completion of a Drug Enforcement Agency (DEA) review that deemed the drug as a Schedule IV substanceBioWorld Today | Wednesday, May 8, 2013 -
Other News To Note
Vical Inc., of San Diego, said preclinical evaluations of its Vaxfectin adjuvant in combination with cell culture-derived seasonal and pandemic influenza vaccines from Baxter International Inc., of Deerfield, Ill., were published online in Human Vaccines & ImmunotherapeuticsBioWorld Today | Tuesday, May 7, 2013 -
Appointments and Advancements
Afraxis Inc., of San Diego, named Carmine Stengone president and CEO, and Christopher Rex chief scientific officerBioWorld Today | Tuesday, May 7, 2013 -
Clinic Roundup
Metreleptin was part of the alliance between BMS and AstraZeneca plc, of London, to buy out Amylin Pharmaceuticals Inc., of San Diego, which had metreleptin among its assets. (See BioWorld Today, July 5, 2012...La Jolla Pharmaceutical Co., of San Diego, treated the last patient in the Phase I (Part A) portion of the Phase I/II trial of GCS-100 in patients with chronic kidney disease (CKDBioWorld Today | Tuesday, May 7, 2013 -
Other Financings Of Public Biotechnology Companies: April 2013
Details Date Anthera Pharmaceuticals Inc. (Hayward, Calif.) Common stock purchase agreement N/A $2 Anthera entered an $18.5M common stock purchase agreement with Lincoln Park Capital Fund LLC, under which it made an initial purchase of $2M in common stock priced at 64.8 cents apiece 4/9/13 Cardium Therapeutics Inc. (San Diego) Private placement of zero coupon Series A convertible preferred stock 0.004S $4 Cardium entered a definitive agreement with a single institutional health care fundBioWorld Insight | Monday, May 6, 2013 -
Re-verb: Conjugates Lure BMS to Ambrx Deal Number Three
I think it is based on the relationship we've built with BMS, but this is a different franchise area, a different portion of our technology platform," said Simon Allen, chief business officer of San Diego-based AmbrxBy Randy Osborne | BioWorld Today | Monday, May 6, 2013 -
Public Financing Of Biotechnology: April 2013
Sunrise Securities Corp. $25 Ambit Biosciences Inc. (San Diego; AMBI)2 2/20/13 4.645S $13-$15 12.9 Citigroup Leerink Swann (co-lead) BMO Capital Markets Baird $65.03 Audeo Oncology Inc. (San Francisco; AURX)3 7/6/12 3.25S $14-$16 10.8 Leerink Swann Oppenheimer & Co. (co-lead) $49 Epizyme Inc. (Cambridge, Mass.; EPZM) 4/26/13 N/A N/A N/A Citigroup Cowen and Co. (co-lead) Leerink Swann (co-lead) JMP Securities Wedbush PacGrow Life Sci. $69 GlobeImmune Inc. (Louisville, Colo.; GBIM) 7/2/12BioWorld Insight | Monday, May 6, 2013 -
Biocom Helps SoCal Grow Its Biotech Sector
A report from real estate firm Jones Lang LaSalle in March lists San Diego as the number two biotechnology cluster in the U.S. Like any list, the ranking is debatable, especially by people in the San Francisco Bay Area who came in third...Looking forward, Panetta hopes that other high-tech industries in San Diego – telecommunication and software, for instance – can join the life sciences, combining the strengths of the regionBy Brian Orelli | BioWorld Insight | Monday, May 6, 2013 -
Arena Yanks MAA, Falls on Belviq Launch Delay in U.S.
were down nearly 10 percent Friday following Thursday's after-market release of first-quarter earnings, which included news that the San Diego-based biotech is pulling its European marketing application for obesity drug Belviq (lorcaserin), though the bigger disappointment may be the ongoing delay in Belviq's U.SBy Jennifer Boggs | BioWorld Today | Monday, May 6, 2013 -
Milestone Payments From Corporate Partners: April 2013
Total: $85.5M Year to Date: $204.55M Company (Location) Partner (Location) Amt. (M) Details Date Arena Pharmaceuticals Inc. (San Diego) Eisai Inc. (Woodcliff Lake, N.J.) $0.5 For the submission of a marketing authorization application for Belviq in Mexico for use as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults 4/2/13 Furiex Pharmaceuticals Inc. (Morrisville, N.C.) Menarini Group (Florence, Italy) $5 For the launch of Priligy inBioWorld Insight | Monday, May 6, 2013 -
Other News To Note
Cardium Therapeutics Inc., of San Diego, said the April 2013 issue of Molecular Therapy published a paper, titled "Mechanistic, Technical, and Clinical Perspectives in Therapeutic Stimulation of Coronary Collateral Development by Angiogenic Growth FactorsBioWorld Today | Friday, May 3, 2013 -
Abide with Me: Merck Paying up to $430M in Diabetes Deal
San Diego-based Abide's platform involves proteomic technology from the Scripps Research InstituteBy Randy Osborne | BioWorld Today | Friday, May 3, 2013
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