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American Association for Cancer Research: April 2013
Company (Location) Product Description Indication Status Date Activartis Biotech GmbH (Vienna, Austria) AVO113 Consists of dendritic cells loaded with antigens derived from each patient's tumor Glioblastoma The first interim analysis in a Phase III trial indicated there will be an overall survival benefit in treated patients 4/10/13 Aprea AB (Stockholm, Sweden) APR-246 Designed to reactivate mutant p53 Ovarian cancer Results showed that APR-246 acts synergistically with platinum compounds andBioWorld Insight | Monday, May 13, 2013 -
Phase II Clinical Trials Update: April 2013
Company (Location) Product Description Indication Status Date AUTOIMMUNE Biogen Idec Inc. (Weston, Mass.) DAC HYP A daclizumab high-yield process Multiple sclerosis Phase IIb data showed it reduced the annualized relapsed rate by 54%, meeting the study's primary endpoint 4/5/13 Fibrocell Science Inc. (Exton, Pa.) LaViv Autologous fibroblast injection azficel-T Moderate-to-severe acne scars Phase II study demonstrated that azficel-T treatment was associated with clinically meaningful improvementBioWorld Insight | Monday, May 13, 2013 -
Pharma Clinical & FDA Action Update: April 2013
Company (Location) Product Description Indication Status Date Actavis Inc. (Parsippany, N.J.) Testosterone Gel 1.62%, a generic version of AbbVie Inc.'s AndroGel 1.62% Absence of endogenous testosterone Filed an abbreviated NDA with the FDA 4/2/13 Almirall SA (Barcelona, Spain) and Forest Laboratories Inc. (New York) Aclidinium bromide and formoterol fumarate A long-acting muscarinic beta2 agonist and a long-acting beta2 agonist Chronic obstructive pulmonary disorder Top-line Phase III dataBioWorld Insight | Monday, May 13, 2013 -
European Congress of Clinical Microbiology and Infectious Diseases: April 2013
Company (Location) Product Description Indication Status Date Pfizer Inc. (New York) Prevenar 13 Pneumococcal polysaccharide conjugate vaccine Infections Phase III data showed it met all primary and secondary objectives focused on immunogenicity, tolerability and safety in adults 18 to 49 4/30/13 Tetraphase Pharmaceuticals Inc. (Watertown, Mass.) Antibiotics Two next-generation antibiotic candidates Community-acquired multidrug-resistant infections Studies demonstrated efficacy 4/30/13 TriusBioWorld Insight | Monday, May 13, 2013 -
International Liver Congress of the European Association for the Study of the Liver: April 2013
Company (Location) Product Description Indication Status Date AbbVie Inc. (Chicago) and Enanta Pharmaceuticals Inc. (Watertown, Mass.) ABT-450/r, ABT-267 and ABT-333 In combination with ribavirinBioWorld Insight | Monday, May 13, 2013 -
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
Company (Location) Product Description Indication Status Date AUTOIMMUNE Rigel Pharmaceuticals Inc. (South San Francisco) and AstraZeneca plc (London) Fostamatinib Oral spleen tyrosine kinase inhibitor Rheumatoid arthritis Missed the X-ray endpoint of modified Total Sharp score, but hit statistical significance in ACR20 scoring, although the Phase III still fell short of those achieved by Pfizer Inc.'s approved Xeljanz 4/8/13 CANCER Array BioPharma Inc. (Boulder, Colo.) ARRY-520 A selective KSPBioWorld Insight | Monday, May 13, 2013 -
Non-U.S. Clinical Trials & Regulatory Actions: April 2013
Company (Location) Product Description Indication Status Date AUTOIMMUNE Genzyme Corp. (Cambridge, Mass.) Aubagio TeriflunomideBioWorld Insight | Monday, May 13, 2013 -
FDA Submissions, Approvals & Other Actions: April 2013
Company (Location) Product Description Indication Status Date CANCER CytRx Corp. (Los Angeles) Aldoxorubicin Tumor-targeting doxorubicin conjugate (formerly INNO-206) Soft tissue sarcomas Reached an agreement with the FDA for an SPA for a global Phase III 4/24/13 CARDIOVASCULAR Amarin CorpBioWorld Insight | Monday, May 13, 2013 -
Pharma Clinical & FDA Action Update: March 2013
Company (Location) Product Description Indication Status Date Actavis Inc. (Parsippany, N.J.) Fortesta Testosterone 2% gel Deficiency or absence of endogenous testosterone Filed an abbreviated NDA 3/4/13 Astellas Pharma Inc. (Tokyo) Myrbetriq Mirabegron, extended-release tablets Overactive bladder Won Health Canada approval 3/11/13 Boehringer Ingelheim GmbH (Ingelheim, Germany) and Eli Lilly and Co. (Indianapolis) Empagliflozin Sodium glucose co-transporter-2 inhibitor Type II diabetesBioWorld Insight | Monday, April 15, 2013 -
FDA Submissions, Approvals & Other Actions: March 2013
Company (Location) Product Description Indication Status Date AUTOIMMUNE Biogen Idec Inc. (Weston, Mass.) Tecfidera Dimethyl fumarate Multiple sclerosis Was approved by the FDA 3/28/13 CANCER Acceleron Pharma Inc. (Cambridge, Mass.) ACE-536 A protein therapeutic that increases red blood cells Beta-thalassemia and myelodysplastic syndromes FDA granted orphan designation 3/27/13 A.P. Pharma Inc. (Redwood City, Calif.) APF530 A long-acting formulation of granisetron To prevent chemotherapy-inducedBioWorld Insight | Monday, April 15, 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 -
American Academy of Dermatology: March 2013
Company (Location) Product Description Indication Status Date Kythera Biopharma-ceuticals Inc. (Calabasas, Calif.) ATX-101 Injectable drug To reduce submental fat Phase IIIb data showed it is well tolerated and may be effective 3/5/13 Merz North America (Greensboro, N.C.) Naftifine hydrochloride Gel 2% Tinea pedis Company reported the ability of the gel to be both efficacious and tolerable in the treatment for interdigital-type and moccasin-type Tinea pedis 3/5/13 Sanofi SA (Paris) andBioWorld 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 -
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 -
American Academy of Neurology: March 2013
Company (Location) Product Description Indication Status Date Acadia Pharmaceuticals Inc. (San Diego) Pimavanserin The nondopaminergic blocker of serotonin 5-HT2A receptors Parkinson's disease psychosis Pivotal Phase III data demonstrated a highly significant antipsychotic efficacy on the nine-item SAPS-PD scaleBioWorld Insight | Monday, April 15, 2013 -
FDA Submissions, Approvals & Other Actions: February 2013
Company (Location) Product Description Indication Status Date CANCER Algeta ASA (Oslo, Norway) radium-223 Radium Ra 223 Dichloride Castration-resistant prostate cancer NDA was accepted for filing 2/14/13 Apogenix GmbH (Heidelberg, Germany) Apocept Drug designed to bind to the CD95 ligand and block activation of the CD95 receptor Myelodysplastic syndromes FDA granted orphan drug designation 2/8/13 Celgene Corp. (Summit, N.J.) Abraxane Paclitaxel protein-bound particles Non-small-cell lung cancerBioWorld Insight | Monday, March 11, 2013 -
Non-U.S. Clinical Trials & Regulatory Actions: February 2013
Company (Location) Product Description Indication Status Date CANCER Regeneron Pharmaceuticals Inc. (Tarrytown, N.Y.) and Sanofi SA (Paris) Zaltrap Ziv-aflibercept Metastatic colorectal cancer European Commission granted marketing authorization in the European Union 2/6/13 Seattle Genetics Inc. (Bothell, Wash.) Adcetris Brentuximab vedotin Hodgkin lymphoma and systemic anaplastic large cell lymphoma Health Canada approved it for HL after failure of autologous stem cell transplant or failure ofBioWorld Insight | Monday, March 11, 2013 -
Pharma Clinical & FDA Action Update: February 2013
Company (Location) Product Description Indication Status Date Baxter International Inc. (Deerfield, Ill.) FEIBA NF Anti-inhibitor coagulant complex Hemophilia A or B Submitted a BLA supplement to the FDA 2/27/13 Bayer HealthCare Inc. (Wayne, N.J.) Ra223 dichloride Oncology compound Castration-resistant prostate cancer NDA has been accepted for filing and was granted priority review 2/14/13 Bayer HealthCare Pharmaceuticals Inc. (Wayne, N.J.) Stivarga Regorafenib Advanced gastrointestinalBioWorld Insight | Monday, March 11, 2013
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