Astellas and Medivation Receive Priority Review from FDA for XTANDI® (Enzalutamide) Capsules In Chemotherapy-Naive Advanced Prostate Cancer
PR Newswire - Tue May 06, 6:00AM CDT
Astellas Pharma Inc. (TSE: 4503) and Medivation Inc. (NASDAQ: MDVN) today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing the supplemental New Drug Application (sNDA) to extend the indication for XTANDI® (enzalutamide) capsules for the treatment of men with metastatic castration-resistant prostate cancer (mCRPC) who have not received chemotherapy. This sNDA application was granted Priority Review designation with a stated FDA Prescription Drug User Fee Act (PDUFA) review date of September 18, 2014. XTANDI is currently approved for the treatment of patients with mCRPC who have previously received docetaxel chemotherapy.
Global Metastatic Prostate Cancer Clinical Trials Review 2014: Espy the 20 Leading Companies/Institutions
M2 - Thu May 01, 7:56AM CDT
Research and Markets (http://www.researchandmarkets.com/research/thv65g/metastatic) has announced the addition of the "Metastatic Prostate Cancer Global Clinical Trials Review, H1, 2014" report to their offering. Metastatic Prostate Cancer Global Clinical Trials Review, H1, 2014" provides data on the Metastatic Prostate Cancer clinical trial scenario. This report provides elemental information and data relating to the clinical trials on Metastatic Prostate Cancer. It includes an overview of the trial numbers and their recruitment status as per the site of trial conduction across the globe. The databook offers a preliminary coverage of disease clinical trials by their phase, trial status, prominence of the sponsors and also provides briefing pertaining to the number of trials for the key drugs for treating Metastatic Prostate Cancer. Espy the commercial landscape of the major Universities / Institutes / Hospitals & Companies - Johnson & Johnson - Astellas Pharma Inc. - AstraZeneca PLC - Medivation, Inc. - Sanofi - Ipsen S.A. - Bristol-Myers Squibb Company - Pfizer Inc. - Novartis AG - Eli Lilly and Company - National Cancer Institute - European Organization for Research and Treatment of Cancer - Memorial Sloan Kettering Cancer Center - Barbara Ann Karmanos Cancer Institute - The University of Texas M. D. Anderson Cancer Center - Southwest Oncology Group - OHSU Knight Cancer Institute - Swiss Group for Clinical Cancer Research - National Prostate Cancer Treatment Group - UNICANCER Group For more information visit http://www.researchandmarkets.com/research/thv65g/metastatic
Vical Reports First Quarter 2014 Financial Results and Progress in Key Development Programs
GlobeNewswire - Thu May 01, 5:30AM CDT
Vical Incorporated (Nasdaq:VICL) today reported financial results for the quarter ended March 31, 2014. The net loss for the first quarter of 2014 was $3.5 million, or $0.04 per share, compared with a net loss of $9.3 million, or $0.11 per share, for the first quarter of 2013. Revenues for the first quarter of 2014 were $2.4 million, compared with revenues of $1.6 million for the first quarter of 2013, reflecting higher payments from Astellas Pharma Inc. under an exclusive worldwide license of ASP0113, Vical's therapeutic vaccine designed to control cytomegalovirus (CMV) reactivation in transplant recipients.
Metastatic Transitional Cell Cancer (Urothelial Cell Cancer) Clinical Trials Review 2014
M2 - Wed Apr 30, 11:10AM CDT
Research and Markets (http://www.researchandmarkets.com/research/k5m6xs/metastatic) has announced the addition of the "Metastatic Transitional Cell Cancer (Urothelial Cell Cancer) Global Clinical Trials Review, H1, 2014" report to their offering. Metastatic Transitional Cell Cancer (Urothelial Cell Cancer) Global Clinical Trials Review, H1, 2014" provides data on the Metastatic Transitional Cell Cancer (Urothelial Cell Cancer) clinical trial scenario. This report provides elemental information and data relating to the clinical trials on Metastatic Transitional Cell Cancer (Urothelial Cell Cancer). It includes an overview of the trial numbers and their recruitment status as per the site of trial conduction across the globe. The databook offers a preliminary coverage of disease clinical trials by their phase, trial status, prominence of the sponsors and also provides briefing pertaining to the number of trials for the key drugs for treating Metastatic Transitional Cell Cancer (Urothelial Cell Cancer). Scope - Data on the number of clinical trials conducted in North America, South and Central America, Europe, Middle-East and Africa and Asia-pacific and top five national contributions in each, along with the clinical trial scenario in BRIC nations - Clinical trial (complete and in progress) data by phase, trial status, subjects recruited and sponsor type - Listings of discontinued trials (suspended, withdrawn and terminated) Reasons to buy - Understand the dynamics of a particular indication in a condensed manner - Abridged view of the performance of the trials in terms of their status, recruitment, location, sponsor type and many more - Obtain discontinued trial listing for trials across the globe Espy the commercial landscape of the major Universities / Institutes / Hospitals & Companies - F. Hoffmann-La Roche Ltd. - Eli Lilly and Company - Bristol-Myers Squibb Company - AstraZeneca PLC - Eisai Co., Ltd. - Boehringer Ingelheim GmbH - Biotest AG - Astellas Pharma Inc. - Altor BioScience Corporation - National Cancer Institute - The University of Chicago - European Organization for Research and Treatment of Cancer - Icahn School of Medicine at Mount Sinai - Memorial Sloan Kettering Cancer Center - Barts and The London NHS Trust - The Wales Cancer Trials Unit - Northern California Cancer Center - The University of Texas M. D. Anderson Cancer Center For more information visit http://www.researchandmarkets.com/research/k5m6xs/metastatic
Papillary Renal Cell Carcinoma Clinical Trials Review 2014
M2 - Wed Apr 30, 9:45AM CDT
Research and Markets (http://www.researchandmarkets.com/research/m2qftt/papillary_renal) has announced the addition of the "Papillary Renal Cell Carcinoma Global Clinical Trials Review, H1, 2014" report to their offering. Papillary Renal Cell Carcinoma Global Clinical Trials Review, H1, 2014" provides data on the Papillary Renal Cell Carcinoma clinical trial scenario. This report provides elemental information and data relating to the clinical trials on Papillary Renal Cell Carcinoma. It includes an overview of the trial numbers and their recruitment status as per the site of trial conduction across the globe. The databook offers a preliminary coverage of disease clinical trials by their phase, trial status, prominence of the sponsors and also provides briefing pertaining to the number of trials for the key drugs for treating Papillary Renal Cell Carcinoma. Espy the commercial landscape of the major Universities / Institutes / Hospitals or Companies - Novartis AG - GlaxoSmithKline plc - Eli Lilly and Company - Bristol-Myers Squibb Company - AstraZeneca PLC - Astellas Pharma Inc. - National Cancer Institute - Fox Chase Cancer Center - Memorial Sloan Kettering Cancer Center - UNICANCER Group - Austrian Urogynecology Working Group - Ohio State University Comprehensive Cancer Center - Fred Hutchinson Cancer Research Center - Children's Oncology Group For more information visit http://www.researchandmarkets.com/research/m2...lary_renal
Metastatic Transitional (Urothelial) Tract Cancer Clinical Trials Review
M2 - Wed Apr 30, 9:45AM CDT
Research and Markets (http://www.researchandmarkets.com/research/2bt339/metastatic) has announced the addition of the "Metastatic Transitional (Urothelial) Tract Cancer Global Clinical Trials Review, H1, 2014" report to their offering. Metastatic Transitional (Urothelial) Tract Cancer Global Clinical Trials Review, H1, 2014" provides data on the Metastatic Transitional (Urothelial) Tract Cancer clinical trial scenario. This report provides elemental information and data relating to the clinical trials on Metastatic Transitional (Urothelial) Tract Cancer. It includes an overview of the trial numbers and their recruitment status as per the site of trial conduction across the globe. The databook offers a preliminary coverage of disease clinical trials by their phase, trial status, prominence of the sponsors and also provides briefing pertaining to the number of trials for the key drugs for treating Metastatic Transitional (Urothelial) Tract Cancer. Espy the commercial landscape of the major Universities / Institutes / Hospitals & Companies - Zeltia, S.A. - Wissenschaftlicher Service Pharma GmbH - Sanofi - Lukaskrankenhaus GmbH - F. Hoffmann-La Roche Ltd. - Astellas Pharma Inc. - National Cancer Institute - Memorial Sloan Kettering Cancer Center - Karolinska University Hospital - Kitasato University School of Medicine - Campania Younger Oncologists Association - Kurume University - China Medical University Hospital - Centre Val d'Aurelle - Paul Lamarque - The University of Chicago - University of Kentucky For more information visit http://www.researchandmarkets.com/research/2bt339/metastatic
Kidney Transplantation - Pipeline Review, H1 2014
M2 - Tue Apr 29, 8:23AM CDT
Research and Markets (http://www.researchandmarkets.com/research/sxcd3n/kidney) has announced the addition of the "Kidney Transplantation - Pipeline Review, H1 2014" report to their offering. This report provides comprehensive information on the therapeutic development for Kidney Transplantation, complete with comparative analysis at various stages, therapeutics assessment by drug target, mechanism of action (MoA), route of administration (RoA) and molecule type, along with latest updates, and featured news and press releases. It also reviews key players involved in the therapeutic development for Kidney Transplantation and special features on late-stage and discontinued projects. The report enhances decision making capabilities and help to create effective counter strategies to gain competitive advantage. It strengthens R&D pipelines by identifying new targets and MOAs to produce first-in-class and best-in-class products. Scope - The report provides a snapshot of the global therapeutic landscape of Kidney Transplantation - The report reviews key pipeline products under drug profile section which includes, product description, MoA and R&D brief, licensing and collaboration details & other developmental activities - The report reviews key players involved in the therapeutics development for Kidney Transplantation and enlists all their major and minor projects - The report summarizes all the dormant and discontinued pipeline projects - A review of the Kidney Transplantation products under development by companies and universities/research institutes based on information derived from company and industry-specific sources - Pipeline products coverage based on various stages of development ranging from pre-registration till discovery and undisclosed stages - A detailed assessment of monotherapy and combination therapy pipeline projects - Coverage of the Kidney Transplantation pipeline on the basis of target, MoA, route of administration and molecule type - Latest news and deals relating related to pipeline products Companies Mentioned - GlaxoSmithKline plc - Quark Pharmaceuticals, Inc. - Pharming Group N.V. - Astellas Pharma Inc. - Shire Plc - 4SC AG - Veloxis Pharmaceuticals A/S - NPS Pharmaceuticals, Inc. - La Jolla Pharmaceutical Company - Alexion Pharmaceuticals, Inc. - Hansa Medical AB - Digna Biotech, S.L. - Viron Therapeutics, Inc. - Opsona Therapeutics Ltd. - Angion Biomedica Corp. - NovImmune SA - Tolera Therapeutics, Inc. - Pharmicell Co., Ltd. For more information visit http://www.researchandmarkets.com/research/sxcd3n/kidney
Global Herpes Simplex Infections Therapeutics Pipeline Review 2014 - Analysis of 30 Companies & 47 Drug Profiles
M2 - Mon Apr 28, 5:26AM CDT
Research and Markets (http://www.researchandmarkets.com/research/2zbrdd/herpes_simplex) has announced the addition of the "Herpes Simplex Infections - Pipeline Review, H1 2014" report to their offering. This report provides comprehensive information on the therapeutic development for Herpes Simplex Infections, complete with comparative analysis at various stages, therapeutics assessment by drug target, mechanism of action (MoA), route of administration (RoA) and molecule type, along with latest updates, and featured news and press releases. It also reviews key players involved in the therapeutic development for Herpes Simplex Infections and special features on late-stage and discontinued projects. The report enhances decision making capabilities and help to create effective counter strategies to gain competitive advantage. It strengthens R&D pipelines by identifying new targets and MOAs to produce first-in-class and best-in-class products. Companies Involved in Therapeutics Development - Vical Incorporated - Sanofi - GenVec, Inc. - Astellas Pharma Inc. - CEL-SCI Corporation - Mymetics Corporation - NovaBay Pharmaceuticals, Inc. - Nutra Pharma Corporation - Peregrine Pharmaceuticals, Inc. - Oryzon Genomics S.A. - Colby Pharmaceutical Company - Osel Inc. - AlphaVax, Inc. - Romark Laboratories, L.C. - Chimerix, Inc. - NanoBio Corporation - Immunovaccine, Inc. - Immune Design Corp. - Seek - Adamis Pharmaceuticals Corporation - Vaxart, Inc. - Genocea Biosciences, Inc. - Profectus BioSciences, Inc. - 3-V Biosciences, Inc. - Spider Biotech S.r.l. - Kala Pharmaceuticals, Inc. - Coridon Pty Ltd - Sanofi Pasteur SA - Humabs BioMed SA - BioApex, s.r.o. Drug Profiles - amenamevir - tenofovir - RPI-78M - RPI-MN - HSV-2 Vaccine - CEL-1000 - HSV Vaccine - HSV-2 Vaccine - C-31-G - MucoCept Platform - HSV-2 Px - NVC-727 - JVRS-100 Herpes Simplex Virus-2 Vaccine - Drug for Herpes Simplex - PGN-632 - GV-2207 - MB-66 - Small Molecule Targeting Fatty Acid Synthase for Infectious Disease - BA-368 - HSV-2 Vaccine - RKP-00156 - CEL-1000 - MAb hu2c - HSV Vaccine - Drug For Herpes Simplex Virus - Subunit Vaccine for Herpes Simplex Virus 2 - Small Molecules for Viral Infections - Small Molecules for Bacterial and Viral Infections For more information visit http://www.researchandmarkets.com/research/2z...es_simplex
Global Gastrointestinal Stromal Tumor (GIST) Therapeutics Pipeline Review 2014 - Analysis of 16 Companies & 23 Drug Profiles
M2 - Mon Apr 28, 4:13AM CDT
Research and Markets (http://www.researchandmarkets.com/research/8rx8bp/gastrointestinal) has announced the addition of the "Gastrointestinal Stromal Tumor (GIST) - Pipeline Review, H1 2014" report to their offering. This report provides comprehensive information on the therapeutic development for Gastrointestinal Stromal Tumor (GIST), complete with comparative analysis at various stages, therapeutics assessment by drug target, mechanism of action (MoA), route of administration (RoA) and molecule type, along with latest updates, and featured news and press releases. It also reviews key players involved in the therapeutic development for Gastrointestinal Stromal Tumor (GIST) and special features on late-stage and discontinued projects. The report enhances decision making capabilities and help to create effective counter strategies to gain competitive advantage. It strengthens R&D pipelines by identifying new targets and MOAs to produce first-in-class and best-in-class products. Scope - The report provides a snapshot of the global therapeutic landscape of Gastrointestinal Stromal Tumor (GIST) - The report reviews key pipeline products under drug profile section which includes, product description, MoA and R&D brief, licensing and collaboration details & other developmental activities - The report reviews key players involved in the therapeutics development for Gastrointestinal Stromal Tumor (GIST) and enlists all their major and minor projects - The report summarizes all the dormant and discontinued pipeline projects - A review of the Gastrointestinal Stromal Tumor (GIST) products under development by companies and universities/research institutes based on information derived from company and industry-specific sources - Pipeline products coverage based on various stages of development ranging from pre-registration till discovery and undisclosed stages Companies Involved in Therapeutics Development - Eli Lilly and Company - Novartis AG - Astellas Pharma Inc. - Astex Pharmaceuticals, Inc. - Bayer AG - Ariad Pharmaceuticals, Inc. - Threshold Pharmaceuticals, Inc. - Synta Pharmaceuticals Corp. - Chipscreen Biosciences Ltd - Ambit Biosciences Corporation - Deciphera Pharmaceuticals, LLC - Xcovery, Inc. - AB Science - Clovis Oncology, Inc. - EirGen Pharma Ltd. - AROG Pharmaceuticals LLC Drug Profiles - regorafenib - masitinib - nilotinib - masitinib - olaratumab - linsitinib - ponatinib - AT-13387 - ganetespib - dovitinib lactate - crenolanib - luminespib - MEK-162 - TH-302 - buparlisib hydrochloride - CS-2164 - Mixed Bacterial Vaccine - X-82 - quizartinib - DCC-2618 - Mutant cKIT Inhibitor - Drug Targeting c-Kit - Eir-108 For more information visit http://www.researchandmarkets.com/research/8r...intestinal
Global Metastatic Hormone Refractory (Castration Resistant, Androgen-Independent) Prostate Cancer Clinical Trials Review 2014
M2 - Mon Apr 28, 4:13AM CDT
Research and Markets (http://www.researchandmarkets.com/research/94xvzp/metastatic) has announced the addition of the "Metastatic Hormone Refractory (Castration Resistant, Androgen-Independent) Prostate Cancer Global Clinical Trials Review, H1, 2014" report to their offering. Metastatic Hormone Refractory (Castration Resistant, Androgen-Independent) Prostate Cancer Global Clinical Trials Review, H1, 2014" provides data on the Metastatic Hormone Refractory (Castration Resistant, Androgen-Independent) Prostate Cancer clinical trial scenario. This report provides elemental information and data relating to the clinical trials on Metastatic Hormone Refractory (Castration Resistant, Androgen-Independent) Prostate Cancer. It includes an overview of the trial numbers and their recruitment status as per the site of trial conduction across the globe. The databook offers a preliminary coverage of disease clinical trials by their phase, trial status, prominence of the sponsors and also provides briefing pertaining to the number of trials for the key drugs for treating Metastatic Hormone Refractory (Castration Resistant, Androgen-Independent) Prostate Cancer. This report is built using data and information sourced from proprietary databases, primary and secondary research and in-house analysis by Our team of industry experts. Scope - Data on the number of clinical trials conducted in North America, South and Central America, Europe, Middle-East and Africa and Asia-pacific and top five national contributions in each, along with the clinical trial scenario in BRIC nations - Clinical trial (complete and in progress) data by phase, trial status, subjects recruited and sponsor type - Listings of discontinued trials (suspended, withdrawn and terminated) Clinical Trial Overview of Top Companies/Organisations - Johnson & Johnson - Sanofi - Novartis AG - AstraZeneca PLC - Astellas Pharma Inc. - Medivation, Inc. - Dendreon Corporation - Takeda Pharmaceutical Company Limited - Exelixis, Inc. - Bristol-Myers Squibb Company - National Cancer Institute - Duke University - The University of Texas M. D. Anderson Cancer Center - University of California, San Francisco - Swiss Group for Clinical Cancer Research - Barbara Ann Karmanos Cancer Institute - NCIC Clinical Trials Group - Memorial Sloan Kettering Cancer Center - University of Southern California For more information visit http://www.researchandmarkets.com/research/94xvzp/metastatic
Global Cytomegalovirus (HHV-5) Infections Therapeutics Pipeline Review 2014 - Analysis of 26 Companies & 57 Drug Profiles
M2 - Mon Apr 28, 4:08AM CDT
Research and Markets (http://www.researchandmarkets.com/research/b58mx2/cytomegalovirus) has announced the addition of the "Cytomegalovirus (HHV-5) Infections - Pipeline Review, H1 2014" report to their offering. This report provides comprehensive information on the therapeutic development for Cytomegalovirus (HHV-5) Infections, complete with comparative analysis at various stages, therapeutics assessment by drug target, mechanism of action (MoA), route of administration (RoA) and molecule type, along with latest updates, and featured news and press releases. It also reviews key players involved in the therapeutic development for Cytomegalovirus (HHV-5) Infections and special features on late-stage and discontinued projects. The report enhances decision making capabilities and help to create effective counter strategies to gain competitive advantage. It strengthens R&D pipelines by identifying new targets and MOAs to produce first-in-class and best-in-class products. Scope - The report provides a snapshot of the global therapeutic landscape of Cytomegalovirus (HHV-5) Infections - The report reviews key pipeline products under drug profile section which includes, product description, MoA and R&D brief, licensing and collaboration details & other developmental activities - The report reviews key players involved in the therapeutics development for Cytomegalovirus (HHV-5) Infections and enlists all their major and minor projects - The report summarizes all the dormant and discontinued pipeline projects - A review of the Cytomegalovirus (HHV-5) Infections products under development by companies and universities/research institutes based on information derived from company and industry-specific sources - Pipeline products coverage based on various stages of development ranging from pre-registration till discovery and undisclosed stages Companies Involved in Therapeutics Development - Vical Incorporated - GlaxoSmithKline plc - Genentech, Inc. - Merck & Co., Inc. - Novartis AG - Astellas Pharma Inc. - 4SC AG - Bionor Pharma ASA - Altor BioScience Corporation - Phoenix Biotechnology, Inc. - Cell Medica Limited - Chimerix, Inc. - Theraclone Sciences, Inc. - Microbiotix, Inc. - 4-Antibody AG - VBI Vaccines - AIMM Therapeutics B.V. - Trellis Bioscience, Inc. - Vakzine Projekt Management GmbH - Spider Biotech S.r.l. - INAGEN ApS - Applied Immune Technologies Ltd - Redbiotec AG - Kadmon Corporation, LLC - Humabs BioMed SA - BioApex, s.r.o. Drug Profiles - brincidofovir - ASP-0113 - Cytovir CMV - maribavir - TCN-202 - ASP-0113 - Donor-Derived CMV-pp65 Peptide-Specific T Cells - letermovir - RG-7667 - Multi-Virus Specific T Cells - CMV pp65 Specific T Cells - T-Cell Immunotherapy - CMV Streptacells - Autologous T-Cell Therapy - AVX-601 - HCMV Specific CTL - CMV Specific CTL - Cytomegalovirus Vaccine - CMV Specific T Cell Donor Lymphocyte - Multi-Virus Cytotoxic T Lymphocytes - Small Molecule 1 For Human Cytomegalovirus Infection - Small Molecule 2 For Human Cytomegalovirus Infection - CMV TCR-001 - CMV-MVA Triplex Vaccine - V-160 - CyMVectin - Antiviral TCR-Ck - Antiviral TCR-Ig - 4Ab-028 - VPM-2001 For more information visit http://www.researchandmarkets.com/research/b5...egalovirus
Global Benign Prostatic Hyperplasia Therapeutic Pipeline Review 2014
M2 - Mon Apr 28, 4:08AM CDT
Research and Markets (http://www.researchandmarkets.com/research/f348jl/benign_prostatic) has announced the addition of the "Global Benign Prostatic Hyperplasia Therapeutic Pipeline Review 2014" report to their offering. This report provides comprehensive information on the therapeutic development for Benign Prostatic Hyperplasia, complete with comparative analysis at various stages, therapeutics assessment by drug target, mechanism of action (MoA), route of administration (RoA) and molecule type, along with latest updates, and featured news and press releases. It also reviews key players involved in the therapeutic development for Benign Prostatic Hyperplasia and special features on late-stage and discontinued projects. The report enhances decision making capabilities and help to create effective counter strategies to gain competitive advantage. It strengthens R&D pipelines by identifying new targets and MOAs to produce first-in-class and best-in-class products. Companies Involved in Therapeutics Development - Eli Lilly and Company - Euroscreen S.A. - Aphios Corporation - Astellas Pharma Inc. - Chong Kun Dang Pharmaceutical Corp. - Chugai Pharmaceutical Co., Ltd. - SK Chemicals Co., Ltd. - Addex Therapeutics - AEterna Zentaris Inc. - IntelGenx Corp. - Kaken Pharmaceutical Co., Ltd. - Karo Bio AB - Nymox Pharmaceutical Corporation - Quest PharmaTech Inc. - Sophiris Bio, Inc. - AndroScience Corporation - NovaLead Pharma Pvt. Ltd. - AmVac AG - KAEL-GemVax Co., Ltd. - Ausio Pharmaceuticals, LLC - Hanmi Pharmaceuticals, Co. Ltd. - SOM Biotech SL - Curadis GmbH - Balonco GMBH Drug Profiles - tadalafil - NX-1207 - topsalysin - MCS-2 - ozarelix - teverelix - AUS-131 - udenafil - AMV-110 - ASP-4901 - AMV-100 - ASP-0306 - ASP-6432 - CKD-902 - ADX-68692 - Sperol - tertomotide - ASC-JM.X2 - VLDM-01 - ESN-364 - SL-052 - Estrogen Receptor Program - S-40542 - NCE-403 - SOM-2391 - (tamsulosin dutasteride) - CH-5036249 - L1AD3 - Kisspeptin Peptide Antagonists - CR-1493 - SOM-2393 - Small Molecule to Inhibit Steroidal 5-Alpha Reductase for Benign Prostatic Hyperplasia - INT-0031 For more information visit http://www.researchandmarkets.com/research/f3..._prostatic
Global Migraine Therapeutics Pipeline Review 2014 - Analysis of 40 Companies & 59 Drug Profiles
M2 - Mon Apr 28, 3:51AM CDT
Research and Markets (http://www.researchandmarkets.com/research/rw5qnf/migraine) has announced the addition of the "Migraine - Pipeline Review, H1 2014" report to their offering. This report provides comprehensive information on the therapeutic development for Migraine, complete with comparative analysis at various stages, therapeutics assessment by drug target, mechanism of action (MoA), route of administration (RoA) and molecule type, along with latest updates, and featured news and press releases. It also reviews key players involved in the therapeutic development for Migraine and special features on late-stage and discontinued projects. The report enhances decision making capabilities and help to create effective counter strategies to gain competitive advantage. It strengthens R&D pipelines by identifying new targets and MOAs to produce first-in-class and best-in-class products. Scope - The report provides a snapshot of the global therapeutic landscape of Migraine - The report reviews key pipeline products under drug profile section which includes, product description, MoA and R&D brief, licensing and collaboration details & other developmental activities - The report reviews key players involved in the therapeutics development for Migraine and enlists all their major and minor projects - The report summarizes all the dormant and discontinued pipeline projects - A review of the Migraine products under development by companies and universities/research institutes based on information derived from company and industry-specific sources - Pipeline products coverage based on various stages of development ranging from pre-registration till discovery and undisclosed stages Companies Involved in Therapeutics Development (Partial List) - Bristol-Myers Squibb Company - Allergan, Inc. - Amgen Inc. - Eli Lilly and Company - Questcor Pharmaceuticals, Inc. - BioDelivery Sciences International, Inc. - Nektar Therapeutics - Merck & Co., Inc. - TheraJect, Inc. - Biofrontera AG - Astellas Pharma Inc. - Dr. Reddy's Laboratories Limited - Pfizer Inc. - Impax Laboratories, Inc. - Revance Therapeutics, Inc. - IntelGenx Corp. - NovaDel Pharma, Inc. - Paladin Labs Inc. - Transcept Pharmaceuticals, Inc. - Pozen, Inc. - D-Pharm Ltd. - Ache Laboratorios Farmaceuticos S/A - Alder Biopharmaceuticals Inc. - CoLucid Pharmaceuticals, Inc. - Charleston Laboratories, Inc. - Pantarhei Bioscience BV - Indus Biotech Private Limited - NeurAxon, Inc. - Noxxon Pharma AG - Monosol Rx, LLC For more information visit http://www.researchandmarkets.com/research/rw5qnf/migraine
CNTRP and Astellas launch Research Innovation Competition to support Transplant Research
CNW Group - Wed Apr 23, 10:07AM CDT
The Canadian transplant field will receive an additional boost in funding thanks to a new collaborative project between Astellas Pharma Canada, Inc. (Astellas) and the Canadian National Transplant Research Program (CNTRP).
Astellas Pharma US Inc. to Pay $7.3 Million to Resolve False Claims Act Allegations Relating to Marketing of Drug Mycamine
M2 - Thu Apr 17, 4:49AM CDT
Pharmaceutical company Astellas Pharma US Inc. will pay $7.3 million to resolve allegations that it violated the False Claims Act in connection with its marketing and promotion of the drug Mycamine for pediatric use, the Justice Department announced today. Astellas Pharma US Inc., located in Northbrook, Ill., manufactures and sells pharmaceutical drugs, including Mycamine.
Sheller Whistleblower Team Announces Astellas Pharma Mycamine $7.3 Million False Claims Act Settlement
PRWeb - Wed Apr 16, 1:12PM CDT
The whistleblower attorney team of Sheller P.C. announced today that Astellas Pharma U.S., Inc. has agreed to pay $7.3 million to resolve allegations by the Sheller whistleblower client that Astellas violated the False Claims Act by submitting fraudulent claims to government healthcare programs while marketing off-label the antifungal drug Mycamine for use in children. Court documents detailing the civil allegations were unsealed today by the Office of the United States Attorney for the Eastern District of Pennsylvania.
Astellas Pharma US, Inc. reaches agreement with U.S. Department of Justice
PR Newswire - Wed Apr 16, 12:23PM CDT
Astellas Pharma US, Inc. ("Astellas"
Astellas US Promotes Jeffrey Bloss to SVP of Medical Affairs for the Americas
PR Newswire - Wed Apr 16, 7:00AM CDT
Astellas US LLC, a subsidiary of Tokyo-based Astellas Pharma Inc. (Tokyo: 4503), announced Jeffrey D. Bloss, M.D., has been promoted to the position of Senior Vice President, Medical Affairs Americas, Astellas Scientific and Medical Affairs (ASMA), effective April 1. Bloss will serve as a member of the Astellas US Management Committee.
Astellas Named National Presenting Sponsor of the National Kidney Foundation Kidney Walk
PR Newswire - Tue Apr 15, 8:03AM CDT
The National Kidney Foundation (NKF) announced today, during National Donate Life Month, that Astellas Pharma US, Inc. was named the first-ever National Presenting Sponsor for the Kidney Walk. Through this partnership, Astellas will support more than 85 Kidney Walk events being held in major cities across the country.
Japan Pharmaceutical Market Outlook 2013-2019 - Deregulation and More Efficient New Drug Approval Process Attract Foreign Investment
M2 - Fri Apr 11, 2:47AM CDT
Research and Markets (http://www.researchandmarkets.com/research/sp5lfl/japan) has announced the addition of the "Japan Pharmaceutical Market Outlook 2013-2019 - Deregulation and More Efficient New Drug Approval Process Attract Foreign Investment" report to their offering. Japan's pharmaceutical industry is the second largest in the world, worth $89 billion in 2011 or 10% of the world market. The industry grew from $62.8 billion in 2005 to its current value at a Compound Annual Growth Rate (CAGR) of 5.1%. Growth of the domestic pharmaceutical industry has recently been hampered by biennial drug price reductions, which are expected to continue as the government attempts to cut healthcare expenditure. Price reviews are also constrained by a national health budget, which limits the increase of drug prices. In addition, the gradual increase in market share and competition from generics has depressed market value and will continue to do so as government policy promotes their use. However, easing of regulatory guidelines, an aging population and a strong product pipeline will provide a strong impetus for growth in the pharmaceutical industry. Although the increasing market share of generics may dampen market value, this represents a great deal of opportunity for generic manufacturers. Historically, the Japanese pharmaceutical market has favored domestic companies. However, since the 1990s, deregulation has promoted investment from abroad and increased the presence of foreign firms. Scope - The report assesses characteristics of the Japanese pharmaceutical market, detailing recent regulatory changes, supply chain and competitive - landscape. It also draws on macroeconomic and demographic factors and the implications on healthcare policy. - A macroeconomic analysis of Japan, focusing on key economic parameters such as Gross Domestic Product (GDP), inflation and unemployment. The implications of the global financial crisis in 2008 and natural disaster in 2011 are considered. - The changing demographic landscape and implications on health economics and policy-making. - The industry characteristics section presents an overview of pricing policies, the regulatory landscape, new drug approval process and pharmaceutical supply chain in Japan. Notable changes that have occurred over recent years, in an attempt to improve the regulatory system and reduce drug review times, are highlighted. - The report then analyzes the competitive landscape in Japan, including the major domestic companies and M&A. The discussed regulatory reforms and cooperation between government and industry have improved the international competitiveness of Japan's pharmaceutical market. Coupled with a number of mergers, the industry now consists of well-known multinationals. The competitive landscape section confirms the top five Japanese pharmaceutical companies by revenue, according to GBI Research data. - The report concludes by providing an overview of the drivers and barriers currently facing the Japanese pharmaceutical industry. Key Topics Covered: - Tables & Figures - Introduction - Market Overview - Industry Characteristics - Competitive Landscape - Drivers and Barriers - Japan Pharmaceutical Market Outlook - Appendix Companies Mentioned - Astellas Pharma Inc. - Daiichi Sankyo Ltd. - Eisia Ltd. - Otsuka Holdings Ltd. - Takeda Pharmaceutical Ltd. For more information visit http://www.researchandmarkets.com/research/sp5lfl/japan