Basilea announces that FDA's Anti-Infective Drugs Advisory Committee recommends approval of isavuconazole for the treatment of invasive aspergillosis and mucormycosis
GlobeNewswire - Thu Jan 22, 2:12PM CST
Basilea Pharmaceutica Ltd. (SIX: BSLN) today announced that the U.S. Food and Drug Administration's (FDA) Anti-Infective Drugs Advisory Committee voted unanimously to recommend approval of the investigational once-daily intravenous and oral antifungal isavuconazole, the active moiety of the prodrug isavuconazonium sulfate, for the treatment of invasive aspergillosis, and eight to two with one abstention to recommend approval for the treatment of invasive mucormycosis (also known as zygomycosis), life-threatening fungal infections predominantly occurring in immunocompromised patients. Basilea's partner Astellas presented the data to the FDA and, if approved, intends to market the drug as Cresemba in the United States.
Aspergillosis - Pipeline Review, H1 2014
M2 - Tue Dec 30, 5:34AM CST
Research and Markets (http://www.researchandmarkets.com/research/tnt27n/aspergillosis) has announced the addition of the "Aspergillosis - Pipeline Review, H1 2014" report to their offering. This report provides comprehensive information on the therapeutic development for Aspergillosis, 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 Aspergillosis and special features on late-stage and discontinued projects. Drug profiles/records featured in the report undergoes periodic updation following a stringent set of processes that ensures that all the profiles are updated with the latest set of information. Additionally, processes including live news & deals tracking, browser based alert-box and clinical trials registries tracking ensure that the most recent developments are captured on a real time basis. Reasons to buy - Provides strategically significant competitor information, analysis, and insights to formulate effective R&D development strategies - Identify emerging players with potentially strong product portfolio and create effective counter-strategies to gain competitive advantage - Develop strategic initiatives by understanding the focus areas of leading companies - Identify and understand important and diverse types of therapeutics under development for Aspergillosis - Plan mergers and acquisitions effectively by identifying key players of the most promising pipeline - Devise corrective measures for pipeline projects by understanding Aspergillosis pipeline depth and focus of Indication therapeutics - Develop and design in-licensing and out-licensing strategies by identifying prospective partners with the most attractive projects to enhance and expand business potential and scope - Modify the therapeutic portfolio by identifying discontinued projects and understanding the factors that drove them from pipeline Companies Mentioned: - Astellas Pharma Inc. - Aureogen Biosciences, Inc. - Basilea Pharmaceutica AG - Biomar Microbial Technologies - Eisai Co., Ltd. - F2G Ltd - MABLife S.A.S - Merck & Co., Inc. - Novabiotics Ltd - Sealife PHARMA GMBH - Sigma-Tau S.p.A. - iCo Therapeutics Inc. For more information visit http://www.researchandmarkets.com/research/tn...ergillosis
MRK: 58.81 (-0.07)
Swissmedic approves Basilea's antibiotic Zevtera(r) (ceftobiprole medocaril) for the treatment of pneumonia
GlobeNewswire - Mon Dec 22, 12:18AM CST
Basilea Pharmaceutica Ltd. (SIX: BSLN) reports that the Swiss regulatory authority Swissmedic has approved the antibiotic Zevtera (ceftobiprole medocaril) for the treatment in adults of community-acquired pneumonia (CAP) and hospital-acquired pneumonia (HAP), excluding ventilator-associated pneumonia (VAP). The license will be issued by Swissmedic following formal publication of the Product Information. Ceftobiprole for the treatment of pneumonia has already been approved in twelve other European countries.
Community-Acquired Bacterial Pneumonia Global Clinical Trials Review, H2, 2014
M2 - Thu Dec 11, 6:52AM CST
Research and Markets (http://www.researchandmarkets.com/research/24xkp9/communityacquired) has announced the addition of the "Community-Acquired Bacterial Pneumonia Global Clinical Trials Review, H2, 2014" report to their offering. Community-Acquired Bacterial Pneumonia Global Clinical Trials Review, H2, 2014" provides data on the Community-Acquired Bacterial Pneumonia clinical trial scenario. This report provides elemental information and data relating to the clinical trials on Community-Acquired Bacterial Pneumonia. 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 Community-Acquired Bacterial Pneumonia. 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 - 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 - Actavis plc - Cempra, Inc. - Pfizer Inc. - Cempra Pharmaceuticals, Inc. - AstraZeneca PLC - Nabriva Therapeutics AG - Cubist Pharmaceuticals, Inc. - Boehringer Ingelheim Auslandsbeteiligungs GmbH - Bayer AG - Basilea Pharmaceutica AG Clinical Trial Overview of Top Institutes / Government - Yokohama Rosai Hospital - Nagasaki Evaluation Organization for Clinical Interventions - Central Japan Lung Study Group - Albany Medical Center For more information visit http://www.researchandmarkets.com/research/24...tyacquired
CBSTZ: 0.06 (unch), PFE: 34.64 (-0.23), AZN: 69.96 (+0.20), CEMP: 27.68 (+1.25)
Candidiasis - Pipeline Review, H2 2014
M2 - Wed Dec 10, 5:01AM CST
Research and Markets (http://www.researchandmarkets.com/research/9jx8b8/candidiasis) has announced the addition of the "Candidiasis - Pipeline Review, H2 2014" report to their offering. This report provides comprehensive information on the therapeutic development for Candidiasis, 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 Candidiasis and special features on late-stage and discontinued projects. Drug profiles/records featured in the report undergoes periodic updation following a stringent set of processes that ensures that all the profiles are updated with the latest set of information. Additionally, processes including live news & deals tracking, browser based alert-box and clinical trials registries tracking ensure that the most recent developments are captured on a real time basis. Reasons to buy - Provides strategically significant competitor information, analysis, and insights to formulate effective R&D development strategies - Identify emerging players with potentially strong product portfolio and create effective counter-strategies to gain competitive advantage - Develop strategic initiatives by understanding the focus areas of leading companies - Identify and understand important and diverse types of therapeutics under development for Candidiasis - Plan mergers and acquisitions effectively by identifying key players of the most promising pipeline - Devise corrective measures for pipeline projects by understanding Candidiasis pipeline depth and focus of Indication therapeutics - Develop and design in-licensing and out-licensing strategies by identifying prospective partners with the most attractive projects to enhance and expand business potential and scope - Modify the therapeutic portfolio by identifying discontinued projects and understanding the factors that drove them from pipeline Companies Mentioned: - Aureogen Biosciences, Inc. - Basilea Pharmaceutica AG - Biomar Microbial Technologies - Cellceutix Corporation - Eisai Co., Ltd. - Merck & Co., Inc. - NovaDigm Therapeutics, Inc. - Novabiotics Ltd - Novartis AG - Pacgen Life Science Corporation - Panacela Labs, Inc. - Sealife PHARMA GMBH - Sequella, Inc. - iCo Therapeutics Inc. For more information visit http://www.researchandmarkets.com/research/9j...andidiasis
MRK: 58.81 (-0.07), PBS.VN: 0.040 (-0.005), NVS: 102.20 (-0.17)
Basilea announces launch of antibiotic Zevtera(r) (ceftobiprole medocaril) in Germany
GlobeNewswire - Fri Dec 05, 1:39AM CST
-- First commercial launch
Chronic Obstructive Pulmonary Disease (COPD) - Pipeline Review, H2 2014
M2 - Tue Dec 02, 6:01AM CST
Research and Markets (http://www.researchandmarkets.com/research/53cpct/chronic) has announced the addition of the "Chronic Obstructive Pulmonary Disease (COPD) - Pipeline Review, H2 2014" report to their offering. This report provides comprehensive information on the therapeutic development for Chronic Obstructive Pulmonary Disease (COPD), 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 Chronic Obstructive Pulmonary Disease (COPD) and special features on late-stage and discontinued projects. Reasons to buy - Provides strategically significant competitor information, analysis, and insights to formulate effective R&D development strategies - Identify emerging players with potentially strong product portfolio and create effective counter-strategies to gain competitive advantage - Develop strategic initiatives by understanding the focus areas of leading companies - Identify and understand important and diverse types of therapeutics under development for Chronic Obstructive Pulmonary Disease (COPD) - Plan mergers and acquisitions effectively by identifying key players of the most promising pipeline - Devise corrective measures for pipeline projects by understanding Chronic Obstructive Pulmonary Disease (COPD) pipeline depth and focus of Indication therapeutics - Develop and design in-licensing and out-licensing strategies by identifying prospective partners with the most attractive projects to enhance and expand business potential and scope - Modify the therapeutic portfolio by identifying discontinued projects and understanding the factors that drove them from pipeline Companies Mentioned: 100 companies are cited in this text including: - Ache Laboratorios Farmaceuticos S/A - Adamis Pharmaceuticals Corporation - Advinus Therapeutics Ltd. - AIM Therapeutics Inc. - Axikin Pharmaceuticals, Inc. - Basilea Pharmaceutica AG - Daiichi Sankyo Company, Limited - Errant Gene Therapeutics, LLC - Five Prime Therapeutics, Inc. - GlaxoSmithKline plc - Hydra Biosciences, Inc. - iCeutica, Inc. - Johnson & Johnson - KaloBios Pharmaceuticals, Inc. - Medestea Research & Production S.p.A. - Novartis AG - Ockham Biotech Limited - Pfizer Inc. - PharmaLundensis - Re-Pharm - Seoul Pharma - Takeda Pharmaceutical Company - Zambon Company For more information visit http://www.researchandmarkets.com/research/53cpct/chronic
JNJ: 99.62 (+1.18), KBIO: 0.45 (+0.06), PFE: 34.64 (-0.23), ADMP: 6.50 (-0.01), GSK: 47.94 (+1.99), NVS: 102.20 (-0.17), FPRX: 24.63 (+0.63)
Global Hospital Acquired Pneumonia Drugs Pipeline Analysis - 2014 Global Industry Analysis
M2 - Thu Nov 27, 2:28AM CST
Research and Markets (http://www.researchandmarkets.com/research/ksl324/pipeline_analysis) has announced the addition of the "Pipeline Analysis of Hospital Acquired Pneumonia Drugs - Global Industry Analysis, Size, Share, Growth, Trends and Forecast, 2014 - 2020" report to their offering. Hospital-acquired pneumonia also called as healthcare associated pneumonia or nosocomial pneumonia is acquired in hospital premises. Unlike community acquired pneumonia hospital acquired pneumonia is mainly caused due to multidrug resistant microorganisms. The report analyzes the market for late stage candidates for treatment of nosocomial pneumonia, and also provides a detailed review of drugs in early stages of clinical trials. The report studies and estimates market for six late stage along with an elucidation of ten early stage candidates for nosocomial pneumonia treatment. Global market for hospital acquired pneumonia drugs is mainly driven by the increasing prevalence of nosocomial infections across the globe. To illustrate this fact, the report includes a statistical comparison of the prevalence of nosocomial infections in various developed and developing countries. Geographical trend of hospital acquired pneumonia drugs market, is explains with a brief regulatory approval process, along with expected time frame for drug launch in various countries. These trends have been explained for geographical regions including North America, Europe, Asia Pacific and Rest of the World. Key companies in the market include: - Achaogen, Inc. - Aridis Pharmaceutical - AstraZeneca PLC - Basilea Pharmaceutica Ltd. - Bayer Healthcare - Cubist Pharmaceutical - GlaxoSmithKline - Meiji Seika Pharma Co., Ltd. - Merck & Co. - Valneva SE. Scope of the Report Pipeline Analysis - Tedizolid Phosphate - Ceftolozane/Tazobactam - Ceftazidime/Avibactam - Amikacin Inhale - Plazomicin - Synflorix For more information visit http://www.researchandmarkets.com/research/ks...e_analysis
MRK: 58.81 (-0.07), AZN: 69.96 (+0.20), AKAO: 11.11 (-0.27), GSK: 47.94 (+1.99)
Basilea reports that U.S. FDA sets date of Advisory Committee meeting on isavuconazole NDA for the treatment of invasive aspergillosis and mucormycosis
GlobeNewswire - Fri Nov 21, 5:31AM CST
Basel, Switzerland, November 21, 2014 - Basilea Pharmaceutica Ltd. (SIX: BSLN) reports today that the U.S. Food and Drug Administration (FDA) announced a public meeting of the Anti-Infective Drugs Advisory Committee to discuss the New Drug Application (NDA) for the investigational antifungal isavuconazole, which was submitted by a subsidiary of Basilea's licensing partner Astellas Pharma Inc. The meeting is scheduled for Thursday, January 22, 2015.
Basilea's oncology drug candidate BAL101553 induces significant anti-tumor effect in treatment-refractory tumor models
Thomson Reuters ONE - Wed Nov 19, 12:16AM CST
Basilea Pharmaceutica AG / Basilea's oncology drug candidate BAL101553 induces significant anti-tumor effect in treatment-refractory tumor models . Processed and transmitted by NASDAQ OMX Corporate Solutions. The issuer is solely responsible for the content of this announcement.
Basilea reports granting of U.S. orphan drug designation to isavuconazole for the treatment of invasive candidiasis
GlobeNewswire - Mon Nov 03, 12:18AM CST
Basilea Pharmaceutica Ltd. (SIX: BSLN) reports today that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to isavuconazole for the treatment of invasive candidiasis/candidemia, a potentially life-threatening infection caused by Candida yeasts. Isavuconazole has previously been granted orphan drug status in the European Union and the U.S. for the treatment of invasive aspergillosis and mucormycosis.
Basilea reports protocol amendment resulting in earlier completion of isavuconazole phase 3 invasive candidiasis study
GlobeNewswire - Thu Oct 16, 12:19AM CDT
Basilea Pharmaceutica Ltd. (SIX: BSLN) announces today that its partner Astellas Pharma Inc. has filed an amendment to the phase 3 ACTIVE study protocol with the relevant health authorities and ethics committees. The study assesses the investigational antifungal isavuconazole in the treatment of candidemia and other invasive Candida infections.
Basilea reports that further subgroup and health economic analyses of isavuconazole phase 3 studies will be presented at IDWeek conference
GlobeNewswire - Wed Oct 08, 12:50PM CDT
Basilea Pharmaceutica Ltd. (SIX:BSLN) announces today that further subgroup and health economic analyses of data from the phase 3 studies SECURE and VITAL with the investigational antifungal isavuconazole will be presented at the infectious disease conference IDWeek 2014, October 8-12 in Philadelphia (PA), USA.