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 The leading web portal for pharmacy resources, news, education and careers September 22, 2018
Pharmacy Choice - News - Pharmaceutical Development - September 22, 2018

Pharmacy News

 Pharmaceutical Development
Current Articles | 7 - 30 Days Old | 30 - 90 Days Old | Over 90 Days
Articles(s): 1 - 25 of 250     Next >>     Go To Page:

9/22/18 - Bayer Receives Positive CHMP Opinion for Its Hemophilia a Treatment BAY94-9027
BAY94-9027 recently received FDA approval in the U.S. where it is marketed under the brand name Jivi (R). Oldenburg, Director of the Hemophilia Centre at the University Clinic in Bonn, Germany. After the approval of BAY94-9027 in the U.S., the positive CHMP recommendation is an important step forward for people with hemophilia A in the European Uni
9/22/18 - Bayer's Jivi Approved in Japan for Hemophilia a
Bayer, a pharmaceutical and life sciences company, issued the following news release:. Bayer announced today that the Japanese Ministry of Health, Labour and Welfare has approved Jivi (R) for the prophylactic treatment of hemophilia A for adults and adolescents 12 years of age or older in Japan. Teruhisa Fujii, director of the Blood Transfusion Div
9/22/18 - BeiGene Announces Preliminary Results from the Phase 1 Clinical Trial of Zanubrutinib in Chinese Patients with B-Cell Lymphoma at Annual Meeting of the Chinese Society of Clinical Oncology
BeiGene, Ltd., a commercial-stage biopharmaceutical company focused on developing and commercializing innovative molecularly-targeted and immuno-oncology drugs for the treatment of cancer, today presented preliminary results from the Phase 1 trial of its investigational BTK inhibitor zanubrutinib in Chinese patients with B-cell lymphoma in an...
9/22/18 - Boston Scientific Eluvia Drug-Eluting Stent Demonstrates Superior Results In IMPERIAL Trial
SAN DIEGO and MARLBOROUGH, Mass., Sept. 22, 2018/ PRNewswire/ Today, Boston Scientific announced positive 12- month data from the IMPERIAL trial, the first head-to-head drug-eluting stent trial in the superficial femoral artery. Results were presented during a late-breaking clinical trial session at the 30th Transcatheter Cardiovascular Therapeut
9/22/18 - Cardurion Pharmaceuticals Announces Initiation of Phase 1 Study of CRD-733, a PDE-9 Inhibitor in Development for the Treatment of Heart Failure [Sudan Tribune]
Cardurion Pharmaceuticals, a biotechnology company focused on the development of novel, next-generation therapeutics for the treatment of cardiovascular diseases, today announced that the U.S. Food and Drug Administration has accepted its Investigational New Drug Application for CRD-733, a Phosphodiesterase-9 inhibitor in development to improve...
9/22/18 - Dr. Jared Gollob Joins Kymera Therapeutics as Chief Medical Officer [News Central Asia]
Kymera Therapeutics LLC, a biotechnology company pioneering targeted protein degradation as a transformative new approach to creating breakthrough medicines for patients, today announced the appointment of Jared Gollob, MD, to the role of Chief Medical Officer. Formerly Vice President of Clinical Development and Global Vice President of Medical...
9/22/18 - DSP Clinical Research Named to Inc. 5000 List of Fastest Growing U.S. Private Companies for 5th Time [Sport360]
-Contract Research Organization DSP Clinical Research announced it achieved a ranking of 3500 on the prestigious Inc. 5000 list. DSP founder and President Darlene Panzitta said, "Were grateful to earn recognition from Inc. for the fifth time. DSP Clinical Research is a specialty Contract Research Organization dedicated to managing and executing Pha
9/22/18 - Innovent Presents Clinical Data of Anti-PD-1 Antibody Sintilimab in Patients with Advanced Malignant Neuroendocrine Tumors at Annual Meeting of the Chinese Society of Clinical Oncology [Syrian Arab News Agency]
Innovent Biologics, Inc., a world-class China- based biopharmaceutical company that develops and commercializes high quality drugs, today presented clinical trial data from a phase Ib clinical trial that treated patients with neuroendocrine tumors who have failed of standard therapy with single agent sintilimab, a fully human anti-programmed cell..
9/22/18 - Keytruda Granted Priority Review by FDA for Treatment of Merkel Cell Carcinoma [Sport360]
The U.S. Food and Drug Administration granted priority review to Mercks supplemental Biologics License Application seeking accelerated approval for Keytruda as a treatment for adults and children with recurrent locally advanced or metastatic Merkel cell carcinoma. The regulatory agency set Dec. 28 as the deadline to reach a decision.
9/22/18 - Late-Breaking Clinical Study Results Demonstrate Exceptional Safety and Efficacy Outcomes for Resolute Onyx(TM) DES
TCT18: BIONYX Study Shows Strong Performance with Durable Polymer Resolute Onyx DES in Head-to-Head Comparison with Biodegradable Polymer DES DUBLIN and SAN DIEGO- September 22, 2018- Investigators today unveiled new clinical data from the physician-initiated BIONYX study, representing the first all-comers analysis in nearly 2,500 patients...
9/22/18 - Lonza Expands IbexTM Solutions to Offer Complete Product Lifecycle Management in One Location [Tehran Times (Iran)]
Lonza announces the addition of two new IbexTM Solutions offerings to Lonza`s 100,000 m2 biopark in Visp. In July 2017 IbexTMDedicate, a modular, technology-agnostic biomanufacturing concept, was launched as the first IbexTM Solutions offering. IbexTM Dedicate offers an innovative facility concept with reduced CAPEX and accelerated timelines, enabl
9/22/18 - Melinta Therapeutics Receives Positive CHMP Opinion for Vabomere (meropenem and vaborbactam) [Sport360]
-Melinta Therapeutics, Inc., a commercial-stage company discovering, developing and commercializing novel antibiotics to treat serious bacterial infections, today announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency has adopted a positive opinion recommending Vabomere for approval as a treatment for...
9/22/18 - Melinta Therapeutics Receives Positive CHMP Opinion for Vabomere (meropenem and vaborbactam) [Sudan Tribune]
Melinta Therapeutics, Inc., a commercial-stage company discovering, developing and commercializing novel antibiotics to treat serious bacterial infections, today announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency has adopted a positive opinion recommending Vabomere for approval as a treatment for...
9/22/18 - MicuRx Announces Receipt of FDAs QIDP and Fast Track Designations for Contezolid and Contezolid Acefosamil [Sport360]
MicuRx Pharmaceuticals, Inc. today announced the receipt of the qualified infectious disease product classification and grant of fast track status by the U.S. Food and Drug Administration for contezolid and its prodrug contezolid acefosamil for the treatment of acute bacterial skin and skin structure infections. QIDP designation is granted under th
9/22/18 - Mylan and Biocon Announce Positive CHMP Opinion for Fulphila, Biosimilar Pegfilgrastim [Syrian Arab News Agency]
Mylan N.V. and Biocon Ltd. today announced that the European Medicines Agency`s Committee for Medicinal Products for Human Use has issued a positive opinion recommending approval of Fulphila, a biosimilar to Amgen`s Neulasta. Fulphila was approved by the U.S. Food and Drug Administration earlier this year and is the first FDA- approved biosimilar f
9/22/18 - New Gene Therapy for Rare Inherited Disorder Causing Vision Loss Recommended for Approval
The European Medicines Agency issued the following news release:. The European Medicines Agency's Committee for Medicinal Products for Human Use has recommended granting a marketing authorisation for the gene therapy Luxturna, for the treatment of adults and children suffering from inherited retinal dystrophy caused by RPE65 gene mutations, a rare.
9/22/18 - Novartis Receives Positive CHMP Opinion for Gilenya for the Treatment of Children and Adolescents With MS, Marking a Major Medical Advance for Young MS Patients in Europe
Novartis today announced the Committee for Medicinal Products for Human Use of the European Medicines Agency has recommended approval of Gilenya (R) for the treatment of children and adolescents 10 to 17 years of age with relapsing remitting forms of multiple sclerosis. Gilenya was previously approved for adults with RRMS aged 18 years and older in
9/22/18 - Pivotal Trial Underway for Zanubrutinib in Waldenstrm Macroglobulinemia [Tehran Times (Iran)]
Zanubrutinib is an investigational oral Bruton tyrosine kinase inhibitor that was granted fast track designation by the US Food and Drug Administration in July 2018 for the treatment of patients with WM.2 Information about the progress of the trial, which is being sponsored by BeiGene, was published in Future Oncology. Study investigators began enr
9/22/18 - Protalix BioTherapeutics Reports Positive Preliminary Data from the BRIDGE Study of pegunigalsidase alfa for the Treatment of Fabry Disease [Sudan Tribune]
-Protalix BioTherapeutics, Inc., a biopharmaceutical company focused on the development and commercialization of recombinant therapeutic proteins expressed through its proprietary plant cell-based expression system, ProCellEx, today announced positive preliminary data from the BRIDGE study of pegunigalsidase alfa for the treatment of Fabry...
9/22/18 - Protalix BioTherapeutics Reports Positive Preliminary Data from the BRIDGE Study of pegunigalsidase alfa for the Treatment of Fabry Disease [Tehran Times (Iran)]
Protalix BioTherapeutics, Inc., a biopharmaceutical company focused on the development and commercialization of recombinant therapeutic proteins expressed through its proprietary plant cell-based expression system, ProCellEx, today announced positive preliminary data from the BRIDGE study of pegunigalsidase alfa for the treatment of Fabry...
9/22/18 - Sandoz Receives Positive CHMP Opinion for Proposed Biosimilar Pegfilgrastim
Sandoz, a Novartis division and the pioneer and global leader in biosimilars, today announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency has adopted a positive opinion for marketing authorization of its proposed biosimilar pegfilgrastim, (R)*** a long-acting version of supportive oncology care medicine.
9/22/18 - Sun Pharma Receives Australian Agency Approval of Ilumya [T-break Tech (Middle East)]
We are pleased to have received this approval and look forward to bringing ILUMYATM to dermatologists and patients in Australia, said Hellen De Kloet, business head, Western Europe& Australia, Sun Pharma. Ilumya is one of the key specialty products of Sun Pharma and it was approved by U.S. FDA in March 2018 while the European Commission approved it
9/22/18 - Takeda Receives Positive CHMP Opinion Recommending ALUNBRIG for the Treatment of ALK+ Non-Small Cell Lung Cancer in Patients Previously Treated With Crizotinib
Takeda Pharmaceutical Company Limited today announced that the European Medicines Agency's Committee for Medicinal Products for Human Use has adopted a positive opinion, recommending the full approval of ALUNBRIG (R) as a monotherapy for the treatment of adult patients with anaplastic lymphoma kinase-positive advanced non-small cell lung cancer...
9/22/18 - US FDA delays approval of GC Pharmas IVIG-SN again [T-break Tech (Middle East)]
South Korean biopharma company GC Pharma said Friday that the US Food and Drug Administration has delayed the approval of the firms immunodeficiency drug IVIG-SN, demanding additional data related to the drugs manufacturing procedures. The company had initially expected the US FDA to grant final approval for IVIG-SN, short for human normal...
9/22/18 - Winship Holds Clinical Trials Meeting to Coincide With Biden Summit
Emory University's Winship Cancer Institute issued the following news release:. Winship Cancer Institute of Emory University hosted a two-hour roundtable discussion today devoted to an in-depth examination of cancer clinical trials and patient enrollment. As the National Cancer Institute-designated Comprehensive Cancer Center for the state of...
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