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 The leading web portal for pharmacy resources, news, education and careers September 19, 2014
Pharmacy Choice - News - Pharmaceutical Development - September 19, 2014

Pharmacy News

 Pharmaceutical Development
Current Articles | 7 - 30 Days Old | 30 - 90 Days Old | Over 90 Days
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9/19/14 - Germany : Merck Serono and Sutro Biopharma to Partner on Development of Antibody Drug Conjugates [TendersInfo (India)]
Merck Serono, the biopharmaceutical division of Merck, and Sutro Biopharma, San Francisco, a biopharmaceutical company developing antibody drug conjugates and bispecific antibodies, today announced a collaboration and license agreement to develop antibody drug conjugates. The collaboration will allow Merck Serono to take advantage of Sutro s...
9/19/14 - United States : Caris Life Sciences Selects IBM to Accelerate Use of Molecular Profiling in Cancer Treatment Selection [TendersInfo (India)]
IBM today announced that Caris Life Sciences is using IBM technical computing and storage technology to accelerate the company s molecular profiling services for cancer patients. These markers are then correlated with 55 FDA- approved cancer therapies and hundreds of clinical trials agents. Widespread access to Big Data resources is revolutionizing
9/19/14 - United States : FDA approves MOVANTIK (naloxegol) tablets C-II for the treatment of opioid-induced constipation in adult patients with chronic... [TendersInfo (India)]
United States: FDA approves MOVANTIK tablets C-II for the treatment of opioid-induced constipation in adult patients with chronic non-cancer pain. AstraZeneca today announced that the US Food and Drug Administration approved MOVANTIK tablets C-II as the first once-daily oral peripherally-acting mu-opioid receptor antagonist medication for the...
9/18/14 - At One Year Post-Launch, Approximately One Half of Surveyed U.S. Medical Oncologists Have Prescribed Single-Agent Tafinlar and Mekinist to Their Malignant Melanoma Patients
Notably, at six months following its accelerated FDA approval, 41 percent of surveyed oncologists have already prescribed Tafinlar in combination with Mekinist outside of clinical trials. Comments from Decision Resources Group Analyst Jennifer Bamford:. About Decision Resources Group Decision Resources Group offers best-in-class, high-value...
9/18/14 - Auxilium Pharma Reports XIAFLEX Data from Multicord, Retreatment Studies at ASSH Annual Meeting
Auxilium Pharmaceuticals, Inc., a specialty biopharmaceutical company, today announced the first presentation of positive safety and efficacy data from the AUX-CC-867 MULTICORD Phase 3 b study. These data will be presented at the 69th Annual Meeting of the American Society for Surgery of the Hand being held in Boston, September 18-20, 2014.
9/18/14 - AUXILIUM PHARMACEUTICALS INC FILES (8-K) Disclosing Regulation FD Disclosure, Financial Statements and Exhibits
On September 18, 2014, Auxilium Pharmaceuticals, Inc. and VIVUS, Inc. issued a joint press release announcing that the U.S. Food and Drug Administration has approved a supplemental new drug application for STENDRA . STENDRA is now the only FDA- approved erectile dysfunction medication indicated to be taken as early as approximately 15 minutes bef
9/18/14 - Auxilium Pharmaceuticals, Inc. Presents XIAFLEX (CCH) Data From MULTICORD And Retreatment Studies At The ASSH Annual Meeting
Auxilium Pharmaceuticals, Inc., a specialty biopharmaceutical company, today announced the first presentation of positive safety and efficacy data from the AUX-CC-867 MULTICORD Phase 3 b study. These data will be presented at the 69 th Annual Meeting of the American Society for Surgery of the Hand being held in Boston, September 18-20, 2014.
9/18/14 - Baxter Gets FDA Approval for RIXUBIS [Coagulation Factor IX (Recombinant)] for Treatment of Children with Hemophilia B [Health & Beauty Close - Up]
Baxter International said that the United States Food and Drug Administration has approved RIXUBIS for routine prophylactic treatment, control and prevention of bleeding episodes, and perioperative management in children with hemophilia B. "In addition to the positive reception we've received from adult RIXUBIS patients, the approval for pediatric
9/18/14 - BioSpecifics Technologies Corp. Announces New MULTICORD and Retreatment Data for XIAFLEX for Dupuytren's Contracture Presented at American Society for Surgery of the Hand Annual Meeting
BioSpecifics Technologies Corp., a biopharmaceutical company developing first in class collagenase-based products marketed as XIAFLEX in the U.S. and XIAPEX in the EU, today announced that positive safety and efficacy data from the MULTICORD Phase 3 b study will be presented by BioSpecifics' partner, Auxilium Pharmaceuticals, Inc. at the 69
9/18/14 - Capricor Presents Safety and Preliminary Efficacy Results From ALLSTAR Phase I Clinical Trial at TCT 2014
Capricor Therapeutics, Inc., a biotechnology company focused on developing novel therapeutics for the treatment of cardiovascular diseases, presented an abstract entitled " ALL ogeneic Heart ST em Cells To A chieve Myocardial R egeneration: The Six Month Phase I Safety Results" with an oral presentation by Dr. Raj R. Makker, M.D., of Cedars-Sinai
9/18/14 - Cleveland BioLabs to Start Phase 1 Study for Hematopoietic Stem Cell Mobilizer CBLB612 in Russian Federation [Professional Services Close - Up]
Cleveland BioLabs reported approval from the Ministry of Health of the Russian Federation to start a Phase 1 clinical trial with CBLB612, a drug in development for the induction and mobilization of hematopoietic stem cells. This study is partially funded through a contract from the Ministry of Industry and Trade of the Russian Federation.
9/18/14 - Cyclacel's CYC065 CDK Inhibitor Demonstrates Therapeutic Potential in Acute Leukemias With Mixed Lineage Leukemia (MLL) Rearrangements
Cyclacel Pharmaceuticals, Inc., today announced the presentation of preclinical data demonstrating the therapeutic potential of CYC065, Cyclacel's second-generation cyclin dependent kinase inhibitor, to treat acute leukemias, and in particular those with rearrangements in the mixed lineage leukemia gene. The data were presented at the 2014 Societ
9/18/14 - FDA approves Eli Lilly's injectable diabetes drug
WASHINGTON The Food and Drug Administration has approved a new injectable diabetes drug from Eli Lilly and Co. for adults with the most common form of the disease. Indianapolis- based Lilly is counting on new drugs like Trulicity to replace falling revenue from blockbusters like the antidepressant Cymbalta, which is facing cheaper generic compet
9/18/14 - FDA Approves Trulicity? (dulaglutide), Lilly's Once-Weekly Therapy for Adults with Type 2 Diabetes
Trulicity?, approved today by the U.S. Food and Drug Administration, is the latest Eli Lilly and Company treatment option for adults with type 2 diabetes. Lilly plans to make Trulicity 0.75 mg and 1.5 mg single-dose pens available for adults in the United States later this year. It has also been submitted to the European Medicines Agency and ot
9/18/14 - FDA Approves Use of 2.4 GHz Wireless Connectivity with the Cochlear Nucleus 6 Sound Processor [Health & Beauty Close - Up]
Cochlear Limited said that the US Food and Drug Administration approved the use of 2.4 GHz wireless connectivity with the Cochlear Nucleus 6 Sound Processor. In a release Cochlear said that, utilizing the same 2.4 GHz wireless protocol that Bluetooth and Wi-Fi devices depend on, Cochlear Wireless Accessories provide a connection to electronic devic
9/18/14 - FDA Gives NewLink Genetics Approval to Proceed to Phase 1 Clinical Studies of Their Ebola Vaccine
By a News Reporter-Staff News Editor at Politics& Government Week NewLink Genetics Corporation announced that the United States Food and Drug Administration has given permission for the Company to proceed to Phase 1 clinical trials with their Ebola vaccine candidate. This vaccine was initially developed by the Public Health Agency of Canada, and
9/18/14 - Flexion Therapeutics Announces Clinical Hold Of FX006 Phase 2B Clinical Trial; OXiGENE Initiates Phase 2 Study of Fosbretabulin
Below is a look at some of the headlines for companies that made news in the healthcare sector on September 17, 2014.{ nfg} Flexion Therapeutics, Inc. announced the FDA informed the company that a clinical hold has been placed on patient enrollment and dosing in an ongoing Phase 2 b clinical trial evaluating FX006 in patients with osteoarthritis of
9/18/14 - Germany : Bayer and Orion Initiate Phase III Trial of Novel Prostate Cancer Agent ODM-201 in Men with High-Risk Non-Metastatic Castration-Resistant... [TendersInfo (India)]
Bayer HealthCare and Orion Corporation, a pharmaceutical company based in Espoo, Finland, have begun to enroll patients in a Phase III trial with ODM-201, an investigational novel oral androgen receptor inhibitor in clinical development for the treatment of patients with prostate cancer. The study, called ARAMIS, evaluates ODM-201 in men with...
9/18/14 - Halozyme Announces SWOG Will Resume Clinical Trial of PEGPH20 In Combo with Modified FOLFIRINOX for Advanced Pancreatic Cancer
Halozyme Therapeutics, Inc. today announced that the U.S. Food and Drug Administration has removed the clinical hold on patient enrollment and dosing of PEGPH20 in SWOG's ongoing Phase 1 b/2 clinical trial. The trial is designed to evaluate Halozyme's investigational drug PEGPH20 in combination with modified FOLFIRINOX chemotherapy in patients with
9/18/14 - Heat Biologics Commences Patient Dosing In Phase 2 Study Of Viagenpumatucel-L For The Treatment Of Non-Small Cell Lung Cancer
Heat Biologics, Inc., a clinical stage biopharmaceutical company focused on the development of cancer immunotherapies, announced today that it has initiated dosing in its Phase 2 trial of Viagenpumatucel-L in patients with non-small cell lung cancer. Roger B. Cohen, M.D., Professor of Medicine at the University of Pennsylvania and Associate Directo
9/18/14 - Immune Pharmaceuticals Initiates Phase II Clinical Trial In Ulcerative Colitis
CAMBRIDGE, Mass. and HERZLIYA PITUACH, Israel, Sept. 18, 2014/ PRNewswire/ Immune Pharmaceuticals Inc. announces today that it has initiated the screening of patients for a Phase II proof of concept clinical trial exploring the safety and efficacy of bertilimumab in the treatment of ulcerative colitis. Daniel Teper, Chairman and CEO of Immune com
9/18/14 - India : TENTATIVE Approval for Glipizide ER Tablets received by Zydus [TendersInfo (India)]
Cadila Healthcare Ltd. said that it had obtained tentative approval from the US FDA o market Glipizide Extended-release tablets in the strengths of 2.5 mg, 5 mg and 10 mg. The drug falls in the anti-diabetic segment. As per IMS data the estimates sales in 2014 for Glipizide ER tables were $90.1 million.
9/18/14 - India,United States : EPIRUS gets approval for its first biosimilar drug distribution called REMICADE [TendersInfo (India)]
The drug company formed out of a merger with Zalicus, Epirus Biopharmaceuticals is announcing its first-ever drug approval. The US Food and Drug Administration is formulating its guidelines for what can be called a biosimilar, other countries, including Europe and India, have moved ahead and are already approving such drugs. It will be manufactured
9/18/14 - Insigniam Consultant Named to Editorial Advisory Board for Applied Clinical Trials Magazine
International management consulting firm Insigniam announced that its consultant, Ira Katz, has been named to the editorial advisory board for Applied Clinical Trials. Ira Katz has more than 30 years of experience in drug development at three major biopharmaceutical companies and brings rich and diverse experience in key aspects of drug research an
9/18/14 - Japan : U.S. FDA Approves New Indication for the Use of XTANDI (enzalutamide) Capsules for Patients with Metastatic Castration-Resistant Prostate... [TendersInfo (India)]
Medivation, Inc. and Astellas Pharma Inc.announced today that the U.S. Food and Drug Administration approved a new indication for the use of XTANDI capsules to treat patients with metastatic castration-resistant prostate cancer. The FDA s priority review and approval of this new indication for XTANDI now enables the use of an important therapy by p
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