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 The leading web portal for pharmacy resources, news, education and careers May 29, 2015
Pharmacy Choice - News - Pharmaceutical Development - May 29, 2015

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:

5/28/15 - Acceleron to Update on Luspatercept Clinical Trials at the 20th Congress of the European Hematology Association [Professional Services Close - Up]
Acceleron Pharma reported that data from two ongoing phase 2 clinical trials of luspatercept in patients with beta-thalassemia and myelodysplastic syndromes will be given as oral presentations at the 20th Congress of the European Hematology Association in Vienna, Austria. Antonio Piga, M.D., Ph.D., San Luigi Gonzaga University Hospital, Torino, Ita
5/28/15 - Actinium Clinical Update on Actimab-A Provided at Targeted Alpha Therapy Symposium
Actinium Pharmaceuticals, Inc., a biopharmaceutical Company developing innovative targeted payload immunotherapeutics for the treatment of advanced cancers, recently sponsored the 9 th Symposium on Targeted Alpha Therapy, held in Warsaw, Poland on May 19-21. Symposium organizers included the Institute for Transuranium Elements of the European...
5/28/15 - Alnylam Secures Orphan Drug Designation from the U.S. FDA for Revusiran [Professional Services Close - Up]
Alnylam Pharmaceuticals, a RNAi therapeutics company, reported that the U.S. Food& Drug Administration has granted Orphan Drug Designation to revusiran, an investigational RNAi therapeutic, for the treatment of transthyretin- mediated amyloidosis. "We are very pleased to have received Orphan Drug Designation from the FDA for revusiran, a key progr
5/28/15 - Altor BioScience Announces Upcoming Data Presentation on Efficacy and Safety of ALT-801 for Advanced Bladder Cancer at 2015 ASCO Annual Meeting
Altor has concluded two Phase 1/ 2 clinical studies of ALT-801 in combination with gemcitabine and cisplatin or gemcitabine alone in patients with advanced/metastatic urothelial cancer. Altor is also conducting a clinical trial of ALT-801 in combination with gemcitabine in patients with Bacillus Calmette Guerin- resistant non-muscle-invasive...
5/28/15 - AMAG Pharmaceuticals Receives Complete Response Letter From FDA for the Single-Dose Vial of Makena(R) (Hydroxyprogesterone Caproate Injection)
AMAG Pharmaceuticals, Inc., today announced that it has received a complete response letter from the U.S. Food and Drug Administration regarding its manufacturing supplement seeking approval for a single-dose vial of Makena. A complete response letter is a communication from the FDA that informs companies that an application cannot be approved in
5/28/15 - Analytical Strategies for Drug Development Seminar in Cambridge
Regis Technologies will host a technical talk in Cambridge, MA delivered by their Director of Analytical Method Development, Paul Wrezel, Ph.D. Dr. Wrezel will answer important questions, such as:? What analytical data is required in order to be granted permission for a clinical trial or commercial distribution? Dr. Wrezel will also provide indus
5/28/15 - Array BioPharma Announces Clinical Data Presentations At The 2015 ASCO Annual Meeting
Array BioPharma Inc. today announced presentations on encorafenib, binimetinib and selumetinib at the 2015 American Society of Clinical Oncology Annual Meeting, which will be held May 29 June 2, 2015 in Chicago, Illinois. Ron Squarer, Chief Executive Officer of Array, noted, "We are encouraged to see eight ASCO abstracts reporting clinical res
5/28/15 - Array BioPharma Reports Clinical Data Presentations Which Will Be Announced at '15 ASCO
Array BioPharma Inc. today announced presentations on encorafenib, binimetinib and selumetinib at the 2015 American Society of Clinical Oncology Annual Meeting, which will be held May 29 June 2, 2015 in Chicago, Illinois. Title: A phase Ib/II study of BRAF inhibitor encorafenib plus MEK inhibitor binimetinib in cutaneous melanoma patients naive
5/28/15 - AVEO Oncology to Present Final Results of Extension Study 902 and FDA Regulatory Feedback for Advancing Tivozanib in Renal Cell Carcinoma [Professional Services Close - Up]
AVEO Oncology reported that final results from the TIVO -1 extension study, known as Study 902, in which patients with advanced renal cell carcinoma received tivozanib as second-line treatment subsequent to disease progression on sorafenib in the Company's Phase 3 TIVO -1 first-line RCC study, will be presented at the 2015 American Society of Clini
5/28/15 - Bristol-Myers Squibb Gets Positive CHMP Opinion in the European Union for Nivolumab (Opdivo, Nivolumab BMS) for the Treatment of Advanced Squamous... [Health & Beauty Close - Up]
Bristol-Myers Squibb Gets Positive CHMP Opinion in the European Union for Nivolumab for the Treatment of Advanced Squamous Non-Small Cell Lung Cancer in Previously-Treated Patients. Bristol-Myers Squibb Company reported that the Committee for Medicinal Products for Human Use of the European Medicines Agency has adopted a positive opinion...
5/28/15 - Cavion to Present Clinical Trial Data at ASCO
Cavion LLC, a pharmaceutical company developing T-type calcium channel inhibitors for the treatment of solid tumors and neurologic diseases, announced today that Matthias Holdhoff, MD, PhD of the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins will present preliminary results from an ongoing multi-site National Cancer Institute Adult Bra
5/28/15 - Cellceutix to Present Poster on Kevetrin, a Novel p53 Targeted Therapy for Solid Tumors at American Society of Clinical Oncology (ASCO) Annual Meeting
Cellceutix Corporation, a clinical stage biopharmaceutical company developing innovative therapies with oncology, dermatology, anti-inflammatory and antibiotic applications, today announced that the Company will be sponsoring an abstract publication at the American Society of Clinical Oncology 2015 Annual Meeting being held May 29- June 2, 2015 at.
5/28/15 - Celldex Therapeutics Initiates Phase 1/2 Study Of Varlilumab
WASHINGTON- Celldex Therapeutics, Inc. announced the initiation of an open-label, Phase 1/ 2 safety and tolerability study examining the investigational combination of varlilumab and sunitinib or SUTENT in patients with metastatic clear cell renal cell carcinoma or CC-RCC. Varlilumab is Celldex's fully human monoclonal agonist antibody that binds a
5/28/15 - Celldex Therapeutics Initiates Phase 1/2 Study of Varlilumab in Combination with Sunitinib in Metastatic Clear Cell Renal Cell Carcinoma
Celldex Therapeutics, Inc. today announced the initiation of an open-label, Phase 1/ 2 safety and tolerability study examining the investigational combination of varlilumab and sunitinib in patients with metastatic clear cell renal cell carcinoma. Sunitinib is approved by the FDA as monotherapy for the treatment of advanced renal cell carcinoma,
5/28/15 - Cocrystal Pharma to Present at Jefferies 2015 Global Healthcare Conference
BOTHELL, WA and ATLANTA, GA 05/28/15 Cocrystal Pharma, Inc., a company focused on developing novel antiviral therapeutics for human diseases, announced today that it will be presenting at the Jefferies 2015 Global Healthcare Conference on Thursday, June 4, 2015 from 12:30 p.m. to 1:00 p.m. at the Grand Hyatt in New York, New York. About Cocry
5/28/15 - Cour Pharmaceuticals To Announce New Breakthrough Data on Treatment for Celiac Disease
For all media inquiries, please email Greg Roberts at groberts@courpharma.com. About Cour: Cour Pharmaceutical Development Company Inc., a private development stage biopharmaceutical company, was founded to develop innovative nanobiological therapeutics for acute inflammation, autoimmunity and allergic conditions based on scientific research...
5/28/15 - EMA Validates Gilead's MAA For Fixed-Dose Combination Of F/TAF For HIV Treatment
FOSTER CITY- Gilead Sciences, Inc. announced that its Marketing Authorization Application or MAA for two doses of an investigational fixed-dose combination of emtricitabine and tenofovir alafenamide or F/TAF has been fully validated and is now under evaluation by the European Medicines Agency or EMA. An MAA for an investigational once-daily single.
5/28/15 - Embera NeuroTherapeutics Initiates Phase 1 Clinical Trial to Test EMB-001 as a Novel Treatment for Addictions
BOSTON& SHREVEPORT, La. Embera NeuroTherapeutics, Inc., a specialty pharmaceutical company developing novel treatments for smoking cessation, cocaine use disorder and other addictions, today announced the first subject received the initial dose in a Phase 1 clinical trial evaluating EMB-001. A novel combination of the FDA- approved drugs metyra
5/28/15 - FDA Approves IBS-D Drugs, GBIM Plunges On Hepatitis B Drug Data, RTRX On A High
WASHINGTON- Valeant Pharmaceuticals International Inc.' s wholly owned subsidiary, Salix Pharmaceuticals Inc., has received FDA approval for Xifaxan 550 mg for the treatment of irritable bowel syndrome with diarrhea in adults. Sales of Xifaxan 550 mg during the first four full quarters following the expanded approval approval are expected to be bet
5/28/15 - FDA approves Salix treatment for irritable bowel syndrome [The News & Observer (Raleigh, N.C.)]
May 28 Federal regulators on Wednesday approved Salix Pharmaceuticals best-selling drug Xifaxan for the treatment of irritable bowel syndrome. The ruling by the Food and Drug Administration was widely expected, and was a major reason that Valeant Pharmaceuticals paid $11.1 billion to acquire Salix in early April. Salix had earlier said it believe
5/28/15 - Former CEO and Chair of the Council of Experts at the USP, Roger L. Williams, MD, Joins NDA Partners as a Premier Expert Consultant
Carl Peck, MD, Chairman of NDA Partners LLC announced today that Roger L. Williams, MD, has joined the firm as a Premier Expert consultant. Prior to that he served in various positions at the FDA Center for Drug Evaluation and Research, including Director of the Office of Generic Drugs; Deputy Center Director, Office of Pharmaceutical Sciences; and
5/28/15 - Hanmi Pharmaceutical to Present Its New Targeted Lung Cancer Drug 'HM61713' at 2015 ASCO Annual Meeting
Hanmi Pharmaceutical co., Ltd. will present the results of the phase I/II domestic clinical trial of HM61713 in patients with EGFR mutation positive non-small cell lung cancer at the 51 st American Society of Clinical Oncology Annual Meeting, taking place May 29- June 2, 2015, in Chicago, USA. During the conference, Hanmi Pharmaceutical will partic
5/28/15 - Heron Therapeutics Announces Positive Results from Phase 3 MAGIC Study of SUSTOL
Heron Therapeutics, Inc. today announced positive, top-line results from its recently completed Phase 3 MAGIC study. MAGIC evaluated the efficacy and safety of the Company s 5- HT 3 receptor antagonist product candidate SUSTOL as part of a three-drug regimen with the intravenous neurokinin-1 receptor antagonist fosaprepitant and the IV...
5/28/15 - Ibrutinib (IMBRUVICA) in Combination with Anti-PD-L1 Antibody (MEDI4736) Study Commences for Patients with Two Relapsed/Refractory Blood Cancers
Pharmacyclics, Inc. today announced the initiation of PCYC-1136-CA, a multi-center study that will investigate the use of ibrutinib in combination with MEDI4736, an investigational anti-PD-L1 immune checkpoint inhibitor being developed by AstraZeneca. IMBRUVICA is jointly developed and commercialized by Pharmacyclics and Janssen Biotech, Inc..
5/28/15 - IGI Laboratories, Inc. Announces Third ANDA Submission Of 2015
IGI Laboratories, Inc., a New Jersey based specialty generic pharmaceutical company, today announced it has submitted its third abbreviated new drug application to the U.S. Food and Drug Administration of 2015, which brings the Company's total number of ANDA submissions now pending at the FDA to twenty-five. We believe our current pipeline of twe
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