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 The leading web portal for pharmacy resources, news, education and careers January 31, 2015
Pharmacy Choice - News - Pharmaceutical Development - January 31, 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:

1/31/15 - Actinium Files Pre-IND Meeting Request to FDA for Iomab-B Drug Candidate [Professional Services Close - Up]
Actinium Pharmaceuticals has submitted a request for a pre-IND meeting to the U.S. Food and Drug Administration for the company's Iomab-B drug candidate currently undergoing final preparations to start the pivotal Phase 3 trial in mid-2015. stated Kaushik J. Dave, President and Chief Executive Officer of Actinium Pharmaceuticals "We believe that ou
1/31/15 - Amgen Files Applications in the US and Europe for Kyprolis (carfilzomib) for the Treatment of Relapsed Multiple Myeloma [Manufacturing Close - Up]
Amgen and its subsidiary Onyx Pharmaceuticals reported the submission of a supplemental New Drug Application to the U.S. Food and Drug Administration and a Marketing Authorization Application to the European Medicines Agency for Kyprolis for Injection to seek approval for the treatment of patients with relapsed multiple myeloma who have received at
1/31/15 - FDA OKs Natpara [Professional Services Close - Up]
NPS Pharmaceuticals reported that the U.S. Food and Drug Administration has approved Natpara as an adjunct to calcium and vitamin D to control hypocalcemia in patients with hypoparathyroidism. In clinical studies, Natpara has been shown to increase serum calcium levels and reduce the need for large doses of calcium and active vitamin D, "said Franc
1/31/15 - Insys Therapeutics Secures FDA Orphan Drug Designation for Ovarian Cancer Treatment [Professional Services Close - Up]
Insys Therapeutics reported that the U.S. Food and Drug Administration has granted orphan drug designation to its Liposomal Encapsulated Paclitaxel candidate for the treatment of ovarian cancer. "We are pleased to have received orphan drug designation for LEP- ETU to treat ovarian cancer, a devastating and difficult-to-treat disease," said Michael
1/31/15 - Intercept Pharmaceuticals Soars 20%, Possible Short Squeeze; Vital Therapies Announces VTI-208 Phase 3 Clinical Trial Reaches Enrollment Target
Below is a look at some of the headlines for companies that made news in the healthcare sector on January 30, 2015.{ nfg} Shares of Intercept Pharmaceuticals Inc. soared more than 20 percent Friday following a favorable FDA ruling on Thursday. Intercept Pharmaceuticals recently traded at $209.41, up 22.7 percent.=============================== Vita
1/31/15 - Ireland : ICON Creates New Global Innovation Hub in Ireland to Advance Clinical Development [TendersInfo (India)]
ICON plc, a global provider of outsourced development services to the pharmaceutical, biotechnology and medical device industries, today announced a new global innovation hub which will create 200 new jobs in Ireland. Commenting on the announcement, Ciaran Murray, Chief Executive Officer, ICON plc, said: Since our foundation in Dublin in 1990, ICON
1/31/15 - Lung Therapeutics, Inc. Granted Orphan Drug Designation in the European Union for LTI-01
By a News Reporter-Staff News Editor at Marketing Weekly News Lung Therapeutics, Inc., a pharmaceutical company focused on niche, orphan drug indications addressing unmet therapeutic needs in lung injury and disease, announced that the European Commission has granted the company's lead drug candidate, LTI-01, orphan medicinal product designation
1/31/15 - Real-World Data Published in Clinical Cardiology Show Consistent Safety Performance of Once-Daily XARELTO
By a News Reporter-Staff News Editor at Marketing Weekly News A new post-marketing study evaluating the safety of once-daily XARELTO shows, in patients with non-valvular atrial fibrillation, rates and patterns of major bleeding in routine clinical practice are generally consistent with those observed in Phase 3 clinical trials used to approve the
1/31/15 - Shire Says FDA Approves Vyvanse To Treat Binge Eating Disorder
SAINT HELIER- Shire plc said Friday that the U.S. Food and Drug Administration has approved Vyvanse Capsules, the first and only medication for the treatment of moderate to severe binge eating disorder in adults, shown to significantly reduce the mean number of binge days per week. Vyvanse is not indicated or recommended for weight loss or the trea
1/31/15 - Spectral Charts Course for Potential Commercialization in First Half of 2016 [Professional Services Close - Up]
Spectral Medical detailed continuing progress towards commercialization of a medical device that addresses the critical care needs of patients in a $3 billion market. In its release, Spectral said its septic shock treatment is a medical device currently in an active U.S. Food and Drug Administration approved Phase III clinical trial to address this
1/31/15 - St. Jude Medical Updates on FDA Approval of FlexAbility Ablation Catheter [Professional Services Close - Up]
St. Jude Medical reported U.S. Food and Drug Administration approval of the FlexAbility Ablation Catheter, a new ablation technology used by electrophysiologists for the treatment of cardiac arrhythmias. Andrea Natale, executive medical director at the Texas Cardiac Arrhythmia Institute. "As we developed the FlexAbility ablation catheter, we worke
1/31/15 - SynteractHCR to Present at International and Domestic Clinical Trials Conferences [Professional Services Close - Up]
SynteractHCR will participate in two biopharmaceutical and life science conferences in early February: the European CRO Federation's 2nd European Conference on Clinical Research in Paris, and the 7th Annual Outsourcing in Clinical Trials West Coast Conference in San Francisco. Martine Dehlinger-Kremer, is attending EUCROF's conference and chairing
1/31/15 - United States : FDA expands approved use of Imbruvica for rare form of non-Hodgkin lymphoma [TendersInfo (India)]
Today s approval highlights the importance of development of drugs for supplemental indications, said Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in the FDA s Center for Drug Evaluation and Research. The FDA initially granted Imbruvica accelerated approval in November 2013 for use in patients with mantle cell ly
1/31/15 - United States : U.S. FDA Approves IMBRUVICA(ibrutinib) for the Treatment of Waldenstrom's Macroglobulinemia: First FDA-Approved Therapy for This... [TendersInfo (India)]
Janssen Biotech, Inc. today announced that the U.S. Food and Drug Administration has approved IMBRUVICA capsules as the first therapy indicated specifically for patients with Waldenstrm s macroglobulinemia, a rare, indolent type of B-cell lymphoma. IMBRUVICA was granted Breakthrough Therapy Designation for WM by the FDA and is being jointly devel
1/31/15 - Vyvanse (lisdexamfetamine dimesylate) Capsules (CII) Becomes First and Only Treatment Approved by the FDA for Adults with Moderate to Severe Binge Eating Disorder
Shire plc announced today that the U.S. Food and Drug Administration approved Vyvanse Capsules, the first and only medication for the treatment of moderate to severe binge eating disorder in adults, shown to significantly reduce the mean number of binge days per week. "Binge eating disorder is the most common adult eating disorder in the Unit
1/31/15 - Zogenix Receives FDA Approval of New Formulation of Zohydro(R) ER
Zogenix, Inc., a pharmaceutical company developing and commercializing products for the treatment of central nervous system disorders, today announced that the U.S. Food and Drug Administration has approved a new formulation of Zohydro ER Extended-Release Capsules, CII, with BeadTek?. Concurrently, Zogenix has ongoing Human Abuse Liability s
1/30/15 - #SaveJosh legislation moves forward in General Assembly [The Free Lance-Star, Fredericksburg, Va.]
Jan. 30 Bills proposed in the General Assembly inspired by Fredericksburg's Josh Hardy's story had mixed results in House of Delegates and Senate hearings Thursday. Margaret Ransone's bill was passed by the House Health Welfare and Institutions Committee today. It allows the physician and patient to go straight to the manufacturer and bypasses th
1/30/15 - 72% of Pharma Companies' Managed Markets Groups Begin Supporting Products in Phase 3
A recent study found that 72% of pharmaceutical companies managed markets teams begin supporting new products during Phase 3 development, according to pharmaceutical intelligence firm Cutting Edge Information. Another 14% of these teams begin as early as Phase 1.. "Previewing the product with payers opens the account managers to future discussions
1/30/15 - Amgen Files Applications in the US and Europe for Kyprolis (carfilzomib) for the Treatment of Relapsed Multiple Myeloma [Professional Services Close - Up]
Amgen and its subsidiary Onyx Pharmaceuticals reported the submission of a supplemental New Drug Application to the U.S. Food and Drug Administration and a Marketing Authorization Application to the European Medicines Agency for Kyprolis for Injection to seek approval for the treatment of patients with relapsed multiple myeloma who have received at
1/30/15 - Bristol-Myers' Evotaz gets FDA approval for HIV-1 treatment in adults [EMBIN (Emerging Markets Business Information News]
The US Food and Drug Administration has approved Bristol-Myers Squibb's Evotaz tablets in combination with other antiretroviral agents to treat HIV-1 infection in adults. The once-daily Evotaz is a combination of the protease inhibitor atazanavir, marketed as Reyataz capsules, and cobicistat, a pharmacokinetic enhancer marketed by Gilead Sciences.
1/30/15 - Chimerix Focusing Efforts on CMV and Adenovirus Pivotal Trials
Chimerix, Inc., a biopharmaceutical company developing novel, oral antivirals in areas of high unmet medical need, today announced that after discussion with the U.S. Food and Drug Administration, the company is ceasing further participation in all current and future clinical studies of brincidofovir for Ebola Virus Disease, including the study a
1/30/15 - Data from Veterans Affairs Medical Center Provide New Insights into Abdominal Aortic Aneurysm (Costs of repair of abdominal aortic aneurysm with...
By a News Reporter-Staff News Editor at Insurance Weekly News Investigators publish new report on Cardiovascular Diseases and Conditions. Our news journalists obtained a quote from the research from Veterans Affairs Medical Center, "Within each selected system, EVR costs are compared with open repair costs. Health care utilization data were obtai
1/30/15 - Dr. Jeffrey H. Lawson to Keynote at the International Symposium for Endovascular Therapy [Professional Services Close - Up]
Jeffrey H. Lawson, M.D., Ph.D., Vice Chair for Research, Professor of Surgery and Pathology at Duke University Medical Center, Director of the Vascular Research Laboratory, Director of Clinical Trials for the Department of Surgery and clinical consultant to Humacyte, is the keynote speaker at the 27th International Symposium on Endovascular Therapy
1/30/15 - DrugDev Hosts New Educational Webinar, Silent Partners? How Virtual Clinical Trials Impact Sites on February 12 with Nathan Morton of Coastal Carolina Research Center
How Virtual Clinical Trials Impact Sites on February 12, featuring expert speaker Nathan Morton, Director and Co-Owner of Coastal Carolina Research Center. How Virtual Clinical Trials Impact Sites Guest Speaker: Nathan Morton, Director and Co-Owner, Coastal Carolina Research Center Date: February 12, 2015 Time: 10:00 -11: 00 am EST CLICK TO R
1/30/15 - FDA approves ADHD drug for binge-eating disorder
WASHINGTON Federal health regulators have approved an attention deficit disorder drug for a new use: A first-of-its kind treatment for binge-eating disorder. About 2 percent of U.S. adults, or about 5 million people, have binge eating disorder, according to the Department of Health and Human Services. The Food and Drug Administration originally
Articles(s): 1 - 25 of 250     Next >>     Go To Page:


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