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 The leading web portal for pharmacy resources, news, education and careers October 26, 2014
Pharmacy Choice - News - Pharmaceutical Development - October 26, 2014

Pharmacy News

 Pharmaceutical Development
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10/25/14 - Bracco Diagnostics Reports U.S. FDA to Approve Ultrasound Contrast Agent [Professional Services Close - Up]
Bracco Diagnostics recently reported that the U.S. Food and Drug Administration approved its new ultrasound contrast agent Lumason for injectable suspension, indicated for use in adults with suboptimal echocardiograms to opacify the left ventricular chamber and to improve the delineation of the left ventricular endocardial border.
10/25/14 - Bracco Diagnostics Secures FDA Approval for New Ultrasound Contrast Agent [Professional Services Close - Up]
Bracco Diagnostics recently reported that the U.S. Food and Drug Administration has approved its new ultrasound contrast agent Lumason for injectable suspension, indicated for use in adults with suboptimal echocardiograms to opacify the left ventricular chamber and to improve the delineation of the left ventricular endocardial border.
10/25/14 - Clinical trials of 2 Ebola vaccines starts,results will be available in December [Cihan News Agency (Turkey)]
Marie Paule Kieny, told reporters that the clinical trials will be conducted on the two "most advanced" vaccines and "at least 5 more vaccines" will be in the clinic in the first months of 2015. Kieny said the pharmaceutical companies developing these vaccines "are committing to ramping up the production capacity to millions of doses to be availabl
10/25/14 - Concert Pharmaceuticals Reports on CTP-354 Data [Professional Services Close - Up]
Concert Pharmaceuticals recently reported Phase 1 data of CTP- 354, a novel, non-sedating, once-daily oral treatment for spasticity. According to a release from Concert Pharmaceuticals, the Company presented the findings October 10 during a poster session at the American Neurological Association's Annual Meeting in Baltimore, Maryland.
10/25/14 - Eisai Gets FDA Approval of sNDA for Rufinamide [Manufacturing Close - Up]
Eisai recently reported that the U.S. Food and Drug Administration accepted the company's sNDA for rufinamide and granted it priority review designation as an adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome in pediatric patients from 1 to 4 years of age. Priority Review designation was assigned to this sNDA because FDA...
10/25/14 - First Ebola vaccines earmarked for health workers as nations speed ahead with trials: Vaccines to be tested in Liberia and Sierra Leone Drug companies promise millions of doses next year
Ebola vaccine trials are to start in west Africa in December, a month earlier than planned, and hundreds of thousands of doses will be available by mid-2015, the World Health Organisation says. The first vaccinations of health workers and others at high risk, including burial teams, are likely to take place in Liberia, with Sierra Leone not far beh
10/25/14 - Gilead: FDA Approvides Harvoni (Ledipasvir/Sofosbuvir) [Professional Services Close - Up]
Gilead Sciences recently reported that the U.S. Food and Drug Administration has approved Harvoni, a once-daily single tablet regimen for the treatment of chronic hepatitis C genotype 1 infection in adults. Gilead Sciences reported in a release that Harvoni combines the NS5A inhibitor ledipasvir with the nucleotide analog polymerase inhibitor...
10/25/14 - Lundbeck presents new efficacy and safety data analyses for desmoteplase in patients with acute ischaemic stroke
Valby, Copenhagen, 2014-10-25 11:30 CEST In the per-protocol population desmoteplase was associated with better functional outcome compared to placebo as assessed by the modified Rankin Scale In additional data analyses it is suggested that magnetic resonance imaging is more sensitive than computed tomography scanning for identifying appropri
10/25/14 - Pfizer Reports Vaccine Candidate Data [Professional Services Close - Up]
Pfizer presented data from a Phase 1/ Phase 2 study evaluating the safety, tolerability and immunogenicity of a single-dose vaccine of Pfizer's investigational 4- antigen Staphylococcus aureus candidate vaccine in healthy adults. Kathrin Jansen, senior vice president of the Vaccine Research and Early Development unit for Pfizer. IDWeek 2014 is an a
10/25/14 - Provectus Biopharmaceuticals Taps INC Research to Perform FDA Due Diligence Audit [Professional Services Close - Up]
Provectus Biopharmaceuticals recently retained INC Research, a global Phase I to IV contract research organization, to conduct an FDA due diligence audit of its regulatory documents for PH-10 and PV- 10.. In the first phase, INC Research Quality and Compliance Consulting will undertake a regulatory document inventory and evaluation of the contents
10/25/14 - Targeted Medical Pharma Reports PTSD Treatment Trial Results [Professional Services Close - Up]
Targeted Medical Pharma recently reported the results of a clinical trial studying the amino acid based medical foods, Sentra AM and Sentra PM in Veterans suffering from symptoms associated with Posttraumatic Stress Disorder. In a release, Targeted Medical Pharma noted that the purpose of this pilot study was to examine the benefit of nutritional..
10/25/14 - Veristat and Molecular Templates Sign Preferred Provider Deal [Professional Services Close - Up]
"We are elated following the FDA's approval of our IND application for MT-3724 and are eager to begin the next steps of our clinical journey with Veristat. Veristat will support the initiation of our Phase I program, which will assess the safety, pharmacokinetics, pharmacodynamics and clinical activity of MT-3724 in patients with non-Hodgkin's B-Ce
10/24/14 - 'Unsung' cells double the benefits of a new osteoporosis drug
By a News Reporter-Staff News Editor at Health& Medicine Week Experiments in mice with a bone disorder similar to that in women after menopause show that a scientifically overlooked group of cells are likely crucial to the process of bone loss caused by the disorder, according to Johns Hopkins researchers. A summary of their work will be publishe
10/24/14 - AbbVie's HUMIRA adalimumab Receives U.S. FDA Approval for Extension of Polyarticular Juvenile Idiopathic Arthritis Indication to Patients Ages 2 and...
AbbVie's HUMIRA adalimumab Receives U.S. By a News Reporter-Staff News Editor at Health& Medicine Week AbbVie announced that the U.S. Food and Drug Administration has approved the extension of the HUMIRA indication for moderately to severely active polyarticular juvenile idiopathic arthritis to reducing signs and symptoms in patients ages 2 an
10/24/14 - Aphios Granted United States Patent for Nanotechnology Formulation of Poorly Soluble Drugs
By a News Reporter-Staff News Editor at Health& Medicine Week Aphios Corporation announced that it has been granted United States Patent No. 8,703,727 entitled "Nanotechnology Formulation of Poorly Soluble Compounds," for difficult to formulate and deliver drugs. These techniques can be applied to a number of existing drugs as well as to several
10/24/14 - AstraZeneca Gets EMA Marketing Approval For Lynparza Cancer Treatment
LONDON- UK pharmaceutical company AstraZeneca PLC has received approval from the European Medicines Agency for its drug Lynparza, paving the way for the UK pharmaceutical company to start marketing the treatment to ovarian cancer patients. "We are delighted that the CHMP has recommended Lynparza as a first-in-class treatment option for women with.
10/24/14 - Burzynski Research Institute, Inc. Announces FDA Permission to Launch a New Clinical Trial in Diffuse Intrinsic Brainstem Glioma
Burzynski Research Institute, Inc. announced today that the U.S. Food and Drug Administration has given the company permission to conduct an open-label study of Antineoplastons A10 and AS2-1 in patients> 3 months of age with a diffuse intrinsic brainstem glioma. Study subjects will be placed in one of five treatment groups based on their age and
THIRD QUARTER 2014 (JUL SEP) ? Net sales in the quarter amounted to SEK 22.4 (16.8) million, corresponding to an increase of 34 percent. ? Net sales for consumables in the quarter amounted to SEK 21.0 (16.8) million, corresponding to an increase of 25 percent in SEK. Sales for consumables increased by 18 percent in local currency. ? Ope
10/24/14 - Europe Approves Novel Australian Drug Developed for Rare Sun Disease
ZUG, Switzerland& MELBOURNE, Australia The first new pharmaceutical drug invented and developed for an untreated disorder by any Australian company has received regulatory approval from the European Medicines Agency. Since 2006 Australian company Clinuvel Pharmaceuticals has invented, developed and tested SCENESSE . The life of a patient w
10/24/14 - FDA Approves New Treatment for Rare Form of Hemophilia
The U.S. Department of Health and Human Services' Food and Drug Administration issued the following news release:. The U.S. Food and Drug Administration yesterday approved Obizur for the treatment of bleeding episodes in adults with acquired hemophilia A. "The approval of this product provides an important therapeutic option for use in the care of
10/24/14 - Helix BioPharma Corp. Announces Fiscal 2014 Results
Helix BioPharma Corp., a biopharmaceutical company developing drug candidates for the prevention and treatment of cancer, today announced its financial results for the year ended July 31, 2014. Completed a second interim review of data collected for the first eight cohorts in the Company's ongoing European Phase I/II clinical study of L-DOS47 in Po
10/24/14 - Johnson & Johnson Announces Major Commitment to Speed Ebola Vaccine Development and Significantly Expand Production
Release date- 22102014- New Brunswick, N.J- Johnson& Johnson today announced that it has made a commitment of up to $200 million to accelerate and significantly expand the production of an Ebola vaccine program in development at its Janssen Pharmaceutical Companies. The vaccine regimen, which was discovered in a collaborative research program with
10/24/14 - Kimberly-Clark Sterilization Wrap Is Now Most Validated On The Market; First and Only Sterilization Wrap Manufacturer to Receive FDA Clearance for All Standard Sterilization Methods in North America
Release date- 23102014- ROSWELL, Ga- Kimberly-Clark Health Care, soon to be Halyard Health, announced today that it is the first and only manufacturer to receive 510 clearance from the U.S. Food and Drug Administration for use of their sterilization wrap portfolio with all standard sterilization modalities. 'Providing innovation in sterilization te
10/24/14 - Lundbeck Provides Update on New Drug Application for Intravenous Carbamazepine
Lundbeck LLC announced today that it has received a Complete Response Letter from the U.S. Food and Drug Administration for its New Drug Application seeking approval of Carbella? injection, an investigational intravenous formulation of the anti-epileptic drug carbamazepine. Lundbeck is currently addressing requests specified in the letter, and is
10/24/14 - Metabolic Solutions Development Company Appoints Robert L. Zerbe, MD to Board of Managers [Global Data Point]
Dr. Zerbe co-founded and is chief executive officer of QuatRx Pharmaceuticals Company, a venture-backed drug development company that developed the recently launched product for postmenopausal dyspareunia, Osphena . Prior to QuatRx, he served as Senior Vice President of Worldwide Clinical Research and Development of Pfizer, where he led the clini
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