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
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
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
Release date- 29012015- HORSHAM, PA- 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 Waldenstrom's macroglobulinemia, 1 a rare, indolent type of B-cell lymphoma. IMBRUVICA was granted Breakthrough Therapy Designation for WM
Octagam 10 percent for the U.S. market can now be manufactured at FDA- licensed facilities in both Stockholm, Sweden and Vienna. "The FDA approval of Octapharma's Vienna manufacturing site for Octagam 10 percent is great news for patients, as it will help facilitate product availability and enhances production flexibility," said Flemming Nielsen,
Reports Summarize Nephrology Study Results from Toranomon General Hospital. According to news originating from Tokyo, Japan, by NewsRx correspondents, research stated, "Topiroxostat, a selective xanthine oxidase inhibitor, shows effective reduction in the serum urate level in hyperuricemic patients with or without gout. Our news journalists obtaine
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
Array Biopharma had its price objective raised by Stifel Nicolaus from $6.00 to $9.00 in a research report released on Monday morning. Analysts at Zacks downgraded shares of Array Biopharma from an outperform rating to a neutral rating and set a $5.20 price target on the stock in a research note on Tuesday, January 6th. Separately, analysts at Jeff
Studies from University of Trondheim Hospital Further Understanding of Hallux Valgus. By a News Reporter-Staff News Editor at Energy Weekly News Researchers detail new data in Musculoskeletal Diseases and Conditions. According to news reporting originating in Trondheim, Norway, by VerticalNews editors, the research stated, "We conducted a prospec
Novo Nordisk declared that the Food and Drug Administration has given green signal to a new 30 mg/3. 0 mL strength of Norditropin FlexPro pen. Norditropin FlexPro is indicated for growth failure in children due to inadequate endogenous GH secretion, children with short stature associated with Noonan or Turner syndrome, children with short stature b
Symplmed Pharmaceuticals reported that the U.S. Food and Drug Administration has approved Prestalia tablets, licensed from Servier, for the treatment of hypertension. "This is a significant milestone for Symplmed and for our development partner Servier as it is the first product from our perindopril pipeline to receive FDA approval," said Erik Eme
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
Theravectys reported the grant of EUR1.9 million from Bpifrance in the form of a repayable advance as part of the Development of Innovation Assistance program. With this support, Theravectys will be able to accelerate the optimization of its manufacturing process and the production of lentiviral vectors and T-cell therapies to be used in clinical t
The U.S. Food and Drug Administration has called off Ranbaxy Laboratories s 180- day exclusivity to market esomeprazole magnesium delayed release capsule 20 mg and 40 mg in the U.S. Ranbaxy commented On November 4, 2014, we received a notice from the US FDA rescinding our tentative approvals for esomeprazole magnesium delayed release capsule 20 mg
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
AgeneBio, a pharmaceutical company developing innovative therapeutics for unserved patients battling amnestic mild cognitive impairment, the pre-dementia stage of Alzheimer's disease, and other neurological and psychiatric diseases, announced that the company has received a $900,000 grant from the Alzheimer's Drug Discovery Foundation.
AliveCor, Inc. announced today that the U.S. Food and Drug Administration has granted the company clearance for two new algorithms giving users instant feedback on their electrocardiogram recordings and expanding its automated interpretation service offerings. AliveCor's new analysis processes include a Normal Detector that identifies when no...
Aquinox Pharmaceuticals, Inc., a clinical-stage pharmaceutical company discovering and developing targeted therapeutics in disease areas of inflammation and immuno-oncology, announced today that David Main, Aquinox's President& CEO, will present a corporate overview at two upcoming investor conferences. 2015 Leerink Global Healthcare Conference..
Research analysts at Stifel Nicolaus boosted their target price on shares of Array Biopharma from $6.00 to $9.00 in a report released on Monday. Analysts at Zacks downgraded shares of Array Biopharma from an outperform rating to a neutral rating and set a $5.20 price target on the stock in a research note on Tuesday, January 6th. Separa
Debbie's significant experience leading the pulmonary arterial hypertension program for Novartis Pharmaceuticals AG, combined with her tenures as a physician at Massachusetts General Hospital and Harvard Medical School, where she focused on pulmonary and critical care medicine, make her a natural choice as the medical lead of our INOpulse programs.
By a News Reporter-Staff News Editor at Gene Therapy Weekly BioRestorative Therapies, Inc., a life sciences company focused on adult stem cell-based products and therapies for various personal medical applications, announced that it has had a successful pre-investigational new drug meeting with the U.S. Food and Drug Administration concerning its
Cellceutix Corp. reported that results of its recently completed phase 2 b clinical trial "A Randomized, Double-Blind Study Comparing Single-Dose and Short-Course Brilacidin to Daptomycin in the Treatment of Acute Bacterial Skin& Skin Structure Infections" will be given in an oral presentation at the European Congress of Clinical Microbiology and..
January 29, 2015 Radnor, Penn., U.S. and Gteborg, Sweden Cortendo AB [ticker: CORT on NOTC-A], a global biopharmaceutical company initially focused on orphan endocrine disorders, today announced that it will present the study protocol of its global Phase 3 study of COR-003 in patients with endogenous Cushing's syndrome at ENDO 2015: The E
Fourth quarter 2014 revenue grows to $9.0 million, a 24 percent increase from the prior quarter and a 119 percent increase from the same period last year Full year 2014 revenue of $26.6 million exceeds 2013 results by 156 percent 2015 revenue guidance is $47-53 million Dose-finding study completed; efficacy study beginning in Phase 1/ 2 trial of Ko
RADNOR, Pa.& STOCKHOLM Regulatory News:. Cortendo AB, a global biopharmaceutical company initially focused on orphan endocrine disorders, today announced that it will present the study protocol of its global Phase 3 study of COR-003 in patients with endogenous Cushing s syndrome at ENDO 2015: The Endocrine Society s 97th Annual Meeting& E