Acceleron Pharma Inc., a clinical stage biopharmaceutical company focused on the discovery, development and commercialization of novel therapeutic candidates that regulate cellular growth and repair, announced that a late breaking abstract describing results from the ACE-083 Phase 1 clinical trial has been selected for an oral plenary presentation.
Advaxis, Inc., a clinical-stage biotechnology company developing cancer immunotherapies, announced that the European Medicines Agency granted Orphan Drug Designation for ADXS-HER2 for the treatment of osteosarcoma.. Receiving Orphan Drug Designation from the EMA is another significant step forward for Advaxis as we continue to advance ADXS-HER
Dolphin Neurostim, the first point locator and stimulator to be cleared by the FDA for over-the-counter use, is now available in the United States enabling patients to treat themselves for the first time at home. Senior Dolphin Instructor: Kelly Armstrong, OTR/L, MPP International author, speaker and educator Kelly Armstrong has been an Occupatio
Bristol-Myers Squibb will present data for elotuzumab, an investigational immunostimulatory antibody, in patients with relapsed or refractory multiple myeloma; for Opdivo for an investigational use in patients with R/R classical Hodgkin lymphoma; and for Sprycel in chronic myeloid leukemia. x0D;. Results from the primary analysis of the ELOQUENT-
Cellceutix Corporation, a clinical stage biopharmaceutical company developing innovative therapies with oncology, dermatology, anti-inflammatory and antibiotic applications, is pleased to announce that on November 30, 2015 the U.S. Food and Drug Administration granted Rare Pediatric Disease Designation to Kevetrin for the treatment of...
MiMedx Group, Inc., the leading regenerative medicine company utilizing human amniotic tissue and patent-protected processes to develop and market advanced products and therapies for the Wound Care, Surgical, Orthopedic, Spine, Sports Medicine, Ophthalmic, and Dental sectors of healthcare, announced today an update of its products' coverage by co
Deciphera Pharmaceuticals, a clinical-stage biotechnology company focused on developing advanced kinase inhibitor treatments targeting the tumor cell and the tumor microenvironment, today announced that Michael D. Taylor, Ph.D., Deciphera s President and Chief Executive Officer will present a corporate update at the Oppenheimer 26 th Annual...
In October, the FDA recommended that Qualgen cease sterile operations until appropriate corrective actions have been implemented by the facility, and recall all non-expired drugs. x0D;. "As soon as we became aware of what the FDA was observing during its September audit, we immediately began correcting the issues." According to Riney, the fact t
Eisai Co., Ltd. announced today that the U.S. Food and Drug Administration has accepted for review a New Drug Application for a once-daily formulation of its antiobesity agent BELVIQ which has the potential to offer patients the convenience of once-daily treatment.Acceptance of the application indicates that the FDA has found the submission to be..
The 98 percent approval rate compares to 86 percent last year and 70 percent in 2012, according to recent FDA figures. For the medical-device industry including Chicago names Abbott Laboratories and Baxter International the approvals could translate into billions of dollars worth of new revenue and profits. The higher numbers come as the FDA is
By a News Reporter-Staff News Editor at Cancer Weekly DENVER- The International Association for the Study of Lung Cancer commends the U.S. Food and Drug Administration's decision to grant accelerated approval for osimertinib, an oral medication for advanced non-small cell lung cancer patients with a specific epidermal growth factor receptor mutat
RAMAT GAN, Israel, December 1, 2015/ PRNewswire/. Molecular Dynamics successfully imaged the first patient on the Valiance X12, its whole-body CZT based digital SPECT/CT prototype at the Chaim Sheba Medical Center in Israel. The scan was completed in the Department of Nuclear Medicine at the Chaim Sheba Medical Center and the clinical study is su
Law360 called Singer "a go-to litigator for drug makers seeking to defend their brand-name prescription drugs from generic challengers" who "helped score a trio of patent victories" for long-time client Allergan Inc. In August 2015, the U.S. Court of Appeals for the Federal Circuit affirmed a win that blocks Allergan's four competitors from selling
Galmed Pharmaceuticals Ltd., a clinical-stage biopharmaceutical company focused on the development of a once-daily, oral therapy for the treatment of liver diseases, announced today that the U.S. Food and Drug Administration has cleared Galmed's Investigational New Drug application for the ARRIVE Study, a proof-of-concept clinical trial that will
By a News Reporter-Staff News Editor at Journal of Technology Legendary guitar maker Paul Reed Smith, founder of PRS Guitars, a team of renowned scientists and physicians and a former Commissioner of the Food and Drug Administration are launching a new technology to develop enhanced sharper x-rays while significantly reducing the amount of radiat
EVENT: Health and Human Services Department; Food and Drug Administration holds a workshop titiled "Clinical Trials-Assessing Safety and Efficacy in Diverse Populations," to discuss approaches in clinical trial design and subgroup analyses for therapeutic product development and life-cycle management.
Nov. 30 Every two weeks, we gather some of the most interesting and intriguing studies from health researchers around the world. Possibly, according to a recent University of Michigan study, which finds that a common ingredient in sunscreens could be an effective antibacterial coating for medical implants, such as pacemakers and replacement joint
Horizon Pharma plc, a biopharmaceutical company focused on improving patients' lives by identifying, developing, acquiring and commercializing differentiated and accessible medicines that address unmet medical needs, today announced it received a Notice of Allowance from the United States Patent and Trademark Office for U.S. patent application numb
ImmunoGen, Inc., a biotechnology company that develops targeted anticancer therapeutics using its antibody-drug conjugate technology, today announced the presentation of new preclinical data with the Company s experimental therapies IMGN529 and IMGN779 to be made at the upcoming American Society of Hematology annual meeting to be held December 5
By a News Reporter-Staff News Editor at Cancer Weekly A new study on Oncology is now available. According to news reporting originating in Erlangen, Germany, by NewsRx journalists, research stated, "When patients present with a perforation of a colon cancer, this situation increases the challenge to treat them properly. The news reporters obtaine
Nov. 30 AUGUSTA, Maine A legislative committee created to examine how Maine uses $50 million a year in tobacco settlement funding disbanded Monday with its mission unfinished because, according to lawmakers, Gov. The committee created this year by the Legislature voted unanimously to order the Department of Health and Human Services to prod
MabVax Therapeutics Holdings, Inc., a clinical-stage oncology drug development company, announces it has filed an Investigational New Drug Application with the U.S. Food and Drug Administration for the Company's lead fully human antibody product HuMab 5 B1 as a therapeutic agent. Subject to FDA acceptance, MabVax plans to initiate the Phase I cli
New Breast Cancer Findings Has Been Reported by Researchers at Cancer Hospital. By a News Reporter-Staff News Editor at Cancer Weekly Fresh data on Oncology are presented in a new report. According to news originating from Shantou, People's Republic of China, by NewsRx correspondents, research stated, "Chromosome 1 open reading frame 63 is locate
VBL Therapeutics, today announced the grant of US Patent No. 9,200,056, entitled "A Fas-Chimera Adenovirus Vector" by the United State Patent Office which covers VB-111, VBL's lead drug candidate. It is a strong addition to our Vascular Targeting System portfolio, "said Erez Feige, Ph.D., Vice President of Business Operations of VBL Therapeutics.
Nivalis Therapeutics, Inc., a clinical stage pharmaceutical company focused on treating people with cystic fibrosis, today announced the first patient was dosed in the Phase 2 clinical study of its lead investigational drug, N91115, a stabilizer of the cystic fibrosis transmembrane conductance regulator protein. We are pleased to initiate the