The company said the Phase I clinical trial will commence at four leading oncology centres in the USA, and can expand into two centres in the United Kingdom. According to a release, ADCT-301 combines HuMax-TAC, a monoclonal antibody targeting CD25 created by Genmab A/S, with a pyrrolobenzodiazepine warhead. Steven M. Horwitz, Medical Oncologist at
ARCA biopharma provided an update on GENETIC-AF, the Company's Phase 2 B/3 clinical trial evaluating Gencaro as a potential treatment for atrial fibrillation. In a release, ARCA noted it was founded on the belief that a personalized medicine approach to drug development, tailoring medical treatment to the individual genetic characteristics of each.
-BioPlus Specialty Pharmacy, one of the nation's leading innovative specialty pharmacies, announces the promotion of Sharon Ferrer to the newly created position of Vice President of Pharmaceutical Relations. Sharon has built strong relationships with the most prominent pharma companies, giving us the opportunity for BioPlus to become a' top 10' spe
Celator Pharmaceuticals reported business highlights and financial results for the fourth quarter and year ended December 31, 2014. "In 2014, Celator continued to meet important milestones as we look to leverage our CombiPlex platform to introduce a new medical standard for combining cancer therapies," said Scott Jackson, chief executive officer o
Cerecor reported the results of an exploratory inpatient pharmacokinetic/ pharmacodynamic study and the results of a Phase 2 outpatient efficacy study of CERC-301 for the adjunctive treatment of patients with major depressive disorder, who had recently experienced suicidal ideation. "The goal of our Phase 2 efficacy study was to recapitulate the r
Biotronik reported that the Food and Drug Administration has approved its ProMRI Eluna pacemaker system. In a release, Biotronik noted that its ProMRI technology allows patients to undergo full-body magnetic resonance imaging scans with both single-chamber and dual-chamber Eluna pacemakers when implanted with Setrox pacing leads.
Flex Pharma reported the appointment of Thomas Wessel, M.D., Ph.D., as its Chief Medical Officer, reporting to Christoph Westphal M.D., Ph.D., Flex Pharma's President, CEO and Chair. Flex Pharma also announced that Elizabeth Woo, M.B.A., has been promoted to Senior Vice President, Investor Relations and Corporate Communications. Before joining Sepr
The event will be held May 4 and 5 in Franklin, Tennessee. Only products which are FDA approved, or those that have completed clinical trials, been submitted to the FDA, and are pending approval will be reviewed. The deadline for supplier submissions is March 31.
March 27 Lake Forest- based Hospira released clinical data Friday for its drug Retacrit, which could become the company's first U.S.-approved biosimilar drug. Retacrit, approved in Europe since 2008, treats anemia as a similar, low-cost version of Amgen's biologic drug Epogen. Hospira submitted its application for Retacrit to the Food and Drug...
The J.R. Simplot Company said it completed the food and feed safety consultation with the Food and Drug Administration for its first generation of Innate potato varieties. In a release, the Company noted that the FDA concluded the Innate potato is as safe and nutritious as conventional potatoes. The FDA statement comes after the recent U. S. Depart
Davis Polk advised the underwriters on a $200 million SEC- registered offering of common stock of Esperion Therapeutics, Inc. The common stock is listed on the NASDAQ Global Market under the symbol ESPR. Esperion Therapeutics, based in Ann Arbor, Michigan, is an emerging pharmaceutical company focused on developing and commercializing first in-clas
Maryland's Emergent BioSolutions secured FDA approval for an injected treatment for anthrax infection, growing the company's stable of biodefense products. Developing picked up Anthrasil in its $222 Million acquisition of Cangene in 2013, inheriting a $160 Million contract with the federal Biomedical Advanced Research and Development Authority.
United States: PPD, a Leading Global Contract Research Organization, Reduces Costs of Clinical Trials by Migrating Data to the Oracle Health Sciences Cloud. PPD is the first CRO to migrate trials from an onsite installation of Oracle s Siebel Clinical Trial Management System to Siebel Clinical Trial Management System Cloud Service creating a highly
Warrant Programme- Veloxis Pharmaceuticals A/S issues new shares in connection with exercise of warrants. Veloxis Pharmaceuticals A/S announces that the company's capital has been increased by 93,416 new shares with a nominal value of DKK 0.10 each corresponding to nominal DKK 9,341.60 as a consequence of the exercise of warrants by former employee
By a News Reporter-Staff News Editor at Drug Week A patent application by the inventors Shah, Manish S.; DiFalco, Ray J., filed on November 7, 2014, was made available online on March 12, 2015, according to news reporting originating from Washington, D.C., by NewsRx correspondents. This patent application has not been assigned to a company or ins
On May 28, 2014, Adamis submitted an NDA to the FDA pursuant to Section 505 of the Food, Drug& Cosmetic Act, as amended, for approval of the Epinephrine PFS product. The questions raised by the FDA pertain only to Chemistry, Manufacturing and Controls relating to the volume of dose delivered by the syringe, including the ability to deliver volume w
Ariad Pharmaceuticals and Medison Pharma reported that the Israeli Ministry of Health has granted regulatory approval for Iclusig in Israel. "Iclusig is an important addition to the treatment armamentarium," said Professor Arnon Nagler, head of hematology and the Bone Marrow Transplant Division at the Chaim Sheba Medical Center in Israel, and chai
Boston Scientific reported that three patients in the United States received the first implants of its WATCHMAN Left Atrial Appendage Closure Device. The WATCHMAN Device received U.S. Food and Drug Administration approval on Friday, March 13. "Boston Scientific is proud to work with physicians in making a meaningful impact on patient lives by brin
-Calithera Biosciences, Inc., a clinical-stage pharmaceutical company focused on discovering and developing novel small molecule drugs directed against tumor metabolism and tumor immunology targets for the treatment of cancer, announced today its financial results for the fiscal fourth quarter and year ended December 31, 2014. As of December 31, 20
CASI Pharmaceuticals, Inc., a biopharmaceutical company dedicated to the acquisition, development and commercialization of innovative therapeutics addressing cancer and other unmet medical needs for the global market with a commercial focus on China, today reported financial results for the three and 12 months ended December 31, 2014.
We are a biopharmaceutical company focused on the acquisition, development and commercialization of innovative therapeutics addressing cancer and other unmet medical needs with a strategic commercial focus on the greater China market. Our mission is to deliver pharmaceutical drugs to patients with unmet medical needs directly in China, and in the r
"Over the past year, we have executed against this goal by building out a new management team, securing a Nasdaq listing, attracting new institutional investors, obtaining FDA approval to initiate clinical trials in two different orphan indications and publishing multiple high profile manuscripts detailing the groundbreaking nature of our product..
Earlier this year, the Capillus272Pro? received FDA clearance for the promotion of hair regrowth in adult men and women with androgenic alopecia having Ludwig Savin classifications I-II or Norwood Hamilton classifications of IIa-V and Fitzpatrick Classification of Skin phototypes I-IV. "I am extremely excited that the U.S. Food and Drug Administ
WASHINGTON, March 27 The U.S. Department of Health& Human Services published the following proposed rule in the Federal Register from the Food& Drug Administration:. A Proposed Rule by the Food and Drug Administration on 03/27/2015. Dates: The public hearing will be held on April 20 and 21, 2015, from 9 a.m. to 4 p.m. The meeting may be extended
Flamel Technologies today announced the results of a First-in-Man clinical study in healthy volunteers using its proprietary LiquiTime drug delivery platform applied to guaifenesin, a broadly used expectorant. The chosen formulation will be optimized and scaled up over the coming months and Flamel plans to perform a pivotal study in 2016. There