By a News Reporter-Staff News Editor at Drug Week Acceleration Laboratory Services Inc., a unit of Acceleration Scientific LLC, a leader in drug development and contract research, announced their acceptance of the 2014 CRO Leadership Awards from Life Science Leader magazine in the categories of Regulatory, Innovation, Productivity and Reliability
By a News Reporter-Staff News Editor at Health& Medicine Week Actavis plc confirmed that the United States Court of Appeals for the Federal Circuit has reversed a lower court ruling that Actavis' generic version of Shire's Lialda infringes United States Patent No. 6,773,720. Actavis' Abbreviated New Drug Application for its generic version of Lia
BioAlliance Pharma SA, a company specialized in the development of drugs within orphan oncology diseases, and Topotarget A/S, a Scandinavian-based biopharmaceutical company, have announced their intention to merge to create a leading orphan oncology company with a highly complementary pipelines of late-stage products addressing significant unmet...
Boston Scientific Corp. has received FDA approval for its latest generation of defibrillators and heart failure devices designed to advance patient care. These newly approved devices continue the Boston Scientific history of projected longevity and a six-year CRT-D warranty. Extending the Boston Scientific portfolio of defibrillators, the ICDs in t
Certara, a technology-enabled drug development and drug safety consultancy, announced that it has acquired specialty contract research organization Synchrogenix Information Strategies Inc.. Donald A. Deieso, Chairman of Certara, said, "Pharmaceutical companies are looking for greater value and increased synergies from their outsourcing partners.
Release date- 17042014- The U.S. Food and Drug Administration today approved Ragwitek, the first allergen extract administered under the tongue to treat short ragweed pollen induced allergic rhinitis, with or without conjunctivitis, in adults 18 years through 65 years of age. 'The approval of Ragwitek offers millions of adults living with ragweed p
By a News Reporter-Staff News Editor at Drug Week Investigators discuss new findings in Drugs and Therapies. According to news reporting from Houston, Texas, by NewsRx editors, the research stated, "The pharmacology, pharmacokinetics, clinical efficacy, and safety of a first-in-class protein synthesis inhibitor for use in treatment-resistant chro
Peter G. Traber, President, Chief Executive Officer, and Chief Medical Officer of Galectin Therapeutics Inc. "These positive results have propelled the enrollment of the second cohort with strong participation across our clinical trial sites. In 2013, Galectin Therapeutics received Fast Track designation from the FDA for this clinical development..
Release date- 17042014- GlaxoSmithKline plc and Genmab A/S announced today that the U.S. Food and Drug Administration has approved a Supplemental Biologic License Application for the use of Arzerra, a CD20-directed cytolytic monoclonal antibody, in combination with chlorambucil for the treatment of previously untreated patients with chronic...
Lannett Company, Inc. said that it has received approval from the U.S. Food and Drug Administration of its Abbreviated New Drug Application for Diazepam Oral Solution, 5 mg/ mL, a Schedule C-IV controlled drug. "We believe our ANDA for Diazepam Oral Solution, 5 mg/mL was the first bioequivalent Diazepam Oral Solution product approved by the FDA,"
ProTrials Research, Inc., a company focusing on the clinical research organization industry, announced the completion of a large Phase III clinical study examining the safety and effectiveness of a new treatment for dry eye disease, a chronic condition affecting approximately 25 million people in the U.S. According to a release, this milestone adds
Reverse Medical Corp. has announced FDA IDE approval for clinical investigation of their BARREL Vascular Reconstruction Device. "FDA approval of this clinical trial represents a significant accomplishment, and we're excited to begin evaluating this promising endovascular treatment alternative for patients with limited options available today.
TransTech Pharma has announced that effective March 28, Stephen L. Holcombe, who previously served as the Company's Senior Vice President and Chief Financial Officer, has been appointed to serve as the President of TransTech and its sister company High Point Pharmaceuticals. In a release, the Company said that Holcombe will also continue his duties
Tokai Pharmaceuticals, Inc., a biopharmaceutical company focusing on developing new treatments for prostate cancer and other hormonally driven diseases, have announced the appointment of Karen J. Ferrante, M.D. as head of R&D and chief medical officer. Ferrante, formerly oncology therapeutic area head for Takeda Pharmaceuticals and the Takeda Cambr
United Kingdom: GSK and Genmab receive FDA approval for Arzerra as first-line treatment in combination with chlorambucil for patients with Chronic Lymphocytic Leukaemia for whom f. GlaxoSmithKline plc and Genmab A/S announced today that the U.S. Food and Drug Administration has approved a Supplemental Biologic License Application for the use of.
The U.S. Food and Drug Administration today approved Ragwitek, the first allergen extract administered under the tongue to treat short ragweed pollen induced allergic rhinitis, with or without conjunctivitis, in adults 18 years through 65 years of age. The approval of Ragwitek offers millions of adults living with ragweed pollen allergies in the Un
Vivolux AB, a drug discovery company specialized in cancer treatment, announced that the FDA has granted clearance to proceed with VLX600 into the clinical phase I/II. VLX600 is one of the company's promising projects, and which was recently published in the journal Nature Communications. The study will be conducted in collaboration with Mayo Clini
By a News Reporter-Staff News Editor at Politics& Government Week A patent application by the inventors Verner Rashkovsky, Ines; Vaynberg, Boris, filed on September 25, 2012, was made available online on April 3, 2014, according to news reporting originating from Washington, D.C., by VerticalNews correspondents. This patent application has not be
Under the terms of the agreement, Actavis will grant Mylan a license to market its generic version of Generess FE under its pending Abbreviated New Drug Application beginning on April 1, 2015. x0D;. Alternatively, Mylan will be permitted to launch an authorized generic version of Actavis' product beginning on October 1, 2015. Actavis remains i
Agios Pharmaceuticals, Inc., a leader in the fields of cancer metabolism and inborn errors of metabolism, today announced dose administration of AG-348 in a Phase 1 study in healthy volunteers. Today s announcement marks the initiation of our first clinical program in IEMs and our third as a company, said David Schenkein, M.D., chief execu
Licensed to Merck for North America by ALK, RAGWITEK (r) is an allergen extract indicated as immunotherapy for the treatment of short ragweed pollen-induced allergic rhinitis with or without conjunctivitis confirmed by positive skin test or in vitro testing for pollen-specific IgE antibodies for short ragweed pollen. Jens Bager, ALK's President and
Licensed to Merck for North America by ALK, RAGWITEK is an allergen extract indicated as immunotherapy for the treatment of short ragweed pollen-induced allergic rhinitis with or without conjunctivitis confirmed by positive skin test or in vitro testing for pollen-specific IgE antibodies for short ragweed pollen. Jens Bager, ALK s President a
Ansell Capital Corp. is extremely pleased to announce that it has entered into a binding letter of intent for the arm's length acquisition of 100% of the issued and outstanding common shares of BriaCell Therapeutics Corp., a private cancer immunotherapy company incorporated under the laws of the State of Delaware with its head office in Los Angeles
ARCA biopharma, Inc., a biopharmaceutical company developing genetically targeted therapies for cardiovascular diseases, today announced that the first patient has been genetically screened in GENETIC-AF, its Phase 2 B/3 adaptive design clinical trial. Michael R. Bristow, President and CEO, ARCA biopharma, Inc. Dr. Michael R. Bristow, President and
BioAlliance Pharma SA, a Company specializing in the development of drugs in orphan oncology diseases, announced that the European Independent Board of Experts, in charge of the safety profile of the ReLive Phase III trial, held its fourth meeting and once more unanimously recommended continuing the study without modification. As of today, about 40