AB Science SA, a pharmaceutical company specialized in research, development and marketing of protein kinase inhibitors, announces that its phase 2 with masitinib in relapsed or refractory peripheral T-cell lymphoma was accelerated into a phase 3 randomized controlled trial. The decision to accelerate the phase 2 into phase 3 was based on the obs
Acasti Pharma Inc., an emerging biopharmaceutical company focused on the research, development and commercialization of new krill oil-based forms of omega-3 phospholipid therapies for the treatment and prevention of certain cardiometabolic disorders, today announced its slate of director nominees for election at its next Annual and Special Meetin
Acceleron Pharma reported that data from two ongoing phase 2 clinical trials of luspatercept in patients with beta-thalassemia and myelodysplastic syndromes will be given as oral presentations at the 20th Congress of the European Hematology Association in Vienna, Austria. Antonio Piga, M.D., Ph.D., San Luigi Gonzaga University Hospital, Torino, Ita
On May 27, 2015, Acorda Therapeutics, Inc. provided an update on the status of its PLUMIAZTM Nasal Spray program. The Company has completed discussions with the U.S. Food and Drug Administration, and is advancing the development of PLUMIAZ. Based on interactions with the FDA, the Company plans to conduct three clinical trials prior to resubmitting
"The FDA's approval of VIBERZI is the first step to providing physicians with a new, evidence-based, treatment option for their adult patients with IBS-D," said David Nicholson, Executive Vice President, Actavis Global Brands R&D. We are very pleased to be working with the FDA to advance this IBS-D treatment and we eagerly await DEA scheduling dete
IRVINE, Calif.& BEDMINSTER, N.J.& RESEARCH TRIANGLE PARK, N.C. Aerie Pharmaceuticals, Inc., a clinical-stage pharmaceutical company focused on the discovery, development and commercialization of first-in-class therapies for the treatment of patients with glaucoma and other diseases of the eye, announced today that Vicente Anido, Jr., Ph.D., Chi
By a News Reporter-Staff News Editor at Biotech Week Amgen announced the first results from its global Phase 2, double-blind, placebo-controlled study evaluating the efficacy and safety of AMG 334 for the prevention of episodic migraine. The data were presented at the 17 Congress of the International Headache Society in Valencia, Spain.
By a News Reporter-Staff News Editor at Biotech Week Angion Biomedica Corp. announced that it plans to commence enrollment of a Phase 3 clinical trial using its investigational drug BB3 to treat delayed graft function in kidney transplant recipients. This Phase 3 "GIFT" trial is a 152- patient, randomized, double-blind, placebo-controlled, multic
Aspyrian Therapeutics Inc. Announces FDA Acceptance of an Investigational New Drug Application for RM-1929, a First-in-Class, Precision-Targeted Therapy for Cancer. By a News Reporter-Staff News Editor at Biotech Week Aspyrian Therapeutics Inc., a drug development company creating precision-targeted therapies to treat cancer based on its...
Aura Biosciences has been granted Orphan Disease Designation by the FDA for its drug AU-011 for the treatment of Uveal Melanoma. The FDA's Orphan Drug Designation program provides orphan status to drugs and biologics, which demonstrate promise for the diagnosis and/or treatment of rare diseases or conditions in the US. Aura's novel approach has the
Chinese pharmaceutical authorities require that when conducting the research and development of biosimilar products in China, the applicant of biosimilar registration application and its sponsor should be in compliance with the Guidance and follow the pathway of license approval of biosimilars. How to grasp the opportunity to smoothly conduct the..
Calimmune Inc., a clinical-stage gene therapy company, has successfully completed its $15 million Series B financing round, led by a large pharmaceutical company. Alexandria Venture Investments also joined with existing investors including RA Capital Healthcare Fund LP and Translational Accelerator LLC. Proceeds will be used to progress the company
James Laufenberg, President and CEO of IGXBio, stated, "I am very excited about this collaboration with Cannabis Science, a company based on our own values of serving the unmet needs of HIV positive patients. The pre-clinical development to date has been largely funded by $21 million in NIH grants. Our collaboration with Cannabis Science is designe
CytRx Corporation, a biopharmaceutical research and development company specializing in oncology, today announced an upcoming poster presentation regarding its lead drug candidate, aldoxorubicin, at the 2015 American Society of Clinical Oncology Annual Meeting, which is being held May 29- June 2, 2015 in Chicago. Based on this data, we are allowe
VANCOUVER, British Columbia and MENLO PARK, Calif., May 27, 2015/ PRNewswire/ DelMar Pharmaceuticals, Inc., a biopharmaceutical company focused on developing and commercializing proven cancer therapies in new orphan drug indications, today announced that it will be presenting at several upcoming investor and scientific conferences. DelMar's data.
DGAP-News: MOLOGEN AG/ Key word: Conference MOLOGEN AG to present poster at ASCO Annual Meeting 27.05. 2015/ 09:57- PRESS RELEASE N 08/ 2015 of 05/27/2015 MOLOGEN AG to present poster at ASCO Annual Meeting Berlin, May 27, 2015- The biotechnology company MOLOGEN AG will present a
By a News Reporter-Staff News Editor at Biotech Week Dicerna Pharmaceuticals, Inc., a leader in the development of RNAi-based therapeutics, announced financial and operational results for the quarter ended March 31, 2015. "In addition, receiving Orphan Drug Designation by the U.S. Food and Drug Administration for DCR-PH1, which we announced in A
By a News Reporter-Staff News Editor at Biotech Week Dicerna Pharmaceuticals, Inc., a leader in the development of RNAi therapeutics, announced that new clinical data from a Phase 1 study of DCR-MYC in patients with solid tumors, multiple myeloma, or lymphoma will be presented at the 2015 American Society of Clinical Oncology Annual Meeting, whic
Although the FDA continues to do their best to police the sale of dangerous and, sometimes illegal, diet products, the online market is simply too vast to prevent all fraudulent companies in a timely manner. For this reason, the FDA encourages consumers to pay strict attention to the validity of products, to investigate the company and its reputati
SAN ANTONIO, May 27, 2015/ PRNewswire-iReach/ A new eye procedure recently approved by the Food and Drug Administration corrects the most common vision problem in adults. The inlay is called "Kamra", because it works to restore the eye's zoom capability, just like a camera. The office of Greg Parkhurst, MD, a San Antonio ophthalmologist, is one o
By a News Reporter-Staff News Editor at Biotech Week Cidara Therapeutics, Inc., a biotechnology company developing novel anti-infectives and immunotherapies to treat fungal and other infections, announced that the U.S. Food and Drug Administration has designated the company's lead antifungal product candidate, CD101 IV, as a Qualified Infectious.
By a News Reporter-Staff News Editor at Biotech Week Irvine, Calif., A first-of-its-kind stem cell-based treatment for retinitis pigmentosa developed by UC Irvine's Dr. Jing Yang and colleagues has received consent from the U.S. Food& Drug Administration for use in a clinical trial. "This milestone is a very important one for our project," said
-Fibrocell Science, Inc.,, an autologous cell and gene therapy company focused on developing first-in-class treatments for rare and serious skin and connective tissue diseases with high unmet medical needs, today announced that David Pernock, Chairman and Chief Executive Officer, will present at the Jefferies 2015 Global Healthcare Conference at...
G1 Therapeutics, Inc., a clinical-stage oncology company, announced today that its lead compound G1T28, a highly potent and selective CDK4/6 inhibitor, demonstrated robust, transient cell-cycle arrest of hematopoietic stem and progenitor cells in a first-in-human Phase 1 a study. These data will be presented on Saturday, May 30 in two posters at
Genelux Corporation, a clinical-stage biopharmaceutical company focused on the development of vaccinia virus for oncolytic immunotherapy, today announced that data from two Phase I trials evaluating its lead oncolytic virotherapy GL-ONC1 in head and neck cancer and malignant pleural mesothelioma demonstrate a favorable safety profile and support.