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
Robotic surgery or robot-assisted surgery is an MIS procedure that utilizes very small tools attached to a robotic arm to perform the surgery. Robot-assisted surgery offers broader visualization of the operating area and precision control of surgical instruments. The report covers the Americas, and APAC and EMEA; it also covers the market landscape
Escalating cancer incidences have made the investigators to come forth with therapeutics that could reduce high morbidity and mortality rates. Cancer segment has several products belonging to different categories having different pharmacological efficacy. Food and Drug Administration is taking effective measures to offer better medical care to...
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
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
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
Findings on Ethanol Reported by Researchers at Brigham and Women's Hospital. By a News Reporter-Staff News Editor at Biotech Week A new study on Ethanol is now available. Our news journalists obtained a quote from the research from Brigham and Women's Hospital, "We evaluated the safety and potential efficacy of 70% ELT for CLABSI at our instituti
After filing the 505 2 application for Rasuvo with the FDA, Medac Pharma needed to quickly build a commercial foundation for product sales and marketing. Four months later, Medac Pharma was ready for business with Veeva Commercial Cloud and fully prepared to take its first product to market. And with Veeva, we were able to meet our aggressive four-
WASHINGTON, May 27 The Department of Health& Human Services published the following rule in the Federal Register from the Food& Drug Administration:. A Rule by the Food and Drug Administration on 05/27/2015. The classification was applicable June 26, 2012.
SAN DIEGO, May 27, 2015 Memorial Hospital, based in Gulfport Mississippi, is the first healthcare provider along the Gulf Coast to pioneer a new approach to chronic care management. This new, user-friendly program is designed to improve patient engagement, reduce hospital readmissions and increase healthcare providers' Medicare reimbursements.
As per an estimate by the Alzheimer Disease International 36 million people globally had Alzheimer's or a related dementia. Untapped, rapidly growing markets of Asia and Latin America have presences of abundant unmet needs and thus offer future growth opportunities to the neurostimulation devices market. The key manufacturers are Boston Scientific.
By a News Reporter-Staff News Editor at Biotech Week AM-Pharma B.V., a privately held Dutch biopharmaceutical company focused on the development of recombinant human Alkaline Phosphatase for inflammatory diseases, and Pfizer Inc. announced that Pfizer has acquired a minority equity interest in AM-Pharma and secured an exclusive option to acquire
POXEL SA, a biopharmaceutical company developing innovative drugs to treat type 2 diabetes, today announced the successful conclusion of a phase 1 clinical trial in Japanese subjects with Imeglimin, its lead drug candidate that has already completed phase 2 clinical trials in type 2 diabetes patients in the US and EU. Yohjiro Itoh has joined Poxel
By a News Reporter-Staff News Editor at Vaccine Weekly Protein Sciences Corporation announced that on May 12, 2015 the U.S. Food and Drug Administration licensed its Pearl River, NY manufacturing facility for the commercial manufacturing of Flublok influenza vaccine. "The approval of our Pearl River facility accelerates the growth of Protein Sci
Sarepta Therapeutics said that the Company held a pre-New Drug Application meeting with the U.S. Food and Drug Administration regarding its lead product candidate, eteplirsen, for the treatment of Duchenne muscular dystrophy. "We will initiate a rolling NDA submission to facilitate the regulatory review of the NDA," said Edward Kaye, M.D., Sarepta
By a News Reporter-Staff News Editor at Biotech Week Sinovac Biotech Ltd., a leading provider of biopharmaceutical products in China, announced that the Company received site inspection notification for the commercial production facilities of its EV71 vaccine candidate from the China Food and Drug Administration. Samples from the trial batches wi
Between 2001 and 2010, the FDA approved 225 drug applications and Health Canada approved 99. In addition, according to WIPO, Europe accounted for 3,822 of the pharmaceutical and 1,998 of the biotechnology patents granted in 2012. Furthermore, according to OECD estimates, in 2011, the total number of biotechnology companies in the U.S. was 7,970. Th
ACADIA Pharmaceuticals Inc., a biopharmaceutical company focused on innovative treatments that address unmet medical needs in neurological and related central nervous system disorders, today announced that it will present at the Jefferies 2015 Healthcare Conference on Tuesday, June 2, 2015, at 1:30 p.m. Eastern Time in New York City.
-Aeterna Zentaris Inc. today announced that it has received written scientific advice from the European Medicines Agency regarding the further development plan, including the study design, for the new confirmatory Phase 3 clinical study of Macrilen? for use in evaluating adult growth hormone deficiency, following a Scientific Advice Meeting that
QU?BEC CITY, May 26, 2015/ PRNewswire/- Aeterna Zentaris Inc. today announced that it has received written scientific advice from the European Medicines Agency regarding the further development plan, including the study design, for the new confirmatory Phase 3 clinical study of Macrilen? for use in evaluating adult growth hormone deficiency, fol
CAMBRIDGE, Mass. Akebia Therapeutics, Inc., a biopharmaceutical company focused on delivering innovative therapies to patients with kidney disease through the biology of hypoxia-inducible factor, today announced that data from its Phase 2 b trial of AKB-6548 in non-dialysis patients with anemia related to chronic kidney disease will be featured
Alnylam Pharmaceuticals, a RNAi therapeutics company, reported that the U.S. Food& Drug Administration has granted Orphan Drug Designation to revusiran, an investigational RNAi therapeutic, for the treatment of transthyretin- mediated amyloidosis. "We are very pleased to have received Orphan Drug Designation from the FDA for revusiran, a key progr
Amerigroup Florida today announced that it has been selected by the Florida Healthy Kids Corporation as part of a re-procurement effort to continue serving the Florida Healthy Kids program. Region 6: Hillsborough, Hardee, Highlands, Manatee and Polk counties Region 7: Brevard, Orange, Osceola and Seminole counties Region 10: Broward County Region 1