By a News Reporter-Staff News Editor at Women's Health Weekly A patent application by the inventors KISELEV, Vsevolod Ivanovich; VASSILIEVA, Irina Gennadievna, filed on June 20, 2014, was made available online on October 16, 2014, according to news reporting originating from Washington, D.C., by NewsRx correspondents. This patent application has
The Association of Clinical Research Organizations reported that it is planning to constitute a CRO Forum in order to provide a formal mechanism for the CRO industry to furnish input into the work of TransCelerate BioPharma. According to a release from ACRO, the CRO Forum, expected to commence operation in January 2015, is open to all CROs and part
NovaBay Pharmaceuticals reported that its partner China Pioneer Pharma Holdings has ordered an additional 150,000 units of its NeutroPhase Skin and Wound Cleanser. "China will be a significant market for NeutroPhase, because the product can bring a major improvement in medical care to China and in the quality of patients' lives," said Dr.
The following statement can be attributed to BayBio, the Biotechnology Industry Organization, the Pharmaceutical Research and Manufacturers of America, the Generic Pharmaceutical Association and the Consumer Healthcare Products Association:. However, there is no rationale for mandating new, costly and redundant disposal options when both the Food a
ENP Newswire- 30 October 2014. Release date- 29102014- The European Medicines Agency has published its revised overarching guideline on biosimilars. This document, together with a series of complementary guidelines that were subsequently developed by EMA, have led to the approval of 19 biosimilars in the European Union to date, including the first
"With their breadth and depth of experience in healthcare, Marc and Stu will provide a tremendous resource as we endeavor to develop solutions for patients with severe neuromuscular disorders," said Flex Pharma Co-Founder, Co-Chair of the Company's Scientific Advisory Board and Nobel Laureate, Rod MacKinnon, M.D. Prior to ACT, Randle was Corporate
QIAGEN N.V. today announced a master collaboration agreement with Astellas Pharma Inc., an R&D-driven global pharmaceutical company headquartered in Japan, to develop and commercialize companion diagnostics paired with Astellas drugs for use in cancer and other diseases. The scope of the agreement is not restricted to certain sample types, platform
Spartan Bioscience announced today that Health Canada has approved the Spartan RX CYP2C19 System. Leading Canadian hospitals such as the University of Ottawa Heart Institute, Toronto General Hospital, St. Michael's Hospital, and Sunnybrook Health Services Center are already using the system as part of a landmark 5,270- patient clinical trial called
According to a release from the Company, EVZIO, approved by the U.S. Food and Drug Administration on April 3, is an opioid antagonist indicated for the emergency treatment of known or suspected opioid overdose, as manifested by respiratory and/or central nervous system depression. The first recipient of the kaleo Cares law enforcement donation prog
Today Eli Lilly and Company published details of its long-standing technology transfer program to increase the global supply of medicines for multidrug-resistant tuberculosis. Begun in 2003, the effort included Lilly donating manufacturing technology and know-how for two antibiotics to pharmaceutical manufacturers in China, India, Russia and Sout
By a News Reporter-Staff News Editor at Women's Health Weekly Mission Pharmacal Company, headquartered in San Antonio, announced that the U.S. District Court for the Western District of Texas has issued a consent judgment confirming the validity of its dual-iron patent at the conclusion of the lawsuit filed against Virtus Pharmaceuticals, LLC.
This is especially important given the rapid increase of expensive oral cancer therapies,' said study leader Dawn L. Hershman, MD, MS, associate professor of medicine at the College of Physicians and Surgeons, and associate professor of epidemiology at the Mailman School of Public Health, Columbia University Medical Center. Dr. Hershman is also lea
By a News Reporter-Staff News Editor at Politics& Government Week According to news reporting originating from Washington, D.C., by VerticalNews journalists, a patent application by the inventors SADOWSKI, Peter L.; LESCH, JR., Paul R.; BREMSETH, David L., filed on June 22, 2014, was made available online on October 16, 2014. The assignee for thi
Patent Application Titled "Methods for Coupling Targeting Peptides onto Recombinant Lysosomal Enzymes for Improved Treatments of Lysosomal Storage Diseases" Published Online. By a News Reporter-Staff News Editor at Gene Therapy Weekly According to news reporting originating from Washington, D.C., by NewsRx journalists, a patent application by the
Release date- 29102014- Pfizer Inc. announced today that the U.S. Food and Drug Administration has granted accelerated approval of TRUMENBA for active immunization to prevent invasive disease caused by Neisseria meningitidis serogroup B in individuals 10 through 25 years of age. As part of the accelerated approval process, Pfizer will complete its
By a News Reporter-Staff News Editor at Politics& Government Week Pharmatech Associates announced the appointment of international regulatory expert Richard Aleman as vice president of Regulatory Compliance. "Richard is an outstanding addition to our expert executive team in terms of FDA and international requirements, and our customers will ben
ALEXANDRIA, Va., Oct. 30 Purdue Pharmaceuticals, Wilson, North Carolina, Purdue Pharma, Stamford, Connecticut, and P.F. Laboratories, Totowa, New Jersey, have been assigned a patent developed by three co-inventors for a "pharmaceutical formulation containing gelling agent." The co-inventors are Benjamin Oshlack, Boca Raton, Florida, Christopher B
Quantia and Capgemini Consulting reported key findings from a new joint study that shows an increasing difficulty for pharmaceutical companies to engage with physicians via traditional methods due to their growing affiliation with health systems. According to a media release, the study, "Working the System: 4 Trends Driving New Opportunities for En
ALEXANDRIA, Va., Oct. 30 Regeneron Pharmaceuticals, Tarrytown, New York, has been assigned a patent developed by Trevor Stitt, Ridgewood, New Jersey, and Esther Latres, New York, for "compositions and methods for increasing muscle mass and muscle strength by specifically antagonizing GDF8 and or Activin A." The patent application was filed on Nov
Researchers Submit Patent Application, "Crystalline Forms for 5- Amino-2, 3- Dihydrophthalazine-1, 4- Dione Sodium Salt, Pharmaceutical Preparations Containing the Same and Method for the Production of Said Forms", for Approval. By a News Reporter-Staff News Editor at Politics& Government Week From Washington, D.C., VerticalNews journalists repor
Sarepta Therapeutics on October 27 provided an update on its discussions with the U.S. Food and Drug Administration regarding its planned New Drug Application submission for the approval of eteplirsen for the treatment of Duchenne muscular dystrophy. The company said that in meeting minutes received last week from a Type B Pre-NDA meeting that took
Positive new clinical data were released on a drug candidate for ulcerative colitis that was first discovered and synthesized at The Scripps Research Institute. "We are delighted that RPC1063 is showing promise for ulcerative colitis patients in addition to its already significant efficacy and safety data in multiple sclerosis," said TSRI Professo
By a News Reporter-Staff News Editor at Gene Therapy Weekly Selecta Biosciences, Inc., a clinical stage biotechnology company developing a novel class of targeted antigen-specific immune therapies, announced it has secured equity funding of more than $20 million from new and all of Selecta's existing investors. "With strong financial support fro
Sunovion Pharmaceuticals reported dose ranging results from a Phase 2, randomized, double-blind, placebo-controlled, parallel group study of SUN-101 delivered via the proprietary eFlow nebulizer system twice a day in patients with moderate-to-severe chronic obstructive pulmonary disease. "While the efficacy and safety of SUN-101 have yet to be...
By a News Reporter-Staff News Editor at Computer Weekly News NEW YORK, NY-Columbia University's imaging software that facilitates 3- D lung tumor segmentation, licensed to Varian Medical Systems, has been incorporated into the Smart Segmentation module of Varian's Eclipse? treatment planning system and has received FDA 510 k clearance.