By a News Reporter-Staff News Editor at Biotech Week Actavis plc announced the U.S. Food and Drug Administration has approved a lower therapeutic dose of VIIBRYD to accompany the 40 mg daily therapeutic dose. VIIBRYD was approved in January 2011 as the first and only selective serotonin reuptake inhibitor and 5 HT1a receptor partial agonist for t
-Antares Pharma, Inc. today announced that Ferring Pharmaceuticals Inc. has received U.S. Food and Drug Administration approval of a name change enabling its newly acquired recombinant human growth hormone to be marketed in the U.S. as ZOMACTON for injection, and the needle-free delivery system to be marketed in the U.S. as ZOMA-Jet.
By a News Reporter-Staff News Editor at Biotech Week With the U.S. Food and Drug Administration's announcement of the first biosimilar approval, the Alliance for Safe Biologic Medicines held a five-hour class offered through the Long Island School of Pharmacy, to educate pharmacists on the fundamentals of these breakthrough new medicines.
Part C of the Statement of Organization, Functions, and Delegations of Authority of the Department of Health and Human Services is amended to reflect the reorganization of the Office of Public Health Scientific Services, Centers for Disease Control and Prevention. Section C-B, Organization and Functions, is hereby amended as follows: Delete in its
The U.S. Food and Drug Administration is issuing an order under the Federal Food, Drug, and Cosmetic Act debarring Jun Yang for a period of 4 years from importing articles of food or offering such articles for importation into the United States. FDA bases this order on a finding that Mr. Yang was convicted, as defined in the FD&C Act, of one felony
Procedures for Meetings of the Medical Devices Advisory Committee; Draft Guidance for Industry and Food and Drug Administration Staff; Availability. The Food and Drug Administration is announcing the availability of the draft guidance entitled "Procedures for Meetings of the Medical Devices Advisory Committee." The Center for Devices and Radiologic
Dr. Coughlin will be responsible for providing medical and regulatory leadership to the pre-clinical and clinical programmes for the Company. Dr. Coughlin has extensive experience in oncology drug development, with expertise in both clinical development and translational medicine. Dr. Coughlin graduated with a B.S., from Temple University and an M.
Horizon Pharma said that it will acquire Brisbane, Calif.- based Hyperion Therapeutics for about $1.1 billion. Horizon, established in Dublin with U.S. headquarters in Deerfield, said it will pay $46 per share in cash, about a 7.6 percent increase over the California company's Friday close of $42.74. Horizon Pharma chief executive Timothy Walbert s
Intercept intends to use the net proceeds of this offering to support the expansion of its clinical, regulatory, medical affairs and commercial infrastructure in the United States and Europe, the clinical development program for obeticholic acid in primary biliary cirrhosis, nonalcoholic steatohepatitis and primary sclerosing cholangitis, the...
By a News Reporter-Staff News Editor at Biotech Week Janssen Pharmaceuticals, Inc., one of the Janssen Pharmaceutical Companies of Johnson& Johnson, announced that it has acquired XO1 Limited, a privately held asset-centric virtual biopharmaceutical company founded to develop the anti-thrombin antibody ichorcumab. This acquisition illustrates how
Release date- 31032015- The European Medicines Agency and the Heads of Medicines Agencies have released the' EU Medicines Agencies Network Strategy to 2020', a draft common strategy to 2020 for the European medicines agencies network, for a three-month public consultation. Europe faces the global threat represented by antimicrobial resistance to hu
Release date- 31032015- DUBLIN- Medtronic plc today announced the U.S. Food and Drug Administration approval of the CoreValve System for valve-in-valve procedures in patients whose surgical aortic heart valves have failed. The CoreValve System is the first transcatheter heart valve approved in the U.S. for VIV procedures in both high and extreme ri
By a News Reporter-Staff News Editor at Biotech Week Merz North America, US affiliate of the global Merz Pharma Group, announces that Radiesse with integral 0.3% Lidocaine has received FDA approval and is now available to US physicians. We are excited to provide our physician customers with yet another Merz technology to help deliver positive
SUMMARY: The Food and Drug Administration is announcing the availability of the draft guidance entitled "Procedures for Meetings of the Medical Devices Advisory Committee." The Center for Devices and Radiological Health is issuing this guidance to provide additional information regarding the processes for meetings of the Medical Devices Advisory...
-RedHill Biopharma Ltd., an Israeli biopharmaceutical company primarily focused on late clinical-stage, proprietary, orally-administered drugs for inflammatory and gastrointestinal diseases, including gastrointestinal cancers, and Apogee Biotechnology Corporation, a privately-held biotech company located in Hummelstown, Pennsylvania, U.S., today...
By a News Reporter-Staff News Editor at Biotech Week Selten Pharma, Inc., a privatively held biopharmaceutical company focused on the development and commercialization of therapies for the treatment of rare diseases, announced that its lead compound tacrolimus has been granted Orphan Drug Designation by the U.S. Food& Drug Administration for the.
Location: Department of Health and Human Services, Food and Drug Administration, Office of Acquisitions and Grants Services. Classification Code: B- Special studies and analysis- not R&D. Subject: In-Vivo Study of Generic Drug Products in Human Subjects.
Center for Surveillance, Epidemiology and Laboratory Services The mission of the Center for Surveillance, Epidemiology, and Laboratory Services is to provide scientific service, expertise, skills, and tools in support of CDC' s efforts to promote health; prevent disease, injury and disability; and prepare for emerging health threats. Provides strat
March 31 Our own Congresswoman Cathy McMorris Rodgers, in the interests of dispassionate inquiry, recently posed the following scientific question about the Affordable Care Act to the Internet:. "This week marks the 5th anniversary of Obamacare being signed into law. From the very first comment to the 9,880th, McMorris Rodgers got an avalanche o
The U.S. Food and Drug Administration today expanded the approved use of the CoreValve System to treat certain patients who have previously had a tissue aortic valve replacement and are in need of a second one. This first-of-its-kind use is called aortic valve-in-valve replacement, and today s approval expands the authorized use of the device to pa
A team of Goodwin attorneys is representing Teva Pharmaceutical Industries in connection with its announced $3.2 billion acquisition of Auspex Pharmaceuticals. Pursuant to the merger agreement, Teva will commence a tender offer for all outstanding shares of Auspex for $101 per share, representing approximately $3.2 billion in enterprise value and $
Dublin- Research and Markets has announced the addition of the "CountryFocus: Healthcare, Regulatory and Reimbursement Landscape- US" report to their offering. The US pharmaceutical market is forecast to increase from an estimated value of $395.2 billion in 2014 to reach $548.4 billion by 2020, representing a Compound Annual Growth Rate of 5.6%, ac
Release date- 31032015- New research from The University of Manchester published in the Journal of Community Genetics reveals a stark variation in genetic testing services for inherited eye disease in England. They quantified the variation in testing rate between the nine NHS regions in England, based on population size and demographics.
Acucela Inc., a clinical-stage biotechnology company that specializes in discovering and developing novel drug candidates to potentially treat and slow the progression of sight-threatening ophthalmic diseases, today announced that the United States Patent and Trademark Office granted U.S. Patent No. 8,993,807 assigned to Acucela Inc., adding...
Adamas Pharmaceuticals, Inc. today announced that United States Patent and Trademark Office issued US Patent No. 8,987,333 entitled "Composition and Method for Treating Neurological Disease." "We are excited with this latest addition to our patent estate," said Gregory T. Went, Chairman and CEO of Adamas Pharmaceuticals, Inc. "It represents the