"We are pleased that DANA has sought and received FDA clearance, leading the way for this type of game-changing technology," said Corinna Lathan, founder and CEO of AnthroTronix. "With the steady growth of the mHealth movement, technology that has evidence and science-based functionality is critical," said Duke University Medical Center's Murali D
Cot Orphan, LLC, the leader in orphan drug regulatory affairs, today announced the launch of OrphanDB, its first mobile app designed to provide industry leaders a single source of truth to all FDA and EMA orphan drug status through a simple search. Features include:? Granular search for orphan drugs matching criteria such as disease, active com
By a News Reporter-Staff News Editor at Cancer Weekly Sin Hang Lee, M.D., a Milford Hospital pathologist and lead author of "From Human Papillomavirus Detection to Cervical Cancer Prevention in Clinical Practice," a medical-scientific paper published in Cancers, a quarterly oncology journal http://www.mdpi.com/2072-6694/6/4/2072, said that to pro
According to news reporting originating in Shantou, People's Republic of China, by NewsRx journalists, research stated, "Triple negative breast cancer is known for its visceral metastasis. Our news correspondents report that additional information may be obtained by contacting P. Yang, (C-W Du) Dept. of Breast Medical Oncology, Cancer Hospital of S
Release date- 20102014- RARITAN, NJ- Janssen Research& Development, LLC today announced the submission of a supplemental New Drug Application for IMBRUVICA to the U.S. Food and Drug Administration by its strategic partner Pharmacyclics, Inc.. IMBRUVICA received FDA Breakthrough Therapy Designation in February 2013 for patients with WM and is being
Release date- 20102014- RARITAN, NJ,- Janssen Research& Development, LLC today announced the submission of a supplemental New Drug Application for IMBRUVICA to the U.S. Food and Drug Administration by its strategic partner Pharmacyclics, Inc.. IMBRUVICA received FDA Breakthrough Therapy Designation in February 2013 for patients with WM and is being
Andy Barr, R- Lexington, and Elisabeth Jensen, his Democratic challenger, laid out stark differences in their ideologies Monday night during a televised appearance on KET's Kentucky Tonight. Jensen told host Bill Goodman that she supported a proposed raise in the federal minimum wage to $10.10 an hour, the Affordable Care Act and the Dodd-Frank ban
In early October, Health-e News broke the story of Andaleeb Rinquest-January. Diagnosed with XDR-TB in 2011, Rinquest-January fought for her life and eventually she said began to recover after being prescribed the XDR-TB drug linezolid. South Africa is a new South Africa now and we all deserve this. " Patented by the pharmaceutical company Pfizer,
Nanobiotix has received approval from the French National Security Agency for Medicines and Health Products to start its Phase II/III registration trial of its lead product, NBTXR3, in patients with locally advanced Soft Tissue Sarcoma. In parallel, Nanobiotix is establishing industrialization, market access and reimbursement strategies for NBTXR3
WASHINGTON- Auxilium Pharmaceuticals Inc.' s supplemental Biologics Application for XIAFLEX for the treatment of up to two Dupuytren's contracture joints in the same hand during a single treatment visit has been approved by FDA. Auxilium Pharma is all set to be acquired by Endo International plc for roughly $2.6 billion, and the transaction is expe
Release date- 20102014- Basel,- Novartis announced the Dermatologic and Ophthalmic Drugs Advisory Committee to the US Food and Drug Administration today voted unanimously to support the approval of AIN457, a selective interleukin-17A inhibitor, for the treatment of moderate-to-severe plaque psoriasis in adult patients who are candidates for systemi
Bloomberg, citing unnamed sources, said Omega could be worth up to $5.1 billion, with final offers expected next month. Also bidding are Perrigo Co. plc and privately held Boehringer Ingelheim, according to Bloomberg. Privately held Omega had $166 million in revenue for the first six months of 2014, up 60 percent from a year earlier, Bloomberg said
SCAN Health Plan reported that in conjunction with partners Monarch Health and MemorialCare Medical Group it has received a grant from the California HealthCare Foundation to help further its work and development in the area of palliative care. "By working together in a collaborative fashion we are pairing providers and payers to expand community-
Release date- 20102014- The European Medicines Agency encourages developers of treatments or vaccines against Ebola to apply for orphan designation. EMA has been collaborating very closely with the United States Food and Drug Administration on orphan medicines over many years. Developers of Ebola medicines are encouraged to submit applications for.
Release date- 20102014- Eisai Co., Ltd. announced today that the U.S. Food and Drug Administration has accepted for review the company's supplemental New Drug Application for its in-house developed antiepileptic drug Fycompa for the treatment of primary generalized tonic-clonic seizures, a severe form of seizures, in patients 12 years or older.
MedImmune licensed the OX40 agonist platform in 2011 from AgonOx as the result of a partnership between the Providence Cancer Center and AgonOx, a spin-off company from the Providence Cancer Center. Providence Cancer Center, one of the sites selected by MedImmune to participate in the clinical trial, has recently enrolled their first patient.
The American Academy of Ophthalmology issued the following news release:. To help address this issue within eye health, the American Academy of Ophthalmology has redesigned its patient education materials to enhance patient readability and understanding. The Academy's new patient education materials meet the health literacy standards used by the...
By a News Reporter-Staff News Editor at Biotech Business Week Amgen announced that the U.S. Food and Drug Administration has accepted for review the Biologics License Application for the investigational bispecific T cell engager antibody construct, blinatumomab. As part of the acceptance, the FDA granted blinatumomab priority review with a Prescr
Asterias Biotherapeutics, Inc. announced today that the Company has signed a Notice of Grant Award with the California Institute of Regenerative Medicine, effective October 1, 2014. In August 2014, Asterias received clearance from the U.S. Food and Drug Administration to initiate the Phase 1/ 2 a clinical trial of AST-OPC1. "There are currently
Auxilium Pharmaceuticals, Inc., a specialty biopharmaceutical company, today announced that the U.S. Food and Drug Administration has approved a supplemental Biologics Application for XIAFLEX for the treatment of up to two Dupuytren's contracture joints in the same hand during a single treatment visit. XIAFLEX is a biologic approved in the U.S.,
By a News Reporter-Staff News Editor at Managed Care Weekly Digest Axxess, an industry leader in home health management software, announced that it has been approved as a vendor for Consumer Assessment of Health Providers Service, in both the home health and hospice markets, by the Centers for Medicaid and Medicare Services. It is managed by the
By a News Reporter-Staff News Editor at Pharma Business Week BioDelivery Sciences International, Inc. will host an investor update conference call and webcast to discuss the launch of BUNAVAIL? buccal film which has been approved by the U.S. Food and Drug Administration for the maintenance treatment of opioid dependence. Since FDA approval of B
Boehringer Ingelheim Pharmaceuticals, Inc. reported that the U.S. Food and Drug Administration approved OFEV capsules for oral use for the treatment of idiopathic pulmonary fibrosis. According to a release from the Company, granted Breakthrough Therapy designation during its review by the FDA, OFEV, capsules for oral use, taken twice daily, is the
By a News Reporter-Staff News Editor at AIDS Weekly Bristol-Myers Squibb Company has successfully resolved all outstanding U.S. patent litigation relating to efavirenz, an active ingredient contained in our Sustiva and Atripla products. Bristol-Myers Squibb remains committed to delivering our medicines and to developing new and innovative...
Cerus Corporation today announced submission of a clinical protocol to the U.S. Food and Drug Administration to make the INTERCEPT Blood System for plasma available under a Compassionate Use Investigational Device Exemption for treatment of convalescent plasma collected from Ebola disease survivors for passive immune therapy. We believe that...