Study: Fitness devices useful in orthopedic surgery--could offer means to placate CMS
10 March 2016
The Centers for Medicare & Medicaid Services is implementing an ambitious requirement for patient engagement that takes effect starting next year. Hospitals are required to have more than 10% of patients engage with their electronic health record in some way, with a specific emphasis on patient-generated health data that must be incorporated into the records of more than 5% patients.
09 March 2016
Tobira Therapeutics, Inc. (NASDAQ: TBRA), a biopharmaceutical company developing novel treatments for non-alcoholic steatohepatitis (NASH) and other serious immuno-inflammatory and fibrotic diseases, today announced that the description of the fully-enrolled CENTAUR Phase 2b clinical trial design has been accepted as a manuscript and published online in the journal Contemporary Clinical Trials.
09 March 2016
ReVision Optics, Inc., a leader in implantable presbyopia-correcting corneal inlay technology, announces that results from its ongoing Phase III U.S. FDA clinical study evaluating the Raindrop Near Vision Inlay for the treatment of presbyopia show significantly improved near visual performance and produced a 92% rate of satisfaction among study subjects one year following the procedure. T
Marinus Pharmaceuticals Provides Business Update and Reports Third Quarter 2015 Financial Results
09 March 2016
Marinus Pharmaceuticals, Inc. (Nasdaq:MRNS), a biopharmaceutical company dedicated to the development of innovative therapeutics to treat epilepsy and neuropsychiatric disorders, today provided a business update on its clinical development activities and reported its financial results for the third quarter ended September 30, 2015.
Immunizing the well and flushing the reservoir may be ways to HIV cure
09 March 2016
Somewhat like a vaccine for HIV, a cure has been on the horizon yet out of reach for a frustratingly long time. "I think it's fair to say that the score card is not very impressive," Mario Stevenson, chief of the division of infectious disease at the University of Miami Medical School, told the audience at a the plenary session of the Conference on Retroviruses and Opportunistic Infections (CROI), which is going on in Boston this week. He cited "40 million or so infected individuals worldwide and one documented cure" in form of "Berlin patient" Timothy Ray Brown.
Bio CEO dishes big city mix of business, policy, science
09 March 2016
As always, the recent Biotechnology Innovation Organization’s annual BIO CEO & Investor Conference offered a lively mix of tough business and policy topics along with in-depth looks at key therapeutic areas, notably oncology, Alzheimer’s disease and ophthalmology. There were some valuable insights which are worth sharing with a broader audience.
Survey: Half of U.S. docs expect to prescribe more biosims in the next three years
09 March 2016
Good news for biosimilar makers: Nearly half of U.S. docs are already planning to prescribe the knockoff drugs in the near term, according to a new survey.
After much delay, the EMA finally gears up for trial transparency drive
09 March 2016
The EMA has published new rules as it prepares for a watershed year that will see the life science industry in Europe make public more clinical trial data than ever before.
Tobira Therapeutics Reports Fourth Quarter 2015 Financial and Year-End Business Results
04 March 2016
Tobira Therapeutics, Inc. (NASDAQ : TBRA), a biopharmaceutical company developing novel treatments for non-alcoholic steatohepatitis (NASH) and other serious immuno-inflammatory and fibrotic diseases, today reported business highlights and financial results for the three and 12 months ended December 31, 2015 .
Generic-Drug Production and Oversight Challenge FDA and Manufacturers
04 March 2016
It’s well known that generic drugs account for 88% of prescription drug sales in the United States and have saved billions for patients and healthcare systems since Congress enacted the Hatch-Waxman Act more than 30 years ago. That growth, though, has created difficulties for FDA in processing the hundreds of resulting abbreviated new drug applications (ANDAs) and in inspecting an expanding number of generic-drug manufacturers and ingredient producers all over the world.
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NovaMedica team wishes you a Merry Christmas and a Happy New Year!
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