He does suggest that this could change soon, however, with the FDA granting the biopharmaceutical firm permission to file for market approval on its bladder cancer treatment although they haven't completed the Phase III trial yet. While this company has been well under the radar, Lahiri said, "Odds are Bioniche will obtain an Orphan Drug Designatio
By a News Reporter-Staff News Editor at Life Science Weekly Cerus Corporation announced today that it has submitted a clinical protocol to the U.S. Food and Drug Administration to make the INTERCEPT Blood System for platelets available under an Expanded Access Investigational Device Exemption to regions in the United States with outbreaks of...
In accordance with section 10 of the Federal Advisory Committee Act, the Centers for Disease Control and Prevention announces the following meeting of the aforementioned committee:. Place: CDC, Century Center, 2500 Century Parkway NE., Room 1200/ 1201, Atlanta, Georgia 30345.. Purpose: This Committee is charged with providing scientific and technic
CANADIAN drugmaker Tekmira Pharmaceuticals said yesterday that US and Canadian regulators had authorised the use of its Ebola treatment in patients who have confirmed or suspected infections from the deadly virus. The Vancouver- based company said its treatment, TKM-Ebola, had been administered to patients on an emergency basis and the repeat infus
eCaring, a leading health care quality company, announced today that it has entered into a contract to provide its unique Web-based home health care management and monitoring system to Elderplan, Inc., one of New York City's largest not-for-profit health plans. Elderplan, an affiliated agency of MJHS, will deploy the eCaring system to help enhance
EOS imaging reported that its next-generation sterEOS 3 D imaging software, sterEOS 1.6, has received 510 clearance from the U.S. Food and Drug Administration. Concurrent with the FDA clearance, the benefits of EOS and its software sterEOS were highlighted at the 49th Annual Meeting of the Scoliosis Research Society in Anchorage, Alaska and during
Vivus and Auxilium Pharmaceuticals reported that the U.S. Food and Drug Administration has approved a supplemental new drug application for Stendra. According to a media release, Stendra is now the only FDA- approved erectile dysfunction medication indicated to be taken as early as approximately 15 minutes before sexual activity. "Stendra is the f
i2i Systems today announced it has been selected by Florida- based Meadowcrest Family Physicians to provide Population Health Management and Analytics solutions. Along this Gulf Coast town, many of those patients are on Medicare. In order to better manage their aging patients and take advantage of new Medicare rules that will soon pay physicians fo
Medivation and Astellas Pharma said that the U.S. Food and Drug Administration has approved a new indication for the use of Xtandi capsules to treat patients with metastatic castration-resistant prostate cancer. "The FDA's priority review and approval of this new indication for Xtandi now enables the use of an important therapy by patients with me
Sept. 23, 2014 Medivo, Inc., a leader in lab data analytics, today announced that it has partnered with NeoGenomics Laboratories, a leading provider of cancer-focused genetic and molecular testing services, for a data analytics collaboration. This collaboration enables NeoGenomics to realize new value in its lab data by participating in the Mediv
BERLIN& BOSTON, Mass. NOXXON Pharma announced today that one of its Spiegelmer therapeutics, olaptesed pegol, received orphan drug designation from the U.S. Food and Drug Administration for treatment of glioblastoma in conjunction with radiotherapy. Glioblastoma is the most common and most aggressive primary malignant brain tumor, associated
Release date- 22092014- WAUKESHA, Wis.- GE Healthcare today announced U.S. FDA 510 clearance of its Discovery* IQ PET/CT system, enabling both outstanding image quality and intelligent quantitation to help physicians deliver the best possible patient outcomes. 'By 2020, it's estimated that 50% of people will develop cancer at some point in their li
Post-Acute Network Solutions, a company that specializes in care coordination models for managed care plans, senior residential facilities and medical providers, has successfully implemented TCS Healthcare Technologies' ACUITY Complete Care? care management cloud hosted system to support their managed care organization model. We were a start-up..
According to Providence, Matrix is a provider of health risk assessments for Medicare Advantage health plans and risk bearing providers with a national footprint across 33 states. Providence will acquire Matrix for an aggregate purchase price of $400 million, comprised of $360 million in cash payable at closing and 946,722 shares of Providence comm
BARTON, Australia, Sept. 23 The Australian Medical Association issued the following news release:. AMA President Associate Professor Brian Owler has called on the Federal Government to immediately drop plans to slash $5 from the Medicare rebate following the release of figures showing claims that health spending is growing unsustainably are basel
CROIX The report from a recent inspection of Luis Hospital by federal regulators draws a damning portrait of a hospital lacking adequate oversight, where all too often, reasonable care was not taken to protect patients from harm. The latest inspection and the hospital's repeated failure to meet CMS standards since 2011 prompted CMS to send a
Reports Outline Diabetes Study Results from Changi General Hospital. By a News Reporter-Staff News Editor at China Weekly News Data detailed on Diabetes have been presented. According to news reporting originating in Singapore, Singapore, by VerticalNews journalists, research stated, "We evaluated a disease management and education programme deli
OTTAWA- Botox maker Allergan Inc. is in advanced talks to buy Salix Pharmaceuticals Ltd. in order to fend off a $53 billion hostile bid from Canada- based Valeant Pharmaceuticals Inc., according to media reports on Monday. Irvine, California- based Allergan's acquisition of Salix would likely halt a hostile bid for the company from Valeant Pharma a
On the heels of the tabling of the Patented Medicine Prices Review Board's 2013 Annual Report in the House of Commons, Canada's Research-Based Pharmaceutical Companies has acknowledged that the environment for life sciences in Canada is facing serious challenges as it tries to compete on the world stage. According to a release from the group, Canad
New Pharmaceuticals research report from Global Markets Direct is now available from Fast Market ResearchBoston, MA 09/22/2014 Affimed Therapeutics AG- Product Pipeline Review- 2014 Summary: Global Markets Direct's,' Affimed Therapeutics AG- Product Pipeline Review- 2014', provides an overview of the Affimed Therapeutics AG's pharmaceutical r
The Association for the Healthcare Environment, a personal membership group of the American Hospital Association, and Kimberly-Clark Professional today announced the recipients of the third annual Heart of Healthcare Awards, honoring outstanding environmental services technicians who make a difference for patients and long-term care residents.
By a News Reporter-Staff News Editor at Clinical Trials Week Advanced Cell Technology, Inc., a leader in the field of regenerative medicine, announced that the US Patent and Trademark Office has issued U.S. patent 8,822,218 covering methods of manufacturing dendritic cells using a highly scalable processing involving a readily renewable stem cell
By a News Reporter-Staff News Editor at Managed Care Weekly Digest Aetna announced a new accountable care agreement with Weill Cornell Physicians, Cornell University's physician group, intended to enhance care for approximately 9,000 of Aetna's commercial and Medicare members in New York. Under the Medicare arrangement, CMS quality and efficiency
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Exceptions or Alternatives to Labeling Requirements for Products Held by the Strategic National Stockpile. SUMMARY: The Food and Drug Administration is announcing that a collection of information entitled "Exceptions Or Alternatives to Labeling...
Amgen today announced submission of a Biologics License Application to the U.S. Food and Drug Administration seeking approval for its investigational bispecific T cell engager antibody construct, blinatumomab. Blinatumomab, the first of the BiTE antibody constructs, has received both orphan drug designation and breakthrough therapy designation..