Boston Scientific Corp. has received FDA and CE Mark approval of the EMBLEM Subcutaneous Implantable Defibrillator System. A controlled and limited market release has begun in a small number of European centers with a broad European launch scheduled for May 2015 and subsequent U.S. launch planned for the third quarter of 2015.. "We are excited to
Celator Pharmaceuticals reported business highlights and financial results for the fourth quarter and year ended December 31, 2014. "In 2014, Celator continued to meet important milestones as we look to leverage our CombiPlex platform to introduce a new medical standard for combining cancer therapies," said Scott Jackson, chief executive officer o
"Mr. Perez and Dr. Franson are recognized leaders in the biotechnology and pharmaceutical industries and bring a wealth of complimentary operational experience to our board," said Jeff Stein, Ph.D., chief executive officer of Cidara. He served as executive vice president and chief operating officer for the company from August 2007 to July 2012 and
The Women's Initiative at the Center for American Progress lately released a concern brief- A Challenge to Congress- that emphasizes quite a few ways that the 114th Congress could improve women's health and economic security. Unfortunately, this Congress is off to a record start in the opposite direction, introducing bills that restrict acces
"Each year substance use disorders have a tangible impact on the societal and economic well-being of the United States," notes a new report from Dobson DaVanzo& Associates, developed for the National Association of Psychiatric Health Systems. The full report, titled "Addiction Treatment Today and Tomorrow: Implications and Policy Recommendations,"
Biotronik reported that the Food and Drug Administration has approved its ProMRI Eluna pacemaker system. In a release, Biotronik noted that its ProMRI technology allows patients to undergo full-body magnetic resonance imaging scans with both single-chamber and dual-chamber Eluna pacemakers when implanted with Setrox pacing leads.
Bayer HealthCare received approval in Japan for Gadovist injection for use with magnetic resonance imaging. Gadovist is the first high concentration/high relaxivity gadolinium-based contrast agent to be approved in Japan and is indicated for contrast-enhancement MRI in cranial, spinal, the body and extremeties at a dose of 0.1 mL/kg body weight.
March 27 Lake Forest- based Hospira released clinical data Friday for its drug Retacrit, which could become the company's first U.S.-approved biosimilar drug. Retacrit, approved in Europe since 2008, treats anemia as a similar, low-cost version of Amgen's biologic drug Epogen. Hospira submitted its application for Retacrit to the Food and Drug...
Research and Markets has announced the addition of the " Personal Accident and Health Insurance in Israel, Key Trends and Opportunities to 2018" report to its offerings. The National Health Insurance Law stipulates that every citizen of Israel should be a member of one of the four health maintenance organizations- Clalit, Maccabi, Kupat Holim or Le
March 28 HELENA The Montana Senate today endorsed a bill to expand Medicaid, under the Affordable Care Act, to cover an estimated 45,000 low-income Montanans. Ed Buttrey, R- Great Falls, the sponsor of the bill, said it would return hundreds of millions of dollars that Montanans have paid to the federal government, to pay for health care for th
10- Year Republican Budget The House on March 25 passed, 228-199, a GOP- drafted budget for fiscal 2016-2025 that would cut personal and corporate tax rates, raise military spending, slash domestic spending, repeal the Affordable Care Act, partially privatize Medicare and strive to reach a balanced budget by 2024. A yes vote was to adopt the Repu
The J.R. Simplot Company said it completed the food and feed safety consultation with the Food and Drug Administration for its first generation of Innate potato varieties. In a release, the Company noted that the FDA concluded the Innate potato is as safe and nutritious as conventional potatoes. The FDA statement comes after the recent U. S. Depart
Oncolytics Biotech Inc. declared that the European Medicines Agency has approved Orphan Drug Designation for its lead product candidate, REOLYSIN , for the treatment of ovarian, fallopian tube and primary peritoneal cancers. Oncolytics Biotech Inc is a clinical-stage biotechnology company focused on the development of oncolytic viruses as..
The following discussion and analysis should be read in conjunction with the "Selected Financial Data" and the consolidated financial statements and related notes included elsewhere in this Annual Report on Form 10- K. This section of this Annual Report on Form 10- K contains forward-looking statements that involve substantial risks and uncertainti
On May 28, 2014, Adamis submitted an NDA to the FDA pursuant to Section 505 of the Food, Drug& Cosmetic Act, as amended, for approval of the Epinephrine PFS product. The questions raised by the FDA pertain only to Chemistry, Manufacturing and Controls relating to the volume of dose delivered by the syringe, including the ability to deliver volume w
Release date- 26032015- Leverkusen,- Bayer HealthCare received approval in Japan for Gadovist injection for use with magnetic resonance imaging. Gadovist is the first high concentration/high relaxivity gadolinium-based contrast agent to be approved in Japan and is indicated for contrast-enhancement MRI in cranial, spinal, the body and extremeties a
Boston Scientific reported that three patients in the United States received the first implants of its WATCHMAN Left Atrial Appendage Closure Device. The WATCHMAN Device received U.S. Food and Drug Administration approval on Friday, March 13. "Boston Scientific is proud to work with physicians in making a meaningful impact on patient lives by brin
Bristol-Myers Squibb reported the company has signed an agreement with Novo Nordisk under which Bristol-Myers Squibb will acquire an exclusive global license to a discovery biologics research program focused on modulating the innate immune system as a therapy for autoimmune diseases. According to a media release, the agreement supports Bristol- Mye
Nguyen, who emigrated from Vietnam when he was 15, enrolled in Medi-Cal, the state's low-income medical insurance plan, while studying mechanical engineering at UC Davis. He said he had a difficult time finding specialists, especially dentists who would accept Medi-Cal reimbursement rates, which to this day cover only a fraction of the cost of cari
Release date- 26032015- Tokyo, Japan- Following its announcement of April 7, 2014, that Sun Pharmaceutical Industries Ltd. was to acquire Ranbaxy Laboratories Limited through a merger entailing an all-stock transaction, Daiichi Sankyo Company, Limited today announced that the aforementioned merger process has been completed. Through this merger...
Earlier this year, the Capillus272Pro? received FDA clearance for the promotion of hair regrowth in adult men and women with androgenic alopecia having Ludwig Savin classifications I-II or Norwood Hamilton classifications of IIa-V and Fitzpatrick Classification of Skin phototypes I-IV. "I am extremely excited that the U.S. Food and Drug Administ
CAMBRIDGE, Mass.& NORTH CHICAGO, Ill. Today Biogen and AbbVie announced that the European Medicines Agency has validated the companies Marketing Authorisation Application for ZINBRYTA? for the treatment of relapsing forms of multiple sclerosis in the European Union. We are committed to bringing to market medicines that may provide remar
WASHINGTON, March 27 The U.S. Department of Health& Human Services published the following rule in the Federal Register from the Food& Drug Administration:. A Rule by the Food and Drug Administration on 03/27/2015. The classification was applicable on November 17, 2014.
WASHINGTON, March 27 The U.S. Department of Health& Human Services published the following proposed rule in the Federal Register from the Food& Drug Administration:. A Proposed Rule by the Food and Drug Administration on 03/27/2015. Dates: The public hearing will be held on April 20 and 21, 2015, from 9 a.m. to 4 p.m. The meeting may be extended
According to news reporting from Hamilton, New Zealand, by NewsRx journalists, research stated, "To date, there has been little research into the clinical outcomes of total hip arthroplasty for intracapsular neck of femur fracture in the very elderly. 44 patients over 75 years underwent THA for an intracapsular NOF fracture over a two year period.