CHICAGO Getting through an FDA advisory committee is an oft-dreaded rite of passage for developers of novel drug candidates, and stories of disastrous adcoms have a tendency to circulate around the biopharma industry like urban myths. For instance, there's the "tale of two adcoms," as Russo Partners' David Schull referred to the two adcom meetin
The announcement is being made at the ISMRM 21st Annual Meeting, being held through April 26, in Salt Lake City, Utah. "The clearance for our M2 compact wrist MRI system by the FDA is an exciting step for Aspect Imaging. With this FDA clearance, we will begin to provide this system to clinicians interested in diagnostic- quality imaging of the wri
Raising the age of eligibility and reforming some Medicare practices can go a long way to making it sustainable, according to three Arizona State University health care policy experts. "Given our demographics and the rapidly increasing costs of medical care, Medicare, as we know it, is unsustainable. "The time to fix Medicare is now."
Matt Baker this week led debate on House passage of legislation he co-sponsored to prohibit health care exchanges created under ObamaCare from covering abortions, except in cases of rape, incest or to avert the death of the mother. Matt Baker this week led debate on House passage of legislation he co-sponsored to prohibit health care exchanges crea
ENP Newswire- 24 April 2013. Release date- 23042013- Franklin Lakes, NJ- BD Rx Inc., a wholly-owned subsidiary of leading global medical technology company BD, announced today that the U.S. Food and Drug Administration has approved the second drug to be offered in the recently launched BD Simplist line of ready-to-administer prefilled generic injec
CHICAGO Officials from the China Food and Drug Administration stammered through a question-and-answer period in which the audience sought the agency's definition of an "innovative" drug, its stance on orphan therapies and its policy with regard to biosimilars, during the first day of the BIO 2013 International Convention here. A series of slides
Home Depot Inc, Alvarion Ltd, Agrium Inc, Blount International Inc, Northwest Natural Gas Co, Gentiva Health Services Inc are all expected to be Down Before their earnings are released. Symbol Company# of Reports Quarter Release Date. HD Home Depot Inc May Earnings Q1 05/21/2013.
Children s Specialized Hospital, the nation s largest provider of the rehabilitation services for children with special needs, announced today that it has launched GetWell Town?, a new interactive patient care system developed by GetWellNetwork . Deployed at all 60- beds in the hospital s New Brunswick location, PSE&G Children s Spe
On April 11, 2013 the FDA issued a warning against the ingredient DMAA, found in popular supplements such as USP Labs Jack3d and Oxyelite Pro. According to the FDA, DMAA can elevate blood pressure and could lead to cardiovascular problems. The suspected amphetamine analogue was also detected in a sample the Australian Sports Anti Doping Authorit
The award was presented as part of the association's annual Spring Executive Forum held in Washington, D.C. on March 19-20, 2013. Congressman Roskam has championed this cause for the industry by highlighting the important role rehabilitation providers such as Marianjoy Rehabilitation Hospital in Wheaton, Illinois play in helping patients regain...
Below is a look at some of the headlines for companies that made news in the healthcare sector on April 23, 2013.{ nfg} CytRx Corporation, a biopharmaceutical research and development company specializing in oncology, announced it has reached an agreement with the U.S. Food and Drug Administration under a special protocol assessment for a global pi
April 24 TOP DEMOCRATS in the state Senate came to Philly on Tuesday to increase pressure on Gov. Corbett to "opt in" to an expansion of Medicaid offered under the Affordable Care Act, or "ObamaCare." Following a report that said the state could save hundreds of millions by opting in, Democratic Leader Jay Costa, of Pittsburgh, and Philly's Vince
OSAN AIR BASE, Republic of Korea, April 24 The U.S. Dimethylamylamine, also known as DMAA, geranium oil and several other names, is commonly used in products promising weight loss, performance enhancement and muscle building such as Oxy Elite Pro and Jack3D, and is banned by the Food and Drug Administration. Dietary supplements containing this in
Delaware Department of Health and Social Services issued the following news release:. Governor joined the Department of Health and Social Services, Department of State, Medical Society of Delaware, and the DEA in Dover yesterday to announce the bi-annual Prescription Drug Take-Back Day on April 27,2013 and the state's policy and program recommendat
The U.S. Food and Drug Administration has authorized a smartphone app for doctors to more easily report safety issues with high-risk medical devices such as metal-on-metal hip replacements, according to the Wall Street Journal. This is positive development for patient safety,? said Rochelle Rottenstein, principal of the Rottenstein Law Group.
The Seniors Task Force, co-chaired by Congresswoman Jan Schakowsky and Congresswoman Doris Matsui, announced it will host its first meeting of the 113th Congress this week. Too many in Congress have repeatedly voted to end Medicare and dramatically raise healthcare costs for the elderly by dismantling the Affordable Care Act. Half of America's seni
Image-guided and robot-assisted surgeries have made successful inroads into the western European market. New analysis from Frost& Sullivan, Image-guided and Robot-assisted Surgery Markets in Western Europe, estimates the market to reach $1,697.5 million in 2018. The research covers surgical imaging systems, surgical navigation systems and robotic..
Inovio Pharmaceuticals, Inc. announced that its SynCon universal H1N1 influenza vaccine generated protective antibody levels comparable to a current FDA- approved seasonal influenza vaccine against a currently circulating influenza strain. The data generated in a phase 1 study of healthy volunteers using Inovio's skin-targeted electroporation...
Stockholm, Sweden Medivir AB (OMX: MVIR) today announces that Janssen -Cilag International NV (Janssen) today has submitted a Marketing Authorization Application to the European Medicines Agency (EMA) seeking approval for simeprevir (TMC435). ?The filing of simeprevir in Europe represents the third filing in major regions in the last two mont
According to release, the radiation therapy system, which recently received 510 clearance from the U.S. Food and Drug Administration, features the versatility to deliver high-volume conventional techniques, in addition to linear-accelerator treatments that require the greatest targeting precision. "To have MD Anderson employ our latest technology.
EAGLEWOOD, Colo., April 24 The Medical Group Management Association issued the following news release:. According to the MGMA benchmarking tool, Medical Directorship and On-Call Compensation Survey: 2013 Report Based on 2012 Data, 40 percent of responding medical directors reported their duties were tied to quality metrics, including length of pa
The Health Ministry's pharmaceutical division has asked doctors to be vigilant for cases of pancreatic infections and pancreatic cancer in diabetics taking incretins, drugs commercialized as Januet, Januvia, Byetta, Victoza, Galvus, Eucreas and Onglyza, among others. The announcement on Monday followed a warning by the US Food and Drug Administrati
Opko Health, Inc. announced that it has acquired an approximate ten percent stake in OAO Pharmsynthez, a fully-integrated Russian pharmaceutical company and life science company listed on the Moscow Stock Exchange. According to a release, OPKO's investment is part of an approximate RUR 1.9 billion two-stage financing in Pharmsynthez alongside the..
CHICAGO It wasn't all that long ago that orphan drugs were considered too small to devote valuable R&D resources on. According to the Pharmaceutical Research and Manufacturers of America, last year biopharmaceutical research companies had approximately 460 medicines targeting rare diseases either in clinical trials or awaiting FDA review.
Intas Biopharmaceuticals Ltd., of Ahmedabad, India, launched its Mabtas, making it the second copy of Rituxan/MabThera to be approved in India to treat non-Hodgkin's lymphoma. Dr. Reddy's Laboratories launched Reditux, its copy of rituximab, in 2007 before India adopted a biosimilar regulatory path, selling it at about half the branded price.
