Navigation Links
Musculoskeletal Network Launches Special Coverage of FDA Biosimilars Policy
Date:11/16/2012

NORWALK, Conn., Nov. 16, 2012 /PRNewswire/ -- UBM Medica US announces that MusculoskeletalNetwork features special coverage of sessions from the annual meeting of the  American College of Rheumatology (ACR), including the latest information about new FDA processes for approval of biosimilars that are like generic versions of expensive medications now used to treat painful rheumatologic conditions such as rheumatoid arthritis (RA).

Many newer "biological" drugs currently approved for these disorders, such as adalimumab (Humira) and rituximab (Rituxan), are identical to molecules created by the human immune system, except that these drugs are manufactured in cell cultures by bioengineering processes. Their high cost, which can run into the tens of thousands of dollars per month, should drop if manufacturers are allowed to sell identical "follow-on" products once the patent on the original drugs expires, just as less-expensive generic versions of other drugs are now on the market. Since the biosimilars would not be produced in exactly the same kinds of cells, there are concerns that they might not be as safe or effective as the original biological.

As part of the Affordable Care Act, the US Congress passed legislation in 2010 authorizing the FDA to establish policies to regulate biosimilars. In the article "FDA Panel on Biosimilars: Analytics Should Trump Clinical Trials" Musculoskeletal Network cites FDA officials at the ACR conference speaking to the specific concerns of rheumatologists attending the conference. These specialists are particularly interested in the issue as th
'/>"/>

SOURCE UBM Medica US
Copyright©2012 PR Newswire.
All rights reserved

0

GOOD

Page: 1 2 3

Related medicine technology :

1. Medical Device Developers - Network at BIOMEDevice Boston Next Week
2. Industry Veteran Brings Sales Expertise to AlloSources Growing Distribution Network
3. Blue Cross Blue Shield of Michigan and Blue Care Network support the Drug Enforcement Administrations Nationwide Prescription "Drug Take-Back Day"
4. RxAlly Expands National Network With Addition Of Nineteen Community Pharmacy Organizations Representing Over 2,000 Pharmacies
5. Mylan Sponsors Drug Store News and Pharmacist Society to Provide a New Business Networking Platform for Pharmacy Schools and Students
6. Medical Device Developers - Network at MD&M East Next Week
7. HIV Vaccine Trials Network Opens Enrollment for Phase 1 Trial of GeoVax Labs Second Generation HIV Vaccine
8. HealthWarehouse.com and Northwest Physicians Network Partner to Provide Exclusive Discount Pharmacy Services to Patients
9. Medical Oncology Association of Southern California Purchasing Network (MPN) Names Cardinal Health Specialty Solutions as its Primary Healthcare Solutions Partner
10. The MED Group Expands MED Suppliers Network to add Ventilator Program
11. RxAlly Member Pharmacies Invited To Become The Preferred Network For Smart Insurance Company Holdings, Inc.
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/24/2013)... 24, 2013 The potential of ... delivery of therapeutic agents has been receiving undeniable attention ... showing significant promise. The crucial formulation considerations for orally ... play a major role in the efficiency of pulmonary ... development of new formulation techniques and devices in recent ...
(Date:5/23/2013)... y PARÍS, 24 de mayo de ... ), un destacado desarrollador y fabricante de herramientas ... la diagnosis y tratamiento de la enfermedad vascular ... del ensayo ADVISE ( Ad enosine V ... E valuation) II durante la sesión de ensayo ...
(Date:5/23/2013)... , May 23, 2013 Nephros, Inc. (OTC ... medical device company that develops and sells high performance ... its rights offering.  In addition, the concurrent temporary reduction ... expired on May 17, 2013. Nephros estimates ... from the rights offering.   A portion of the proceeds ...
Breaking Medicine Technology:Inhalaltion Drug Delivery: 11-12 September - Berlin, Germany 2Volcano anuncia los resultados preliminares del estudio ADVISE II y su inclusión en el ensayo SYNTAX2 2Volcano anuncia los resultados preliminares del estudio ADVISE II y su inclusión en el ensayo SYNTAX2 3Volcano anuncia los resultados preliminares del estudio ADVISE II y su inclusión en el ensayo SYNTAX2 4Volcano anuncia los resultados preliminares del estudio ADVISE II y su inclusión en el ensayo SYNTAX2 5Volcano anuncia los resultados preliminares del estudio ADVISE II y su inclusión en el ensayo SYNTAX2 6Nephros Announces Completion of Rights Offering 2Nephros Announces Completion of Rights Offering 3Nephros Announces Completion of Rights Offering 4
... SILVER SPRING, Md., May 9, 2011 /PRNewswire-USNewswire/ – CoMeD ... a Republican State Senator filed an amendment to regulate ... made it illegal to buy, sell, manufacture, deliver, import, ... 0.3 micrograms of organic or inorganic mercury per milliliter ...
... May 9, 2011 TriReme Medical, Inc. (TriReme), a ... treatment of complex vascular disease, announced today the appointment ... their Board of Directors. Mr. Bose, Founder ... Singapore and was until recently Company Group Chairman at ...
Cached Medicine Technology:Florida Legislature Refuses to Limit Mercury in Vaccines 2Florida Legislature Refuses to Limit Mercury in Vaccines 3TriReme Medical Lines Up Asian Strategy With Key Appointment of New Board Members 2
(Date:5/24/2013)... 2013 General Data Company Inc., ... tracking and data management products and solutions, has ... Inc., (TBS) of Durham, North Carolina, a leading ... for the clinical and research pathology marketplace. TBS ... which provides specialty products and solutions to hospitals, ...
(Date:5/24/2013)... the first conference of its kind, Impacts World ... and decision makers from politics, business and civil ... integrated climate impact research across sectors and scales. ... World 2013 on May 27th, 1pm to 1:55pm ... , Speakers include: , Connie Hedegaard, ...
(Date:5/24/2013)... Finding the answer for this is at the centre of ... the Bergen fMRI Group at the University of Bergen (UiB) ... The way they do this is by studying people who ... mental illness. For a five-year period, the group is studying ... report published in Frontiers in Human Neuroscience shows ...
(Date:5/24/2013)... May 24, 2013 The Icahn School ... International (CDI) exclusive license rights to commercially develop ... medicine applications. These cells are capable of further differentiation ... cardiomyocytes, endothelial cells, and vascular smooth muscle cells, and ... damaged heart tissue. , The original agreement announced in ...
(Date:5/24/2013)... The creative flair and design talent of ... Institute of Textiles and Clothing (ITC) have won applause ... held on 22 May at The Mira Hong Kong. ... design students, various knitwear producers and yarn suppliers, the ... four outfits from 20 graduating students majoring in knitwear ...
Breaking Medicine News(10 mins):Health News:General Data Acquires Triangle Biomedical Sciences 2Health News:General Data Acquires Triangle Biomedical Sciences 3Health News:Help at hand for schizophrenics 2Health News:Icahn School of Medicine at Mount Sinai Grants Exclusive License to Cellular Dynamics International for Development of a Cellular Therapy for Cardiac Muscles 2Health News:Icahn School of Medicine at Mount Sinai Grants Exclusive License to Cellular Dynamics International for Development of a Cellular Therapy for Cardiac Muscles 3Health News:Icahn School of Medicine at Mount Sinai Grants Exclusive License to Cellular Dynamics International for Development of a Cellular Therapy for Cardiac Muscles 4Health News:PolyU Stages Knitwear Fashion Show 2
... of their work linking mutations in BRAC2 gene leading to ... Journal of Medical Ethics. //Mutations in BRAC2 gene which was ... women has now found to increase the risk of development ... the study also confirmed the relation between BRAC2 mutations and ...
... population its possible to drive safely if they take ... latest edition of Harvard Men's Health Watch, chronic illnesses ... for auto accidents. Even normal, healthy aging can take ... sensory abilities. But simple preparations and precautions can help ...
... risk of picking up infections like MRSA if they glucose ... recent issue of the journal Thorax.// ,The authors base ... in intensive care who required mechanical help with their breathing ... medical and surgical specialties., ,Levels of glucose were measured ...
... from Johns Hopkins had found that patients, who are treated ... follow all the advice of their physicians for effective treatment ... of more than 5,000 Americans, those who said they were ... likely to report higher levels of satisfaction with their care, ...
... have discovered the brain patterns associated with amusia or tone ... associated with other learning disorders like dyslexia. // ... are tone deaf -- in scientific terms, suffering from amusia ... note from another. The disorder can be congenital, present from ...
... before. The problem seems to be worse now that scientists ... proves, when it comes to being overweight, past is most ... shows that we can't afford to wait," said Vivien Morris, ... that brought the girls to the health center's pool, a ...
Cached Medicine News:Health News:Critically Ill Patients More At Risk Of Infection If Glucose Is Present In Their Lung Secretions 2Health News:Early Awareness About Weight Management Needed To Tackle Lifelong Obesity 2
The 7700 Reciprocating Saw completes the large power system with our simple twist-lock blade hub and selection of saw blades....
The 7500 Drill/Reamer operates at two speeds for multiple applications, which is automatically controlled by the 16 different coupler attachments. The drill reamer can be used for, but is not limited...
... SmartDriver System consists of a pistol-grip handpiece ... with a wide range of couplers that ... orthopedic surgical applications., ,The Battery SmartDriver ... compared to the original Battery SmartDriver. The ...
... Meniscus Implant (CMI) is a type I ... irreparable meniscus tear or loss of meniscus ... procedure. The purpose of the CMI ... and return to a more vigorous lifestyle, ...
Medicine Products: