Navigation Links
EU rules are denying children latest cancer drugs
Date:2/10/2014

GFR genes, but the manufacturers have been granted waivers from testing the drugs in children, even though ALK and EGFR mutations have been shown to play a role in some childhood cancers.

The analysis by the ICR and the ITCC also shows that the European Commission's alternative route for getting cancer drugs to children its regulation on rare, or 'orphan', conditions is failing to be effective. Of the 25 EU-approved orphan medicinal products for cancer, none were registered for children in a different cancer type to that in adults.

The ICR is calling for a change in the implementation of the 2007 European Union Regulation on Paediatric Medicine, originally designed to improve children's access to new treatments.

Specifically, the ICR wants the European Commission to refuse to grant waivers to pharmaceutical companies exempting them from testing cancer drugs in children on the basis that the adult cancer targeted does not occur in children.

These so-called 'class waivers' allow pharma companies to avoid the implementation of Paediatric Investigation Plans (PIPs), which are supposed to give companies an incentive to test their products in children by offering longer market exclusivity.

Although waivers are appropriate when an adult cancer drug will not work in childhood cancers, they are often granted even when evidence shows that a drug for adult cancers has a mechanism of action that could treat childhood cancers too.

The ICR has already asked the European Commission to make changes to the implementation of the EU Regulation on Paediatric Medicine, and now plans to speak to key partners in the UK and internationally to try to secure change.

The ICR also believes in the need for stronger financial incentives to compensate pharmaceutical companies for the financial challenge of developing drugs for small patient populations. Some pharmaceutical companies already voluntarily submit PIPs based on mechanism
'/>"/>

Contact: Henry French
claire.bithell@icr.ac.uk
020-715-35380
Institute of Cancer Research
Source:Eurekalert

Page: 1 2 3 4

Related medicine news :

1. Jan. 16 Atlantic Information Services Webinar to Offer a “Crash Course” on New Reform Rules
2. FDA Proposes New Rules to Strengthen Food Safety
3. Chips, Sodas Out, Healthier Fare In With New School Snack Rules
4. NuvaRing Lawsuits Move Forward, as Federal Judge Rules that Plaintiffs’ Experts May Testify on “Bursts” of Estrogen Allegedly Delivered by NuvaRing, Wright & Schulte LLC
5. Is Blunt Honesty The Best Policy? Queendom.com’s Latest Research Reveals That Tact Still Rules
6. Beyond Rules—Sean A. Anderson’s Remarkable 275 Pound Weight-Loss Approach Now on Paperback and E-book
7. TheBeautyPlace.com Features Martha Stewart’s Ten Golden Rules of Successful Aging
8. Scott R. Tischler of Tischler Brothers Fitness unveils the 4 rules to losing weight while going out
9. Johns Hopkins rewrites obsolete blood-ordering rules
10. Scott Tischler of Tischler Brothers Fitness Unveils the 7 Rules to a Healthy Diet
11. Orriant Announced They Have Been Compliant with New Federal Rules for Corporate Wellness Programs for Nearly a Decade
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/4/2015)... SACRAMENTO, Calif. (PRWEB) May 04, 2015 ... Permanente Medical Group today launched a new initiative ... building the next generation of physicians committed to ... Estudiantes Para Ser Medicos, or Preparing Students to ... multi-faceted initiative that will provide scholarships, mentorship and ...
(Date:5/4/2015)... Atlanta, Georgia (PRWEB) May 04, 2015 Each ... the country to raise funds and awareness for breast cancer. ... Plastic Surgery will be featured as the entertainment sponsor for ... the Cure” on May 9 at the Lenox Square Mall. ... year’s Atlanta race, and to raise $1.2 million. Perimeter Plastic ...
(Date:5/4/2015)... R.I. (PRWEB) May 04, 2015 Johnson & ... $40 million engineering and science academic center on Wednesday, April ... the ground for land made available by the re-alignment of ... the corner of Friendship and Chestnut streets in Providence, is ... built on a parcel of land the university purchased in ...
(Date:5/4/2015)... 04, 2015 The Lymphoma Research Foundation ... to funding innovative lymphoma research and serving the lymphoma ... initiatives and patient services – is set to host ... Farms in West Orange, NJ on June 1, 2015. ... innovative research programs through LRF. , This year, the ...
(Date:5/4/2015)... 04, 2015 Baptist Medical Center ... Association’s Get With The Guidelines®-Stroke Gold Plus Quality ... Roll. The award recognizes the hospital’s commitment and ... most appropriate treatment according to nationally recognized, research-based ... To receive the Gold Plus Quality Achievement Award, ...
Breaking Medicine News(10 mins):Health News:New UC Davis Program Targets Next Generation of Physicians to Advance Latino Health 2Health News:New UC Davis Program Targets Next Generation of Physicians to Advance Latino Health 3Health News:New UC Davis Program Targets Next Generation of Physicians to Advance Latino Health 4Health News:New UC Davis Program Targets Next Generation of Physicians to Advance Latino Health 5Health News:Perimeter Plastic Surgery Sponsors 2015 Susan G. Komen Greater Atlanta "Race for the Cure" 2Health News:Johnson & Wales University “Breaks Ground” On New $40 Million Engineering and Science Academic Center 2Health News:Johnson & Wales University “Breaks Ground” On New $40 Million Engineering and Science Academic Center 3Health News:Lymphoma Research Foundation Set to Host Annual Ace Lymphoma Luncheon at Mayfair Farms in West Orange, NJ 2Health News:Baptist Medical Center Jacksonville Receives Top Honor for Stroke Care 2Health News:Baptist Medical Center Jacksonville Receives Top Honor for Stroke Care 3Health News:Baptist Medical Center Jacksonville Receives Top Honor for Stroke Care 4
... a strain of HIV that is extremely hard to treat, ... ,At least two types of HIV drugs don't work ... from Public Health — Seattle & King County said Thursday. ... the gay community is at highest risk," said Dr. Bob ...
... genes from an ancient wheat variety have led to a ... a recent set of papers published in the journal Plant ... and Nax2. The genes work by excluding salt from different ... from the leaves. The discovery of the two genes is ...
... has continued to decrease since the early 1990s, the rate ... percent higher in African American women than in white men ... ,However, the disparity among men has narrowed over ... African Americans than whites. These data appear in the newly ...
... increase in allergic reactions among people who use hair dye, ... Teenagers appear to be more susceptible, as they are seen ... ,The common allergic reactions are rashes, facial swelling and ... ,Now researchers are pressing for a wider debate about ...
... being tired or exhausted, people should take these complaints ... or even death, says a University of Alberta researcher ... of A professor from the Faculty of Nursing, argues ... and that recognizing those distinctions will help health-care workers ...
... clinical practice guidelines for diagnosis and management of venous ... causes clotting in the veins. ,Key elements ... prediction rules to establish pretest probability of deep vein ... testing and the utility of various diagnostic tools such ...
Cached Medicine News:Health News:New HIV Threat Found in King County 2Health News:Ancient Genes Used to Produce Salt-Tolerant Wheat 2Health News:Cancer Death Rates High in African-Americans 2Health News:Take Fatigue Seriously - Says Researcher 2Health News:Take Fatigue Seriously - Says Researcher 3Health News:New Guidelines for Diagnosis of Venous Thromboembolism 2
(Date:5/4/2015)... , May 4, 2015  By looking at ... to distinguish between two very different conditions that ... Theodore Henderson , MD, PhD., a ... cases, this study can help the ... therefore treatment options, for Post-Traumatic Stress Disorder (PTSD) ...
(Date:5/4/2015)... 2015  CytRx Corporation (Nasdaq: CYTR ), ... oncology, today announced an interim analysis from its ... aldoxorubicin with either gemcitabine or ifosfamide. Both studies ... escalating doses of aldoxorubicin. The combinations appear to ... dose level of aldoxorubicin (170 mg/m2), impressive tumor ...
(Date:5/4/2015)... CONCORD, N.H. , May 4, 2015 /PRNewswire/ ... creating analytic and technology solutions to improve healthcare ... Bedford Nursing & Rehabilitation Center (BNRC) use ... monitoring platform to improve the quality and lower ... analytics platform integrates clinical, outcomes, claims and utilization ...
Breaking Medicine Technology:New Medical Research Shows Brain Imaging Can Now Help Doctors Differentiate Between PTSD and Traumatic Brain Injuries 2New Medical Research Shows Brain Imaging Can Now Help Doctors Differentiate Between PTSD and Traumatic Brain Injuries 3CytRx Reports Aldoxorubicin Demonstrates Both Tumor Shrinkage and Improved Quality of Life in Chemotherapy Resistant Cancers 2CytRx Reports Aldoxorubicin Demonstrates Both Tumor Shrinkage and Improved Quality of Life in Chemotherapy Resistant Cancers 3CytRx Reports Aldoxorubicin Demonstrates Both Tumor Shrinkage and Improved Quality of Life in Chemotherapy Resistant Cancers 4CytRx Reports Aldoxorubicin Demonstrates Both Tumor Shrinkage and Improved Quality of Life in Chemotherapy Resistant Cancers 5CytRx Reports Aldoxorubicin Demonstrates Both Tumor Shrinkage and Improved Quality of Life in Chemotherapy Resistant Cancers 6CytRx Reports Aldoxorubicin Demonstrates Both Tumor Shrinkage and Improved Quality of Life in Chemotherapy Resistant Cancers 7Geneia Launches First-of-its-Kind Partnership to Use Advanced Analytics to Improve the Quality and Cost of Care for Skilled Nursing and Rehabilitation Patients 2Geneia Launches First-of-its-Kind Partnership to Use Advanced Analytics to Improve the Quality and Cost of Care for Skilled Nursing and Rehabilitation Patients 3
... 2010 /PRNewswire-Asia-FirstCall/ -- Lotus Pharmaceuticals, Inc. (OTC Bulletin Board: ... developer, manufacturer and seller of medicine and drugs in the ... four members of its board of directors and the subsequent ... Mr. Lijun Fan, Mr. Zhaohui Li, and Mr. Jun Lu ...
... Dec. 21, 2010 Silence Therapeutics plc (AIM: SLN) ... dedicated to the discovery, development and delivery of targeted, ... serious diseases, today provides a year-end update on trading ... Silence Therapeutics, comments: "2010 has been an exciting ...
Cached Medicine Technology:Lotus Pharmaceuticals Announces Change of Directors 2Lotus Pharmaceuticals Announces Change of Directors 3Lotus Pharmaceuticals Announces Change of Directors 4Silence Therapeutics Provides Year-end Update 2Silence Therapeutics Provides Year-end Update 3
... Laboratories is a national reference laboratory and ... and development. ARUP offers an extensive test ... tests in clinical and anatomic pathology. Owned ... clients include more than half of the ...
... a national reference laboratory and a worldwide ... ARUP offers an extensive test menu of ... clinical and anatomic pathology. Owned by the ... more than half of the nation's university ...
... Laboratories is a national reference laboratory and ... and development. ARUP offers an extensive test ... tests in clinical and anatomic pathology. Owned ... clients include more than half of the ...
... Laboratories is a national reference laboratory and ... and development. ARUP offers an extensive test ... tests in clinical and anatomic pathology. Owned ... clients include more than half of the ...
Medicine Products: