EMA confirms Glybera decision

by IainBate 26. April 2012 17:12

Pharma Product News The EMA’s CHMP has maintained its decision not to recommend a marketing authorisation for the orphan medicine Glybera (alipogene tiparvovec).

The Committee again reviewed the benefit risk of Glybera in lipoprotein lipase deficiency patients with severe or multiple pancreatitis attacks.

But it concluded there was insufficient evidence to show the benefit of the gene-therapy in the restricted group of patients and was unable to recommend marketing authorisation.

The European Commission requested in January 2012 that the EMA review its negative opinion confirmed in October 2011. That followed a request from the applicant Amsterdam Molecular Therapeutics B.V. after the CHMP had originally failed to recommend the marketing of the product in June 2011.

Glybera is a gene-therapy product that uses an adeno-associated viral vector intended to treat adult patients diagnosed with lipoprotein lipase deficiency demonstrating hyperchylomicronaemia or who have a history of acute pancreatitis.

But the CHMP found it difficult to obtain and assess data in this very rare disease.

After considering all of the evidence, it concluded that Glybera reduced pancreatitis attacks in the small number of patients assessed, but the evidence was not sufficiently convincing.

In addition, the Committee decided that the reduced risk of pancreatitis attacks may have been due to other factors, such as lifestyle and diet.

Pharma and diagnostics partner for HIV and cancer care

by JoelLane 8. February 2012 16:57

Pf industry news Siemens Healthcare Diagnostics has partnered with two pharmaceutical companies, ViiV Healthcare and Tocagen, to develop diagnostic tests alongside targeted drugs for HIV and cerebral cancer.

As ViiV Healthcare is a joint venture of Pfizer and GSK focused on HIV treatment, the partnership represents a collaboration of leading pharma and medtech companies.

It also signals major company investment in ‘stratified medicine’, where drugs targeting narrow patient groups are developed alongside ‘companion diagnostics’ to identify suitable patients.

Siemens CEO Michael Reitermann said the new projects would “align Siemens with new classes of therapies tailored to the individual”.

ViiV Healthcare will partner with Siemens for clinical trials of its first-in-class CCR5 co-receptor antagonist Celsentri (maraviroc) and investigate the commercial prospects of a diagnostic test to assist in patient selection.

Celsentri was licensed in 2007 in Europe and the US as a treatment for CCR5-tropic HIV. It is currently in a phase III study to establish its efficacy in combination with darunavir/ritonavir.

The planned trials will put the combination head-to-head with the combination of Gilead’s Truvada and darunavir/ritonavir.

US company Tocagen will partner with Siemens to produce diagnostic tests to support clinical trials of Tocagen’s viral gene therapy Toca in two forms, injectable Toca 511 and extended-release Toca FC tablets, in treating primary brain cancer.

For diagnostics companies such as Siemens, gaining access to the companion diagnostics market – which is already worth $1.5bn – depends on collaboration with pharma companies.

Medical Futures Innovation Awards 2011

by Joel 11. August 2011 14:55

MEDICALFUTURES_BLACK web

Old Billingsgate, London, Monday 6 June

The Medical Futures Innovation Awards, Europe’s leading showcase of early-stage healthcare innovation, this year recognised new ideas such as a 3D imaging system to assess lung function, a dental syringe that uses chemistry to make injections less painful, and a Wii-style rehabilitation therapy for stroke patients.

More than 1500 people from medicine, business and politics attended the daytime innovation showcase and the evening awards ceremony.

In the daytime event, hosted by BBC Executive Producer Dr Michael Mosley, 40 innovative products were demonstrated. Each inventor was interviewed by Dr Moseley, explaining their technology’s potential or proven achievement.

The evening event was hosted by comedian Rory Bremner and Dynasty actress Emma Samms. The guests included broadcasters such as Sir Trevor McDonald, senior NHS figures such as Sir Bruce Keogh and clinical pioneers such as laryngeal transplant surgeon Prof. Martin Birchall.

Medical Innovations Awards 2011
Sir Trevor McDonald, Emma Samms and Nina Wadia

Tomorrow’s healthcare

The Medical Futures Awards, which started in 2001, are a non-profit initiative to assist early-stage innovations that can provide realistic solutions to improve clinical outcomes and reduce healthcare costs. Medical Futures works with industry, government organisations, angel investors, medical associations and research bodies to run the Awards and ensure their real-world impact.

The Awards judging process is a transparent peer review in which three criteria are applied: novelty, viability (both clinical and commercial) and potential benefit to patient care.

Clinicians, scientists and entrepreneurs are invited to pitch their ideas to expert judging panels. This year, the 100 shortlisted teams pitched to judges including Sir Bruce Keogh, Medical Director of the NHS, and Professor Martin Rothman, VP of Medical Affairs for Medtronic.

Limbs Alive
Limbs Alive

Changing patients’ lives

Past winners of the Medical Futures Innovation awards joined this year’s winning teams in a daytime showcase of groundbreaking solutions that demonstrated the potential of the life science industry to transform patient experience.

• 2003 winner Diagnostics for the Real World has made progress towards meeting the need for reliable low-cost point of care tests for HIV and other infections that can be used in the developing world, where medical facilities are limited.

• Stanmore Implants has followed its 2002 award by continuing to develop and commercialise high-tech prostheses such as the iTAP, a prosthetic arm that can be implanted directly into the bone.

• Dr Vince Forte, a 2001 winner, has seen his Peezy device – a disposable funnel for urine collection in female patients – gain a place on the NHS drug tariff.

• The TightRope suture-button device developed by 2003 winner Brian Thornes and now available from Arthrex Inc, has been used to heal ankle fractures in 60,000 patients worldwide.

Stanmore Implants web
Stanmore Implants

Solutions for the future

The Medical Futures Innovation Awards 2011 were divided into three categories:

1. Cardiovascular Innovation

The overall winner and winner of Best Innovative Concept was the Temporary Cardiac Assist, developed by a team from Papworth Hospital NHS Trust: a modification to the heart-lung machine that listens to the patient’s heart and ensures it is supplied with oxygenated blood.

The Best Innovation in Service Redesign award went to a team from Liverpool Women’s Hospital, Worcestershire Royal Hospital and Memorial Hospital Darlington for Basics, a new type of resuscitation trolley that allows the newborn baby to be resuscitated at the mother’s bedside.

The winner of Best Innovation to Improve Patient Care in this category, as well as Overall Best NHS Innovation, was Limbs Alive. This technology – developed by teams from Royal Victoria Infirmary and Newcastle University – uses Wii-style circus skills games to help rehabilitate paralysed stroke patients.

The Best Innovation in Diagnostics award went to teams from University Hospitals of Leicester NHS Trust and the University of Leicester for Lifemap: a non-invasive test that identifies abnormal cardiac areas to predict the risk of sudden heart attacks.

A research team from Queen’s University, Belfast received a Commendation for its discovery of angiogenesis-regulating peptides: a protein in frog skin that has the potential to allow long-term control of cancer.

2. Dental and Oral Health Innovation

The overall winner and winner of Best Blue Sky Idea was the Smart Dental Injection System, developed by teams from the University of Newcastle: a double-barrelled syringe cartridge designed to reduce the pain of injection by adding a buffer solution to the anaesthetic.

The Best Educational Innovation award went to teams from Kings College London for Haptel, a virtual reality dental school.

The Best Translational Research Innovation award was won by teams from Kings College London and St George’s Hospital, University of London, for Preventing Cavities the Smart Way: a topical gel that targets the bacterial cause of dental caries.

Identifi, a digital camera system that takes images of patient’s teeth and sends them to a wireless tablet device accessible to the patient and dentist, won the Best Innovation in Patient Engagement award. It was developed by teams from Inspektor Research Systems and the University of Liverpool.

Researchers from the University of London won a Commendation for their Blue Sky Idea of synthetic peptides: two synthetic proteins used to regenerate bone, blood vessels and nerves by stimulating the patient’s stem cells.

3. Respiratory Innovation

The overall winner and Best Blue Sky Idea winner was the Nox therapy, developed by teams from Edixomed Ltd and Queen Mary University of London, which protects patients against ventilator-associated pneumonia by restoring the body’s natural levels of nitric oxide.

The Best Translational Research award went to a team from the University of Sheffield for its Polaris MRI system, which uses inhaled inert gases to produce high-resolution lung images without the need for radiation.

The Best Therapeutic Innovation in this category, and the Best Translational Research Innovation overall, was the Cystic Fybrosis Gene Therapy developed by researchers from Imperial College, London and the Universities of Edinburgh and Oxford, which delivers a normal version of the faulty cystic fibrosis gene into the lungs of sufferers via a virus.

The PneumaScan device from PneumaCare Ltd and a medical team from Addenbrookes Hospital won the Best Business Proposition award. This non-invasive product allows clinicians to assess lung function using 3D imaging technology similar to that used in entertainments.

Researchers from the University of Houston, Texas received a Commendation for Inverseon, a therapy that uses beta-blockers to treat COPD.

 Medical Innovations Awards 2011
PneumaCare Ltd

A life in innovation

The Lifetime Achievement Award 2011 was presented to Prof. Rodney Perkins of Stanford University School of Medicine, one of the world’s greatest medical device entrepreneurs. Rodney Perkins is the creator of such breakthrough technologies as the injectable collagens used in facial reconstruction, the world’s smallest hearing aid, laser surgery and the non-surgical hysterectomy.

perkins 2 web
Professor Rodney Perkins

The long game

The founder of Medical Futures, consultant surgeon Dr Andy Goldberg OBE, said: “Since we started 10 years ago, a Medical Futures Innovation Award has become one of the most sought after healthcare and business accolades, and past winners have gone on to raise more than £100 million of investment.”

However, he added, the road to investment needs to be simpler: “Most of the successful innovations have taken 10 to 20 years before they benefit patients, and some great British inventions such as the MRI scanner and the laryngeal mask airway have leaked from the UK and are now owned and marketed by American and Japanese companies.

“If we can connect the best healthcare ideas to the right people and money and keep the resulting companies in the UK, we can bring significant benefits to UK Plc, demonstrate the UK as a first-class place for ideas and, most importantly, improve the NHS and the lives of the patients it treats.”

NOX DAYTIME web
Nox therapy development team

TextBox

Tag cloud

Calendar

<<  June 2013  >>
MoTuWeThFrSaSu
272829303112
3456789
10111213141516
17181920212223
24252627282930
1234567

View posts in large calendar