EMA’s public hearing 26 September 2017

Partner News
The European Medicines Agency

 

The European Medicines Agency would like to let you know it is going to hold a Public Hearing on 26 September 2017.

The hearing is part of an ongoing review of valproate-containing medicines in the treatment of women or girls who are pregnant or of childbearing age.

This review (a so-called Article 31 referral) is being carried out by the Agency’s experts in medicines safety, the Pharmacovigilance Risk Assessment Committee (PRAC).

Those wishing to participate at the hearing, which will take place at the EMA offices in London, need to register in advance and may request to speak in front of the Committee or simply observe the proceedings. The hearing will also be broadcast live.

The public hearing will be based on several questions to which the PRAC is seeking the views of all stakeholders.

These questions and the safety issues of concern are published on the EMA website together with a guidance document, a video, and the application form.

The deadline for applications is 25 August 2017.

If you have any questions please contact the agency at: PublicHearings@ema.europa.eu

 

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EFIC-GRÜNENTHAL Grant 2016

Partner News

Cutting edge science in pain treatment in order to improve patients’ lives

EFIC-GRÜNENTHAL GRANT 2016 supports six young scientists in their advanced pain research projects

Brussels/Aachen, 23 May, 2017. The European Pain Federation EFIC® in cooperation with the pharmaceutical company Grünenthal announced that six young research scientists in the field of pain will be awarded an EFIC-GRÜNENTHAL Grant (E-G-G). This biennial grant, totaling € 200,000, supports up-and-coming pain scientists in translating their experimental project ideas into funded pain research projects.

Pain treatment still a challenge

Pain is one of the most common reasons for which people seek medical attention. It is a major healthcare problem in Europe impacting both the individual suffering from symptoms limiting their quality of life and for the society through its economic burden. The estimated direct and indirect healthcare costs for chronic pain disorders in the European Member States vary between 2% and 3% of GDP across the EU. For 2015 this estimate would result in € 294 – 441 billion. Although acute pain may reasonably be considered a symptom of disease or injury, chronic and recurrent pain is a specific challenge and can even be considered as a disease in its own right.

For the tenth time now, the European Pain Federation EFIC® together with the pharmaceutical company Grünenthal supports young pain scientists. Research Grants are supported by up to € 40,000  per project. Awards are decided by the EFIC® Scientific Research Committee, a multi-disciplinary team of renowned experts in the field.

“I am quite optimistic about the increasing interest in pain research as illustrated by a growing number of young people involved in preclinical and clinical pain studies“, expresses Dr Luis Villanueva, Chair of the Scientific Research Committee. He continues: „The EFIC-GRÜNENTHAL Grant represents an original and helpful support to young scientists at early stages of their career. The E-G-G program thus contributes to develop innovative clinical research to help millions of people suffering from pain.”

The E-G-G winners 2016

The Scientific Research Committee of the European Pain Federation EFIC® reviewed 70 applications submitted in the competition of the E-G-G 2016 program and judged six project proposals to be the best for funding. Global criteria for selection took into account the highest scores, but also other important aspects including excellence and diversity in terms of subjects, areas of research, originality and potential clinical impact.

The winners are:

  • Susanne BECKER, Mannheim, Germany
    Altered cognitive-emotional networks in chronic pain: the modulatory role of dopamine. 
  • Piero CHIACCHIARETTAChieti, Italy
    Intersubject variability of brainstem modulation of the endogenous analgesia and phenotypical characterization of the nociceptive profile in humans. A cortical-brainstem connectivity study. 
  • Joukje OOSTERMAN, Nijmegen, The Netherlands
    Disentangling pain and fatigue: a clinical and neurocognitive approach. 
  • Max ORTIZ CATALAN, Gothenburg, Sweden
    Motor execution as a treatment for Phantom Limb Pain.
  • Roi TREISTER, Haifa, Israel
    Can training increase reporting accuracy and study power in human pain trials. 
  • Anne-Priscille TROUVIN, Paris, France
    Peripheral and central effects of TNF in inflammatory pain. Evolution of pain and conditioned pain modulation after anti-TNF therapies in rheumatoid arthritis. The RAPID study.

The prize winners will be presented during the Opening Ceremony of the 10th Congress of the European Pain Federation EFIC®, taking place in Copenhagen, Denmark from 6 – 9th September 2017.

In addition, on the following day, former E-G-G winners will have the opportunity to give insights into the results of their awarded projects at the Symposium “New Findings in Clinical Pain Research”.

For further information please visit www.e-g-g.info

About the European Pain Federation EFIC®

With headquarters in Diegem/Brussels, the European Pain Federation EFIC® is a multidisciplinary professional organisation in the field of pain research and medicine, consisting of the 37 chapters of the International Association for the Study of Pain (IASP®), which are the IASP approved official National Pain Societies in each country. Established in 1993, EFIC’s constituent chapters represent Pain Societies from 37 European countries and more than 20,000 physicians, basic researchers, nurses, physiotherapists, psychologists and other healthcare professionals across Europe, who are involved in pain management and pain research.

For more information, please visit www.europeanpainfederation.eu.

About Grünenthal

The Grünenthal Group is an entrepreneurial, science-based pharmaceutical company specialized in pain, gout and inflammation. Our ambition is to deliver four to five new products to patients in diseases with high unmet medical need by 2022 and become a € 2 billion company. We are a fully integrated research & development company with a long track record of bringing innovative pain treatments and state-of-the-art technologies to patients. By sustainably investing in our R&D above the industrial average, we are strongly committed to innovation.

Grünenthal is an independent, family-owned company headquartered in Aachen, Germany. We are present in 32 countries with affiliates in Europe, Latin America, and the US. Our products are sold in more than 155 countries and approx. 5,500 employees are working for the Grünenthal Group worldwide. In 2016, Grünenthal achieved revenues of approx. € 1.4 bn.

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TEVA News

Partner News

Teva Announces Positive Results for the Prevention of Chronic Migraine

 

Chronic migraine study met all primary and secondary endpoints in both monthly and quarterly dosing regimens

May 31, 2017– Teva Pharmaceutical Industries Ltd. (NYSE: TEVA) today announced positive results from a Phase III HALO study of fremanezumab, an investigational treatment for the prevention of migraine. In the chronic migraine (CM) study, patients treated with fremanezumab experienced statistically significant reduction in the number of monthly headache days of at least moderate severity vs. placebo (-2.5 days) during the 12 week period after first dose, for both monthly (-4.6 days p<0.0001) and quarterly (-4.3 days p<0.0001) dosing regimens. Similar to the Phase II trials, both patients that were on monotherapy and stable doses of prophylactic medications were included in the trial.

In addition, patients treated with fremanezumab experienced significant improvement compared to placebo on all secondary endpoints for both monthly and quarterly dosing regimens, including: response rate, onset of efficacy, efficacy as monotherapy, and disability. The results were positive, and of 13 hierarchical comparisons, p was <0.0001 in 12 of them, being 0.0004 in the remaining. The most commonly-reported adverse event in the study was injection site pain, with similar rates in the placebo and active groups.

“Migraine is a serious, debilitating neurological condition that substantially impacts all aspects of a person’s life,” said Michael Hayden, M.D., Ph.D., President of Global R&D and Chief Scientific Officer at Teva. “Our Phase III clinical trial program has exhibited extremely encouraging results, including with a quarterly dosing regimen, for fremanezumab in chronic migraine. We are grateful to the patients and clinical investigators who participated in this study and helped to advance our understanding of the potential of fremanezumab as a preventive treatment option for the millions of people suffering from migraine.”

Find the complete content of this press release here

About Migraine

Migraine is an unpredictable neurological condition with symptoms such as severe head pain and physical impairment that can impact quality of life and productivity. There are two clinical manifestations of migraine – chronic, where patients suffer 15 or more headache days per month, and episodic, where patients have 14 or less headache days per month. With more than 1 billion people affected worldwide, migraine is the third most prevalent illness in the world. More than 38 million Americans have migraine. Of the approximately 40% of patients suffering from migraine for whom prevention is appropriate, only 13% are currently receiving therapy. According to the Migraine Research Foundation, healthcare and lost productivity costs associated with migraine are estimated to be as high as $36 billion annually in the U.S. There remains a significant medical need for treatments designed specifically to prevent migraines.

About Teva

Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is a leading global pharmaceutical company that delivers high-quality, patient-centric healthcare solutions used by approximately 200 million patients in 100 markets every day. Headquartered in Israel, Teva is the world’s largest generic medicines producer, leveraging its portfolio of more than 1,800 molecules to produce a wide range of generic products in nearly every therapeutic area. In specialty medicines, Teva has the world-leading innovative treatment for multiple sclerosis as well as late-stage development programs for other disorders of the central nervous system, including movement disorders, migraine, pain and neurodegenerative conditions, as well as a broad portfolio of respiratory products. Teva is leveraging its generics and specialty capabilities in order to seek new ways of addressing unmet patient needs by combining drug development with devices, services and technologies. Teva’s net revenues in 2016 were $21.9 billion. For more information, visit www.tevapharm.com.

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Boston Scientific’s new project

PAE News

“Now you hear me”

 

The collaboration between Pain Alliance Europe and Boston Scientific on the Red Balloon project has been an enriching experience. Until the end of August, you can still upload your pictures and post them on the social media channels (Facebook, Instagram, and Tweeter) with the hashtag #RELEASETHEPAIN

But the commitment of the two parties for raising awareness for chronic pain will not end with the closing of the Red Balloon project. Boston Scientific prepares a follow up of this first initiative, called ‘Now you hear me”.

Pain Alliance Europe endorses this new campaign and we are excited for this new project to shape so we are able to share with you soon details on how you can get involved.

Stay tuned by visiting our website regularly.

 

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