Molecular Medicine SpA : Update on the registration …

02/03/2014 | 04:20pm US/Eastern

PRESS RELEASE

MolMed provides an update on the registration strategy for its gene therapy TK in Europe and in the United States

Milan (Italy), 3 February 2014 - MolMed S.p.A. (Milan:MLM) today provided an update on the registration strategy for its gene therapy TK in Europe and in the US.

With regard to the Conditional Approval procedure in EU, after two meetings with the national agencies from rapporteur and co-rapporteur member states designated by the European Medicines Agency (EMA), the Company confirms the expected filing date of the application in the first quarter of 2014. As far as the Breakthrough Therapy submission is concerned, the U.S. Food and Drug Administration (FDA) has not - at this time - granted the designation for the cell therapy TK as adjunctive treatment in hematopoietic stem cell transplantation (HSCT) for adult patients affected by high risk acute leukaemia. However, the FDA indicates that the Company can submit a new request once new clinical evidence becomes available. According to this suggestion, MolMed intends to re-apply for Breakthrough Therapy designation in the US since new evidence is now becoming available, including initial efficacy data from the ongoing Phase III clinical trial. These data will be submitted for presentation at next meeting of the American Society of Clinical Oncology (ASCO).

About Breakthrough Therapy

Breakthrough Therapy designation is a new regulatory option available at FDA and is intended to expedite the development and review of drugs for serious or life-threatening conditions. The criteria for breakthrough therapy designation require preliminary clinical evidence that demonstrates the drug may have substantial improvement on at least one clinically significant endpoint over available therapy. A breakthrough therapy designation conveys all of the fast track program features as well as more intensive FDA guidance on an efficient drug development program. Details of these regulatory processes can be found at this link: http://www.fda.gov/RegulatoryInformation/Legislation/FederalFoodDrugandCosmeticActFDCAct/SignificantA mendmentstotheFDCAct/FDASIA/ucm341027.htm The last update provided by the FDA on Dec 31st 2013 shows that only 2 requests have been granted out of the 22 submitted.

About TK

TK is a cell therapy product, based on the use of genetically engineered donor T cells carrying a "suicide gene". These cells are administered to patients during the haematopoietic stem cell transplantation for the treatment of high risk leukaemia. TK therapy allows to eliminate the post-transplant immunosuppression treatment thus accelerating the immune reconstitution and controlling the immunological consequences arising from the genetic differences with the donor, known as Graft versus Host Disease (GvHD).

About Phase III trial TK008

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Entourage Yearbooks Launches Smartphone App to Address Most Difficult Aspect of Creating a Yearbook

Princeton, NJ (PRWEB) February 06, 2014

While surveying yearbook advisors, Entourage Yearbooks found that gathering photos is believed to be the most difficult aspect of creating a yearbook. Many advisors depend on teachers, parents and students to take pictures at all of the events throughout the school year, and to submit them in a timely manner to the yearbook staff. Entourage Yearbooks has created a new Smartphone app to make submitting photos as easy as possible.

"We created the app with the entire school community in mind," said Entourage Yearbooks President, Elias Jo. "Getting everyone involved in taking and uploading photos will not only make the yearbook process easier for the yearbook advisor and staff, but will also result in a broader representation of the school year."

In the past, using photos from Smartphones was often discouraged as they often resulted in pixilated or poorly lit photographs. Over the last year, phone manufacturers have started including such technologically advanced cameras in phones that the print quality of pictures taken with most Smartphones and submitted at their full resolution no longer remains an issue.

The Entourage Yearbooks Smartphone App is simple to use and will soon be available for all school yearbooks working with Entourage. The app allows the user to upload pictures directly into pre-created folders on the school's yearbook website hosted by Entourage Yearbooks. Once uploaded, the yearbook advisor has access to all of the photos.

"It's as easy as posting a photo on Facebook or Google+," said Jo. "Having the app set up on a phone will cut out a few steps like searching for the school's name, or filling out login information to access the website. The simplicity of the process, and it's similarity to other popular interfaces should encourage more members of the school community to submit photos. More photos means easier and more awesome yearbooks!"

Entourage Yearbooks plans to announce the official launch date of the app within the coming months.

About Entourage Yearbooks: Founded in 2006, Entourage Yearbooks provides yearbooks to over 3,000 schools across the US and in 18 countries around the world. Entourages unique collaborative yearbook technologies and industry leading production times has made the company one of the fastest growing in the country, recently recognized by Inc. Magazine as the 17th fastest growing private education company in the US. For more information about Entourage Yearbooks, visit http://www.entourageyearbooks.com.

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Entourage Yearbooks Launches Smartphone App to Address Most Difficult Aspect of Creating a Yearbook

Pop Syd: Adventures in YouTube

Hey there, Towson. My name is Sydney Adamson and Im back for another semester to give you my thoughts on whatever pop-culture topic is currently at the forefront of my mind.

If you read POPSyd last semester, youll know that I have mentioned (once, twice maybe 10 times) that I love YouTube. Most of the time I prefer watching YouTube videos to watching TV.

Just as one would become invested in a TV show, I have become invested in certain YouTube channels. FunForLouis is one of those channels.

But unlike a TV show, all the videos on FunforLouis are filmed, edited and uploaded to the channel by one person Louis Cole.

Cole has always been an adventurous YouTuber. His earliest YouTube videos were of him eating strange and often disgusting foods, and were posted on his first channel, FoodForLouis.

In 2012, Cole created a second YouTube channel to share vlogs (video blogs) of his travels, which is how FunForLouis was born.

Coles travel videos always prove to be interesting, well filmed and intriguingly edited. Cole does not simply film himself hanging out with friends or lying in the sun on vacation using his cell phone camera.

No, his life is a bit more exciting than that, as is his filming equipment.

Originally from England, Cole and his cameras have traveled across cities, countries, and continents. Just last year, he visited Australia, France, Uganda, Switzerland, Romania, New Zealand, the United States, Canada and more.

To document his adventures, Cole uses a small GoPro camera, a point and shoot camera and a DSLR camera.

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Pop Syd: Adventures in YouTube

FAQ About Texila American University, Medicine & Nursing Programs, About Guyana – Video


FAQ About Texila American University, Medicine Nursing Programs, About Guyana
http://www.tauedu.org/youtube/signup.html) Texila American University, best medical university in Caribbean is well known for academic excellence and the ac...

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FAQ About Texila American University, Medicine & Nursing Programs, About Guyana - Video

About TAU’s College of Medicine & College of Nursing Programs, About Texila American University – Video


About TAU #39;s College of Medicine College of Nursing Programs, About Texila American University
http://www.tauedu.org/youtube/signup.html) Texila American University is one of the best medical universities in Caribbean offers on-campus programs like Do...

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A startup club for doctors only

Dr. Tim Gueramy and Dr. Tracey Haas launched The Walters Physician Incubator last year to help doctors pursue their startups.

NEW YORK (CNNMoney)

Last March, the husband-wife team launched The Walters Physician Incubator, an Austin, Texas, nonprofit that's open only to physicians with a startup idea.

In less than a year, the incubator has grown from five to 56 physicians, ranging from newly minted doctors to seasoned physicians in their late 60s. Their ideas range from innovative medical devices to interactive websites.

"Doctors come to this incubator typically because they have been batting around an idea that could help their patients or change the way medicine is currently being practiced," said Haas. "Very few consider leaving medicine."

Each month, Gueramy and Haas invite lawyers, marketing execs, venture capitalists and business school professors to coach doctors about startup fundamentals like how to craft business plans, pitch ideas, draft patents and fund raise.

Related: They ditched medical school to start a business

"We toyed with the idea of mandatory meetings but haven't done it because we know doctors are very busy," said Haas.

Currently, the doctors decide how long they want to stay in the program, which is free, but that could change.

"As we grow and look for funding, we'll likely tie membership with a commitment to attending 80% of meetings and start charging fees," she said.

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A startup club for doctors only

Family Medicine Residency Training Program in Palm Springs Receives Accreditation

UCR School of Medicine-sponsored program will receive its first eight residents in July 2015

By Kathy Barton on February 6, 2014

PALM SPRINGS, Calif. The UCR School of Medicine residency training program in family medicine, in partnership with Desert Regional Medical Center, has received accreditation and will accept its first residents for the three-year training program in July 2015.

The program designed and located in Palm Springs to help address the shortage of primary care physicians in the Coachella Valley was granted accreditation in late January by the Accreditation Council for Graduate Medical Education (ACGME), the national body responsible for post-M.D. training programs in the U.S.

Family medicine is a primary care medical specialty in which physicians provide comprehensive medical care to patients of all ages and, increasingly, coordinate patients care by subspecialists. It is estimated that the area of the Coachella Valley served by Desert Regional Medical Center has a 50 percent shortage of family medicine physicians.

Family medicine will remain pivotal in addressing the healthcare needs of both our region

Gemma Kim, MD

and our nation, said Dr. Gemma Kim, program director of the medical schools family medicine residency training program in Palm Springs. We hope to expand access and strengthen primary care in the Coachella Valley while providing personalized care of the highest quality that is patient-, family- and community-centered.

Residents will train primarily at Desert Regional Medical Center and the UCR Health Family Medicine Center adjacent to the medical center. The three-year program will enroll eight residents each year, meaning there will be a total of 24 residents when the family medicine program is fully developed. Eight family physicians will graduate from the residency program each year starting in 2018.

The approval of the UCR residency program at Desert Regional Medical Center is such an exciting event for our hospital, as we continue to grow as an academic medical center, said Carolyn Caldwell, president and chief executive officer of Desert Regional Medical Center. The physician faculty of UCR Health have already provided a wonderful resource to patients through the primary care offices they have opened on our campus. They are already making a difference in helping to solve the primary care physician shortage in our Valley.

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Family Medicine Residency Training Program in Palm Springs Receives Accreditation

Stritch Student Receives Leadership Award from AAMC

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Newswise MAYWOOD, Ill. Ray Mendez, third-year medical student at Loyola University Chicago Stritch School of Medicine, was named a 2013 Herbert W. Nickens Medical Student Scholarship recipient.

The Nickens awards, administered by the Association of American Medical Colleges (AAMC), consist of five scholarships given to outstanding students entering their third year of medical school who have shown leadership in efforts to eliminate inequities in medical education and health care and have demonstrated leadership efforts in addressing educational, societal, and health care needs of racial and ethnic minorities in the United States. Each recipient receives a $5,000 scholarship.

As president of Loyolas chapter of the Latino Medical Student Association (LMSA), Mendez helped reinstate the chapter that has now become a vibrant part of the medical school culture. Under his leadership, Loyola served as host for the 2013 LMSA regional conference.

In his second year of medical school, Mendez was selected as a Chicago Area Schweitzer Fellow and began working on a community-based project that combined his passion for community empowerment with preventative medicine. His goal was to provide minority students from low-income backgrounds with tools, skills, and confidence to pursue a career in medicine.

With the support of the Schweitzer Fellowship, he launched the Loyola chapter of the Health Professionals Recruitment and Exposure Program (HPREP), a bi-annual, six-week program aimed at decreasing health and health care disparities through the recruitment of underrepresented minorities into health care careers. Each six-week cohort includes workshops on health/health care disparities, preventative medicine, nutrition, study skills, career guidance, mentoring from medical students, and panels with minority health professionals. Mendez worked with school administrators to institutionalize the HPREP program within the Stritch Office of Diversity and Inclusion.

Mendez grew up in Chicago, and attended Millikin University in Decatur, Ill., where he received a B.S. in biology with a minor in chemistry. Hes preparing for a career as a community physician to provide high quality and accessible care to minority groups. The AAMC presented the Nickens award to Mendez and fellow recipients in a ceremony last November in Washington, DC.

For media inquiries, contact Evie Polsley at epolsley@lumc.edu or call (708) 216-5313 or (708) 417-5100.

The Loyola University Chicago Health Sciences Division (HSD) advances interprofessional, multidisciplinary, and transformative education and research while promoting service to others through stewardship of scientific knowledge and preparation of tomorrow's leaders. The HSD is located on the Health Sciences Campus in Maywood, Illinois. It includes the Marcella Niehoff School of Nursing, the Stritch School of Medicine, the biomedical research programs of the Graduate School, and several other institutes and centers encouraging new research and interprofessional education opportunities across all of Loyola University Chicago. The faculty and staff of the HSD bring a wealth of knowledge, experience, and a strong commitment to seeing that Loyola's health sciences continue to excel and exceed the standard for academic and research excellence. For more on the HSD, visit LUC.edu/hsd.

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Stritch Student Receives Leadership Award from AAMC

Study: Campus, area 'ideal' for medical school

Published:Thursday, February 6, 2014

Updated:Thursday, February 6, 2014 16:02

Bethany Gallimore, News Editor

Chancellor Tim Hudson, Paul Umbach and Jason Penry deliver the results of the Tripp Umbach firms study as to the feasibility of having an osteopathic medical school on campus. The proposed school would be the only licensed osteopathic medical school within Arkansas and could be welcoming students as early as 2016.

Development consulting firm Tripp Umbach has identified A-State as an ideal host institution for a proposed school of osteopathic medicine.

In a press conference Tuesday, Paul Umbach, president and founder of the Tripp Umbach firm, said A-State is in a very strong position to develop a medical program to serve the Delta and Northeast region of Arkansas.

The university already has a long history of doing medical, health science and nursing education, Umbach said. Its a school that has great relationships with its hospitals and physicians and it is in a community that is dynamic and growing and has a lot of support.

The osteopathic school would create a Bachelor of Science and graduate degree program for primary care physicians. Osteopathy places an emphasis on manipulative medicine techniques for reducing pain, restoring joint mobility and enhancing the bodys natural functions.

The Tripp Umbach feasibility study predicted a 25 percent decline in the number of osteopathic physicians practicing in Arkansas over the next five years, creating a wide open field for new osteopathic graduates.

We want students who are from this area to have access to medical education. Places in medical education are hard to find in Arkansas, Chancellor Tim Hudson said.

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Study: Campus, area 'ideal' for medical school