PBR Staff Writer Published 13 April 2015 Irish biopharmaceutical firm Horizon Pharma has granted fast track designation from the US Food and Drug Administration (FDA) for actimmune (interferon gamma-1b) to treat Friedreich's ataxia (FA), a degenerative neuro-muscular disorder. In February 2015, the company submitted the investigational new drug (IND) application for Actimmune in the treatment of FA. The company has also announced plans to initiate a Phase III trial in the second quarter in collaboration with the Friedreich's Ataxia Research Alliance (FARA) and a sub-set of FARA's Collaborative Clinical Research Network (CCRN) study centers in FA. Horizon Pharma chairman, president and chief executive officer Timothy Walbert said: "We commend the FDA for granting fast track designation for actimmune in Friedreich's ataxia to potentially help treat patients suffering from this debilitating disorder, for which there are no FDA approved treatments available. "We look forward to continuing our ongoing clinical development program as we evaluate actimmune in this patient population." Actimmune is a biologically manufactured protein similar to one the body makes naturally to help prevent infection. Currently, actimmune is approved by the FDA for use in two rare diseases and it is indicated to reduce the frequency and severity of serious … Continue reading →

Medical researchers call it the "Angelina Effect," the surge in demand for genetic testing attributable to movie star Angelina Jolie's public crusade for more aggressive detection of hereditary breast and ovarian cancer. But there's a catch: Major insurance companies including Aetna, Anthem and Cigna are declining to pay for the latest generation of tests, known as multi-gene panel tests, Reuters has learned. The insurers say that the tests are unproven and may lead patients to seek out medical care they don't need. That's a dangerous miscalculation, a range of doctors, genetic counselors, academics and diagnostics companies said. While they acknowledge that multi-gene tests produce data that may not be useful from a diagnostic standpoint, they say that by refusing or delaying coverage, insurance companies are endangering patients who could be undergoing screenings or changing their diets if they knew about the possible risks. The tests have come a long way since Jolie, 39, went public in 2013, revealing that she underwent a double mastectomy after a genetic test found she carried mutations in the BRCA1 and BRCA2 genes, indicating a high risk of breast and ovarian cancer. She disclosed last month that she had her ovaries and fallopian tubes removed. … Continue reading →

NYC, NY (PRWEB) April 13, 2015 NYC Health & Longevity Center is now offering outpatient stem cell therapy to help patients avoid joint replacement in all extremities. The treatments are performed by a Board Certified physician, with most patients being able to avoid or delay the need for surgery. Simply call (844) GET-STEM for more information and scheduling with stem cell therapy NYC trusts. Millions of joint replacements are performed in the US annually for degenerative arthritis of the knee, hip, shoulder, elbow, wrist and ankle. While these are mostly effective, they are not risk free procedures and should be avoided as long as possible. In addition, the implants placed are not meant to last forever. With stem cell therapy now being commercially available, individuals now have access to the most cutting-edge procedures with the potentially to actually regenerate damaged tissue. This includes cartilage, ligament and tendon. The stem cell procedures are performed by a Board Certified Anti-Aging doctor with considerable experience in both the stem cell procedures along with prolotherapy too. The stem cell material comes from amniotic fluid that is obtained from consenting donors after a scheduled C-section, which is then processed at an FDA regulated lab. No … Continue reading →

Beverly Hills, California (PRWEB) April 13, 2015 Dr. Raj, who is the top orthopedic surgeon in Los Angeles and Beverly Hills, appeared on The Doctors TV show this week performing successful stem cell therapy. The patient received an outpatient stem cell procedure for bilateral labral tears in the shoulders, with an incredible outcome displayed on the show. The segment can be viewed here: http://www.thedoctorstv.com/videos/stem-cells-instead-of-surgery For years, Dr. Raj has been helping patients avoid invasive surgeries with outpatient, low risk stem cell procedures. The focus of the segment on The Doctors was a patient who was having severe functional limitations due to her shoulder injuries. She could not drive without pain or do any regular activities such as brushing her hair or reaching overhead without immediate pain. While being interviewed on the show four days after the procedure, Jennifer stated, "This is crazy. What's really shocking is I can put my arms above my head, I haven't done that in 10 years!" Dr. Raj, as he has done for hundreds of patients, first aspirated some of the patients bone marrow. Then the marrow was processed immediately to concentrate the stem cells and growth factors. The processed marrow was then injected bilaterally … Continue reading →

Mesoblast chief executive Silviu Itescu says new strategic partner Celgene has a "strong franchise and sales and marketing. Photo: Josh Robenstone Mesoblast chief executive Silviu Itescu says a $58.5 million investment from pharmaceutical giant Celgene gives the company a strong potential route to market as the stem cell therapy developernears its first sales. The American giant Celgene, which had revenue of $US7.7 billion ($10 billion) from treatments for cancers and inflammatory diseases like psoriasis, picked up 15.3 million shares at $3.82 a share. Investors welcomed the deal, pushing the volatile stock up 24 per cent to $3.99 on Monday. The surge boosted the value of Mr Itescu's 22 per cent stake in the company by $53 million to $272 million. Mesoblast shares have lost about 16 per cent in the past year, compared with a 10 per cent rise in the benchmark S&P/ASX 200 index. The stock last traded at the placement price a month ago, but has traded as high as $5.75 in the past year. Mr Itescu said Mesoblast and Celgene began talks about six months ago. He described the deal as "a fair transaction". "The right time is when you come to an arrangement with a strategic … Continue reading →