Manila, Philippines -- The Food and Drug Administration (FDA) ordered that all human cells, tissues, and cellular and tissue-based products, or HCT/P's, should be registered with the agency before August 31. Acting FDA Director General Kenneth Hartigan Go said based on a circular issued last month that required all stem-cell products be registered in the country. "Accredited and licensed facilities dealing with HCT/P's must file their applications for registration at the FDA before August 31, 2013. Otherwise, these products shall be considered unapproved and unauthorized for use," according to the FDA circular. The FDA said it recognizes three applications of stem cell therapy. These are hematopoietic stem cell transplantation, corneal resurfacing with limbal stem cells, and skin regeneration with epidermal stem cells. Go said all researches dealing with HCT/P's and the propagation of such other than their approved use are all considered clinical investigations and will have to comply with the existing FDA process and guidelines. The FDA vowed to go after those perpetuators who endanger the public through the use of unauthorized stem cell products. "Strict compliance is mandatory. FDA will pursue perpetrators who expose the Filipino public to the dangers of unapproved human cells and cellular-based products and … Continue reading →

The Food and Drugs Administration (FDA) asked patients who underwent stem cell treatment and suffered adverse reactions to submit a report online. Those who have availed such products or therapies and have experienced any untoward event or side effect or treatment failures as well as those currently availing such are highly encouraged to submit reports through the FDA website at http://www.fda.gov.ph under eReport and ADR (Adverse Drug Reaction) Report Section, FDA Advisory no. 2013-023 said. The government agency assured all reports will be treated with confidentiality. This advisory is being issued as part of FDAs initiative to empower consumers in the surveillance and monitoring of drug safety, the advisory added. Early this week, the Department of Health (DoH) announced the deadline for the application for accreditation of hospitals and health facilities offering stem cell-based treatments in the Philippines. The Bureau of Health Facilities (BHFS) will lead the assessment of the health facilities. Applications will be reviewed jointly by a bio-ethics committee and a hospital-based review board. Some five big hospitals in Metro Manila have already submitted their application for accreditation. (Jenny F. Manongdo) Previous Next Follow this link: Stem cell clients urged to report side effects … Continue reading →

4:49pm, Fri 16 Aug 2013 - last updated Fri 16 Aug 2013 Repairing damaged hearts in rats through stem cell treatment could work for human hearts as well. Photo: You've had a heart attack. You're wheeled into A&E on a gurney. You survive, but your heart muscle is damaged. It's called heart failure - your heart just doesn't pump properly. Your long-term prospects look none too good. All that could change if experiments on rats at Kings College on London are shown to hold for human beings too. After a heart attack, you would get an injection of heart stem cells - cells that can repair the damage to your heart muscles. The stem cells would "home in" on your heart and grow into new muscle - triggering the stem cells already in your heart to leap onto action. Sounds like science fiction, but Georgina Ellison, one of the Kings College researchers, told me it could be part of regular clinical practice within the next decade. Everyone has stem cells in their hearts. Their job is to repair the normal wear and tear on your heart muscles by growing into new muscle cells. Trouble is, as you get older, the … Continue reading →

SAN DIEGO--(BUSINESS WIRE)-- Ligand Pharmaceuticals Incorporated (LGND) announces it has entered a global license agreement with CURx Pharmaceuticals, Inc. for the development and commercialization of Ligands Captisol-enabled Topiramate Injection for the treatment of partial onset or primary generalized tonic-clonic seizures in hospitalized epilepsy patients who are unable to take oral topiramate. Under the terms of the agreement, Ligand will be eligible to receive more than $21 million in potential net milestone payments and net royalties on future sales of 6.0% to 7.5%. This is another great deal for Ligand and our Captisol technology, pairing our proven formulation agent with an approved medicine to create a potentially novel, important and highly differentiated drug, commented John Higgins, President and Chief Executive Officer of Ligand. We are very pleased to be entering this agreement. CURx is highly motivated to advance development with current plans calling for a Phase II trial to commence in 2014. This deal represents our latest addition to our growing pipeline of partnerships and another potentially lucrative shot-on-goal. Dinu Sen, Chief Executive Officer and founder of CURx, said of this transaction, We are delighted to sign a licensing agreement with Ligand and plan to bring Captisol-enabled Topiramate Injection to our … Continue reading →

Press Releases of Wednesday, 14 August 2013 Source: cll PRESS RELEASE London, 13 August 2013 London parents returned to the classroom in July to learn an innovative approach designed to improve the way they relate to their autistic children. Guided by speech and language therapist Selve Krishnan, who is also CEO of Communication Links Limited, these parents embarked on a crash course in the Treatment and Education of Autistic and related Communication handicapped Children (TEACCH) workshop. The TEACCH workshop has been in use over many years and is considered by clinicians as a useful tool for independence and learning in the school context. People with autism are often very focused, have excellent memory and thrive in routine-oriented environments and this programme sought to harness their valuable skills. Parents were schooled in creating visual timetables to promote daily routines at home, and introducing colour coding to organise their childrens toys, to strengthen these qualities. The TEACCH programme focuses on the strength of the individual to lessen their difficulties in social situations. Adapting the school, home, community and work environment were key features in the half-day workshop and Ms Krishnan urged attendees to work in partnership with live-minded parents, education and support … Continue reading →

LOS ANGELES (CBSLA.com) A treatment for children with autism and whether insurance companies are obligated to cover it was considered by a state appellate court Wednesday. The case regarding applied behavior analysis has been long-running dispute between families, covered by Medi-Cal, Healthy Families and Calpers, and insurance companies. The outcome of the case could affect more than 13,000 children with autism in California. Applied behavior analysis, or ABA, is a system in which every moment and action by the child is monitored and rewarded by the therapist on a one-to-one relationship for periods of 35, 40 hours a week, plaintiffs attorney Fred Woocher said. Insurers often deny claims involving applied behavior analysis, according to the lawsuit. An attorney representing an insurance company says that the therapy is denied when it is administered by a behavioral health practitioner, rather than a doctor. According to Pat Sturdevant of the state Department of Insurance, these behavioral health practitioners are highly qualified. They typically have 3,000 hours of experience and degrees in order to get certified by a nationally accredited board, she said. Sturdevant says the treatment is potentially life changing and should be covered. For thousands of children who receive this treatment as … Continue reading →