By Anna Rose Welch, associate editor Hemophilia A Treatment Wins FDA Approval Last week, Baxter gained FDA approval for its acquired hemophilia A treatment, Obizur, an Antihemophilic Factor (Recombinant), Porcine Sequence treatment. Obizur underwent evaluation to determine its efficacy in treating serious bleeding episodes in adults in a Phase 2/3 clinical trial. Within 24 hours of administration, patients were showing that the drug effectively or partially stopped bleeding; 86 percent saw success taking the drug after an initial bleeding episode. As acquired hemophilia A is a rare disease, the drug was named an orphan drug and received priority review. FDA Requests More Data From Lundbeck For Epilepsy Drug The FDA requested more info from Lundbeck last week for its NDA for Carbella (carbamazepine) injection for epilepsy. The company hopes to address the issues listed in the Complete Response Letter and have the drug available in 2015 following FDA approval. The letter requested more information on the companys chemistry, manufacturing, and controls data. Carbella is an intravenous formulation of carbamazepinean oral drug which was originally approved by the FDA in 1968. In 2013, Carbella won orphan drug designation from the FDA. De Vivo Disease Drug Gains Orphan Drug Designation Ultragenyx Pharma … Continue reading →

Unlike other psychiatric and neurological conditions there is currently no medical treatment for high functioning autism or Asperger's. Photo: Virginia Star Unlike other psychiatric and neurological conditions there is currently no medical treatment for high functioning autism or Asperger's. But researchers in Melbourne say a "critically important" new treatment could improve the social skills of people with autism spectrum disorder and it all comes down to stimulating the brain with magnetic fields. Treatment for autism at present centres on behaviour intervention, but it relies on the early diagnoses of children, associate professor of psychology from Deakin University Dr Peter Enticott said ahead of his talk at the Australian Academy of Science Shine Dome on Wednesday night. "As it stands autism is incredibly prevalent, the rates at the moment suggest one in 68 kids are being diagnosed in the states [US] and we're not too different from that in Australia," he said. Advertisement But adolescents and adults with autism have few treatment options. "They'll often get treatment for the associated problems, around depression and anxiety, but in terms of the social symptoms and obsessions and restricted interests of autism there really isn't much out there past early childhood," Dr Enticott said. … Continue reading →

When I can see a child that when I start working with does not talk and the first time they say their first word, you remember that, Grossett said. Students will get to see a child with autism blossom and grow to their fullest potential. Thats awesome. Thats a great experience for both the child and for the student. /UPNORTHLIVE.COM ISABELLA CO. -- Central Michigan University (CMU) launched a program that is the first of its kind in northern Michiganan autism assessment and treatment clinic. CMU received a grant from the Michigan Department of Community Health to fund the autism assessment center. Graduate students will help in diagnosing and treating children in mid-northern Michigan. The center is the eight of its kind in Michigan and also the farthest north. I want to train more clinicians as the rate of autism increases in this country, Deborah Grossett, CMU BSBA Director of Training, said. I think we also need to see an increase in the clinicians and providers of these services so that more and more children can have applied behavior analysis services provided to them. Our number one goal is to train our students very well so that we can expand … Continue reading →

PUBLIC RELEASE DATE: 3-Nov-2014 Contact: Doug Carlson doug.carlson@med.fsu.edu 850-645-1255 Florida State University @floridastate TALLAHASSEE, Fla. For the first time, toddlers with autism have demonstrated significant improvement after intensive intervention by parents rather than clinicians, according to a new Florida State University study published online in the journal Pediatrics. "We've come up with a treatment model that can teach parents to support their child's learning during everyday activities, and we've documented that the children improved their developmental level, social communication skills and autism symptoms," said Amy Wetherby, director of the Autism Institute at Florida State University's College of Medicine and lead author of the Pediatrics study. Social communication includes eye gaze, facial expressions, gestures, sounds, sharing of emotion, listening, learning to understand words, discovering how to use objects things that children with autism have difficulty learning. "The findings are important because this treatment is viable for any community," Wetherby said. "We have early intervention that's federally and state funded. Now we've tested a model that any early intervention system should be able to offer to all families of toddlers with autism. It's affordable, and it's efficient in terms of clinicians' time." Most children are not diagnosed with autism spectrum disorder (ASD) … Continue reading →

TWO months ago, the Autism Society Philippines organized a seminar on Relationship Development Intervention (RDI). This reminded me of my experience years ago when I attended a talk on RDI from a Singaporean resource speaker during one of the break-out sessions of ASPs Autism Convention. I have not done RDI with my son but I want to share what I have learned. Given the many traditional and non-traditional strategies in management of autism spectrum disorder (ASD), I leave it up to the parents, teachers or caregivers to decide and choose what strategy to use to improve the quality of life of a child or person with ASD. From the website of Autism Speaks, Relationship Development Intervention (RDI) is a family-based, behavioral treatment designed to address autisms core symptoms. Developed by psychologist Steven Gutstein, Ph.D., it builds on the theory that dynamic intelligence is key to improving quality of life for individuals with autism. Dr. Gutstein defines dynamic intelligence as the ability to think flexibly. This includes appreciating different perspectives, coping with change and integrating information from multiple sources (e.g. sights and sounds). RDI Programs coach parents and primary care-givers how to break down and then gradually rebuild complex dynamic processes … Continue reading →

PUBLIC RELEASE DATE: 4-Nov-2014 Contact: Mary Billingsley mbillingsley@jaacap.org 202-587-9672 Elsevier @ElsevierConnect Washington D.C., November 4, 2014 A Clinical Perspectives article published in the November 2014 issue of the Journal of the American Academy of Child and Adolescent Psychiatry proposes a tool to empower stakeholders, guide caregivers, and provide a rationale for advocates, when considering the systems of support offered to people with an autism spectrum disorder (ASD). Organizations such as the American Academy of Child and Adolescent Psychiatry, the European Society for Child and Adolescent Psychiatry, the International Association for Child and Adolescent Psychiatry and Allied Professions, and Autism Europe have long stressed the need for an effective evidence-based support approach, which not only promotes the active participation of the ASD individual, but also includes his or her family, and community. With the hope of providing a framework for clinical practice and global advocacy, Dr. Joaquin Fuentes, of Policlnica Gipuzkoa, San Sebastin, Spain, has developed a set of brief 'tips' to guide such an approach and which he anticipates will be accepted in many countries. Dr. Fuentes said of his article, "We see in our nations a radical evolution in the development of services to people with ASD. We consider … Continue reading →