By Anna Rose Welch, associate editor In the news this week, the FDA recently approved the first immunotherapy for melanoma, as well as drugs for epilepsy and myelodysplastic syndrome. The FDA also cleared several drugs for new indications, QIDP status, and orphan drug status. UCB Earns Approval For Vimpat UCBs supplemental NDA for its epilepsy treatment Vimpat was awarded an approval from the FDA as a monotherapy for those 17 and older with epilepsy. The drug previously received approval as an adjunctive treatment. All formulations of the drug can be administered with a new single loading dose administration option, which also received a nod of approval from the FDA. Because of the drugs multiple formulation options (tablets, oral solution, or injectable), Vimpat has brought in a good chunk of change for the company: nearly 217 million euros in the first half of 2014. The company expects this new monotherapy approval will help boost sales. Mercks Pembrolizumab Get FDA Thumbs Up A new big player in the realm of cancer treatments is poised to hit the market and is expected to garner billions in sales. Mercks Keytruda, pembrolizumab, is an immunotherapy indicated for those suffering from melanoma who didnt improve following … Continue reading →

When Lusanda Ngwenya, 13, comes to he is disorientated. He looks around at the faces of concerned family members and then becomes aware of a new pain somewhere on his body maybe a knocked limb or a bitten tongue. He has just woken up from one of the seizures that accompany his epilepsy. A leading cause of acquired epilepsy in sub-Saharan Africa is attributable to tape worms found in pork, according to the World Health Organisation. I usually dont know when the seizures will start or end they just happen unexpectedly, he tells OurHealth. Ill wake up not knowing what happened until my family or friends tell me. Sometimes I wake up with an injury, says the teenager, who adds that when seizures strike at school, his school will call his mother or his friends will help take him. Lusanda was diagnosed with epilepsy four years ago. Epilepsy is a neurological disorder that can cause for instance seizures, abnormal sensations and loss of consciousness. According to Epilepsy South Africa, about one in every 100 people have epilepsy. In about 80 percent of patients, epilepsy medication will control their symptoms. According to the US non-profit Mayo Clinic, epilepsy has no identifiable … Continue reading →

How early can autism be detected in babies, and how soon can they be treated? A babys first birthday visit to the pediatrician usually includes a screening for the social deficits common with autism spectrum disorder. But doctors and scientists tend to agree that they cant make a very reliable diagnosis until the toddler is 2 years old. The bulk of treatment programs begin then. Several recent studies, however, have documented subtle signs of the disorder, including erratic eye motion, among infants as young at 2 months old. That and other behavioral differences become more noticeablebetween 6 months and a year of age, other studies have shown. Researchers at UC Davis MIND Institute have been watching and playing with babies for many years to study autism and other development issues. This time, researchers set out to test whether they could accurately identify early signs associated with autism, and whether parents would be willing and able to follow directed therapy aimed at improving interaction with their babies. And if they did, would it help? The study, published online Tuesday in the Journal of Autism and Development Disorders, suggests a qualified yes on all counts. The data from the pilot program jibe … Continue reading →

(Sacramento, Calif.) -- Treatment at the earliest age when symptoms of autism spectrum disorder (ASD) appear - sometimes in infants as young as 6 months old - significantly reduces symptoms so that, by age 3, most who received the therapy had neither ASD nor developmental delay, a UC Davis MIND Institute research study has found. The treatment, known as Infant Start, was administered over a six-month period to 6- to 15-month-old infants who exhibited marked autism symptoms, such as decreased eye contact, social interest or engagement, repetitive movement patterns and a lack of intentional communication. It was delivered by the people who were most in tune with and spent the most time with the babies: their parents. "Autism treatment in the first year of life: A pilot study of Infant Start, a parent-implemented intervention for symptomatic infants," is co-authored by UC Davis professors of Psychiatry and Behavioral Sciences Sally J. Rogers and Sally Ozonoff. It is published online today in the Journal of Autism and Developmental Disorders. "Most of the children in the study, six out of seven, caught up in all of their learning skills and their language by the time they were 2 to 3," said Rogers, the … Continue reading →

PUBLIC RELEASE DATE: 9-Sep-2014 Contact: Phyllis Brown phyllis.brown@ucdmc.ucdavis.edu 916-734-9023 University of California - Davis Health System http://www.twitter.com/UCDavisHealth Treatment at the earliest age when symptoms of autism spectrum disorder (ASD) appear sometimes in infants as young as 6 months old significantly reduces symptoms so that, by age 3, most who received the therapy had neither ASD nor developmental delay, a UC Davis MIND Institute research study has found. The treatment, known as Infant Start, was administered over a six-month period to 6- to 15-month-old infants who exhibited marked autism symptoms, such as decreased eye contact, social interest or engagement, repetitive movement patterns, and a lack of intentional communication. It was delivered by the people who were most in tune with and spent the most time with the babies: their parents. Autism treatment in the first year of life: A pilot study of Infant Start, a parent-implemented intervention for symptomatic infants, is co-authored by UC Davis professors of Psychiatry and Behavioral Sciences Sally J. Rogers and Sally Ozonoff. It is published online today in the Journal of Autism and Developmental Disorders. "Most of the children in the study, six out of seven, caught up in all of their learning skills and their … Continue reading →

Heres how you might be able to turn autism around in a baby: Carefully watch her cues, and push just a little harder with that game of peek-a-boo or This little piggy. But dont push too hard kids with autism are super-sensitive. Thats what Sally Rogers of the University of California, Davis has found in an intense experiment with the parents of infants who showed clear signs of autism. Its one of the most hopeful signs yet that if you diagnose autism very early, you can help children rewire their brains and reverse the symptoms. It was a small study, and its very hard to find infants who are likely to have autism, which is usually diagnosed in the toddler years. But the findings, published in the Journal of Autism and Developmental Disorders, offer some hope to parents worried about their babies. With only seven infants in the treatment group, no conclusions can be drawn, they wrote. However, the effects were striking. Six out of the seven children in the study had normal learning and language skills by the time they were 2 to 3. Isabel was one of them. She is 3 years old now and she is a … Continue reading →

Published September 09, 2014 Parents concerned that their babies are showing signs of autism may be able to help them develop normally, according to a small but intriguing new published study. Researchers analyzed seven babies at high risk for developing autism. Most of those whose parents received 12 weekly sessions on how to more effectively improve their babies' social communication and play caught up developmentally to babies who were considered low-risk and displayed no symptoms. By 3 years of age, five of the seven babies were considered to be developing normally and had no diagnosis of autism-spectrum disorder, or ASD. Four had older siblings diagnosed with the condition. Researchers believe repeated social stimulation and making engagement with other people more appealing helped the babies learn more about social information, which is critical to their learning about language and communication. "They went from a period of being behind to catching up or accelerating" in their development, says Sally J. Rogers, a professor of psychiatry at the University of California, Davis and one of the authors on the study, which was published Tuesday in the Journal of Autism and Developmental Disorders. Carmen Aguilar's then-6-month-old son Emilio was identified as having developmental delays … Continue reading →

For more information Individuals living in Northern California with concerns about their infant's development may contact the UC Davis MIND Institute, e-mail infantconcerns@ucdmc.ucdavis.edu. Individuals living elsewhere should share their concerns with their child's primary care physician. The treatment, known as Infant Start, was administered over a six-month period to 6- to 15-month-old infants who exhibited marked autism symptoms, such as decreased eye contact, social interest or engagement, repetitive movement patterns and a lack of intentional communication. It was delivered by the people who were most in tune with and spent the most time with the babies: their parents. Autism treatment in the first year of life: A pilot study of Infant Start, a parent-implemented intervention for symptomatic infants, is co-authored by UC Davis professors of Psychiatry and Behavioral Sciences Sally J. Rogers and Sally Ozonoff. It is published online today in the Journal of Autism and Developmental Disorders. "Most of the children in the study, six out of seven, caught up in all of their learning skills and their language by the time they were 2 to 3," said Rogers, the study's lead author and the developer of the Infant Start therapy. "Most children with ASD are barely even getting … Continue reading →

(Sacramento, Calif.) -- Treatment at the earliest age when symptoms of autism spectrum disorder (ASD) appear - sometimes in infants as young as 6 months old - significantly reduces symptoms so that, by age 3, most who received the therapy had neither ASD nor developmental delay, a UC Davis MIND Institute research study has found. The treatment, known as Infant Start, was administered over a six-month period to 6- to 15-month-old infants who exhibited marked autism symptoms, such as decreased eye contact, social interest or engagement, repetitive movement patterns and a lack of intentional communication. It was delivered by the people who were most in tune with and spent the most time with the babies: their parents. "Autism treatment in the first year of life: A pilot study of Infant Start, a parent-implemented intervention for symptomatic infants," is co-authored by UC Davis professors of Psychiatry and Behavioral Sciences Sally J. Rogers and Sally Ozonoff. It is published online today in the Journal of Autism and Developmental Disorders. "Most of the children in the study, six out of seven, caught up in all of their learning skills and their language by the time they were 2 to 3," said Rogers, the … Continue reading →

Sheriff: More arrests likely in Holly Bobo case Sheriff: More arrests likely in Holly Bobo case Updated: Tuesday, September 9 2014 4:17 PM EDT2014-09-09 20:17:50 GMT The Decatur County sheriff said more arrests are likely in the Holly Bobo case during a news conference on Tuesday afternoon. The Decatur County sheriff said more arrests are likely in the Holly Bobo case during a news conference on Tuesday afternoon. Updated: Monday, September 8 2014 4:08 PM EDT2014-09-08 20:08:44 GMT 37-year-old Ricky Roy House Jr. and 44-year-old Kendra Tooley are preliminarily charged with criminal confinement and rape. 37-year-old Ricky Roy House Jr. and 44-year-old Kendra Tooley are preliminarily charged with criminal confinement and rape. Updated: Thursday, July 10 2014 5:30 PM EDT2014-07-10 21:30:26 GMT The following are mugshots of individuals arrested on a variety of charges in June by local authorities in Northeast Tennessee. Updated: Tuesday, September 9 2014 11:54 AM EDT2014-09-09 15:54:08 GMT Here is the original post: Early treatment could mean normal lives for kids with autism … Continue reading →