FDA Approves Hunter Syndrome Drug On Heels Of Similar Drug Rejections
Last month, the FDA rejected a Hunter syndrome gene therapy from Regenxbio over a lack of clinical data. Denali Therapeutics' drug is a form of enzyme replacement therapy — not a gene therapy — that can enter the brain and slow the cognitive decline affecting two-thirds of patients.
Stat:
FDA Approves Denali Therapeutics Drug For Hunter Syndrome
The Food and Drug Administration on Wednesday approved a new medicine from Denali Therapeutics for a condition called Hunter syndrome, a notable decision by the agency as it has recently taken tougher stances on rare disease drugs. (Joseph and Mast, 3/25)
More pharma and tech developments —
The Wall Street Journal:
Merck Reaches Nearly $6 Billion Deal For Cancer Biotech Terns
Merck has reached a nearly $6 billion cash deal to buy the cancer biotech Terns Pharmaceuticals and its promising leukemia treatment. If it proves to work safely, the experimental drug would give Merck a boost as the company prepares for its top-selling drug, Keytruda, to lose patent protection. (Loftus, 3/25)
NBC News:
ADHD Drug May Reduce Later Risk Of Psychotic Disorders, Study Finds
A large, new study found that the stimulant methylphenidate, such as the drugs Ritalin and Concerta, may lower the risk of psychosis when prescribed to younger children with ADHD. Children with attention-deficit/hyperactivity disorder have been identified to be at greater risk of developing psychotic conditions such as bipolar or schizophrenia, compared with neurotypical kids. Some studies have suggested a link to stimulants prescribed for ADHD. (Cox, 3/25)
MedPage Today:
Non-Doctors Now Handle 40% Of Antipsychotic Scripts In Medicare
A growing proportion of antipsychotic prescriptions for older adults were written by nonphysician clinicians, reflecting shifts in the mental health care workforce and prescribing practices, cross-sectional data showed. (Monaco, 3/25)
MedPage Today:
Alzheimer's Blood Tests Together Improve Accuracy, Cut Overdiagnosis
A combination of two blood tests improved Alzheimer's disease triaging and reduced overdiagnosis in people with asymptomatic Alzheimer's pathology, a prospective cohort study showed. (George, 3/25)
Stat:
Heart Failure Detection Could Be Improved With New 3-Minute MRI
Hearts need oxygen. Heart attacks are the most dramatic example of this hunger, when blocked coronary arteries starve muscles of the oxygen they need to keep beating. Less sudden is heart failure, when lagging levels of oxygen consumption can mean the heart doesn’t pump blood through the body as well as it should. (Cooney, 3/25)
KFF Health News:
Taking A GLP-1? Doctors Say Not To Forget About Movement And Mental Health
Severe ankle pain drove Jelon Smart to start taking a weight loss injection a year and a half ago. Smart was 285 pounds and worked as a caterer in Savannah, Georgia. After she’d been standing on her feet for long hours, her ankles would be “as swollen as a football,” she said. She was walking with a limp. An orthopedic doctor diagnosed her with Achilles tendinitis and recommended losing weight to mitigate the symptoms. Smart began taking the brand-name GLP-1 Ozempic. The appetite suppression resulted in her shedding pounds quickly, at first. (Siner, Anthony and Farmer, 3/26)
