UCB Drug Becomes First FDA-Approved Treatment for Ultra-Rare and Fatal Mitochondrial Disease
The FDA has approved UCB’s Kygevvi for treating children and adults with thymidine kinase 2…
UCB Drug Becomes First FDA-Approved Treatment for Ultra-Rare and Fatal Mitochondrial Disease
The FDA has approved UCB’s Kygevvi for treating children and adults with thymidine kinase 2 deficiency, an inherited mitochondrial disorder. It’s the drugmaker’s first ultra-rare disease product. The post UCB Drug Becomes First FDA-Approved Treatment for Ultra-Rare and Fatal Mitochondrial Disease appeared first on MedCity News.
Oncologists Turn To Genomics For Improved Answers
Genomic technologies not only help to identify cancers, but also offer opportunities for assessing the potential efficacy of different treatment options. By analyzing the genomic profile of a particular patient, doctors can see which medications might offer the most support, and which could cause more harm. The post Oncologists Turn To Genomics For Improved Answers…
The Future of Specialty Care: APPs, MDs, and Machine-Guided Supervision
Many of today’s systems weren’t built for speed, supervision, or scale, and they can’t support the level of intelligence or flexibility that modern care delivery demands. The solution isn’t to retreat from APPs. It’s to invest in models that make their work safe, effective, and scalable. The post The Future of Specialty Care: APPs, MDs,…
An Arm and a Leg: This Health Economist Wants Your Medical Bills
Economist Vivian Ho has been researching the U.S. health care system for four decades. These days, she’s focused on what she thinks are the biggest burdens on the average American: runaway hospital prices and rising health insurance premiums. She has developed a strategy for addressing high insurance premiums — one that’s based on giving patients…
Is Covid During Pregnancy Linked to Autism? What a New Study Shows, and What It Doesn’t
A large study from Massachusetts has found that babies whose mothers had covid-19 while pregnant were slightly more likely to have a range of neurodevelopmental diagnoses by age 3. Most of these children had speech or motor delays, and the link was strongest in boys and when the mother was infected late in pregnancy. The…
While Politicos Dispense Blame, These Doctors Aim To Take Shame Out of Medicine
The distress that Will Bynum later recognized as shame settled over him nearly immediately. Bynum, then in his second year of residency training as a family medicine physician, was wrapping up a long shift when he was called into an emergency delivery. To save the baby’s life, he used a vacuum device, which applies suction…
Artificial Intelligence Renders the FDA’s Current Drug Approval Process to be Obsolete
By STEVEN ZECOLA Artificial intelligence (“AI”) has taken root in the field of drug discovery and development and already has shown signs of running past the traditional model of doing research. Congress should take note of these rapid changes and: 1) direct the Department of Health and Human Services (“HHS”) to phase down the government’s…
Is Mark Cuban Wrong About Employers, PBMs and Drug Prices?
The billionaire Mark Cuban whose Cost Plus Drugs company has been shaking up the world of prescription drug coverage minces no words when it comes to the role of employers in bringing down healthcare costs. But some employers believe he is wrong. The post Is Mark Cuban Wrong About Employers, PBMs and Drug Prices? appeared…
Nearly 40,000 People Urge Employers to Cover Comprehensive Obesity Care
Nearly 40,000 people have signed a petition from the Alliance for Women’s Health and Prevention’s EveryBODY Covered Campaign urging employers to recognize obesity as a chronic condition and expand comprehensive coverage. The post Nearly 40,000 People Urge Employers to Cover Comprehensive Obesity Care appeared first on MedCity News.
Despite Phase 3 Failure, Sarepta Still Sees Path for Muscle Disease Drugs to Secure Full FDA Approval
Sarepta Therapeutics attributed the Phase 3 failure to the Covid-19 pandemic, during which many patients missed multiple doses of its Duchenne muscular dystrophy therapies. The company plans to discuss with the FDA traditional regulatory approvals based on the totality of data that includes real world evidence from the years these drugs have been commercially available…
