Ultragenyx Gene Therapy Becomes First FDA-Approved Treatment for Ultra-Rare Disease
Ultragenyx Pharmaceutical’s Genglycos received accelerated FDA approval for glycogen storage disease type Ia, an inherited…
Ultragenyx Gene Therapy Becomes First FDA-Approved Treatment for Ultra-Rare Disease
Ultragenyx Pharmaceutical’s Genglycos received accelerated FDA approval for glycogen storage disease type Ia, an inherited enzyme deficiency. It’s also the first approved gene therapy for Ultragenyx, which specializes in rare disease treatments. The post Ultragenyx Gene Therapy Becomes First FDA-Approved Treatment for Ultra-Rare Disease appeared first on MedCity News.
The Imperative of Distinguishing Medical-Grade Devices from Wellness Tech
Why the flood of consumer wellness devices demands clear boundaries between lifestyle improvement and clinical diagnostics The post The Imperative of Distinguishing Medical-Grade Devices from Wellness Tech appeared first on MedCity News.
AI in Pharmacovigilance: Why Governance Will Define Success
As adoption accelerates, organizations must ensure that the use of AI strengthens and not weakens accountability and patient safety. The post AI in Pharmacovigilance: Why Governance Will Define Success appeared first on MedCity News.
How Much of a Cancer Drug Is Too Much? Patients, Researchers Challenge FDA-Approved Dosages
Northwestern University economist Chuck Manski studies decision-making amid uncertainty. That prepared him better than many other cancer patients to decide whether to stay on an immunotherapy treatment that was making him very ill. For six months in 2022, Manski received monthly infusions of nivolumab to fight advanced melanoma. The drug ruined his thyroid gland, he…
Violence Against Healthcare Workers and Staffing Shortages Fuel Hospital Strikes
Nurse Crystal Dhooghe is used to dealing with blood and broken bones in the emergency room. But she didn’t expect to witness so much violence against her own colleagues. “I’ve seen nurses get shoved, pushed, scratched. The biggest one is bitten,” said Dhooghe, who works at Henry Ford Genesys Hospital in Grand Blanc, Michigan. The…
Prior Authorization
By EMANUEL SARKEES Most people have never heard of prior authorization until it personally stops them from getting care they actually need. The way it usually goes is pretty straightforward: a doctor sees a patient, figures out what is wrong, decides on a treatment, and writes the order. Then everything stops. Before anything can actually…
Happy Health Snags $75M to Support Home-Based Care
Happy Health’s $75 million round was from ARCH Venture Partners and OpenLoop. The post Happy Health Snags $75M to Support Home-Based Care appeared first on MedCity News.
Merck, Moderna Personalized mRNA Cancer Therapy Achieves a First for Melanoma
Merck and Moderna said intismeran autogene, an mRNA cancer vaccine that prompts an immune response to proteins expressed by a patient’s tumors, met the main goal of a pivotal test in melanoma. It’s the most advanced trial in a 50/50 partnership evaluating the personalized cancer treatment in a wide range of tumor types. The post…
Why Bone Health Is Preventive Healthcare’s Next Big Category
The next healthcare revolution isn’t about treating osteoporosis, it’s about preserving mobility and healthspan. The post Why Bone Health Is Preventive Healthcare’s Next Big Category appeared first on MedCity News.
You Want To Join a Clinical Trial. Here’s What To Know About the Hurdles.
Connecting people with clinical trials is complicated — even if people identify a promising match, there’s a slew of potentially thorny factors, including geographic incompatibility, and financial and time considerations. Simply finding an appropriate trial can present an enormous hurdle. In a recent online survey of more than 2,000 adults, 71% of patients with chronic…
