Morning Briefing
Summaries of health policy coverage from major news organizations
Increased FDA Approvals Of Novel Drugs Could Spur Biotech Investment
The U.S. Food and Drug Administration approved nearly 50% more novel drugs in 2023 than in 2022, putting it back on pace with historical levels, an improvement analysts and investors said could lead to increased investment in biotech firms. FDA nods for innovative therapies containing an active ingredient or molecule not previously approved, rose to 55 in 2023, up from 37 in 2022 and 51 in 2021. Historical data shows the FDA typically green lights about 45-50 new drugs a year and hit a peak of 59 in 2018. (Mishra and Jain, 1/2)
The start of a new year means a fresh round of out-of-pocket costs for people taking prescription drugs. Health-insurance deductibles reset on Jan. 1. That means, if your deductible applies to your prescription-drug costs, you could be on the hook for thousands of dollars while you鈥檙e spending down the deductible and more favorable insurance coverage kicks in. (Of course, you might still be on the hook for any copays and coinsurance.)If you鈥檙e uninsured, you鈥檒l face the challenge of paying the full cost of a medicine throughout the year. Here are steps you can take鈥攕ome of which are new this year鈥攖o help control your prescription-drug costs. (Loftus, 1/3)
On marijuana use 鈥
The 82-year-old dementia patient鈥檚 condition stumped his psychiatrist. His anxiety was overwhelming, she recalled him saying. He had repeatedly gone to the emergency room after intense abdominal pain and vomiting. He insisted he never drank or smoked tobacco. Then he told her medical assistant how he fell asleep: 鈥淭wo hits of Burmese Kush, and I鈥檓 good to go. 鈥漈hat鈥檚 when it clicked: His nightly marijuana habit could be causing problems. 鈥淚 said, 鈥業 thought you said you don鈥檛 use drugs,鈥 and he said, 鈥業 don鈥檛. That鈥檚 my medicine,鈥欌 said Libby Stuyt, the Colorado psychiatrist who treated the patient three years ago. (Nirappil, 1/2)
In other pharmaceutical news 鈥
New data suggests that semaglutide may also cut the risk of stroke or heart attack, and may delay the progression of kidney disease in diabetes patients. Here are other conditions that GLP-1 treatments are being tested against. (1/2)
Powerful weight-loss medicines like Novo Nordisk's Wegovy leapt into public view in 2023, from social media to doctors' offices and cocktail parties, offering a new way to address record obesity rates. But extraordinary demand, and high prices, for these drugs will keep them out of reach in the coming year for many patients who are likely to benefit. The new drugs are known as GLP-1 agonists, which mimic the activity of a hormone that slows digestion and helps people feel full for longer. In clinical trials, people lost 15% to 20% of their body weight, depending on the drug. Nearly 120 million American adults could be eligible for treatment, while Novo says its target market is more than 760 million people with obesity worldwide. (Gershberg, 1/2)
Acute sleeping sickness 鈥 the treatment is almost as horrific as the disease. But now there is encouraging news about an oral medication 鈥 one that's also been used for chronic sleeping sickness to great success. ... The European Medicines Agency has given their "positive scientific opinion" on the use of fexinidazole for the treatment of acute sleeping sickness as well. That opinion is based on results from an ongoing clinical trial showing that a 10-day course of pills cures the disease in 97% of patients 鈥 and should lead to approval of the drug by countries outside of the EU. (Barnhart, 1/2)
麻豆女优 Health News and Tampa Bay Times: Patients With Narcolepsy Face A Dual Nightmare Of Medication Shortages And Stigma
Nina Shand couldn鈥檛 stay awake. She had taken afternoon naps since she was a teenager to accommodate her 鈥渨ork hard, play hard鈥 attitude, but when she was in her mid-20s the sleepiness became more severe. Menial computer tasks put her to sleep, and a 20-minute drive across her city, St. Petersburg, Florida, brought on a drowsiness so intense that her eyelids would flutter, forcing her to pull over. She knew something was really wrong when she no longer felt safe behind the wheel. In 2021, she received a diagnosis: narcolepsy, a rare disorder that causes excessive daytime sleepiness. (Peace, 1/3)