Hospital lobby calls for national emergency over IV shortage

Hurricane Helene killed more than 230 people when it tore through the Southeast U.S. just over a week ago. The storm also shut down an IV manufacturing plant in Marion, North Carolina, that’s responsible for about 60% of the IV solutions for the U.S. As the company, Baxter, deals with the damage, the American Hospital Association is asking the Biden administration to declare a shortage of IV solutions and invoke national emergency powers to ease the crisis. 

It’s unclear how long it will take for the Marion plant to get back up and running. Some hospitals have already declared internal shortages and restricted IV use, and as Hurricane Milton barrels toward central Florida, another IV manufacturing plant is in its current path.

biotech

Scholar Rock sees SMA data boosting obesity effort

Scholar Rock yesterday reported that its experimental treatment for spinal muscular atrophy succeeded in a Phase 3 trial, boosting muscle function in patients. Shares of the biotech surged over 360% on the news.vTFET-scholar-rock-shares-surge-on-spinal-muscular-atrophy-data

The company is also hoping that the mechanism behind the treatment, blocking a protein called myostatin, could be helpful in obesity by offsetting the lean mass and muscle loss that patients experience while taking weight loss drugs.

It’s running a Phase 2 trial testing the drug, apitegromab, in obese patients who are also taking a GLP-1 drug. It’s a proof-of-concept study that’ll inform the development of a new myostatin inhibitor, called SRK-439, that’s specifically focused on obesity.

Jay Backstrom, CEO of Scholar Rock, said in an interview that the new results are “further affirming” of his confidence in the obesity indication. What’ll be interesting to watch is how the biotech prices the drugs, if they both eventually make it on the market, given that SMA is considered a rare disease and obesity is widespread. 

“We’re looking at apitegromab from the lens of orphan disease, and we’ll be thinking about the pricing and reimbursement against that lens,” Backstrom said. “And then because it’ll be a separate program that’ll be a few years down the road as we run the studies, [the new molecule] will be in more of that general medicine marketing.”

virtual careBiogen uses telehealth to boost postpartum depression drug
In what appears to be the latest partnership between drug makers and talehealth companies, biotech giant Biogen is partnering with Talkiatry to raise awareness about its postpartum depression drug Zurzuvae, my colleague Mario Aguilar reports. (Talkiatry recently raised $130 million in venture funding and has a staff of more than 350 psychiatrists.)
Under the partnership, Talkiatry has a new landing page on its own site aimed at raising awareness about postpartum depression. After taking an initial assessment, visitors are directed to the telehealth company’s care programs, and the Zurzuvae website includes a link to Talkiatry’s landing page. The financial terms of the deal weren’t disclosed.It’s a similar model to ones followed by pharma giants like Eli Lilly and Pfizer, both of whom are working with telehealth companies to make it easier for patients to learn about, and get their drugs. Read more on the deal, and what it means, from Mario.What Kaiser Permanente learned from using Apple Watch tech in Parkinson’s careapplewatchMario also dug into a Kaiser Permanente pilot exploring how Apple Watches help keep Parkinson’s disease patients out of the hospital. Since 2023, the health system has been furnishing some patients with an Apple Watch app called StrivePD; the app, sold by Rune Labs, uses onboard sensors to track tremors and other symptoms of the neurodegenerative disease, and shares the data with the patients, their caregivers as well as their doctors. Read about what Kaiser clinicians found in the experiment’s early days, and whether the program is financially sustainable, here.The case for a new medical specialty: asynchronous careIn a thought-provoking First Opinion, physicians Muthu Alagappan, Rishi Khakhkhar, and Ben Kornitzer propose an entirely new model in which doctors don’t need to juggle in-person and online messaging-based care, but instead carve out a new specialty devoted specifically to “asynchronous medicine.””Today, the fastest-growing care setting isn’t the hospital or home — it’s the mobile phone,” they write. “The explosion in patient messaging is a clear sign that patients want more access to information about their health, despite the long wait times and often unclear responses.” Read more on their proposal that leans on technology, and how they’re hoping to build a reimbursement model that rewards asynchronous care.

from AXIOS:

New HIV shot poses access dilemma
By Maya Goldman
 
Illustration of a syringe pinned on a HIV awareness ribbon.
Illustration: Lindsey Bailey/Axios
 
A new, long-acting shot to prevent HIV could represent a turning point in efforts to reduce cases around the world — if enough people can access it.Why it matters: The twice-a-year injection to prevent sexually transmitted infections is seen as more viable than a daily pre-exposure prophylaxis, or PrEP, pill, which patients frequently stop taking.”For all of the wonders of product development, PrEP has not even begun to have the impact we need it to,” said Mitchell Warren, executive director of international HIV prevention nonprofit AVAC.The big picture: More than 40 years after it was discovered, HIV is still a global scourge affecting nearly 40 million people.New treatments have made HIV and AIDS easier to live with in wealthy nations. A handful of people have even been cured through stem cell transplants.But there’s no scalable cure, and while AIDS-related deaths are down 69% since their peak in 2004, around 630,000 people globally still died from the illness last year.Where it stands: The new shot from Gilead, known as lenacapavir, is already approved to treat HIV in the U.S. Gilead is now testing how well the drug prevents infections, and the results are promising.The company announced in September that the shots prevented HIV infection in 99.9% of participants in a trial of cisgender men, transgender men, transgender women and gender nonbinary individuals.A separate trial showed the drug to be 100% effective in preventing new HIV infections among cisgender women.Analysts expect FDA approval for HIV prevention next year.Driving the news: Gilead announced an agreement last week under which six generic drug companies will manufacture and sell lenacapavir in 120 low-income countries, pending the necessary regulatory approvals.The drug is a key focus of this week’s HIV Research for Prevention Conference in Lima, Peru. Extreme weather may bring more drug shortagesBy Adriel Bettelheim Illustration of an RX symbol with a thermometer forming part of theIllustration: Aïda Amer/Axios Climate change could drive up demand for drugs to treat asthma, kidney disease and Alzheimer’s and add to supply chain disruptions that can jeopardize patient care, according to new RAND estimates.Why it matters: While a growing body of research has established a link between extreme weather and poor health, there’s a knowledge gap around how climate change could affect supplies of common medicines.Researchers say improved models could help guide contingency planning, including stockpiling drugs, strengthening supply chains for some high-demand products, or onshoring production.Threat level: The RAND simulation looked at how events like extreme heat days, hurricanes and wildfire-associated changes in air quality could affect the prevalence of cardiovascular disease, asthma, end-stage renal disease and Alzheimer’s — and, in turn, alter drug usage.Demand for three common frontline treatments — the inhalation drug albuterol for asthma, the blood-thinner heparin used in dialysis, and the Alzheimer’s drug donepezil, or Aricept — is likely to rise through 2040.But extreme weather will result in more deaths from cardiovascular disease over that time and actually lower demand for a fourth widely used drug — the blood pressure treatment metoprolol.What’s ahead: Future studies could examine infectious diseases that are spreading faster because of climate change and demand for drugs that can be interchangeably used to treat a given condition.

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