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Good morning health tech readers!
Today, the latest on tech company pledges to CMS. Plus: ChatGPT Health is now generally available and Whoop’s new CMO answers my questions.
Top of the morning to you. Gray skies are hovering over the Pharmalot campus right now, but our spirits remain sunny, nonetheless. Why? We will trot out a bit of insight from the Morning Mayor, who would say “Every new day should be unwrapped like a precious gift.” To celebrate the notion, we are brewing still more cups of stimulation and invite you to join us. Our choice today is witch’s brew. Meanwhile, here are a few items of interest. Hope you have a smashing day and, of course, do stay in touch. …
The U.S. Food and Drug Administration said that a Capricor Therapeutics stem cell treatment for Duchenne muscular dystrophy did not meet the objectives of a Phase 3 trial — contrary to company claims last year, STAT says. Last December, Capricor said its drug, known as deramiocel, met both the primary and secondary endpoints in a large, randomized study. It was a striking result in a fatal, childhood disease that has proven stubbornly difficult to treat, despite immense advances in genetic medicine. But in documents released Monday in advance of a hearing this week where FDA advisers will weigh in on the drug, the agency said the study fell short.
The world risks a resurgence of the HIV epidemic after international financing to combat the infectious disease suffered a “profound shock” last year, STAT writes, citing a new report from UNAIDS, the United Nations agency. Overall, government funding declined by more than $1.5 billion to $7.3 billion in 2025, an 18% drop and the lowest level in nearly two decades. Prevention programs, in particular, have historically relied heavily on donor assistance in most regions, especially in sub-Saharan Africa, where it reached 83% two years ago. Although the U.S. was blamed for funding cuts, it still provides 74% of government donor funding.
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Good morning. We’ve got a pretty juicy story from STAT’s Jason Mast for you today. Pour your coffee and scroll down.
Biotechs are spending billions to cure a rare liver disorder most Americans have never heard of. The contentious race features dueling technologies, patent wars, a broken alliance, and a boiling competition between the U.S. and Chinese drug industries.
The disease, known as alpha-1 antitrypsin deficiency (AATD), is a slow-moving disaster for patients. Thanks to a single misspelled letter of DNA, their livers produce a mutant version of a protein that normally travels through the bloodstream and protects the lung from damage.
An interim look at an Alzheimer’s disease clinical trial evaluating an amyloid-targeting treatment from ProMIS Neurosciences showed low rates of brain bleeding and no incidences of brain swelling — results reported Tuesday that suggest the drug could be safer than approved treatments.
In a blinded analysis that pooled safety data from patients receiving the ProMIS drug and a placebo, the total rate of ARIA was 4.4%, with all cases mild and asymptomatic, the company said.
None of the patients experienced ARIA-E, which is the more severe side effect that causes brain swelling. All the cases were characterized as ARIA-H, which involves tiny bleeds in the brain.
It was a skit worthy of an Agatha Christie whodunit reveal: Against the perhaps-too-joyous strains of a jazzy “When The Saints Go Marching In,” a gaggle of health IT professionals and Medicare staffers accompanied a Spirit Halloween-style coffin prop onstage at Health and Human Services headquarters on Monday. Some wore black veils, some held white roses.
The coffin read, “RIP CLIPBOARD,” referring to the decades-old information-gathering staple of health care provider waiting rooms.
“So who killed the clipboard?” asked Zac Jiwa, a federal Medicare official. Health IT officials and experts, reading from cue cards, denied that it was standards implementation, health information exchange networks, electronic health records, or apps — all parts of the various health data initiatives that private industry promised Medicare a year ago that it would improve.
In the nine years since my last visit to the Docklands’ Excel conference center for the 2017 annual Alzheimer Association International Conference, or AAIC, little of London’s infrastructure has changed. I traveled via the same low-ceilinged, clattering trains with signs advising riders to “mind the gap” and “mind the step.” The center has the same weird jack-o’-lantern-esque façade and forgettable restaurants and hotels. I was even here for the same conference.
Same meeting, in the same place, but what transpired was quite different. In just nine years, how we think about the aging brain has transformed.
One moment captured this. It was a speaker’s remark at a breakfast meeting convened by the Davos Alzheimer’s Collaborative. The 5-year-old organization describes itself as “uniting leading organizations worldwide to build an innovation ecosystem that will accelerate breakthroughs, develop and scale promising solutions and equip every healthcare system to end Alzheimer’s disease everywhere.”
Bontle Moka-Moliki starts and ends every day in pain.
The 32-year-old Atlanta resident was diagnosed with endometriosis in 2019. A year later came fibroids. Then in 2024 she was diagnosed with a condition now called polyendocrine metabolic ovarian syndrome. “If someone is at a zero, my pain is at a three every day, and then it’s only up from there,” she said.
The world risks a resurgence of the HIV epidemic after international financing to combat the infectious disease suffered a “profound shock” last year, according to a new report from UNAIDS, the United Nations agency.
Overall, government funding declined by more than $1.5 billion to $7.3 billion in 2025 — an 18% decline and the lowest level in nearly two decades. Prevention programs, in particular, have historically relied heavily on donor assistance in most regions, with especially high dependency in sub-Saharan Africa, where it reached 83% two years ago.
Other factors contributing to the worrisome outlook are high debt burdens in countries most affected by the disease and backsliding on human rights and gender equality, the report noted.
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Hello! Wanna drop some cars in an open pasture? The internet does it again. Drop some tips and feedback here: bob.herman@statnews.com.
Lobbying groups frequently send news releases and talking points to journalists as a way to influence reporting. Right now, the pharmaceutical industry’s primary lobbying shop, PhRMA, wants everyone to ignore the clear-cut rise in prescription drug spending.
Sarepta Therapeutics, the bruised maker of Duchenne muscular dystrophy treatments, on Monday named Michael Severino, formerly the CEO of Tessera Therapeutics, as its new chief executive, starting Tuesday.
Severino is replacing Doug Ingram, who announced earlier this year that he planned to retire after leading the biotech for nearly a decade. During his tenure, the company got three Duchenne treatments approved, but has faced ongoing questions about how effective they are and run into regulatory scrutiny over the safety of its gene therapy.
The company’s share price has tanked from where it was at the beginning of 2025.
The Food and Drug Administration said Monday that Capricor Therapeutics’ stem cell treatment for Duchenne muscular dystrophy did not meet the objectives of Phase 3 trial — contrary to the company’s claims last year.
Capricor said in December that the drug, known as deramiocel, met both the primary and secondary endpoints in a large, randomized study. It was a striking result in a fatal, childhood disease that has proven stubbornly difficult to treat, despite immense advances in genetic medicine.
The data were also notable for coming primarily in teenagers and young men who have already lost the ability to walk, a population with few options. The drug appeared to both preserve their upper-arm function and stave off the heart failure most patients eventually experience, Capricor had said.
Good morning, everyone, and welcome to another working week. We hope the weekend respite was relaxing and invigorating because that oh-too-familiar routine of meetings, deadlines, and the like has returned with a vengeance. You knew this would happen, yes? To cope, we are relying, as always, on a cuppa stimulation. Our choice today is Earl Grey, an old standby. Feel free to join us. Remember, no prescription is required. Meanwhile, here are some items of interest to help you on your journey today, which we hope will be productive and meaningful. Best of luck and, of course, do keep in touch. …
A U.S. Food and Drug Administration advisory panel on Friday recommended that compounding pharmacies be allowed to manufacture the peptides epitalon and semax, but narrowly voted to recommend against manufacturing emideltide, STAT writes. The votes, which followed the panel’s decision on Thursday to recommend allowing pharmacies to make four other peptides, bring U.S. Health and Human Services secretary Robert F. Kennedy Jr. one step closer to his mission of making these unapproved compounds more available for Americans. Peptides have become increasingly popular in the U.S., driven by endorsements from social media influencers.
Amgen submitted new evidence to the FDA as it seeks a hearing to challenge the proposed withdrawal of its rare disease drug Tavneos from the U.S. market, Reuters says. In April, the agency proposed withdrawing the drug, which treats a rare autoimmune disease that damages blood vessels, citing a lack of proven effectiveness and false statements in its original marketing application. Amgen strongly disagrees with the FDA and noted its submission includes more than 70 real-world studies involving over 2,200 patients supporting the drug’s effectiveness and safety.
RA Capital and a fleet of other investors are putting $175 million behind Oak Hill Bio, a startup trying to revive an experimental Angelman syndrome drug that Roche shelved.
Oak Hill is competing with Ultragenyx Pharmaceutical and Ionis Pharmaceuticals, both of which are already running Phase 3 trials of similar drugs for the same disease. Ultragenyx will have results this year.
Oak Hill is betting it has the best molecule.
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Good morning. In a search for silver linings yesterday, I found this: I can finally spell the word “diarrhea” confidently! The latest on cyclosporiasis, measles, and more below.
When we were children, it wasn’t unusual to hear about a kid wiping out on a bike, skateboard, or roller skates and coming home with scrapes, bruises, and occasionally broken bones that needed to be fixed. While painful, those injuries generally matched the speed and physics of childhood play and rarely led to permanent injuries.
However, now, with the increasing prevalence of electric bicycles and scooters, known as e-bikes and e-scooters, the equation has changed for children and teens.
When students return to McGovern Medical School at UT Health Houston this year, they will get to participate in hands-on nutrition experiences, including cooking demonstrations in the teaching kitchen, tours of the campus “holistic garden,” and the opportunity to take a culinary-medicine-focused elective.
These immersive programs are a response to health secretary Robert F. Kennedy’s call for medical schools to teach more nutrition — part of the Trump administration’s push to address the rising rates of chronic diseases in the United States. Kennedy has blamed the problem, in part, on doctors not routinely discussing diet and nutrition with their patients.
Lessons in culinary medicine are part of the 71 nutrition-related topics that the Department of Health and Human Services wants future physicians to be well versed in. Other topics in the department’s Advancing Nutrition Education push include enhancing nutrient bioavailability through soaking, sprouting, and fermenting foods as well as prioritizing food-based medicine as the primary approach to manage chronic diseases driven by metabolic dysfunction.
The vast majority of 163 M.D.-granting and 48 D.O.-granting schools aren’t yet part of Kennedy’s new initiative, including several leading institutions. So far, some 73 medical schools — 54 M.D. programs, 19 D.O. programs — across 36 states have signed on.
Even as some medical schools heed Kennedy’s call for more nutrition education, several told STAT that they plan to steer clear of topics that aren’t backed by evidence, including some that align with the priorities of the Make America Healthy Again political movement championed by the health secretary. Nutrition experts cautioned that some of those topics could lead to “wellness creep” in medical education.
In the dimmed light of a hospital room in Nevada, the placenta — blue and shining — has just delivered. I coaxed it gently, spinning the warm, bloody organ and twisting the trailing membranes into a compact coil, leaving nothing behind. Even a small fragment of placenta or membrane can prevent the uterus from contracting properly, failing to squeeze shut the great vessels that have spent 40 weeks surging with blood to feed a growing baby. If those vessels do not abruptly close, blood continues pumping into the empty uterus and a hemorrhage begins.
I am always vigilant for bleeding — but today I am also uneasy. My patient has made it clear that she does not consent to blood products, even in an emergency. She will not risk receiving blood from a donor who has been vaccinated against Covid-19. No hospital or blood bank tracks donor vaccine status, because it poses no known transfusion risk — but no fact will change her mind.
Argenx said Monday it would buy Forte Biosciences to expand its immunology pipeline, continuing the sector’s acquisition run, as even midsize companies hunt for pick-up targets.
The deal, worth $2.2 billion in cash, values Dallas-based Forte at $77 per share, a 41% premium to the biotech’s closing price on Friday.
Argenx, which has its main operations in Belgium, has become a top success story in immunology. Its drug Vyvgart, approved to treat the autoimmune diseases generalized myasthenia gravis and chronic inflammatory demyelinating polyneuropathy, has delivered steady sales increases as its label has been widened to cover more patients.
WASHINGTON — A Food and Drug Administration advisory panel recommended on Friday that compounding pharmacies be allowed to manufacture the peptides epitalon and semax, but narrowly voted to recommend against manufacturing emideltide.
The votes, which followed the panel’s decision on Thursday to recommend allowing pharmacies to make four other peptides, bring health secretary Robert F. Kennedy Jr. one step closer to his mission of making these unapproved compounds more available for Americans. Peptides, which are short-chain amino acids, have become increasingly popular in the U.S., driven by endorsements from social media influencers.
I spent nearly a decade leading FDA’s Center for Food Safety and Applied Nutrition. That role convinced me that food safety and nutrition are interdependent in so many ways, and if we want to make our population healthier, we need to support both.
Over the past few weeks, record numbers of cases of cyclosporiasis have driven that message home broadly, including to consumers. FDA is currently investigating six cyclospora outbreaks, only one of which is currently linked to shredded iceberg lettuce.
NASHVILLE, Tenn., July 24, 2026 — HCA Healthcare reported an 8.7% increase in second-quarter revenue Friday as rising patient demand continued to lift the nation’s largest publicly traded hospital operator, even as labor and operating costs remained elevated.
Revenue reached $20.23 billion, up from $18.61 billion a year earlier. Net income attributable to HCA increased 2.8% to $1.70 billion, while diluted earnings rose 11.6% to $7.62 a share.
Adjusted earnings before interest, taxes, depreciation and amortization increased 4.6% to $4.03 billion.
The results were consistent with the preliminary figures HCA released earlier in July, reducing the likelihood of a major surprise for investors. The stronger revenue still provides a broader signal about healthcare spending, hospital admissions and the financial pressure facing employers and insurers.
Higher hospital revenue eventually moves through insurance premiums, employer health plans and household medical bills.
Cash generated from operations fell to $2.34 billion from $4.21 billion a year earlier, a reminder that stronger earnings do not always translate into the same level of immediate cash generation.
HCA’s scale gives it greater purchasing and staffing flexibility than smaller hospital systems, but it also makes the company an important indicator of nationwide medical utilization.
Investors will now focus on patient volumes, wage expenses and whether reimbursement increases can continue to offset higher costs during the second half of the year.
JBizNews Desk | Nashville
© JBizNews.com All Rights Reserved. Reproduction or distribution without written permission is prohibited.
The number of measles cases in the U.S. has surpassed the record-breaking tally for all of 2025, with five more months of 2026 still to come.
The U.S. Centers for Disease Control and Prevention logged 2,318 cases of measles as of Thursday, according to an agency update on Friday.
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Today, a win for RFK Jr., as an FDA panel narrowly voted in favor of allowing compounding pharmacies to produce certain unregulated peptides. Also, in heart-wrenching detail, Science writes of the six-year-old girl who died in China after receiving an experimental, brain-directed CRISPR therapy.
The Readout’s taking a summer break next week, so we’ll see you in August!
And so, another working week will soon draw to a close. Not a moment too soon, yes? This is, you may recall, our treasured signal to daydream about weekend plans. Our agenda is still in the works, but we do plan to promenade extensively with the official mascots, stroll the supermarket aisles, and spend time with the Pharmalot ancestor. We also hope to hold yet another listening party, where the rotation will likely include this, this, this, this and this. And what about you? The possibilities are endless — you could stop by your favorite restaurant, curl up with a good book, hang with your best friend, or take a long drive to nowhere. Well, whatever you do, have a grand time. But be safe. Enjoy, and see you soon. …
In a win for peptide proponents and for U.S. Health and Human Services Secretary Robert F. Kennedy Jr., an advisory panel to the U.S. Food and Drug Administration recommended compounding pharmacies be allowed to make the drugs BPC-157, KPV, TB-500, and MOTS-c., STAT says The FDA panel will vote on additional compounds on Friday. The votes are not binding, so the FDA will decide whether to lift restrictions and make them more accessible to people who have been turning to the little-researched but popular drugs. The vote reflects tensions between FDA staff, who recommended against lifting restrictions on the peptides because of safety and efficacy concerns, and the panel, which critics have said was “stacked” by Kennedy with people who stand to benefit from broader peptide access.
People with diabetes who use a popular long-acting insulin pen made by Sanofi have had to become pharmacy scouts in recent weeks as they encounter supply issues, STAT explains. The Lantus Solostar pen containing 3 milliliters of insulin glargine has been running low for several weeks because of increased demand “driven by broader market dynamics,” according to Sanofi. The issue is not technically considered a shortage by the FDA, but patients are having trouble finding the medication. While some diabetes patients have had luck finding the medication at small independent pharmacies or their hospital pharmacy, large pharmacies like CVS and Walgreens are coming up dry.
Get your daily dose of health and medicine every weekday with STAT’s free newsletter Morning Rounds. Sign up here.
Yesterday, my friend who lives in the Bay Area told me that I should be asking people about their peptide “stack,” which is where someone takes multiple peptides for presumably greater health benefit.
Amid rising concern over efforts to contain HIV, Merck has reached voluntary licensing deals with seven companies to make generic versions of an experimental, once-a-month prevention pill in 129 low- and middle-income countries.
The agreements will allow the manufacturers — three of which are based in Africa and four in India — to sell generic versions to both public and private buyers, which is designed to ensure the medicine becomes available to the widest possible population. Moreover, the deals are royalty free, which makes it easier for the generic companies to predict costs.
The timing of the announcement is notable because Merck is striking these deals while its medicine, known as alimatravir, is currently undergoing a pair of late-stage clinical trials. By doing so now, the company believes it will help the generic makers plan for wide-scale production and the necessary steps to receive regulatory approvals around the world.
For 18 months, the Trump administration has been accused by science advocates of shredding a social contract between academic researchers and the federal government that made the United States the world’s most powerful engine of discovery. Now it’s proposing a way to rebuild American science.
Taking inspiration from “Science — The Endless Frontier,” a 1945 manifesto that became the blueprint for the rise of American research universities, Trump’s science adviser, Michael Kratsios, this week put forth his version of such a report. Called “Science: A New Golden Age” and drafted by the White House Office of Science and Technology Policy, it calls for shifting hundreds of billions of research dollars from universities to industry, primarily tech and artificial intelligence companies.
The report acknowledges problems scientists have long attempted to grapple with, but advocates and scientists expressed concern that the report’s espoused goal of improving science is being undermined by other administration actions, chiefly the grievances expressed by President Trump and his aides against immigration, universities, and programs that they deem as promoting diversity, equity, and inclusion.
Amid debates over whether the political influence of the Make America Healthy Again movement is on the wane, a new bill advanced in the Senate on Wednesday shows that concerns over ultra-processed food continue to upend the usual partisan stances in Washington.
The bill, which would ban junk food advertisements targeted to children and require the Food and Drug Administration to put strong warning labels on ultra-processed foods high in sugar, salt, and saturated fat, was proposed by Sen. Bernie Sanders (I-Vt.).
In 2025, there were 216 active drug shortages in the U.S., impacting Americans’ access to lifesaving medications. The resilience of our pharmaceuticals supply chains has been increasingly framed as a national security issue, including by the White House — and rightly so, as Covid-19 magnified the massive costs of a health system ill-equipped to care for its population.
But this national security framing has heavily skewed toward a U.S.-China competition lens, distracting from the real root causes of our pharmaceuticals supply chain vulnerabilities: inadequate regulation of an industry that tends to prioritize profit over America’s health.
Every so often, I catch myself wondering, what if I had applied to medical school just two years later?
As another class of medical students matriculates, that question has become harder to ignore.
In a win for peptide proponents and for health secretary Robert F. Kennedy Jr., an advisory panel to the Food and Drug Administration recommended on Thursday that compounding pharmacies be allowed to manufacture the drugs BPC-157 and KPV.
The FDA will vote on two other peptides, TB-500 and MOTS-c, later on Thursday afternoon, and on additional compounds on Friday.
The votes are not binding, and the FDA will ultimately decide whether to lift current restrictions on these peptides and make them more easily accessible to people who’ve been turning to the little-researched but highly popular drugs to improve their health. It’s unusual for the FDA to go against the recommendations of the Pharmacy Compounding Advisory Committee, or PCAC, but it has happened at least once before.
Federal health officials are investigating a new outbreak involving the diarrhea-causing parasite cyclospora.
The outbreak included 72 people as of Wednesday.
The U.S. Food and Drug Administration disclosed Wednesday that it is investigating yet another outbreak of Cyclospora, the diarrhea-causing parasite, with 72 new cases tied to a source that has not yet been identified. The latest cluster adds to a surge of illness centered in the Midwest and deepens what has become one of the most disruptive food-safety episodes of the year for the fresh-produce industry.
The new cases join a national picture that has escalated sharply through the summer. The parasite, Cyclospora cayetanensis, causes a gastrointestinal illness marked by prolonged, watery diarrhea, and while cases typically climb every summer, 2026 has been far worse than usual. More than 11,000 confirmed or probable cases have been reported to the Centers for Disease Control and Prevention so far this year, compared with roughly 2,700 in all of 2025. In a mid-July health advisory, the CDC counted 1,645 laboratory-confirmed domestically acquired infections across 34 states, with thousands more awaiting analysis. About 9 percent of patients with available data have been hospitalized, and no deaths have been reported.
The commercial center of the crisis is fresh lettuce. The largest identified cluster — a five-state outbreak spanning Indiana, Kentucky, Michigan, Ohio, and West Virginia — has been linked to shredded iceberg lettuce from Taylor Farms de Mexico that was served at Taco Bell locations. On July 17, Taylor Farms recalled all iceberg lettuce sourced from central Mexico, a recall that reached well beyond restaurants into grocery aisles. It included Marketside-brand product sold at Walmart in various package sizes, along with a range of food-service products distributed to commercial customers.
For the produce supply chain, the episode illustrates how a single contaminated source can cascade across the entire food economy. One supplier’s lettuce moved through both a national fast-food chain and the country’s largest grocery retailer, forcing recalls, pulled inventory, and consumer warnings across multiple states at once. Fresh leafy greens are a high-volume, low-margin, fast-turnover category, and a recall tied to a widely distributed supplier can ripple through restaurant menus, retail shelves, and grower relationships in a matter of days.
The investigation has not been without complications. A lettuce sample from Taylor Farms initially flagged as positive on July 18 was later re-reviewed by FDA laboratory experts and deemed a false positive. The agency stressed that the correction did not undercut the basis for the recall, pointing to what it called overwhelming epidemiological and traceback data still tying the illnesses to the company’s iceberg lettuce. The nuance matters for the industry: because Cyclospora is notoriously difficult to detect on produce, outbreak investigations often rest on epidemiological patterns rather than a positive product test, leaving companies exposed to recalls before laboratory confirmation is possible.
The 72-case cluster announced Wednesday is separate from the Taco Bell-linked outbreak and remains without an identified food source. FDA officials have said they tracked multiple subclusters of Cyclospora since the season opened in May, several of which are now considered closed. The persistence of new, unlinked clusters underscores the challenge regulators face in pinning down contamination that can enter the food chain through produce grown in or washed with contaminated water.
That difficulty carries real cost for growers and importers. Cyclospora is resistant to routine chemical disinfection, and washing alone cannot guarantee its removal — only cooking to a sufficient temperature reliably kills it, which is little comfort for a category consumed raw. With fresh produce the most common culprit and imported product increasingly implicated, the outbreak is likely to sharpen scrutiny of sourcing practices, water safety at farms, and traceback systems across the produce sector heading into the back half of peak season.
For restaurants, grocers, and suppliers, the immediate exposure is financial and reputational: pulled product, disrupted sourcing, and wary consumers during the highest-volume months for fresh greens. For regulators, the widening case count and the appearance of fresh clusters with unknown origins suggest the investigation — and the pressure on the fresh-produce industry — is far from over.
This is a public-health matter as much as a business story; readers with health concerns or symptoms should consult the CDC’s current guidance or a medical provider.
JBizNews Desk | Washington, D.C.
© JBizNews.com All Rights Reserved. Reproduction or distribution without written permission is prohibited.
WASHINGTON — The Senate’s health panel delayed until next week a vote on Erica Schwartz to run the Centers for Disease Control and Prevention, after postponing a separate vote on Sean Kaufman for a key public health preparedness role.
The committee vote on Schwartz was pushed back because too few senators showed up. Sen. Lisa Murkowski (R-Alaska) is dealing with a family emergency, and at least one other lawmaker was also absent.
People with diabetes who use a popular long-acting insulin pen made by Sanofi have had to become pharmacy scouts in recent weeks as they encounter supply issues.
The Lantus Solostar pen containing 3 mL of insulin glargine has been running low for several weeks due to increased demand “driven by broader market dynamics,” a Sanofi spokesperson told STAT. The issue is not technically considered a shortage by the Food and Drug Administration, but patients are nonetheless having trouble getting the medication, sometimes having to call multiple locations to find a pen.
“Our priority is ensuring patients have access to their medications,” the spokesperson said, noting the company is “accelerating production and expediting all incoming replenishment stock.”
In a boost for greater clinical trial transparency, the European Medicines Agency (EMA) is taking what consumer advocacy groups are calling unexpectedly “rapid action” to ensure that study results are made public as required by law.
The move comes after a recent analysis found results for less than half of the studies registered in a key European database were reported within the required time frame and complete results were fully reported for only 42%. The researchers contended that overall compliance with legal reporting requirements was weak and regulatory oversight is lacking.
This was the first analysis to examine the Clinical Trial Information System (CTIS) that was created in 2022 as part of an effort to enhance transparency across the European Union and the European Economic Area. The registry contains more than 8,400 mid- and late-stage trials and, in the coming months and years, sponsors will be legally required to make results public.
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In this announcement that HHS is on TikTok, Dr. Oz is represented by a stethoscope and RFK Jr. by a slab of red meat. Send news tips and your avatars to John.Wilkerson@statnews.com or John_Wilkerson.07 on Signal.
This is the last week that the House and Senate will be in session together until Sept. 14. Lawmakers are scrambling to get a lot done, including on health care. (Each chamber will be in session alone during a portion of that time.)
What does it take to develop a therapy for an ultra-rare disease? What are the allegations against a telehealth company that’s partnered with Novo Nordisk? And has a wanted fugitive been posing as a biotech executive?
We discuss all that and more on this week’s episode of “The Readout LOUD,” STAT’s biotech podcast. We speak with our colleagues Jason Mast and Matthew Herper about their impactful look at one father’s mission to develop a treatment for his daughter’s ultra-rare disease. The subject of that feature, Matt Wilsey, also joins us.
