Johnson & JohnsonJNJhas no immediate plans to venture into weight-loss drugs due to the existing competition saturation, as Chief Executive Officer Joaquin Duato highlighted.
During the firm's investor day on Tuesday, Duato emphasized that the company's priorities lie in extensive expansion, particularly within neurology and oncology.
Although dismissing the notion of entering this specific drug category for now, Duato did leave a slight window open for reconsideration, Bloomberg reported.
He mentioned that if J&J identifies an opportunity to distinguish itself within the market through a supplementary asset aligned with the company's focus, it might contemplate a shift in strategy.
The burgeoning market for obesity treatment has already witnessed substantial penetration by Eli Lilly & CoLLY and Novo Nordisk A/SNVO.
Most recently, Roche Holdings AGRHHBY agreed to acquire obesity-focused CarmotTherapeutics for$2.7 billion in cash. Additionally, Carmot's equity holders are entitled to receive payments of up to $400 million depending on achieving certain milestones.
Last week, Altimmune IncALT shares gained after the company released topline results from its 48-week MOMENTUM Phase 2 obesity trial of pemvidutide with 391 subjects.
Meanwhile, Pfizer IncPFE stock fell on topline data from the Phase 2b trial of danuglipron. Shares fell as the patients in the study discontinued at rates greater than 50% across all doses compared to 40% of patients on placebo.
Popular AI tool ChatGPT flubbed nearly 75% of questions about prescription drug usage — with some responses causing potential harm if followed, according to a new study.
Pharmacists at Long Island University posed 39 drug-related questions to OpenAI’s free chatbot — with only 10 of the responses deemed “satisfactory,” per the study, which was first reported by CNBC.
For the other 29 questions, the responses either did not directly address the question, were inaccurate or incomplete, according to LIU’s researchers, who presented the findings during the American Study of Health-System Pharmacists meeting in Anaheim, Calif., which began Dec. 3 and runs through Dec. 7.
“Healthcare professionals and patients should be cautious about using ChatGPT as an authoritative source for medication-related information,” said Sara Grossman, an associate professor of pharmacy practice at LIU and the leader of the study.
Grossman and her team pointed to a query about the relationship between the COVID-19 antiviral Paxlovid and the blood-pressure lowering medication verapamil as an example.
When asked if there’s a drug interaction between Paxlovid and verapamil, ChatGPT responded that there were no reported interactions for this combination of drugs, per LIU.
“In reality, these medications have the potential to interact with one another, and combined use may result in excessive lowering of blood pressure,” Grossman said. “Without knowledge of this interaction, a patient may suffer from an unwanted and preventable side effect.”
An OpenAI spokesperson pointed out that its models are not fine-tuned to provide medical information.
“We guide the model to inform users that they should not rely on its responses as a substitute for professional medical advice or traditional care,” the rep told The Post.
LIU’s researchers had asked ChatGPT to provide references with each of its responses for verification purposes.
Only eight of 39 replies included references.
All of the references were “non-existent,” LIU reported — proving ChatGPT may not be the go-to resource for medication-related questions.
OpenAI’s usage policies denote that its technologies should not be used to “tell someone that they have or do not have a certain health condition, or providing instructions on how to cure or treat a health condition.”
The guidelines also warned: “OpenAI’s models are not fine-tuned to provide medical information. You should never use our models to provide diagnostic or treatment services for serious medical conditions.”
However, since ChatGPT’s debut in November 2022, it has been groundbreaking for the development of AI and in unrelated fields — including medicine.
ChatGPT scored an average of 77.2% on the ob-gyn specialist exam, while human candidates only eked out a 73.7% average, a study from the National University of Singapore revealed.
ChaptGPT also took an average of just under three minutes to complete each station, well under the 10-minute time limit, the study noted.
JAMA’s researchers randomly selected 195 exchanges on the Reddit forum r/AskDocs.
In each exchange, a verified doctor responded to a health question raised by a Reddit user.
Then, the same questions were posted to ChatGPT.
The results won’t make a doctor too happy: ChatGPT gave better answers 78.6% of the time, JAMA found. Its responses were also lengthier and more comprehensive in most instances.
Perhaps most damningly, the chatbot gave the most empathetic response nearly 10 times more often than the humans.
Doctors weren’t sweating for too long, though, as just two months later ChatGPT was tapped for yet another medical-related study — and spewed out cancer treatment regimens that contained a “potentially dangerous” mixture of correct and false information.
In August, researchers at Brigham and Women’s Hospital, a brand of Harvard Medical School, prompted OpenAI’s popular chatbot to provide treatment advice that aligned with guidelines established by the National Comprehensive Cancer Network.
While all of ChatGPT’s outputs “included at least 1 NCCN-concordant treatment,” about 34% also contained an incorrect treatment recommendation, the study found.
Tandem Diabetes Care, Inc. (NASDAQ: TNDM), a leading insulin delivery and diabetes technology company, today announced the launch of updated t:slim X2™ insulin pump software with Dexcom G7 Continuous Glucose Monitoring (CGM) integration in the United States. Tandem’s #1-rated automated insulin delivery (AID) system* with Control-IQ technology is the only AID option in the world today to use Dexcom’s latest CGM technology.
Former PresidentDonald Trumpaccused Democrats on Tuesday of donating to Republican White House hopefuls Nikki Haley and Ron DeSantis to keep him from becoming the 2024 GOP presidential nominee.
Trump, 77, made the claim during a town hall event in Davenport, Iowa, after being asked by Fox News host Sean Hannity about his reaction to President Biden’s remark that he likely would have retired after a single term if his 2020 opponent wasn’t running in next year’s election.
“Well, I think somebody gave him a talking point they thought that would sound good,” the GOP presidential front-runner said of the 81-year-old incumbent’s remark, before suggesting that the alleged donations going to his primary rivals indicate Democrats — and Biden — are being dishonest about who they want to face in the general election.
“You know, I just found out that Democrats are funding Nikki Haley’s campaign,” Trump said.
“I hear that Democrats are contributing to Ron DeSanctus’ — or Ron DeSanctimonious — to Ron DeSanctus’ campaign,” he added, using the two derisive nicknames he frequently employs when talking or posting about the Florida governor.
“That’s the only thing they’re good at — cheating on elections and great talking points,” Trump said of Democrats. “They say, ‘We want to run against Trump.’ They want to run? Well, we did really well in 2016. And we did so much better in 2020. The person they don’t want to run against is us”
Trump may have been referring to a report in the New York Times that LinkedIn co-founder and Democratic megadonor Reid Hoffman contributed $250,000 to SFA Fund, a pro-Nikki Haley super PAC that has spent more than $33 million supporting the former South Carolina governor’s GOP primary bid.
Hoffman also dumped nearly $700,000 into the Biden Victory Fund war chest, a joint fundraising committee authorized by the Biden campaign, in April, federal election records show.
The tech billionaire admitted to the Wall Street Journal earlier this year that he paid a visit to convicted pedophile Jeffrey Epstein’s private island in the Caribbean in 2014, to raise funds for the Massachusetts Institute of Technology — a decision that he called a “mistake” and a “personal misjudgment.”
The Haley campaign did not respond to The Post’s request for comment.
It’s unclear which Democrats Trump was referring to as “contributing” to DeSantis’ White House bid. A spokesperson for the DeSantis campaign suggested Trump may have confused the Florida governor with Haley.
Trump holds a nearly 29-point lead over DeSantis and a 32-point lead over Haley in the Hawkeye State with just over a month to go until the 2024 Iowa Republican presidential caucuses — the first GOP presidential nominating contest of the 2024 cycle.
“I feel great,” Trump told Hannity about the state of the race.
When asked by the Fox News host to assuage voters that, if elected, he would “never abuse power as retribution against anybody,” Trump responded, “Except for Day One.”
“Other than Day One. We’re closing the border. And we’re drilling, drilling, drilling. After that I’m not a dictator,” he clarified.
Organovo, Inc. (NASDAQ: ONVO), a clinical stage biotechnology company that is focused on developing FXR314 in ulcerative colitis and inflammatory bowel disease (IBD), based on demonstration of clinical promise in three-dimensional (3D) human tissues as well as strong preclinical data, today announced that it will release final and complete data from a Phase 2a trial of FXR314 in non-alcoholic steatohepatitis (NASH) patients by April 2024. The Company anticipates presentations at scientific meetings as well as publication in peer-reviewed journals. The release of this data will be the first public release of the completed clinical trial data.
Every form of cancer is devastating, but the unfortunate reality is not all cancers are created equal. There are certain forms of cancer that are more deadly. Glioblastoma (GBM) is a highly aggressive type of brain cancer with no cure, leading to a grim prognosis and average survival time of only 14 to 16 months. Oftentimes, people first become suspicious that something might be wrong when a persistent headache occurs followed by intensifying pain and bouts of dizziness and blurred vision, and it is a highly invasive tumor that makes complete surgical removal difficult.
The diagnostic process begins with a series of tests: MRI scans, CT scans and a battery of examinations. People who decide to seek treatment often face a grueling experience, yet the prognosis remains grim. The cancer rapidly infiltrates healthy tissue, evading the most advanced medical interventions. Current treatments like surgery, chemotherapy and radiation are not very effective in prolonging survival. However, there is growing interest in developing treatments that target specific genetic mutations and molecular pathways involved in glioblastoma growth, including immunotherapy and precision medicine.
Taking A Different Approach: CNS Pharmaceuticals
CNS Pharmaceuticals, Inc. (NASDAQ: CNSP) is a biopharmaceutical company focused on developing innovative therapies for central nervous system disorders, specifically aggressive brain cancers. One of their leading treatment candidates is Berubicin, a chemotherapy drug that interferes with the DNA of cancer cells to inhibit their growth and potentially shrink tumors. Unlike traditional chemotherapy drugs, Berubicin has the ability to penetrate the blood-brain barrier and directly target cancer cells in the brain, increasing its potential effectiveness.
In September, the company announced that 200 out of 243 expected patients had been enrolled in their ongoing study evaluating the effectiveness of Berubicin for recurrent GBM, a highly aggressive and incurable form of brain cancer. This global study of Berubicin is a critical and adaptive trial that involves multiple centers and is open-label. It is randomized and controlled, comparing Berubicin to Lomustine - the standard of care - in adult patients with recurrent GBM (WHO Grade IV) after standard first-line therapy has failed. The primary goal of the study is Overall Survival (OS), a rigorous measure that the FDA recognizes as fundamental for approving oncology drugs when there is a statistically significant improvement compared to a randomized control arm. Currently, the company has opened 46 clinical trial sites out of approximately 60 selected locations across the United States, Italy, France, Spain and Switzerland.
The company reports that its interim analysis is also showing promising results. CNS Pharmaceuticals had set a specific goal to analyze the trial data after more than half of the patients enrolled in the study reached the main effectiveness measure. This represents a significant portion of the total patient population in the trial. During this analysis, an independent review board closely examines the number of deaths in each treatment group to ensure that patients receiving Berubicin show a significant improvement in overall survival compared to those receiving Lomustine. They also look at other important factors like how long patients live without the cancer progressing, response rates and safety.
Sen. Bill Cassidy (R-La.), ranking member of the Senate Health, Education, Labor, and Pensions Committee, isasking stakeholdersfor feedback regarding gene therapies, with an eye toward crafting legislation that could make these expensive treatments more accessible for patients.
“Policymakers have a responsibility to evaluate the market structure and identify where targeted changes can be made to ensure market access for patients with ultra-rare diseases,” Cassidy wrote in Tuesday’s request for information. “Any proposal put forward by Congress should be informed by the current work of states and the private market.”
Cassidy is looking for guidance on defining ultra-rare diseases and identifying patients who should be eligible for new coverage schemes. The Republican senator is also looking into the current payment and access practices for patients with ultra-rare diseases: how they pay for their therapy, how physicians provide access to these treatments and what programs—state-sponsored or otherwise—are there for them to leverage.
In addition, Cassidy is asking stakeholders—including health insurers and manufacturers—how they decide on a list price for gene therapies and how they manage the financial risk of covering these expensive treatments.
Responses to Cassidy’s request for information are due by Jan. 22, 2024, and will help lawmakers determine the appropriate role of the federal government in maximizing access to gene therapies without inadvertently hurting innovation, according to the announcement.
“Given the current limited number of approved gene therapies, manufacturers and commercial health plans alike are currently able to absorb costs in order to provide patient access,” but this current market environment is unsustainable, according to Cassidy, particularly as approvals in this space “are expected to grow dramatically over the next decade.”
Cassidy warned that “artificially low prices could promote patient access, but eliminate the incentive to bring these treatments to market.” At the same time, without pricing safeguards, “the small patient population runs the risk of bearing the full weight of the high price tag,” he noted.
The initiative in the U.S. Senate to draft legislation tackling the access and affordability of gene therapies comes as the industry and the FDA anticipate a looming boom not only in cell and gene therapy applications, but also in approvals.
On Friday, the FDA is set to release its verdict on yet another gene therapy, Vertex Pharmaceuticals and CRISPR Therapeutics’ exagamglogene autotemcel (exa-cel), for the treatment of sickle cell disease. Neither company has indicated how much they plan to market the therapy, if approved, but it is likely to cost well above $1 million for a single dose.
In November 2022, the FDA approved CSL’s Hemgenix (etranacogene dezaparvovec-drlb) as the first gene therapy to treat adults with hemophilia B. The treatment costs $3.5 million per dose, a price tag that has won it the title of being the most expensive drug in the world.
Bluebird bio, also focused on cell and gene therapies, owns Zynteglo (betibeglogene autotemcel), an ex-vivo lentiviral treatment indicated for beta-thalassemia, and Skysona (elivaldogene autotemcel), indicated for active cerebral adrenoleukodystrophy. The therapies cost $2.8 million and $3 million, respectively.