PharmaFocus Today – Page 268 – media

Laboratory trade group, providers oppose FDA’s lab developed test proposal

Dive Brief The Food and Drug Administration received more than 19,600 comments related to its planned changes to the oversight of laboratory developed tests (LDTs). The public comment period closed on Monday. Multiple groups pushed back against plans to increase FDA oversight of LDTs. The American Clinical Laboratory Association (ACLA) is at the forefront of the resistance, submitting a 107-page document that outlines “grave concerns” and urges the FDA to withdraw the proposal. Hospitals and healthcare provider groups, like the American Hospital Association (AHA), also opposed the FDA’s proposal, arguing that the rule would limit patients’ access to tests. Dive Insight The FDA closed the comment period Monday, resisting calls to give affected groups more time to send feedback. The length of the comment period is one of many points of contention. Plans to increase regulatory oversight of LDTs, without gaining additional powers from Congress, have alarmed a spectrum of ...
- Source: drugdu
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- December 9, 2023
Large language models enhance differential diagnosis, paving the way for AI-assisted medical decision-making

A recent study published in the ArXiv preprint* server discusses the optimization of large language models (LLMs) for accurate differential diagnosis (DDx). Background Accurate diagnosis is the first step in effective medical care. It has been perceived that artificial intelligence (AI)-based models can be used to assist clinicians for accurate diagnosis of a disease. The real-world diagnostic process involves an interactive and iterative process with rational reasoning about a DDx. A physician weighs different diagnostic possibilities based on varied clinical information procured from advanced diagnostic procedures. Deep learning has been applied to the generation of DDx in ophthalmology, dermatology, and radiology. Due to the absence of interactive capabilities, deep learning models cannot assist patients with diagnosis through fluent communication in their native language. This interactive shortcoming can be overcome with the development of LLMs, which can be used to design effective tools for DDx. LLMs are trained using a massive ...
- Source: drugdu
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- December 9, 2023
Microbot Medical is a step closer to an FDA IDE submission

BY CHRIS NEWMARKER Microbot Medical today announced the successful completion of its pivotal pre-clinical study of its Liberty endovascular robotic surgical system. The study, performed under good laboratory practice (GLP) and essential for the company’s investigational device exemption (IDE) submission, took place under rigorous FDA guidelines. The study involved pigs. In this study, three interventional radiologists performed 96 robotic navigations using Liberty. They used the system to control various commercially available intravascular catheterization devices. They then microscopically examined and evaluated the target vessels and surrounding tissue. Microbot Medical officials think Liberty’s remote operation could enable it to democratize endovascular interventional procedures. “I am very pleased with the positive outcomes of the histopathology report and the completion of the GLP study,” said Juan Diaz Cartelle, chief medical officer of Braintree, Massachusetts–based Microbot Medical. “This gives us confidence to move forward to the next stage of human clinical study.” Microbot Medical CEO ...
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- December 9, 2023
ChatGPT Does a Bad Job of Answering People’s Medication Questions

Study Finds Researchers recently tested ChatGPT’s ability to answer patient questions about medication, finding that the AI model gave wrong or incomplete answers about 75% of the time. Providers should be wary of the fact that the model does not always give sound medical advice, given many of their patients could be turning to ChatGPT to answer health-related questions. By KATIE ADAMS Researchers recently tested ChatGPT’s ability to answer patient questions about medication, finding that the viral chatbot came up dangerously short. The research was presented at the American Society of Health-System Pharmacists’ annual meeting, which was held this week in Anaheim. The free version of ChatGPT, which was the one tested in the study, has more than 100 million users. Providers should be wary of the fact that the generative AI model does not always give sound medical advice, given many of their patients could be turning to ChatGPT ...
- Source: drugdu
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- December 9, 2023
Sanofi’s quiet Sarclisa chalks up a first-in-class win with eyes on a first-line multiple myeloma nod

In the currently mismatched CD38 antibody race, Sanofi’s Sarclisa has delivered a pivotal trial win, which might help the lagging follower level the playing field a little. Using Sarclisa on top of Takeda’s Velcade, Bristol Myers Squibb’s Revlimid and the steroid dexamethasone (VRd), significantly reduced the risk of disease progression or death versus VRd alone in patients with newly diagnosed multiple myeloma not eligible for transplant, Sanofi said Thursday. Sanofi’s phase 3 IMROZ readout comes as Sarclisa’s in-class rival, Johnson & Johnson’s Darzalex, is sharing a positive phase 3 for its VRd combo in transplant-eligible patients at the upcoming American Society of Hematology annual meeting. Still, the J&J data don’t prevent Sanofi from claiming the first phase 3 win for an anti-CD38 antibody with VRd in transplant-ineligible patients. Results from the IMROZ trial will be shared at a future medical meeting and will support a regulatory filing, Sanofi said. A ...
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- December 9, 2023
Pfizer and Arvinas plan vepdegestrant programme expansion after data at SABCS.

Pfizer and Arvinas are broadening their vepdegestrant programme to include more settings, as positive data is reported from the Phase Ib study of the drug to treat breast cancer. Vepdegestrant is an orally administered protein degrader designed as a proteolysis targeting chimera (PROTAC) that targets both wild-type and mutant oestrogen receptor (ER) found in some breast cancers. The collaboration between the two companies began in July 2021 in a $2.4bn deal to develop the PROTAC drug. Under the terms of the agreement, both firms would co-develop and market vepdegestrant. In the abstract on data from a Phase Ib study (NCT04072952) presented at the ongoing 2023 San Antonio Breast Cancer Symposium (SABCS), the reported clinical benefit rate (CBR) was 37.1% with 200mg and 38.9% with 500mg of the drug amongst 71 patients who received either dose (abstract no. Abstract GS3-03). The treatment was generally well tolerated, with the most common side ...
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- December 9, 2023
Secretary of state sets out priorities for UK health and social care systems

The commitments will make health systems faster, simpler and fairer for patients Health and social care secretary Victoria Atkins has set out new priorities to improve the health and social care system in the UK. The new commitments intend to make the health and social care system faster, simpler and fairer for patients. As healthcare systems approach the winter season, Atkins has committed to ensuring that health and social care services are faster for patients by making it easier to get treatment locally, improving A&E performance and cutting waiting lists. She commits to making systems simpler for patients and staff with joined-up integrated care and reducing bureaucracy by giving them the latest technology to free up their time to care for patients. Furthermore, Atkins committed to making systems fairer by ensuring that children are protected from health harms; health outcomes are not determined by where people live; the government supports ...
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- December 9, 2023
Study reveals motor neuron region is affected in ALS

The neurological condition currently affects one in 300 people in the UK King’s College London (KCL) researchers have revealed a mechanism behind dysregulated neuronal activity, a key pathology of amyotrophic lateral sclerosis (ALS). The new study, published in Cell Reports, identifies the axon initial segment (AIS) as the region that drives abnormal regulation of neuronal activity in ALS. Affecting one in 300 people in the UK, ALS, or motor neurone disease, is a neurological disorder that progressively destroys neurons in the brain and spinal cord. Researchers found that the molecular, structural and functional changes in the AIS, the region where electrical signals in neurons initiate, cause abnormal neuronal excitability. In the study, researchers examined two of the most common genetic causes of AIS mutations in the genes, TDP-43 and C9ORF72. In ALS, the electrical signalling in motor neurons initially increases during the early stages of the condition and progressively becomes ...
- Source: drugdu
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- December 9, 2023
Q&A With UCB’s Camille Lee on New Psoriasis Medication Approval

Don Tracy, Associate Editor UCB executive speaks on recent FDA approval of Bimzelx. In an interview with Pharm Exec associate editor Don Tracy, Camille Lee, VP, head of US immunology, UCB, speaks about the company’s recent FDA approval for Bimzelx, a treatmemt for psoriasis. Q&A With UCB’s Camille Lee on New Psoriasis Medication Approval 1 Play Video Pharm Exec: Generally speaking, how far does UCB’s work in psoriasis span? Lee: UCB started its research work in psoriasis over a decade ago. Through that work, we have two assets available. Most recently and most directly related to UCB’s work is our recent approval of Bimzelx. That approval has been specifically first and foremost in the area of psoriasis. It is the first and only approved treatment that is selectively targeted to directly inhibit the IL-17A and IL-17F, which are two key things causing the inflammation of psoriasis. That product has been ...
- Source: drugdu
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- December 8, 2023
What Excites One Mayo Clinic Radiologist About AI in Her Field

Dr. Wendaline VanBuren, a radiology chair at Mayo Clinic, thinks that AI is in the beginning stages of improving radiologists’ workflows. Some of the most developed radiology AI research projects at Mayo center on image segmentation and 3D printing, she said. In the future, she’s excited to see more tools that aid radiologists in triage and lesion measurement. By KATIE ADAMS Radiology, like most physician specialties, is dealing with a labor shortage driven by burnout and an aging workforce. AI is often heralded as something that can help solve these workforce problems, but a lot of AI deployment in radiology is still in its iterative phase, said Dr. Wendaline VanBuren, chair of the gynecological imaging section within the division of abdominal radiology at Mayo Clinic. Dr. VanBuren made this remark last week during an interview at RSNA 2023, the annual radiology and medical imaging conference in Chicago. While AI still ...
- Source: drugdu
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- December 8, 2023

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