Wed.Mar 26, 2025

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March 26, 2025: GPT-4–Based Plain Language Translation of Clinical Notes for Patients, in This Week’s PCT Grand Rounds

Rethinking Clinical Trials

Dr. Matthew Engelhard and Anivarya Kumar In this Friday’s PCT Grand Rounds, Matthew Engelhard and Anivarya Kumar of Duke University will present “A Cross-Sectional Study of GPT-4Based Plain Language Translation of Clinical Notes to Improve Patient Comprehension of Disease Course and Management.” The Grand Rounds session will be held on Friday, March 28, 2025, at 1:00 pm eastern.

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First Prader-Willi drug to reduce hunger approved by FDA

Bio Pharma Dive

Clearance of Vykat unlocks what analysts anticipate will be a lucrative market opportunity for Soleno Therapeutics.

Drugs 317
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Beverage & Food IPOs in 2025: Companies Taking the Public Leap

XTalks

After a strong showing in 2024, leading packaged foods company BBB Foods saw their stocks rise from $17.50 to over $28 per share, followed by a successful secondary offering this year. Moreover, Guzman y Gomezs, a renowned Australian fast-casual chain known for a fresh, made-to-order Mexican food experience, whose shares surged 37% on debut, now has its very first location in Illinois.

Packaging 105
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Wave to seek approval of Duchenne drug after mid-stage study data

Bio Pharma Dive

The company plans to file next year for an accelerated clearance of its "exon-skipping" treatment, which would compete with one of Sarepta's medicines.

Medicine 267
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Bridging Innovation & Patient Care: The Growing Role of AI

Speaker: Simran Kaur, Co-founder & CEO at Tattva.Health

AI is transforming clinical trials—accelerating drug discovery, optimizing patient recruitment, and improving data analysis. But its impact goes far beyond research. As AI-driven innovation reshapes the clinical trial process, it’s also influencing broader healthcare trends, from personalized medicine to patient outcomes. Join this new webinar featuring Simran Kaur for an insightful discussion on what all of this means for the future of healthcare!

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FDA fast tracks Sanofi’s mRNA vaccine for chlamydia

Pharmaceutical Technology

Sanofi will commence a Phase I/II trial with its vaccine candidate in the next few days to start generating immunogenicity data.

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Makary confirmed by Senate as FDA commissioner

Bio Pharma Dive

The Johns Hopkins surgeon will helm the agency as layoffs loom and important decisions on treatments for rare and infectious diseases await.

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More Trending

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Epicrispr banks $68M to test epigenetic editing on rare muscle disease

Bio Pharma Dive

The startup is using CRISPR tools to stop errant expression of a gene linked to facioscapulohumeral muscular dystrophy, a disorder on the radars of several drugmakers.

Gene 187
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Big pharma faces headwinds in China as vaccine sales decline

Pharmaceutical Technology

Multinational companies in Chinas vaccine market face headwinds amid an anti-corruption crackdown and rising competition.

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Bayer gains cancer drug from China’s Puhe; Axsome gets mixed ADHD data

Bio Pharma Dive

The German firm licensed a PRMT5 inhibitor that’s now in Phase 1 testing. Elsewhere, GSK is testing an intriguing hypothesis and Novo fine tuned its Wegovy cash-pay program.

Licensing 152
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AI in Pharma Marketing: Innovation or Compliance Nightmare?

Pharma Marketing Network

Artificial intelligence (AI) is no longer a futuristic concept in healthcareits here, embedded in nearly every touchpoint of modern pharma marketing. From generative AI tools that draft emails to predictive algorithms that segment target audiences, the speed and scale of innovation are staggering. But as pharma marketers race to adopt these tools, a central question looms: Is AI fueling smarter engagement, or setting the stage for a compliance disaster?

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From Diagnosis to Delivery: How AI is Revolutionizing the Patient Experience

Speaker: Simran Kaur, Founder & CEO at Tattva Health Inc.

The healthcare landscape is being revolutionized by AI and cutting-edge digital technologies, reshaping how patients receive care and interact with providers. In this webinar led by Simran Kaur, we will explore how AI-driven solutions are enhancing patient communication, improving care quality, and empowering preventive and predictive medicine. You'll also learn how AI is streamlining healthcare processes, helping providers offer more efficient, personalized care and enabling faster, data-driven

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FDA approves first-of-its-kind antibiotic from GSK

Bio Pharma Dive

The drug is a needed new option for treating uncomplicated UTIs, a common infection that’s becoming harder to treat as rates of microbial resistance rise.

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EU Health Data Space strikes a chord in EU harmonisation plans

Pharmaceutical Technology

EU member states are set to launch the EU Health Data Space Regulation for harmonised data transfer on 26 March.

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Compliance Challenges in Generic Drug Development: Lessons Learned

Drug Patent Watch

The Unseen Hurdles of Generic Drug Development: Lessons Learned As the pharmaceutical industry continues to evolve, one thing remains constant: the pursuit of affordable, high-quality medications for patients worldwide. Generic drugs have long been a vital part of this equation, offering a more accessible alternative to brand-name medications. However, the journey to bringing a generic drug to market is often fraught with challenges.

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Unmatched quality in pharmaceutical logistics: Why it matters

Pharmaceutical Technology

Ensuring the highest standards in pharmaceutical logistics is crucial for patient safety and treatment efficacy.

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Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model

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Innovation enabled by new drug discovery technologies

Drug Discovery World podcast

This is the latest episode of the free DDW narrated podcast, titled Innovation enabled by new drug discovery technologies, which covers two articles written for DDW Volume 24 Issue 3, Summer 2023. They are called: CRISPR breakthroughs: New solutions for common diseases and Re-assessing the risks of drug-induced arrhythmias during drug discovery .

Drugs 52
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Cassava ends simufilam Alzheimer’s programme after second Phase III failure

Pharmaceutical Technology

While Cassava is stopping investigations into simufilam in Alzheimers disease, the therapy is now being evaluated in TSC-related epilepsy.

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5 Ways Thought Leaders Are Shaping the Future of Clinical Research

XTalks

In the fast-evolving field of clinical research, thought leaders do more than just keep up; they lead the charge and shape the direction of the industry. True thought leadership is achieved by consistently providing valuable insights, challenging the status quo and offering innovative solutions that address the fields most pressing challenges. Businesses that establish themselves as trusted voices not only gain credibility but also attract key partnerships and position themselves as pioneers.

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MHRA launches new monthly safety bulletins

Pharmaceutical Technology

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has introduced new monthly safety bulletins aimed at making medical device and medicine safety information clearer and more accessible for healthcare professionals.

Medicine 130
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The New Age of Decentralized Clinical Trials

White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations

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Nouscom reveals promising results for lynch syndrome immunotherapy

Pharma Times

NOUS-209 shows potential to intercept cancer in its early stages

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FDA approves GSK’s Blujepa for uncomplicated UTIs

Pharmaceutical Technology

The FDA has approved GSKs Blujepa for treating uncomplicated urinary tract infections (uUTIs) in adult females and paediatric patients.

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Drug Channels News Roundup, March 2025: PBM Unbundling Update, Stelara Biosimilar Price War, My $0.02 on the Optum Rx News, Follow the Dollar, and #DCLF2025

Drug Channels

Spring has officially arrived in sunny downtown Philadelphiathe proud home base of Drug Channels. As you can see on the right, we celebrated in Miami at the Drug Channels Leadership Forum. The vernal equinox also brought a surprising surge of industry updates and noteworthy news you wont want to miss: Blue Shield of California provides a puzzling update to its PBM unbundling effort The Stelara biosimilar price war begins My reaction to Optum Rxs pharmacy reimbursement announcement A valuable Fol

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Character Biosciences gains $93m for precision eye disease therapies

Pharmaceutical Technology

Character Biosciences has raised $93m in an oversubscribed Series B funding round to expedite the progression of precision therapies.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Character raises $93m for eye drugs, plus other financings

pharmaphorum

Recent financings in the biotech space include rounds for Character Bio, Tempero, Epicrispr, Hillstar Bio, and Ampersand Biomedicines

Drugs 105
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MSD makes licence agreement with Hengrui Pharma for Lp(a) inhibitor

Pharmaceutical Technology

MSD has entered an exclusive licence agreement with Hengrui Pharma for the oral small molecule Lp(a) inhibitor, HRS-5346.

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AIDCOC asks Ayush ministry to reconsider decision to limit qualification to inspect ASU units only with ASU graduates

AuroBlog - Aurous Healthcare Clinical Trials blog

As the last date ended on March 21 to submit objections and suggestions on the draft notification issued by Union Ayush Ministry to change the qualification requirements for inspectors to inspect Ayush facilities only with Ayurveda graduates, the All India Drug Control Officers Confederation (AIDCOC) has urged the Union Ayush secretary to reconsider its decision […]

Drugs 100
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Support Systems: Building Your Multiple Sclerosis (MS) Care Team

Antidote

Living with multiple sclerosis (MS) can sometimes feel like youre navigating an unpredictable roadone with unexpected twists, turns, and detours. Theres so much information to absorb, decisions to make, and changes to navigate. At times, it might feel isolatingbut heres the truth: You are not alone in this.

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The New Age of Decentralized Clinical Trials

This new white paper defines and details the impact of Decentralized Clinical Trials on the Pharmaceutical industry and how the impact can be measured along with steps companies can take to ensure adoption.

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UK sets aside £2m for digitally-enhanced dementia tests

pharmaphorum

The UK is providing 2m in funding to allow digital assessment to be added to a highly-anticipated trial of blood tests for diagnosing dementia

Trials 79
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Inequities in Clinical Research: Learning from Communities to Overcome Challenges

ACRP blog

Institutional barriers remain a key driver of health inequities based on race, ethnicity, age, and gender, particularly in the United States. The U.S. Food and Drug Administration (FDA) has taken steps to address these disparities in clinical trial study enrollment over the past two decades, including recent draft guidance issued in June 2024, which mandates diversity action plans for all Phase II and III registrational studies.

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Hubs East 2025: Navigating Specialty Medication Onboarding

Pharmaceutical Commerce

Jen Butler, chief commercial officer, Pleio, discusses how the companys GoodStart programs help patients navigate specialty pharmacies.

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GSK ends decades-long hiatus in oral antibiotics for UTIs

pharmaphorum

The FDA has approved GSK's Blujepa, the first new-mechanism oral antibiotic for uncomplicated UTIs in nearly 30 years, after a priority review

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Unlocking Excellence: How Catalent Is Transforming Japan’s Clinical Research

Planning on running clinical trials in Japan? How can you reliably supply these studies? Discover Catalent’s clinical supply packaging facility in Shiga, Japan. Strategically located between Tokyo and Osaka, and one of largest in Japan, this 6,000 square meter facility offers comprehensive services including primary and secondary clinical packaging and labelling, comparator sourcing, cold chain storage, local and global distribution, local language support and white glove service to support stud