Wed.Feb 19, 2025

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Biogen and Stoke Therapeutics to commercialise Dravet syndrome treatment

Pharmaceutical Technology

Biogen has entered a collaboration with Stoke Therapeutics to develop and commercialise zorevunersen to treat Dravet syndrome.

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February 19, 2025: Texting for Behavior Change to Improve Chronic Care Management, in This Week’s PCT Grand Rounds

Rethinking Clinical Trials

In this Friday’s PCT Grand Rounds, Michael Ho and Sheana Bull will present “Texting for Behavior Change: Lessons Learned Across 2 Interventions to Improve Chronic Care Management.” The Grand Rounds session will be held on Friday, February 21, 2025, at 1:00 pm eastern. This Grand Rounds session will report the results of Chat 4 Heart Health, an NIH Collaboratory Trial.

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Amazon joins forces with Memorial Sloan Kettering for AI-powered drug discovery

Pharmaceutical Technology

MSK plans to speed up early-stage drug development by using AWS Drug Discovery Workbench to screen potential candidates.

Drugs 273
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Advamed CEO warns FDA job cuts put patients, industry at risk

Bio Pharma Dive

Scott Whitaker sent a letter to HHS calling for staff cuts at the FDA to be reversed, arguing patient care and U.S. leadership in medical devices are on the line.

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Bridging Innovation & Patient Care: The Growing Role of AI

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

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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The Role of Quality Assurance in Generic Drugs

Drug Patent Watch

The Unsung Heroes of Generic Drugs: The Importance of Quality Assurance As we navigate the complex world of pharmaceuticals, it's easy to overlook the behind-the-scenes efforts that ensure the quality and safety of the medications we rely on. But today, I want to shine a spotlight on the often-overlooked heroes of the generic drug industry: Quality Assurance (QA) professionals.

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Recursion CEO launches pre-seed fund in response to NIH cuts

Bio Pharma Dive

Chris Gibson, Recursion’s head, cited the role small business grants played in helping his company grow its business.

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More Trending

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Sanofi reaches consumer health deal; Supernus antidepressant fails study

Bio Pharma Dive

The pharma signed an agreement handing PE firm CD&R a 50% stake in its Capella unit. Elsewhere, Gilead and Ultragenyx secured PDUFA dates for important new medicines.

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Scientists develop largest ever biological AI model that ‘thinks in nucleotides’

Pharmaceutical Technology

A team of scientists has developed a new AI-based foundation model that can give insights into disease-causing mutations and genome design.

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The CRA’s Role in Site-Sponsor Relationships

ACRP blog

A healthy relationship between sites and sponsors is critical to the success of clinical trials, including efficient and effective management, adaptability, innovation, problem-solving, and feedback mechanisms on the parts of those involved on both sides. Clinical research associate (CRA) competencies are key to creating and nurturing this relationship under all circumstances.

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Cumberland’s Vibativ injection gains China’s NMPA approval

Pharmaceutical Technology

Cumberland Pharmaceuticals' antibiotic Vibativ (telavancin) injection has gained approval from Chinas NMPA.

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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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Romvimza (Vimseltinib) for TGCT: FDA Approves Oral CSF1-Targeted Drug

XTalks

The FDA has approved Decipheras Romvimza (vimseltinib) for adult patients with symptomatic tenosynovial giant cell tumor (TGCT) when surgery may lead to worsened joint function or severe complications. The approval was largely based on the results of the MOTION Phase III study. Dr. Hans Gelderblom, chair of Medical Oncology at Leiden University Medical Center, noted in the press release that the study data could establish Romvimza as a potential new standard of care for TGCT patients who are no

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Sanofi moves closer to selling controlling stake in $17bn-valued Opella

Pharmaceutical Technology

Sanofi and CD&R have signed a share purchase agreement for the sale of a 50% stake in the consumer health business.

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Advancing Alzheimer’s Diagnostics: Insights from ALZpath’s Dr. Lee Honigberg on the Future of Blood-Based Biomarker Assays

XTalks

In this episode, Ayesha spoke with Lee Honigberg, PhD, VP of Research & Development, ALZpath , a provider of diagnostic tools for Alzheimers disease. This includes a blood-based biomarker assay, called the ALZpathDx assay, which measures pTau217 in the blood. Prior to joining ALZpath, Dr. Honigberg was most recently Senior Director and Distinguished Scientist in Translational Medicine at Genentech, where he was leading a group responsible for biomarker development for programs in neuroscienc

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New CEOs to join Merck KGaA’s executive board

Pharmaceutical Technology

E. Merck KG board of partners has announced the appointment of new CEOs to Merck KGaAs executive board, aiding its ongoing growth strategy.

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

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FDA sets June date for Gilead's twice-yearly HIV PrEP

pharmaphorum

Gilead's already dominant position in HIV PrEP could be extended if the FDA approves a new twice-yearly injectable product later this year

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Can innovation in clinical trial delivery meet the demands of increasing complexity in drug development?

Pharmaceutical Technology

Clinical trial complexity has significantly increased in the past decade. How can the industry adapt and innovate to remain productive?

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UK study highlights importance of GP data in understanding atrial fibrillation

Pharma Times

The common heart condition affects approximately 1.

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2025: The year of the patient?

pharmaphorum

Explore the potential impact of increased patient involvement in clinical trials and the importance of diversity in research as we look ahead to 2025.

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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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Email Marketing Campaigns for Pharma: Boost Engagement & Compliance

Pharma Marketing Network

Introduction Email marketing remains one of the most powerful tools for pharma brands , helping reach healthcare professionals (HCPs), patients, and stakeholders with tailored messaging. But email marketing campaigns in the pharmaceutical industry come with unique challenges regulatory restrictions, privacy concerns, and engagement barriers. How can pharma marketers craft high-performing email marketing campaigns while staying compliant?

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When licensing deals go bad - Novo sues KBP Bio for $830m

pharmaphorum

Novo Nordisk lawsuit claims KBP concealed clinical data ahead of a $1.

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Real-Time Bidding in Pharma Marketing: Maximizing Ad Efficiency and Compliance

Pharma Marketing Network

Introduction Digital advertising in the pharmaceutical industry is evolving fast. With real-time bidding (RTB) , pharma marketers can place highly targeted ads in milliseconds, reaching healthcare professionals (HCPs) and patients at the right moment. But as powerful as RTB is, pharma brands must navigate strict regulatory challenges to ensure compliance with FDA and GDPR guidelines.

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RFK 'willing to be wrong' on vaccines, but a probe is coming

pharmaphorum

In his maiden speech, HHS Secretary RFK Jr says he will investigate the role of childhood vaccines and other 'taboo' topics in chronic disease

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Digital Advertising Strategies for Pharma: Maximizing Reach and Compliance

Pharma Marketing Network

Introduction Pharma marketing is evolving fast. Traditional methods like print ads and TV spots are no longer enough to engage todays digitally connected audience. With the rise of digital advertising strategies , pharmaceutical brands now have an opportunity to target healthcare professionals (HCPs), patients, and caregivers more effectively. But pharma marketing isnt like regular advertising.

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Biogen bags rights to epilepsy drug from Stoke in $550m deal

pharmaphorum

Biogen has bolstered its pipeline by licensing ex-US rights to a drug for Dravet syndrome a rare form of epilepsy from Stoke Therapeutics

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How EDC Software Improves Patient Safety

Crucial Data Soutions

The Link Between EDC and Patient Safety The shared commitment among researchers and healthcare providers to patient safety influences every. The post How EDC Software Improves Patient Safety appeared first on Crucial Data Solutions.

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Supernus reports less than super data for depression drug

pharmaphorum

Supernus Pharma has suffered a blow to its R&D pipeline after a candidate for treatment-resistant depression failed a phase 2b trial

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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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Pharma Pulse 2/19/25: Pharma in the Age of Social Media, Rising Demand for GLP-1 Receptor Agonists Means More Questions & more

Pharmaceutical Commerce

The latest news for pharma industry insiders.

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JP Morgan Week 2025 – Catherine Owen Adams

pharmaphorum

Explore the insightful video interview with Catherine Owen Adams during JP Morgan Week 2025, as she shares valuable insights and perspectives on industry trends and developments.

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GLP-1RAs and opioid use disorder: a new frontier in addiction treatment

Pharmaceutical Technology

An NIH-funded clinical trial is underway investigating GLP-1RAs as a treatment for opioid use disorder.

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Trump Reveals Plan to Enact 25% Tariff on Pharmaceuticals

Pharmaceutical Commerce

The timing for the potential tax is yet to be determined, as the industry awaits to see the impact it could bring.

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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