Sat.Mar 01, 2025 - Fri.Mar 07, 2025

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The Importance of Pharmacovigilance in Generic Drug Development

Drug Patent Watch

The Unseen Heroes of Generic Drug Development: Pharmacovigilance As a generic drug developer, you're no stranger to the challenges of bringing affordable medications to market. From navigating complex regulatory landscapes to ensuring the quality and safety of your products, every step of the process requires meticulous attention to detail. But have you ever stopped to think about the unsung heroes of generic drug development?

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March 4, 2025: PRIM-ER Team Develops Innovative Statistical Techniques for Stepped-Wedge Trials

Rethinking Clinical Trials

Researchers with PRIM-ER, an NIH Collaboratory Trial, published 2 innovative statistical techniques for evaluating intervention effects in stepped-wedge, cluster randomized trials. The new models, which use Bayesian methods, outperformed traditional analytic methods and other Bayesian approaches in simulations and real-world applications. The article was published online in Statistics in Medicine.

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Calcium channel inhibition promotes cardiac regeneration, offering hope for heart failure treatment

Medical Xpress

Researchers report a discovery in cardiac regeneration that offers new hope for the treatment of ischemic heart failure. Published in npj Regenerative Medicine, the study reveals a novel approach to promoting cardiomyocyte proliferation. The researchers are from the Michael E. DeBakey Department of Surgery at Baylor College of Medicine, the QIMR Berghofer Medical Research Institute in Brisbane, Australia, and collaborating institutions.

Medicine 129
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Using artificial intelligence to enhance regenerative medicine

Pharmaceutical Technology

As the field of regenerative medicine continues to advance, the incorporation of AI is playing a transformative role in the pharmaceutical industry.

Medicine 269
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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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Biotech startup pulls in $187M to make ‘multi-payload’ ADCs

Bio Pharma Dive

Callio Therapeutics is launching with an ADC technology and programs licensed from Singapore-based antibody drug developer Hummingbird Bioscience.

Licensing 254
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March 6, 2025: Enrollment Begins for Several of the Newest NIH Collaboratory Trials

Rethinking Clinical Trials

In recent months, 5 of the newest NIH Collaboratory Trials have begun to enroll research participants. Congratulations to the study teams from ARBOR-Telehealth, BEST-ICU, Chat 4 Heart Health, I CAN DO Surgical ACP, and the MOMs Chat & Care Study for reaching this important project milestone! ARBOR-Telehealth is evaluating the use of a telehealth physical therapy strategy for patients who present to primary care clinics with low back pain in rural communities.

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EU set to approve AstraZeneca’s Imfinzi-chemo combo for NSCLC

Pharmaceutical Technology

AstraZeneca's Imfinzi (durvalumab) plus chemotherapy, has gained CHMP recommendation for approval in the EU to treat NSCLC.

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Vertex’s new pain drug gets first coverage nod from major insurer

Bio Pharma Dive

Optum, the pharmacy benefit manager owned by UnitedHealth Group, placed Journavx on some of its commercial formularies in an interim decision while a formal review continues.

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Grand Rounds February 28, 2025: Behavioral Economic and Staffing Strategies To Increase Adoption of the ABCDEF Bundle in the Intensive Care Unit (BEST-ICU): Protocol, Challenges, and Major Updates (Eduard Vasilevskis, MD, MPH; Michele C. Balas PhD, RN, CCRN-K, FCCM, FAAN)

Rethinking Clinical Trials

Speakers Eduard Vasilevskis, MD, MPH Professor of Medicine Department of Medicine, Division of Hospital Medicine University of Wisconsin-Madison Michele C. Balas PhD, RN, CCRN-K, FCCM, FAAN Associate Dean of Research Dorothy Hodges Olson Distinguished Professor of Nursing University of Nebraska Medical Center College of Nursing Slides Keywords Intensive Care; ICU; Implementation; Evidence-Based Practices Key Points With recent increases in survivorship for Intensive Care U

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Down syndrome case challenges Alzheimer's assumptions with unexpected cognitive stability

Medical Xpress

Studies reveal that people with Down syndrome (DS) have over a 90% lifetime risk of developing dementia caused by Alzheimer's disease (AD) as they age. Research from the University of Pittsburgh's Swanson School of Engineering aims could uncover why some people with DS develop dementia while others do not providing insight that could ultimately benefit the entire DS community.

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

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Magnet Biomedicine and Lilly link for molecular glue therapeutics

Pharmaceutical Technology

Magnet Biomedicine has entered a partnership and licence agreement with Eli Lilly for molecular glue therapeutics.

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Roche launches new Boston center; NIH centralizes peer review

Bio Pharma Dive

The Swiss pharma will base cardiometabolic drug research at the new Allston site. Elsewhere, AskBio advanced a gene therapy and Pfizer hired a scientist well versed in GLP-1 science.

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Bridging the Gap in Patient Support: How GoodRx is Revolutionizing Access to Specialty Meds

Drug Channels

Todays guest post is from Divya Iyer, SVP Go-to-Market (GTM) Strategy at GoodRx. Divya argues that patient support programs (PSPs) struggle with awareness and accessibility, preventing patients from fully benefiting from the financial and educational resources available to them. Divya discusses how integrating digital solutions from GoodRx can enhance engagement, streamline access to therapy, and improve patient outcomes.

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Real-time DNA analysis during neurosurgery offers personalized brain tumor treatment

Medical Xpress

A team of researchers at the University Medical Center Schleswig-Holstein (UKSH), Kiel Campus, the Kiel University, and the Max Planck Institute for Molecular Genetics, Berlin, have developed an innovative method for real-time molecular genetic classification of brain tumors during surgery. This approach combines DNA methylation analysis with advanced machine learning technologies to provide detailed information about the tumor type during surgery.

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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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Antibody drug conjugates: Tackling the unsolved challenges with novel technologies

Pharmaceutical Technology

ADCs are currently at the forefront of cancer treatment, but persistent drug development challenges call for a new approach.

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Blocking PD-1 and VEGF: The bispecific cancer drugs that could best Keytruda

Bio Pharma Dive

Striking study results last year indicated a new type of medicine may improve on Merck’s dominant immunotherapy, spurring a wave of research practically overnight.

Medicine 204
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Velocity Appoints Craig Koch to Lead European Expansion, Reinforcing Commitment to the Region

Velocity Clinical Research

Craig Koch has been appointed as Velocitys new Executive Vice President, Europe, to spearhead the next phase of growth across the region. His appointment underscores the companys long-term commitment to Europe. Previously serving as EVP, Global Head of Sales, Craig has been with Velocity since 2019. He is now relocating to Europe to provide hands-on leadership as Velocity scales its integrated site network model across the continent.

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PBM Industry Update: Trends, Challenges, and What's Ahead (NEW Live Video Webinar)

Drug Channels

Dr. Adam J. Fein, president of Drug Channels Institute (DCI) and the author of Drug Channels , invites you to join him for DCIs new live video webinar: PBM Industry Update: Trends, Challenges, and What's Ahead This event will be broadcast live on Friday, April 4, 2025, from 12:00 p.m. to 1:30 p.m. ET This page describes the event and explains how to purchase a registration.

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Deliver Fast, Flexible Clinical Trial Insights with Spotfire

Clinical research has entered a new era, one that requires real-time analytics and visualization to allow trial leaders to work collaboratively and to develop, at the click of a mouse, deep insights that enable proactive study management. Learn how Revvity Signals helps drug developers deliver clinical trial data insights in real-time using a fast and flexible data and analytics platform to empower data-driven decision-making.

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Callio raises $187m for proof-of-concept for dual-payload ADC

Pharmaceutical Technology

Callio Therapeutics has raised $187m in Series A financing round for achieving clinical proof-of-concept for HER2-targeted dual-payload ADC.

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AbbVie gets into obesity with $350M deal for once-weekly shot

Bio Pharma Dive

A licensing deal with Denmark’s Gubra gives the immunology giant control of an experimental therapy that could compete with drugs from Novo Nordisk, Eli Lilly and Zealand.

Licensing 205
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Top Pharma & Biotech Companies to Work For in Canada in 2025, According to Forbes

XTalks

Over the last five years, Canadas pharmaceutical and biotechnology sector has experienced remarkable growth adding over 10,000 new jobs and attracting billions in public and private investments. Federal initiatives have allocated more than approximately $1.53 billion across 38 projects to expand domestic biomanufacturing capacity, while private venture capital surged, with Canadian startups raising over $488.2 million in 2020 alone.

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Establishing Excellence With the Women’s Health CARE Council

Velocity Clinical Research

Womens health remains one of the most overlooked and underrepresented areas in clinical research, often leading to gaps in treatment and understanding. Similar to obesity research, disorders relating to reproductive health include symptoms that are highly stigmatized and patients can be reluctant to seek treatment or join clinical trials. This is why Velocity set up a dedicated Womens Health Council to Accelerate Research Excellence (CARE Council).

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2022 Research: The Rapid Rise of Ocean Freight Visibility

A research study conducted by The Journal of Commerce and FourKites surveyed hundreds of international shippers, exploring how their usage of global supply chain visibility technology has evolved since the onset of global disruptions caused by COVID-19. For international shippers, ocean freight visibility has evolved from optional to essential and satisfaction with visibility varies greatly depending on how it is obtained and delivered.

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Machine learning adoption into supply chain management on the horizon

Pharmaceutical Technology

Large-scale integration of AI into pharma supply chains is on the way as companies seek optimised ordering.

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Nimbus swaps CEOs and turns to new leader for ‘next chapter’

Bio Pharma Dive

CBO Abbas Kazimi will replace longtime CEO Jeb Keiper as part of a planned leadership transition at the unorthodox drug startup.

Drugs 173
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Redefining Loyalty: The Role of Decentralized Healthcare and Data Ownership

Intouch Solutions

This POV explores how decentralized healthcare models and data ownership are transforming patient loyalty, and highlights strategies to foster loyalty in this new landscape. Patient empowerment, patient-centric, choices, responsiveness, flexibility, competition and innovation are just a few of the positive attributes of decentralized healthcare delivery systems such as those in the United States.

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Paul Evans Joins the Leaders & Legends Podcast With Patty Leuchten

Velocity Clinical Research

Paul Evans sat down with Patricia Leuchten on the Leaders & Legends podcast, where they discussed the state of research sites and the broader industry. Listen now to hear Paul’s thoughts on: The evolution of clinical research sites and whats ahead for the industry. Challenges in patient recruitment and the role of site-based technology. His journey from growing up in Swansea, Wales, to leading the worlds largest research site organization.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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UK’s pricing watchdog rejects Alzheimer treatments for the second time

Pharmaceutical Technology

NICE previously rejected Leqembi and Kisunla for NHS coverage in August and October 2024, respectively.

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Tris to ask for approval of dual-acting pain drug

Bio Pharma Dive

Positive data from a pair of acute pain studies convinced the company that its drug, which works differently than existing medications, has a good shot at reaching market.

Drugs 162
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Butter and Plant-Based Oils Intake and Mortality

JAMA Internal Medicine

This cohort study investigates associations of butter and plant-based oil intakes with risk of total and cause-specific mortality among US adults.

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Biogen, Apple study finds smart devices can track cognition

pharmaphorum

An observational study backed by Biogen has suggested that Apple smartphones and watches may be able to spot the signs of mild cognitive impairment

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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.