FDA to phase out animal testing with AI and lab-based models
Pharmaceutical Technology
APRIL 11, 2025
The FDA has announced plans to phase out animal testing in the development of monoclonal antibodies and other drugs.
Fri.Apr 11, 2025
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FDA plans to phase out animal testing for some drugs
Bio Pharma Dive
APRIL 11, 2025
The initiative, which will start with monoclonal antibodies, is the first big regulatory shift from the FDA since Martin Makary was sworn in.
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Jobevne (Bevacizumab) Gains FDA Nod, Biocon Expands US Oncology Biosimilars Portfolio
XTalks
APRIL 11, 2025
The FDA has approved Jobevne (bevacizumabnwgd) , a biosimilar to Avastin (bevacizumab). This marks BioconBiologics seventh biosimilar cleared for use in the US. Jobevne, like Avastin, is a humanized monoclonal antibody that blocks vascular endothelial growth factor (VEGF). By preventing VEGF from binding its receptors on blood vessel linings, the drug cuts off tumors oxygen and nutrient supply.
AstraZeneca’s oral breast cancer drug Truqap greenlit for NHS use
Pharmaceutical Technology
APRIL 11, 2025
The twice daily tablet represents a significant step forward for patients with advanced breast cancer.
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!
Amgen says Imdelltra extended survival; Parker Institute adds new leaders
Bio Pharma Dive
APRIL 11, 2025
The bispecific antibody helped people with small cell lung cancer live longer, Amgen said. Elsewhere, J&J shared new autoimmune drug data and Alzheon reported an Alzheimer’s drug failure.
Can AI replace medical writers? Experts say not immediately
Pharmaceutical Technology
APRIL 11, 2025
AI tools are faster at drafting clinical trial documents, but human writers remain indispensable for logical reasoning.
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Pluri’s immune cell expansion technologies gain patents
Pharmaceutical Technology
APRIL 11, 2025
Pluri has announced the issuance of a patent by the US Patent and Trademark Office (USPTO) for its immune cell expansion technologies.
New immune boost could expand access to cancer immunotherapy
Medical Xpress
APRIL 11, 2025
Researchers at Moffitt Cancer Center have found that tapping into the body's own immune system and activating a type of immune cell known as B cells, could be the key to boosting the effectiveness of tumor-infiltrating lymphocyte, or TIL therapy. Results of their study were published in the Journal for Immunotherapy of Cancer.
NMPA approves BBM and Takeda China’s haemophilia B therapy
Pharmaceutical Technology
APRIL 11, 2025
Belief BioMed (BBM) and Takeda China have announced the receipt of Chinas NMPA approval for BBM-H901for treating haemophilia B
Research reveals a hidden vulnerability of lung cancer
Medical Xpress
APRIL 11, 2025
Treatment resistance and relapse in the most common type of lung cancer can be traced to a protein called agrin, according to a preclinical study led by Roswell Park Comprehensive Cancer Center. Results of the study, led by Sayan Chakraborty, Ph.D., Assistant Professor of Oncology, Department of Pharmacology & Therapeutics at Roswell Park, have been published in the journal Advanced Science.
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
FDA approves Biocon Biologics’ bevacizumab biosimilar for cancer
Pharmaceutical Technology
APRIL 11, 2025
Biocon Biologics has received approval from the US Food and Drug Administration for the intravenous use of Jobevne (bevacizumab-nwgd).
Candidate deafness genes revealed in new study
Medical Xpress
APRIL 11, 2025
New candidate genes which could be responsible for deafness have been identified. Congenital deafness (hearing loss from birth) is common, impacting around one in 1,000 babies born in the UK. The condition affects communication, social and cognitive development of children and general quality of life. It is largely caused by mutations in genes, but many of these genes remain to be discovered.
Can AI replace medical writers? Experts say not immediately
Pharmaceutical Technology
APRIL 11, 2025
AI tools are faster at drafting clinical trial documents, but human writers remain indispensable for logical reasoning.
Exploring the unique needs and experiences of autistic mothers
Medical Xpress
APRIL 11, 2025
An article by researchers at the Universitat Jaume I of Castell published in the journal Autism in adulthood has collected some of the needs detected in autistic women regarding motherhood. Among them, the shortage of professionals with updated knowledge to identify autism and provide a better individualized attention or the convenience of a family and social support network that favors the transition to the experience of being mothers.
Alzheon Alzheimer's hopes dented by trial readout
pharmaphorum
APRIL 11, 2025
Alzheon has been left sifting through data from a failed Alzheimer's trial for crumbs of evidence that its oral therapy may have some efficacy
Social isolation linked to poor diet in older women
Medical Xpress
APRIL 11, 2025
A new UBC study finds that persistently isolated older Canadian women are more likely to fall short of recommended fruit and vegetable intake, leading to poorer overall diet quality.
Novartis plans $23bn manufacturing, R&D spend in US
pharmaphorum
APRIL 11, 2025
Novartis has announced a massive investment in manufacturing and R&D facilities in the US so it can make "100% of its key medicines" there
Low-dose opioids could help promote social behaviors for people with autism spectrum disorder
Medical Xpress
APRIL 11, 2025
The same chemicals and receptors that control the sensation of pain in the opioid system also play a role in regulating social behavior. The body produces natural opioid substances which are drawn to receptors throughout the nervous system, sending signals through neurons that induce pain relief, pleasure, and more.
The New Age of Decentralized Clinical Trials
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White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations
RFK Jr unorthodox vaccine views on show in interview
pharmaphorum
APRIL 11, 2025
Robert F Kennedy Jr's controversial views on vaccines were on display this week during an interview that touched on delays to a COVID-19 shot review
Medical complexity seen in 12% of military-connected children
Medical Xpress
APRIL 11, 2025
The cumulative incidence of children with medical complexity (CMC)-defining diagnoses in military-connected children is 12.0% by age 60 months, according to a study published online April 8 in Pediatrics.
The Power of Giving Back
My Local Study
APRIL 11, 2025
April marks National Volunteer Month, a time dedicated to recognizing and celebrating the invaluable contributions of volunteers across the nation. While many think of traditional roles like serving at food banks or animal shelters, there’s another powerful way to give back to your community through participation in clinical research. Let’s dive into how volunteering.
AI-generated 'synthetic scarred hearts' aid atrial fibrillation treatment
Medical Xpress
APRIL 11, 2025
Researchers from Queen Mary University of London have developed an AI tool that creates synthetic yet medically accurate models of fibrotic heart tissue (heart scarring), aiding treatment planning for atrial fibrillation (AF) patients. The study, published in Frontiers in Cardiovascular Medicine, could lead to more personalized care for patients affected by this common heart rhythm disorder.
FDA plans to phase out animal testing for antibodies
pharmaphorum
APRIL 11, 2025
The FDA has said it intends to reduce or replace animal testing of some medicines, including monoclonal antibodies, with other methods.
Pig kidney removed from US transplant patient, but she set record
Medical Xpress
APRIL 11, 2025
Doctors have had to remove the pig kidney implanted in an American woman after her body rejected it, but her four months living with the animal's organ set a record, the hospital that performed the operation said Friday.
Pill that can slow breast cancer cleared for NHS use
pharmaphorum
APRIL 11, 2025
AstraZeneca's oral drug Truqap will soon be available for people with advanced breast cancer via the NHS in England, as long as testing is available
Study identifies promising biomarker for early sepsis detection in neonates, children and pregnant women
Medical Xpress
APRIL 11, 2025
A study presented at ESCMID Global 2025 has uncovered the potential of interleukin-6 (IL-6) as a powerful diagnostic biomarker for the early detection of sepsis in high-risk patient groups, including neonates, children and pregnant women. This study is the first to evaluate IL-6's diagnostic performance in a real-world cohort across all three populations.
The New Age of Decentralized Clinical Trials
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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.
Pharma Pulse 4/11/25: Long-Term Sustainability for Diverse Trial Initiatives, Payers Consider Policy Options for GLP-1 Access & more
Pharmaceutical Commerce
APRIL 11, 2025
The latest news for pharma industry insiders.
Three-year study of tirzepatide shows that most patients only regain 5% or less from their lowest weight
Medical Xpress
APRIL 11, 2025
New research to be presented at the European Congress on Obesity (ECO 2025, Malaga, Spain, 1114 May) shows that around two-thirds of participants of the SURMOUNT-1 trial had only regained 5% or less of their so-called nadir (or lowest weight) three years after beginning treatment with tirzepatide.
Hubs East 2025: Building a Thriving Culture
Pharmaceutical Commerce
APRIL 11, 2025
In the final part of her video interview with Pharma Commerce Editor Nicholas Saraceno, Kimberly Westrich, chief strategy officer at the National Pharmaceutical Council, comments on another presentation that has caught her eye at the conference.
Nearly half of Americans are stressed at least once a week, and one in six are stressed every day
Medical Xpress
APRIL 11, 2025
A new national survey commissioned by the Ohio State University Wexner Medical Center found that nearly half of U.S. adults (45%) are stressed at least once a week because of the news or what's happening on social media. The survey of 1,005 American adults also found that 16% of those respondents reported feeling stressed every day.
Unlocking Excellence: How Catalent Is Transforming Japan’s Clinical Research
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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
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