Fri.Jan 10, 2025

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Patrizia Cavazzoni, key FDA official, to leave agency

Bio Pharma Dive

The director of the FDA's main drug review office will exit on Jan. 18, according to an email sent to staff. Her departure is one of several announced by high-ranking FDA leaders ahead of the coming administration change.

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FDA CDER director Patrizia Cavazzoni announces resignation

Pharmaceutical Technology

Following a string of FDA resignations, Patrizia Cavazzoni has announced that her last day will be 18 January.

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Intellia to stop work on rare disease therapy, lay off staff

Bio Pharma Dive

The CRISPR gene editing company will reduce its workforce by 27% over the course of the year as it discontinues a treatment for alpha-1 antitrypsin deficiency.

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Alzheimer’s total prevalent cases to reach 22.51 million in 8MM in 2033

Pharmaceutical Technology

GlobalData analysis suggests that China will lead with the highest number of prevalent cases of Alzheimers disease in 2033.

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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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Ouro, backed by GSK, joins hunt to bring bispecifics to autoimmune disease

Bio Pharma Dive

“Practice of medicine could fundamentally change with these types of therapies,” said CEO Jaideep Dudani, of T cell engagers now being tested in inflammatory conditions.

Medicine 169
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Climb Bio enters licensing deal with Mabworks for CLYM116 development

Pharmaceutical Technology

Climb Bio has entered an exclusive licence agreement with Beijing Mabworks Biotech for developing and commercialising CLYM116.

Licensing 147

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Coave Therapeutics raises $33m in funding to advance ALIGATER platform

Pharmaceutical Technology

Coave has raised 32m ($33m) in a Series A financing round for advancing its Advanced Vectors-Ligand Conjugates (ALIGATER) platform.

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Cambodian man dies from bird flu

Medical Xpress

A 28-year-old Cambodian man died from bird flu on Friday after eating sick chickens, the health ministry said.

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Light Horse emerges with $62m and Novartis partnership worth up to $1bn

Pharmaceutical Technology

Light Horses CEO said the biotechs initial focus will be on high-value and historically challenging oncology targets.

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Algorithm spots common sleep disorder linked to dementia

pharmaphorum

An AI algorithm can help detect REM sleep behaviour disorder, which affects millions of people and is a warning signal for neurological diseases.

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

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A2 Biotherapeutics raises $80m to advance CAR-T therapies for solid tumours

Pharmaceutical Technology

A2 Biotherapeutics has secured $80m in funding to advance its pipeline of CAR-T cell therapies for solid tumour cancers.

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New study suggests hearing loss may be early indicator of Parkinson's

Medical Xpress

There may be a link between hearing impairment and an increased risk of developing Parkinson's according to research led by Lancaster University.

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Newron and Myung In Pharm sign agreement for evenamide development

Pharmaceutical Technology

Newron and Myung In Pharm have signed a licence agreement for evenamide, for schizophrenia treatment in South Korea.

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Lung cancer trial reveals 40% drop in deaths using biomarker testing

Medical Xpress

New research from the University of St Andrews School of Medicine has found that biomarker testing in individuals at risk of lung cancer led to a major reduction in deaths.

Trials 85
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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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Ouro makes debut with $120m for autoimmune disease TCEs

pharmaphorum

Ouro launches today with $120m in funding and a plan to develop bispecific antibody-based T cell engagers for autoimmune diseases.

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Red light linked to lowered risk of blood clots

Medical Xpress

Humans and mice exposed to long-wavelength red light had lower rates of blood clots that can cause heart attacks, lung damage and strokes, according to research led by University of Pittsburgh School of Medicine and UPMC surgeon-scientists and published today in the Journal of Thrombosis and Haemostasis.

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CRISPR biotech Intellia cuts staff as it eyes 2027 launch

pharmaphorum

Eyeing a first commercial launch in 2027, Intellia is re-prioritising by cutting 27% of its workforce and shelving a lung disease candidate.

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Study reveals cost differences between Medicare Advantage and traditional Medicare patients in cancer drugs

Medical Xpress

A new study examining the use of high-cost drugs among patients with colorectal cancer and non-small cell lung cancer found those insured through Medicare Advantage received less expensive cancer drugs compared to others on Traditional Medicare.

Drugs 83
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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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World's largest proteomics trial launched by UK Biobank

pharmaphorum

A major population proteomics study using UK Biobank patient samples backed by 14 pharma companies has launched today.

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'Explant' technique predicts a tumor's responsiveness to breast cancer treatment

Medical Xpress

Cancer researchers at the University of Leicester have developed a technique that could predict how well some breast cancer patients will respond to chemotherapy and antibody-directed cancer treatments.

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How will SearchGPT impact pharma and healthcare?

pharmaphorum

Discover how the AI tool SearchGPT is revolutionising the pharma and healthcare industries, providing advanced search capabilities and insights for professionals in medical research and practice.

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Clinical trial highlights promising new treatment for intestinal worms

Medical Xpress

A new tablet combining albendazole and ivermectin is safe and more effective than albendazole alone in treating Trichuris trichiura and other soil-transmitted helminths (STH), according to a clinical trial conducted by the STOP consortium and led by the Barcelona Institute of Global Health (ISGlobal).

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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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FDA Clears New Module for Anterion Eye Imaging Platform

XTalks

The FDA has granted clearance to Heidelberg Engineerings Epithelial Thickness Module (ETM) integrated into the companys Cornea App, which is a part of the Anterion ocular imaging platform. The new module is expected to enhance precision in corneal health assessment, offering ophthalmologists a robust tool for more comprehensive and accurate evaluation of the corneal epithelium.

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AI analysis reveals four long COVID patient subgroups and needs

Medical Xpress

Across the United States, no hospital is the same. Equipment, staffing, technical capabilities, and patient populations can all differ. So, while the profiles developed for people with common conditions may seem universal, the reality is that there are nuances that require individual attention, both in the make-up of the patients being seen and the situations of the hospitals providing their care.

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FDA Accepts Review of New GSK Prefilled Syringe Presentation

Pharmaceutical Commerce

The new form of the vaccine would remove the need for HCPs to combine the powder antigen and liquid adjuvant themselves prior to administering.

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T cells' capability to fully prevent acute viral infections opens new avenues for vaccine development

Medical Xpress

Scientists from Duke-NUS Medical School and the Singapore General Hospital have discovered that T cellswhite blood cells that can destroy harmful pathogenscan completely prevent viral infection, to an extent previously thought only possible due to neutralizing antibodies.

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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

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Novo Nordisk, Valo Health Grow Partnership Centered Around Cardiometabolic Disease Therapies

Pharmaceutical Commerce

The collaboration is powered by the discovery and development of obesity, type 2 diabetes, and cardiovascular disease treatments.

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United States sees significant increase in orphanhood

Medical Xpress

There has been a significant increase in orphanhood in the last two decades in the U.S., according to a new study. The research, published in Nature Medicine, estimates that in 2021, 2.9 million children in the United States, or 4.2% of all U.S. children, had experienced the death of at least one parent or a grandparent caregiver responsible for most of the basic needs of the child.

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Health literacy matters: 3 ways to improve patient understanding

pharmaphorum

Improving health literacy is essential for patient understanding and better health outcomes. Learn three effective ways to enhance health literacy and empower patients.

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How many children use TikTok against the rules? Most, study finds

Medical Xpress

As the U.S. Supreme Court considers whether Congress can ban TikTok, new research highlights the health risks that top social media platforms pose to children.

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How Machine Learning Drives Clinical Trial Efficiency

Clinical trial data management is increasingly challenging as studies grow in complexity. Quickly accessing and analyzing study data is vital for assessing trial progress and patient safety. In this paper, we explore real-time data access and analysis for proactive study management. We investigate using adverse event (AE) data to monitor safety and discuss a clinical analytics platform that supports collaboration and data review workflows.