Sat.Jan 27, 2024 - Fri.Feb 02, 2024

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CAR-T for lupus: the ‘tip of the iceberg’ for cell therapy in autoimmune disease

Bio Pharma Dive

Since a landmark paper in 2022, drugmakers have begun nearly a dozen trials of cell therapies for lupus, with more set to start. Here’s why their efforts are worth watching.

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Merck is on the lookout for more opportunities within immunology

Pharmaceutical Technology

At the JP Morgan Healthcare conference, Merck (MSD) indicated its eagerness to continue to establish its place in the immunological space.

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January 31, 2024: Improving the Public’s Understanding of the FDA, in This Week’s PCT Grand Rounds

Rethinking Clinical Trials

In this Friday's PCT Grand Rounds, Susan Winckler of the Reagan-Udall Foundation for the FDA will present "Strategies for Improving Public Understanding of FDA and the Products It Regulates: Why Should We Care, and What Might We Do?" The Grand Rounds session will be held on Friday, February 2, 2024, at 1:00 pm eastern. Winckler is the chief executive officer of the Reagan-Udall Foundation for the FDA, a nonprofit organization created by Congress “to advance the mission of the FDA to modernize me

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Pfizer's layoff campaign ramps back up with dozens of SF-area cuts expected next month

Fierce Pharma

The start of the new year doesn’t seem to have dulled the zeal of Pfizer’s global cost-cutting campaign, which has already left hundreds of jobs in its wake. | Come mid-February, Pfizer will lay off some 52 employees at a facility in South San Francisco, according to a recent Worker Adjustment and Retraining Notification Act alert. The site is the former headquarters of Global Blood Therapeutics.

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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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AstraZeneca, Daiichi aim for first pan-tumor ADC approval

Bio Pharma Dive

The FDA is reviewing the companies’ application for a “tumor agnostic” indication for their drug Enhertu, which would break new ground for antibody-drug conjugates.

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Moderna leads the development of mRNA vaccines in infectious diseases

Pharmaceutical Technology

The rapid sequencing of the SARS-CoV-2 and the subsequent development of mRNA vaccines led to the authorisation of the first of these vaccines in late 2020.

More Trending

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Biogen abandons Aduhelm efforts, focuses on Eisai-partnered Leqembi and pipeline drugs

Fierce Pharma

More than two years after Aduhelm's controversial and ill-fated FDA accelerated approval, Bi | Biogen is discontinuing its first Alzheimer's disease therapy, Aduhelm, after walking a rocky path. The company is taking a $60 million charge, halting sales and terminating a confirmatory trial.

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Non-opioid drug from Vertex cuts pain in major trial tests

Bio Pharma Dive

The company plans to soon ask the FDA for approval of the drug, which it has pitched as a safer alternative to addictive opioid painkillers.

Drugs 337
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Keytruda remains Merck & Co’s biggest 2023 success story as patent expiry looms

Pharmaceutical Technology

Merck & Co (MSD) has reported a 1% revenue increase from 2022, and may face setbacks in the next few years from top-selling drugs.

Drugs 262
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An overview of endometrial cancer

Antidote

Endometrial cancer, also known as endometrial carcinoma or uterine cancer , is a condition that approximately 66,000 individuals are diagnosed with annually, and instances rise roughly 2% in the United States each year. Because it is often caught early, a person’s prognosis is typically good — but it is still a disheartening diagnosis that significantly impacts the lives of those who experience it.

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Roles and Responsibilities of Specialized Clinical Supply Experts

When selecting a clinical supply provider, consideration often focuses upon the manufacturing, packaging, storage and distribution capabilities available that will, at face-value, be sufficient to meet the needs of the sponsor and their trial. However, there are human-based and knowledge-driven factors that are often overlooked that go beyond these basic physical capabilities and are integral to the development and delivery of high performing clinical supply chains.

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FDA sets date for high-profile CAR-T adcomm for Bristol’s Abecma, J&J’s Carvykti

Fierce Pharma

Mark your calendars, oncology drug and CAR-T therapy developers. | Mark your calendars, oncology drug and CAR-T therapy developers. The FDA has decided on a date for a highly anticipated advisory committee meeting for Bristol Myers' Abecma and J&J's Carvykti.

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Brain drug developer Alto Neuroscience prices $129M IPO

Bio Pharma Dive

The California biotech is the third this year to go public, following stock offerings from CG Oncology and Arrivent Biopharma.

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GSK seeks to extend RSV vaccine use in adults aged 50-59

Pharmaceutical Technology

The EMA has accepted GSK’s regulatory application seeking expansion of its RSVvaccine, Arexvy, to include adults aged 50 to 59 years.

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Patient Perspective: Jamie Troil Goldfarb shares her clinical trial experience [video]

Antidote

For individuals living with a condition like melanoma, volunteering to participate in a clinical trial can be a rewarding experience. Not only will patients be able to gain access to potential new treatments, but they will also be directly contributing to research that can save lives — something that Jamie Troil Goldfarb has experienced firsthand. Jamie received a diagnosis of stage IV melanoma in 2011, only 11 weeks after giving birth to her child.

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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.

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GSK confirms Arexvy is a blockbuster but says the RSV battle has just begun

Fierce Pharma

Beaten to the punch by Pfizer in developing a vaccine for COVID, GSK has regained some of its lost luster as a vaccine powerhouse with its advancement of respiratory syncytial virus (RSV) shot Arex | GSK's RSV vaccine Arexvy generated $1.5 billion in sales in 2023 compared to $890 million for Pfizer's Abrysvo. But the British pharma major says that the successful launch represents just one round of a boxing match, and much is still to be decided, especially with Moderna expected to joi

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Roche shuffles early stage pipeline as it joins obesity rush

Bio Pharma Dive

Roche said it was shelving those drugs in favor of experimental programs to treat obesity that it gained from its takeover of Carmot Therapeutics.

Drugs 298
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Vertex aims for approval after Phase III win with non-opioid pain reliever

Pharmaceutical Technology

Vertex is planning to submit a new drug application to the FDA following the announcement of its Phase III programme meeting its primary endpoint.

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JP Morgan 2024 – Gene Kinney

pharmaphorum

In this exclusive interview, Gene Kinney, CEO of Prothena, discusses the latest developments in the field of neurodegenerative diseases such as Alzheimer's and Parkinson's. Gain insights and advancements being made in the treatment of these conditions.

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What the FDA's New Dosage Guidance Means for the Future of Clinical Research

Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist

What will the future hold for clinical research? A recent draft from the FDA provides valuable insight. In "Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases," the FDA notes that "targeted therapies demonstrate different dose-response relationships compared to cytotoxic chemotherapy, such that doses below the Maximum Tolerated Dose (MTD) may have similar efficacy to the MTD but with fewer toxicities.

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The Path for Prescription Drug Sales

Pharmaceutical Commerce

A dive into this market reveals that the latest numbers yield promising results—a global value of a worldwide $1.6 trillion—but it will continue to be attributed to past, present, and future healthcare spending.

Sales 116
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Cour gets $105M, pharma help to ‘reprogram’ autoimmune disease

Bio Pharma Dive

Roche, Pfizer and Bristol Myers Squibb have all invested in the startup, which is using nanoparticle technology to retrain the body’s immune system.

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Ascidian launches first-ever clinical study of RNA exon editor for vision loss

Pharmaceutical Technology

An eye-catching milestone in hand, Ascidian will begin the Phase I/II STELLAR study of ACDN-01 for Stargardt disease in H1 2024.

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WuXi Biologics plays defense after US bill brands certain Chinese biopharmas as security threats

Fierce Pharma

New legislation aimed at blocking a group of Chinese biopharma firms from tapping into U.S. federal funding has sent shares tumbling in recent days. | New legislation aimed at blocking a group of Chinese biopharma firms from tapping into U.S. federal funding has sent shares tumbling in recent days. WuXi Bio, for its part, says it's not affiliated with the military in China.

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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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Exploring the Endocannabinoid System for Drug Development, Featuring Punit Dhillon, Chairman & CEO of Skye Bioscience – Xtalks Life Science Podcast Ep. 144

XTalks

This episode features an interview with Punit Dhillon, Chairman & CEO of Skye Bioscience , a pharmaceutical company developing proprietary molecules to treat diseases involving inflammatory, fibrotic and metabolic conditions. Skye Bioscience is at the forefront of exploring the endocannabinoid system for drug development. Punit Dhillon, Chairman & CEO Skye Bioscience Punit brings two decades of experience as a leader and investor within the life sciences sector.

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New CMS pilot to test payment scheme for pricey sickle cell gene therapies

Bio Pharma Dive

The agency is planning a pilot program across states to help sickle cell patients access treatments like the newly approved Casgevy and Lyfgenia.

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CMS sets up negotiating framework for expensive sickle cell disease gene therapies

Pharmaceutical Technology

CMS’ CGT Access Model will see allow the agency to negotiate negotiate pricing and build a framework that expands access to treatments.

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Who's No. 1? With $25B in sales, Merck's Keytruda looks to be the top-selling drug of 2023

Fierce Pharma

With Merck reporting a whopping $25 billion sales haul for | With Merck reporting a whopping $25 billion sales haul for Keytruda on Thursday, the PD-1 cancer superstar appears to be the world’s top-selling drug in 2023. Keytruda looks set to take over the top spot from Pfizer and BioNTech’s Comirnaty, which ruled the previous two years, scoring sales of $55.9 billion in 2022 and $55.1 billion in 2021.

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Accelerating Clinical Supply Through Integrated Drug Development

As the development pipeline for new drugs continues to grow, biopharmaceutical companies are re-evaluating how to best manage and balance resources across an increasing number of development projects and complex clinical trials. There are two approaches that can be used to speed a drug from development to clinic faster: timeline compression and parallel processing, but only one that considers the benefits of integrating clinical supply into the overall drug development process.

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First impressions matter: Why getting your onboarding right is key for digital engagement

pharmaphorum

Creating a positive onboarding experience is crucial for engaging healthcare professionals (HCPs) in digital platforms and utilising data effectively. Discover why first impressions matter and how to get your onboarding process right for optimal digital engagement.

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Biogen quits Aduhelm, handing back rights to original developer

Bio Pharma Dive

The decision to discontinue the controversial drug closes a tumultuous three-year saga that brought significant upheaval to the company.

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Cell and gene therapies – top pharmaceutical industry trend to watch for 2024

Pharmaceutical Technology

The full potential of cell and gene therapies (CGTs) has not yet been discovered as these therapies promise life-changing treatments.

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Revolutionizing Patent Landscaping: A Human-Supervised AI Approach to Identify Tech Clusters

Drug Patent Watch

The recent paper published in PLOS ONE presents a novel approach for efficiently retrieving a substantial number of patents related to specific technologies. The authors enhance an automated patent landscaping… The post Revolutionizing Patent Landscaping: A Human-Supervised AI Approach to Identify Tech Clusters appeared first on DrugPatentWatch - Make Better Decisions.

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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.