Bio Pharma Dive
JANUARY 30, 2024
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.
Pharmaceutical Technology
JANUARY 29, 2024
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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Rethinking Clinical Trials
JANUARY 31, 2024
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
Fierce Pharma
JANUARY 29, 2024
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.
Bio Pharma Dive
JANUARY 29, 2024
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.
Pharmaceutical Technology
JANUARY 29, 2024
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.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Fierce Pharma
JANUARY 31, 2024
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.
Bio Pharma Dive
JANUARY 30, 2024
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.
Pharmaceutical Technology
FEBRUARY 1, 2024
Merck & Co (MSD) has reported a 1% revenue increase from 2022, and may face setbacks in the next few years from top-selling drugs.
Antidote
FEBRUARY 2, 2024
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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White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations
Fierce Pharma
FEBRUARY 2, 2024
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.
Bio Pharma Dive
JANUARY 30, 2024
Roche, Pfizer and Bristol Myers Squibb have all invested in the startup, which is using nanoparticle technology to retrain the body’s immune system.
Pharmaceutical Technology
JANUARY 30, 2024
The EMA has accepted GSK’s regulatory application seeking expansion of its RSVvaccine, Arexvy, to include adults aged 50 to 59 years.
Antidote
JANUARY 29, 2024
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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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.
Fierce Pharma
JANUARY 31, 2024
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
Bio Pharma Dive
FEBRUARY 2, 2024
The California biotech is the third this year to go public, following stock offerings from CG Oncology and Arrivent Biopharma.
Pharmaceutical Technology
JANUARY 29, 2024
An eye-catching milestone in hand, Ascidian will begin the Phase I/II STELLAR study of ACDN-01 for Stargardt disease in H1 2024.
pharmaphorum
JANUARY 31, 2024
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.
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.
Pharmaceutical Commerce
FEBRUARY 2, 2024
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.
Bio Pharma Dive
FEBRUARY 1, 2024
Roche said it was shelving those drugs in favor of experimental programs to treat obesity that it gained from its takeover of Carmot Therapeutics.
Pharmaceutical Technology
JANUARY 30, 2024
Vertex is planning to submit a new drug application to the FDA following the announcement of its Phase III programme meeting its primary endpoint.
XTalks
JANUARY 31, 2024
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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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
Fierce Pharma
JANUARY 29, 2024
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.
Bio Pharma Dive
JANUARY 31, 2024
The agency is planning a pilot program across states to help sickle cell patients access treatments like the newly approved Casgevy and Lyfgenia.
Pharmaceutical Technology
JANUARY 31, 2024
CMS’ CGT Access Model will see allow the agency to negotiate negotiate pricing and build a framework that expands access to treatments.
pharmaphorum
JANUARY 29, 2024
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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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.
Fierce Pharma
FEBRUARY 1, 2024
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.
Bio Pharma Dive
JANUARY 31, 2024
The decision to discontinue the controversial drug closes a tumultuous three-year saga that brought significant upheaval to the company.
Pharmaceutical Technology
JANUARY 29, 2024
The full potential of cell and gene therapies (CGTs) has not yet been discovered as these therapies promise life-changing treatments.
Drug Patent Watch
JANUARY 30, 2024
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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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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