Bio Pharma Dive
MARCH 14, 2024
Rezdiffra’s clearance is a turning point in the fight against the liver disease. But its sales potential is unclear, and competition could emerge from popular weight loss drugs.
Pharmaceutical Technology
MARCH 14, 2024
The EMA raised concerns about the lack of long-term data for Novartis Vijoice in its initial bid, as the Swiss company prepares for a new regulatory submission.
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.
Bio Pharma Dive
MARCH 14, 2024
The funding for the startup, which partnered with Bristol Myers Squibb last year, adds to a surge of recent investments in developers of antibody-drug conjugates.
Pharmaceutical Technology
MARCH 14, 2024
The funds will be used to expand Zephyr AI's headcount and enhance datasets.
Bio Pharma Dive
MARCH 14, 2024
Pressed by lawmakers, the lobbying group is also “taking steps” to end its relationship with Wuxi-AppTec, a major contract manufacturer to the biopharmaceutical industry.
AuroBlog - Aurous Healthcare Clinical Trials blog
MARCH 14, 2024
Plastics are now everywhere, with tiny fragments found in several major organs of the human body, including the placenta. Given how easily the microscopic particles infiltrate our tissues, it’s vital that we learn exactly what kinds of risks they could pose to our health.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
AuroBlog - Aurous Healthcare Clinical Trials blog
MARCH 14, 2024
In continuation to the efforts of the drug regulatory experts to amend the Drug Rules, 1945 and incorporate necessary provisions to decide a drug to be declared as over-the-counter (OTC), the Drugs Technical Advisory Board (DTAB) has recommended to constitute a sub-committee.
Pharmaceutical Technology
MARCH 14, 2024
Almirall has signed a licence agreement to gain the rights for Eloxx Pharmaceuticals’ ZKN-013 for rare dermatological disease indications.
Rethinking Clinical Trials
MARCH 14, 2024
The NIA IMPACT Collaboratory, a program to advance pragmatic clinical trials of interventions for people living with dementia and their care partners, announced a new collection of statistical tools for researchers. The tools are available on a new Statistical Tools webpage that will be updated as new resources become available. The program’s Design and Statistics Core developed the statistical tools and related resources to aid in the design and analyses of pragmatic trials embedded in he
Pharmaceutical Technology
MARCH 14, 2024
Research puts the spotlight on potential financial conflicts of interest (COI) and limited disclosure practices in pharmaceutical patient-focusing relationships.
Advertisement
White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations
Bio Pharma Dive
MARCH 14, 2024
The Swedish biotech will use the investment to advance a kind of personalized cancer therapy that reprograms tumor cells inside the body.
Pharmaceutical Technology
MARCH 14, 2024
Contract development and manufacturing organisation LGM Pharma has announced the advancement of its analytical testing services.
BioSpace
MARCH 14, 2024
The FDA approved Bristol Myers Squibb’s Breyanzi for chronic lymphocytic leukemia and small lymphocytic leukemia prior to Friday’s adcomm for the company’s other CAR-T therapy, Abecma.
Pharmaceutical Technology
MARCH 14, 2024
The US FDA has granted approval for Mirum Pharmaceuticals’s LIVMARLI (maralixibat) oral solution to treat cholestatic pruritus.
Advertisement
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
Pharma Times
MARCH 14, 2024
In the study, the Lymphoma Artificial Reader System accurately detected 90% of lymphatic cancers
Pharmaceutical Technology
MARCH 14, 2024
AstraZeneca will pay an upfront purchase price of $800m along with a potential regulatory milestone payment of $250m.
Antidote
MARCH 14, 2024
Receiving a multiple sclerosis (MS) diagnosis can feel overwhelming and isolating for many. MS is a neurodegenerative disease that often involves challenging symptoms — but knowing what to expect and what resources are available can help.
Pharmaceutical Technology
MARCH 14, 2024
The new drug application included data from the Phase III eXalt3 study, published in JAMA Oncology in September 2021.
Advertisement
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.
BioSpace
MARCH 14, 2024
BMS and J&J will meet with the Oncologic Drugs Advisory Committee Friday to discuss their CAR-T therapies Abecma and Carvykti as the companies seek their approval as earlier lines of treatment.
Pharmaceutical Technology
MARCH 14, 2024
Novartis has exercised an option for the acquisition of all outstanding capital stock of IFM Due for $835m.
XTalks
MARCH 14, 2024
March marks National Nutrition Month 2024 — a time when the food industry, health professionals and communities across the globe unite to emphasize the importance of making informed food choices and developing sound eating and physical activity habits. In this episode of the Xtalks Food Podcast, Sydney talks about the history of National Nutrition Month as well as how various food industry stakeholders can contribute to the significant month.
BioSpace
MARCH 14, 2024
Despite skepticism from FDA reviewers, the Oncologic Drugs Advisory Committee on Thursday strongly supported Geron’s imetelstat for the treatment of anemia in patients with lower-risk myelodysplastic syndromes.
Advertisement
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.
XTalks
MARCH 14, 2024
At a time when the quest for healthier and environmentally-friendly beverage options continues to gain momentum, Liquid Death has emerged as a frontrunner, carving out a significant niche in the bottled and canned water market. The brand recently announced a staggering $67 million in financing from an array of strategic partners and investors, propelling its valuation to an impressive $1.4 billion.
pharmaphorum
MARCH 14, 2024
Researchers have developed an artificial intelligence algorithm to assist in the diagnosis of lymph node cancer from medical images that has an accuracy of around 90%. The team carried out a retrospective study on the deep learning model, using PET-CT scans from more than 5,000 patients treated for lymphoma at Memorial Sloan Kettering Cancer Centre in the US and the Medical University of Vienna in Austria.
Fierce Pharma
MARCH 14, 2024
Just as BeiGene’s Brukinsa encroaches on C | Just as BeiGene’s Brukinsa encroaches on CAR-T territory, Bristol Myers Squibb has brought its CAR-T therapy Breyanzi into chronic lymphocytic leukemia, which is considered the BTK inhibitor class’s home turf.
BioSpace
MARCH 14, 2024
After several delays, BeiGene on Thursday finally secured the FDA’s approval for its PD-1 inhibitor Tevimbra for the treatment of unresectable or metastatic esophageal squamous cell carcinoma.
Advertisement
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.
Pharma Times
MARCH 14, 2024
Affecting 55 million people globally, dementia impairs the ability to remember, think or make decisions
pharmaphorum
MARCH 14, 2024
AstraZeneca adds a late-stage rare disease therapy to its pipeline, buying Amolyt Pharma and hypoparathyroidism drug eneboparatide for $800 million upfront.
BioSpace
MARCH 14, 2024
Madrigal Pharmaceuticals’ Rezdiffra is the first FDA-approved treatment for noncirrhotic non-alcoholic steatohepatitis, now referred to as metabolic dysfunction-associated steatohepatitis.
Fierce Pharma
MARCH 14, 2024
Ever since Vertex and CRISPR therapeutics scored a groundbreaking U.K. | In its draft guidance, the U.K.'s cost effectiveness watchdog recognized the need for the sickle cell therapy but needs more data from Vertex on its effectiveness in an updated managed access proposal.
Advertisement
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.
Expert insights. Personalized for you.
315 
Let's personalize your content