Bio Pharma Dive
NOVEMBER 5, 2024
The companies’ CAR-T seemed to cause fewer movement disorders in a multiple myeloma trial than J&J's Carvykti has in other tests, although Wall Street analysts were divided on how the two drugs compare.
Rethinking Clinical Trials
NOVEMBER 5, 2024
A new study snapshot and updated ethics and regulatory documentation are now available for the MOMs Chat and Care Study. One year into the study, the research team reviewed and updated the minutes of their initial consultation with the Ethics and Regulatory Core. The MOMs Chat and Care Study , and NIH Collaboratory Trial, is testing the effectiveness of an integrated care model approach at 2 levels of intensity designed to facilitate timely, appropriate care for Black birthing people to reduce t
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Pharmaceutical Technology
NOVEMBER 1, 2024
Verastem Oncology has concluded the rolling submission of a new drug application (NDA) to the US Food and Drug Administration (FDA) for a combination of avutometinib and defactinib for low-grade serous ovarian cancer (LGSOC).
Worldwide Clinical Trials
NOVEMBER 5, 2024
In preparation for World Orphan Drug Congress Europe, we interviewed Nathan Chadwick, Senior Director, Therapeutic Strategy Lead, Rare Disease, and Derek Ansel, MS, LCGC, Vice President, Therapeutic Strategy Lead, Rare Disease, to hear their insights into the current progress in rare disease research and their hopes for 2025. What was the biggest development in rare disease in 2024, and how has that impacted clinical research or patient outcomes?
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
Fierce Pharma
NOVEMBER 1, 2024
With a positive readout for metabolic dysfunction-associated steatohepatitis (MASH) now in the bag, Novo Nordisk is gearing up to pursue yet another indication for its star GLP-1 medicine semagluti | Novo Nordisk on Friday revealed that its star GLP-1 semaglutide met the mark in a late-stage MASH study. The positive results build on the thesis that GLP-1s could become a foundational piece in the treatment paradigm for the fatty liver disease, according to analysts at William Blair.
Bio Pharma Dive
NOVEMBER 5, 2024
The death, which investigators linked to a preparatory chemo treatment rather than Beam's medicine, highlights the risks of using decades-old transplant drugs alongside cutting-edge CRISPR medicines.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Rethinking Clinical Trials
NOVEMBER 4, 2024
The NIH and the Patient-Centered Outcomes Research Institute (PCORI) are major funders of pragmatic clinical trials embedded in healthcare systems. An existing chapter of the Living Textbook of Pragmatic Clinical Trials provided guidance on how to Develop a Compelling Grant Application for the NIH. The updated chapter now includes information about how to develop a grant application for PCORI.
pharmaphorum
NOVEMBER 5, 2024
Disc Medicine has charted a route to market for bitopertin, its drug candidate for rare disease erythropoietic protoporphyria (EPP), after meeting with the FDA.Shares in the company gained almost 24% after it announced that the end of phase 2 meeting with the US regulator had firmed up plans for a phase 3 trial of bitopertin in EPP, as well as the potential for accelerated approval.
Fierce Pharma
NOVEMBER 5, 2024
Intra-Cellular Therapies’ atypical antipsychotic medication Caplyta has been on a roll, delivering fast commercial growth and coming up triumphant in yet another late-stage trial. | Intra-Cellular Therapies’ atypical antipsychotic medication Caplyta has been on a roll, delivering fast commercial growth and coming up triumphant in yet another late-stage trial.
Bio Pharma Dive
NOVEMBER 1, 2024
The Phase 3 findings position semaglutide to become the first drug of its kind for the liver disease. But they also confirm GLP-1s aren't a "silver bullet" for MASH, one analyst argued.
Pharmaceutical Technology
NOVEMBER 4, 2024
The US FDA has granted fast track designation to FELIQS’ lead product FLQ-101 for preventing retinopathy of prematurity (ROP).
Rethinking Clinical Trials
NOVEMBER 6, 2024
In this Friday’s PCT Grand Rounds, Sumit Agarwal of the University of Michigan will present “The Effect of Cash Benefits on Health Care Utilization and Health: A Randomized Study of an Income Support.” The Grand Rounds session will be held on Friday, November 8, 2024, at 1:00 pm eastern. Agarwal is an assistant professor of internal medicine and health management and policy at the University of Michigan.
Pharmaceutical Commerce
OCTOBER 31, 2024
With today's pharmacy landscape shaken by unprecedented and wider disruption to healthcare support and delivery, community and independent entities strive to remain an integral cog in the mix.
Fierce Pharma
NOVEMBER 5, 2024
With new approvals on the horizon and the closely watched Casgevy launch picking up steam in sickle cell disease and beta thalassemia, “there has never been a more exciting time to be at Vertex,” c | With its first Casgevy revenues in the books, Vertex lifted its full-year sales outlook as it turns its attention to two product launches in 2025, including an expected new entrant in the pain market.
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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
Bio Pharma Dive
OCTOBER 30, 2024
All doses of the two drugs are now listed as available in the U.S., per an FDA database, although the company cautioned patients may still experience "variability" filling their prescriptions.
Pharmaceutical Technology
OCTOBER 30, 2024
Biogen and Neomorph have partnered to discover and develop molecular glue degraders for treating Alzheimer’s and other rare conditions.
Rethinking Clinical Trials
OCTOBER 30, 2024
Dr. Thomas Carton and Dr. Anitha John In this Friday’s PCT Grand Rounds, Thomas Carton of the Louisiana Public Health Institute and Anitha John of George Washington University and the Children’s National Hospital will present “Congenital Heart Initiative: Redefining Outcomes and Navigation to Adult Centered Care (CHI-RON) Study.” The Grand Rounds session will be held on Friday, November 1, 2024, at 1:00 pm eastern.
pharmaphorum
NOVEMBER 5, 2024
Therapeutic or focused ultrasound began being applied to neurologic conditions less than a decade ago, but its potential in a wide spectrum of brain applications is high. In today’s podcast, web editor Nicole Raleigh speaks with Dr Neal Kassell, chair and founder of the Focused Ultrasound Foundation and previously a neurosurgeon, who created the Foundation in 2006 to improve the lives of millions of people with serious medical disorders by accelerating the development and adoption of focused ult
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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
NOVEMBER 4, 2024
BioNTech reported surprisingly strong sales of its COVID-1 | BioNTech reported surprisingly strong sales of its COVID-19 vaccine in the third quarter. Despite the performance, the company expects to be at the lower end of its revenue guidance window for the year of between €2.5 billion to €3.1 billion.
Bio Pharma Dive
OCTOBER 30, 2024
Archon Biosciences, co-founded by the winner of the 2024 Nobel Prize in Chemistry, emerged from stealth Wednesday with $20 million in seed capital.
Pharmaceutical Technology
OCTOBER 30, 2024
GlaxoSmithKline (GSK) has entered an agreement to acquire Chimagen Biosciences’ CMG1A46 for $300m upfront.
Rethinking Clinical Trials
OCTOBER 30, 2024
Speaker Nicholas Bloom, PhD Professor of Economics Stanford University Slides Keywords Remote Work; Hybrid Work; Job Performance; Attrition Key Points Dr. Bloom conducted a randomized controlled trial at the Trip.com headquarters in Shanghai to test the efficacy of a hybrid WFH model. 1,612 employees in the IT and Airfare divisions were randomized to come into the office either five days/week (the control arm) or three days/week, with the option to
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.
pharmaphorum
NOVEMBER 4, 2024
Outlook Therapeutics' Lytenava is the first ophthalmic formulation of bevacizumab to be cleared for use by NICE for use in the NHS for wet AMD
Fierce Pharma
NOVEMBER 1, 2024
An FDA announcement last year of an investigation into the risk of patients developing secondary cancers following the treatment of CAR-T cell therapies sent shock waves across the industry. | An FDA investigation last year into the risk of patients developing secondary cancers following the treatment of CAR-T cell therapies sent shock waves across the industry.
Bio Pharma Dive
OCTOBER 31, 2024
The biotech expects three Phase 2 readouts in urticaria and eczema over the next two years, and will keep its “options open” regarding an IPO, its CEO said.
Pharmaceutical Technology
NOVEMBER 5, 2024
This initiative brings together UK Biobank, Genomics England, NHS England, and Oxford Nanopore to accelerate genomics-based research in the UK.
Advertiser: FourKites
A research study conducted by The Journal of Commerce and FourKites surveyed hundreds of international shippers, exploring how their usage of global supply chain visibility technology has evolved since the onset of global disruptions caused by COVID-19. For international shippers, ocean freight visibility has evolved from optional to essential and satisfaction with visibility varies greatly depending on how it is obtained and delivered.
Outsourcing Pharma
NOVEMBER 4, 2024
Thermo Fisher Scientific has joined forces with Labguru to integrate Labguruâs Electronic Lab Notebook (ELN) into Thermo Fisherâs Laboratory Information Management System (LIMS) and lab operations software.
pharmaphorum
NOVEMBER 1, 2024
With artificial intelligence technologies for healthcare on the rise, UK health technology assessment (HTA) agency NICE has published an economic evaluation standard that it says will help inform coverage and reimbursement decisions.
Fierce Pharma
NOVEMBER 4, 2024
Despite winning an alopecia areata approval for its drug Leqselvi in July, Sun Pharma will have to wait a while longer to launch its JAK inhibitor competitor to Eli Lilly and Incyte’s Olumiant and | Sun Pharma, which had been plotting a mid-October launch for its JAK inhibitor Leqselvi, has been slapped with in an injunction blocking the rollout of the alopecia areata drug.
Bio Pharma Dive
OCTOBER 30, 2024
The British pharma’s experience during the third quarter mirrored that of rival Pfizer, which also reported lower sales of its competing RSV shot.
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