XTalks

NOVEMBER 26, 2024

As oncology continues to dominate the pharmaceutical market, the global demand for effective cancer therapies has reached unprecedented levels. With advances in precision medicine and immunotherapy driving innovation, leading oncology drugs are not only transforming treatment paradigms but also generating billions in revenue. The year 2023 was no exception, with several cancer drugs achieving remarkable sales milestones, reflecting their efficacy, expanding indications and the growing global can

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Sales FDA Approval Drugs Marketing 78

AuroBlog - Aurous Healthcare Clinical Trials blog

NOVEMBER 26, 2024

(SciePro/Science Photo Library/Getty Images) Stem cells are special in the way they can keep on replicating, and turn themselves into many other types of cell. Now scientists have discovered how their superpowers get a remarkable boost when they’re grown in space.

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Pharmaceutical Technology

NOVEMBER 26, 2024

Gilead and Aelix first teamed up in 2018 for a clinical research collaboration agreement to investigate the vaccine.

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Vaccination Vaccine Clinical Research Research 233

Bio Pharma Dive

NOVEMBER 26, 2024

The brain drug developer is letting go of around 41 of its 238 employees, in a move the company says will help “align resources” with its strategic priorities.

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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

Medicine

Rethinking Clinical Trials

NOVEMBER 26, 2024

In an article published online this week , leaders from the NIH Pragmatic Trials Collaboratory share lessons learned about the collection of patient-reported outcome measures (PROMs) in medically underserved patients, including people with incomes below the federal poverty threshold, racial or ethnically minoritized groups, and rural and frontier communities.

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Trials Clinical Trials Clinical Trials Research 147

Bio Pharma Dive

NOVEMBER 26, 2024

The deal suggests Roche sees substantial promise in Poseida’s technology, as the offer is 215% above the biotech’s closing share price on Monday.

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Development 157

Bio Pharma Dive

NOVEMBER 26, 2024

Shares in Amgen fell by double digits Tuesday on results for the company’s MariTide shot, which is viewed as a potential rival to Wegovy and Zepbound.

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Drugs 157

Pharmaceutical Technology

NOVEMBER 26, 2024

Tiragolumab missed the chance to prove a survival benefit in SKYSCRAPER-01 adding to previous trial failures for the anti-TIGIT therapy.

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Trials 130

Bio Pharma Dive

NOVEMBER 26, 2024

Long-awaited results released Tuesday showed adding tiragolumab to Roche's immunotherapy Tecentriq did not extend survival in a closely followed Phase 3 study called SKYSCRAPER-01.

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Drugs 144

Pharmaceutical Technology

NOVEMBER 26, 2024

The Food and Drug Administration (FDA) has approved Shorla Oncology‘s IMKELDI for the treatment of specific leukaemia cancer forms.

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Drugs 130

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AuroBlog - Aurous Healthcare Clinical Trials blog

NOVEMBER 26, 2024

The Indian Council of Medical Research (ICMR) has announced an open call for proposals under its Centre for Advanced Research (CAR) scheme to support clinical studies for medical device and diagnostic technologies developed through the ICMR-DHR-Centre of Excellence (CoEs) programme at various IITs.

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Pharmaceutical Technology

NOVEMBER 26, 2024

Roche has signed an agreement for the acquisition of Poseida Therapeutics in a deal representing a total value of up to $1.5bn.

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Fierce Pharma

NOVEMBER 26, 2024

While Novartis has largely wrapped up its transformation into a leaner innovative medicines company—which included multiple rounds of staff cuts over the years—employment changes are still afoot at | Novartis is laying off a total of 139 staffers in East Hanover, New Jersey, where the company’s U.S. headquarters is located. The move will primarily affect commercial field sales associates working on the brands Xolair for asthma and allergies and the oncology combo made up of kinase inhibitors Taf

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Pharmaceutical Technology

NOVEMBER 26, 2024

Eton has acquired the rights in the US to Amglidia for neonatal diabetes mellitus, from French biotechnology company AMMTeK.

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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

Clinical Trials

Drug Patent Watch

NOVEMBER 26, 2024

In the ever-evolving landscape of pharmaceutical research and development, drug repurposing has emerged as a promising strategy to bring new treatments to patients more quickly and cost-effectively. However, navigating the complex web of intellectual property rights and regulatory considerations in this field can be challenging.

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Drugs Development Research 92

Pharmaceutical Technology

NOVEMBER 26, 2024

The NHS will provide the monoclonal antibody Crysvita at 20 specialist centres across England for patients with XLH.

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Antibody 130

XTalks

NOVEMBER 26, 2024

The US Food and Drug Administration (FDA) has approved Attruby (acoramidis) , marking a significant advancement for patients with transthyretin-mediated amyloid cardiomyopathy (ATTR-CM). This progressive disease occurs when misfolded transthyretin (TTR) proteins form amyloid deposits in the heart, leading to cardiac dysfunction. Attruby offers a near-complete stabilization of TTR — over 90 percent — halting the formation of amyloid fibrils that cause tissue damage and addressing the underlying p

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pharmaphorum

NOVEMBER 26, 2024

Medigene slashes staff and delays trials of its lead TCR therapy candidate as it refocuses its pipeline.

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Trials 105

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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.

Clinical Trials

Fierce Pharma

NOVEMBER 26, 2024

German CDMO Adragos Pharma has been on a growth tear this year, drafting plans to boost capacity in Japan, upgrading a facility in France, taking over another from Fresenius Kabi in Norway and more | German CDMO Adragos Pharma has been on a growth tear this year. Now, the manufacturing arriviste—which was founded in 2020—is expanding its production network again with the acquisition of Switzerland's Baccinex, which specializes in fill and finish services.

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Manufacturing Production 75

pharmaphorum

NOVEMBER 26, 2024

Roche has upgraded its partnership with off-the-shelf CAR-T therapy specialist Poseida to a $1 billion-plus takeover bid.

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Fierce Pharma

NOVEMBER 26, 2024

In 2001, a Time Magazine cover story touted Novartis’ targeted leukemia treatment Gleevec (imatinib) as a new kind of “am | Shorla Oncology has scored an FDA approval for its strawberry-flavored drink version of Novartis' cancer drug Gleevec. Dubbed Imkeldi, it becomes the first oral liquid form of imatinib.

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FDA Approval Drugs 74

pharmaphorum

NOVEMBER 26, 2024

ZENITH trial of MSD's Winrevair in PAH could add further momentum to an already impressive launch.

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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.

Clinical Research

ACRP blog

NOVEMBER 26, 2024

A sponsor representative, site representative, and an institutional review board (IRB) representative walk into a bar with a mission to solve patient recruitment challenges once and for all. Each of them orders a wildly different drink. Each of them spills most of their drink while scribbling obscure notes on bar napkins in huddled consultations with everyone but their original companions.

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Clinical Trials Clinical Trials Trials Marketing 59

pharmaphorum

NOVEMBER 26, 2024

Outgoing US President Joe Biden has proposed a dramatic expansion of Medicare coverage of obesity drugs, but will the plan see the light of day?

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Drugs 78

FDA Law Blog

NOVEMBER 26, 2024

By Larry K. Houck — Last May the Department of Justice (“DOJ”) and the Drug Enforcement Administration (“DEA”) issued a Notice of Proposed Rulemaking (“NPRM”) to transfer marijuana from schedule I of the Controlled Substances Act (“CSA”) to schedule III. Schedules of Controlled Substances: Rescheduling of Marijuana, 89 Fed. Reg. 44,597 (May 21, 2024).

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Engineer Cosmetics Containment Drugs 57

pharmaphorum

NOVEMBER 26, 2024

Discover the revolutionary impact of generative artificial intelligence (GenAI) on drug safety in pharmacovigilance. Learn how this cutting-edge technology is transforming the industry.

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Drugs 59

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.

Research

Crucial Data Soutions

NOVEMBER 26, 2024

For years, electronic data capture (EDC) systems have been the backbone of clinical trials, efficiently collecting and managing study data. The post Beyond Data Collection: How Modern EDC Systems Are Becoming Clinical Intelligence Hubs appeared first on Crucial Data Solutions.

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Clinical Trials Clinical Trials Trials 52

pharmaphorum

NOVEMBER 26, 2024

Tune in to this podcast episode featuring an interview with Phil Johnson from Interius Biotherapeutics as he discusses the latest advancements in CAR-T therapies, focusing on faster, better, and cheaper treatments.

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Intouch Solutions

NOVEMBER 26, 2024

The Current Landscape: AI’s Transformative Impact on Healthcare Marketing The healthcare marketing industry is at the forefront of a significant transformation, driven by advances in artificial intelligence (AI). Today, generative AI applications – particularly large language models (LLMs) and image-generation tools – are streamlining labor-intensive tasks such as research, documentation, content editing and concept ideation.

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Pharmaceutical Commerce

NOVEMBER 26, 2024

In the final part of his video interview with Pharma Commerce Editor Nicholas Saraceno, Gaurav Gupta, managing director and head of R&D at Kotter, offers advice for effectively being able to adjust plans.

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