Pharmaceutical Technology
NOVEMBER 6, 2024
The top 20 biopharmaceutical companies demonstrated signs of recovery during the third quarter (Q3) of 2024 as investor optimism improved following the interest rate cuts by the US Federal Reserve in September 2024.
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?
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pharmaphorum
NOVEMBER 5, 2024
AstraZeneca's shares have fallen more than 8% on speculation about an anti-corruption probe in China, its second-largest market, wiping around $14 billion off its value.The sell-off appears to have been prompted by an article in Chinese financial media outlet Yicai which suggested that "dozens of senior executives" at AZ's Chinese subsidiary have been implicated in an ongoing insurance fraud case.
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.
Speaker: Simran Kaur, Co-founder & CEO at Tattva Health Inc.
AI is transforming clinical trials—accelerating drug discovery, optimizing patient recruitment, and improving data analysis. But its impact goes far beyond research. As AI-driven innovation reshapes the clinical trial process, it’s also influencing broader healthcare trends, from personalized medicine to patient outcomes. Join this new webinar featuring Simran Kaur for an insightful discussion on what all of this means for the future of healthcare!
Outsourcing Pharma
NOVEMBER 6, 2024
As clinical trials evolve, electronic Clinical Outcome Assessments (eCOA) remain central to data quality but often lag in adoption due to complex setup and deployment challenges.
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
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Bio Pharma Dive
NOVEMBER 6, 2024
Pioneers like Alnylam Pharmaceuticals have led the RNA interference field for years. Now, a crop of young biotechs is building on that foundation by taking the drugmaking technology in new directions.
Pharmaceutical Technology
NOVEMBER 8, 2024
The seemingly inexorable rise in global obesity is being reflected in the sales of diabetes and weight-loss drugs, including Ozempic.
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.
XTalks
NOVEMBER 8, 2024
This blog is the fourth in our series exploring TIME’s “Best Inventions of 2024” list, following our deep dives into some of the most transformative medical devices , pharma and food innovations. Today, we spotlight healthcare inventions transforming clinical and at-home care, selected by TIME for their potential to tackle major healthcare challenges and elevate patient care.
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
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.
Pharmaceutical Technology
NOVEMBER 8, 2024
A Phase III trial with the companies’ monoclonal antibody in patients with chronic rhinosinusitis with nasal polyps met its primary endpoint.
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 7, 2024
Novo Nordisk has abandoned a drug it licensed from KBP Biosciences last year in a deal valued at up to $1.3 billion after it missed the mark in a chronic kidney disease (CKD) trial.The Danish group bought rights to ocedurenone, an oral non-steroidal mineralocorticoid receptor antagonist (nsMRA), from the Singapore biotech in October 2023 as a companion to its GLP-1-based therapies for reducing cardiovascular risk and kidney disease in people with diabetes and obesity.
Bio Pharma Dive
NOVEMBER 7, 2024
Elevidys sales have increased since the FDA made a controversial choice to expand the therapy's use. Now, Sarepta is abandoning a successor to its drug Exondys 51, citing an “evolving" treatment landscape.
Pharmaceutical Technology
NOVEMBER 7, 2024
The EMA has granted approval for Sanofi/Regeneron’s Dupixent (dupilumab) to treat EoE in children as young as one.
Drug Patent Watch
NOVEMBER 5, 2024
The development and approval of biosimilars have become increasingly important in the biopharmaceutical industry, offering cost-effective alternatives to original biological medicines. However, biosimilars pose unique challenges in terms of risk management due to their complex nature and potential for immunogenicity.
XTalks
NOVEMBER 6, 2024
Gelteq Limited, a biotechnology innovator in ingestible gel delivery solutions, recently completed its initial public offering (IPO), raising gross proceeds of $5.2 million. Priced at $4.0 per share, the offering included 1,300,000 ordinary shares, which began trading on the Nasdaq Global Market under the ticker symbol GELS on October 29, 2024. Gelteq centers its technology on a proprietary, customizable gel platform designed for precise drug delivery, supporting prescription drugs, nutraceutica
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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
NOVEMBER 4, 2024
Bio-Rad’s extensive ddPCR assay offerings help researchers leverage the full power of digital PCR.
Pharmaceutical Technology
NOVEMBER 8, 2024
Analysis of future trends highlights that the cold chain logistics sector is at a critical juncture, with tech advancements driving change.
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
Drug Patent Watch
NOVEMBER 6, 2024
Developing a Risk Management Plan (RMP) for generic drugs is a crucial step in ensuring the safety and efficacy of these medications. An RMP provides detailed information on a medicine’s safety profile, measures to prevent or minimize risks, and plans for ongoing safety monitoring and evaluation.
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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.
Bio Pharma Dive
NOVEMBER 4, 2024
As novel therapeutics become more complex — and costly — to bring to market, drug developers are looking to unified clinical development platforms to streamline operations.
Pharmaceutical Technology
NOVEMBER 7, 2024
Lord Vallance stated the government sees investment, innovation, and public-private partnership as crucial to UK healthcare.
pharmaphorum
NOVEMBER 5, 2024
Journey Medical has claimed FDA approval for its Emrosi therapy for rosacea, which it thinks could become a "standard of care" drug for the common skin disorder.The new capsule formulation of the antibiotic minocycline hydrochloride has been cleared by the US regulator to treat the inflammatory lesions caused by rosacea – which causes flushing or long-term redness and pustules on the face – in adults.
Fierce Pharma
NOVEMBER 8, 2024
After a positive phase 3 trial, Johnson & Johnson hopes its Darzalex could become the first treatment option for patients with smoldering multiple myeloma, an early-stage form of the blood diso | After a positive phase 3 trial, Johnson & Johnson hopes its Darzalex could become the first treatment option for patients with smoldering multiple myeloma, an early-stage form of the blood disorder.
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.
Bio Pharma Dive
NOVEMBER 4, 2024
Wall Street analysts were impressed by data showing competitive rates of weight loss for Viking’s therapy, but shares in the company still slipped.
Pharmaceutical Technology
NOVEMBER 7, 2024
The company reported that it does not have sufficient cash reserves to operate for the next 12 months, can only fund operations into Q1 2025.
Pharma Times
NOVEMBER 7, 2024
Trial to evaluate safety and efficacy of MVA-BN vaccine
ACRP blog
NOVEMBER 7, 2024
The wisdom of generations before ours says that “a rising tide lifts all boats,” to which modern clinical research veterans might add, “building a sense of community among scattered clinical trial sites can help to keep all of the stakeholders in medical research afloat in trying times.” Addressing a framework for assessing the overall robustness at sites in terms of compliance, business, financial, regulatory, and clinical dimensions is the goal of an ACRP 2025 preconference half-day workshop
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