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 29, 2024
The EC has approved AstraZeneca's Fasenra as an add-on therapy for adults with relapsing or refractory EGPA.
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Pharmaceutical Technology
OCTOBER 30, 2024
Pharmaceutical management expert Kenneth Getz shares insights on broader trends in the pharma sector influencing the recent wave of layoffs.
Worldwide Clinical Trials
OCTOBER 29, 2024
By: Juliane Mills, Senior Director, Therapeutic Strategy Lead, Rare Disease The rise of patient-led clinical research, particularly in rare disease, represents a significant shift in the clinical trial landscape. Increasingly, patients and patient-led organizations are playing a pivotal role in shaping drug development, underscoring the importance of collaboration between patient organizations, CROs, and pharmaceutical and biotechnology companies.
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!
pharmaphorum
OCTOBER 30, 2024
Discover how leveraging AI can help biopharma companies future-proof their operations and strategies. Learn about innovative AI strategies that can drive success in the biopharma industry.
Fierce Pharma
OCTOBER 28, 2024
Novartis and Apellis Pharmaceuticals have rolled out detailed data on iptacopan and pegcetacoplan, respectively, as they race for the prize in a type of rare kidney disease. | Novartis and Apellis dropped new data on their respective meds, iptacopan and pegcetacoplan, in the rare kidney disease C3 glomerulopathy. While Apellis' drug seems to have an efficacy edge based on a cross-trial comparison, Novartis may have gotten the jump by filing for approvals ahead of its competitor.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
XTalks
OCTOBER 31, 2024
Paragonix Technologies, an innovator in organ transport and preservation solutions, has received US Food and Drug Administration (FDA) 510(k) clearance for its KidneyVault Portable Renal Perfusion System. This clearance allows the KidneyVault system to be used in the US to improve the quality of kidney preservation and ultimately improve outcomes for patients undergoing kidney transplants.
pharmaphorum
OCTOBER 28, 2024
Biogen has revealed encouraging phase 2 results with its anti-CD38 antibody felzartamab in rare kidney disease IgA nephropathy (IgAN), which it hopes could join a series of first-in-class therapies for the disorder.Data reported at the Kidney Week 2024 congress in San Diego showed that felzartamab was able to achieve "substantial" reductions in proteinuria and stabilised kidney function in the 54-subject IGNAZ study that extended for 18 months after the last dose of the antibody.
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.
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.
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
XTalks
OCTOBER 29, 2024
Genomic sequencing is a window into our genetic makeup. For a parent, it could prepare them or help them understand their child’s potential health needs early on. The GUARDIAN (Genomic Uniform-screening Against Rare Diseases In All Newborns) study, recently published in the Journal of the American Medical Association (JAMA) , highlights how adding genome sequencing to newborn screening could reshape early detection for rare genetic conditions.
pharmaphorum
OCTOBER 30, 2024
Eli Lilly says a new starting dose regimen for its Alzheimer's disease therapy Kisunla reduces the risk of side effects that have stood in the way of approvals and reimbursement decisions for drugs in its class.Simply shifting one vial of the anti-amyloid antibody from the first infusion to the third infusion of the titration phase of dosing – the period used to achieve therapeutic levels in the body – is enough to lower the incidence of a potentially serious side effect known as ARIA-E, accordi
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).
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.
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.
XTalks
OCTOBER 28, 2024
November is National Diabetes Month. This year’s theme of National Diabetes Month 2024, “Take Charge of Tomorrow: Preventing Diabetes Health Problems,” highlights how today’s actions can shape healthier futures. On National Diabetes Month 2024, healthcare organizations, policymakers and community programs are raising awareness for the nearly 29.3 million Americans with diagnosed diabetes, alongside 9.7 million undiagnosed and 115.9 million at risk with prediabetes, based on the Ameri
Pharmaceutical Technology
OCTOBER 28, 2024
The enduring effects of redlining on public health, particularly on asthma prevalence, provide a striking example of how discriminatory housing policies from the 20th century continue to shape the well-being of marginalised communities affected by this practice today.
Bio Pharma Dive
OCTOBER 30, 2024
The partners no longer intend to develop Zurzuvae for one of the most common forms of depression, citing the time and cost of running new studies that would satisfy the FDA.
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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
NOVEMBER 1, 2024
Despite its unique ability to block sodium-glucose linked transporter 2 (SGLT2) in the kidneys and SGLT1 in the intestines, Lexicon’s Zynquista (sotagliflozin) has had difficulty negotiating r | Despite its unique ability to block sodium-glucose linked transporter 2 (SGLT2) in the kidneys and SGLT1 in the intestines, Lexicon’s Zynquista (sotagliflozin) has had difficulty negotiating regulatory hurdles.
ACRP blog
OCTOBER 30, 2024
In 1976, at a moment in history when U.S. enrollment of women in medical schools had just climbed to 20%, it is notable that the chronicles of the Association of Clinical Research Professionals (ACRP) describe the first meeting of two nurses who were among the field’s earliest clinical research coordinators, Sarah Boyer and Anne LeSher, as the impetus for the formation of the Association.
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.
Bio Pharma Dive
OCTOBER 30, 2024
Third quarter Mounjaro and Zepbound sales, while up substantially versus the same period last year, grew little compared to the second quarter amid inventory decreases in the U.S.
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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
OCTOBER 29, 2024
After the recent FDA approval for the promising schizophrenia drug Cobenfy (xanomeline and trospium chloride), Bristol Myers Squibb and its partners are moving fast to expand the global reach of th | In a phase 3 bridging study run by Zai Lab in China, Bristol Myers Squibb's KarXT helped schizophrenia patients chart a 9.2-point total-score reduction on the Positive and Negative Syndrome Scale versus placebo at week 5, teeing up a forthcoming regulatory filing.
Pharmaceutical Technology
OCTOBER 30, 2024
GlaxoSmithKline (GSK) has entered an agreement to acquire Chimagen Biosciences’ CMG1A46 for $300m upfront.
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.
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
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.
Pharma Times
OCTOBER 31, 2024
The new Dementia Trials Accelerator is set to receive £20m of government funding
Pharmaceutical Technology
OCTOBER 30, 2024
Green chemistry has the potential to revolutionise the pharmaceutical industry.
Bio Pharma Dive
OCTOBER 29, 2024
Daniel Quirk, an immunology and neuroscience executive at Bristol Myers Squibb, will be Biogen’s next chief medical officer, while Robin Kramer will replace retiring CFO Michael McDonnell.
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