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: Brian Richardson, Brian Richardson, Founder and CEO of Richardson Consulting Group
Let’s face it—most ethics and compliance training programs aren’t winning awards for engagement. But that doesn’t mean they can’t be effective, captivating, and maybe even enjoyable! Join learning design expert Brian Richardson for a dynamic session on how to breathe new life into your ethics and compliance training. We'll explore innovative strategies to bring traditionally dry topics to life, making them resonate with learners and drive tangible change.
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.
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.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
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.
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.
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.
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Enhancing Transparency & Efficiency Throughout the Trial Lifecycle for AI Readiness
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.
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
Rethinking Clinical Trials
OCTOBER 28, 2024
Research-identifiable Medicare data can come from traditional fee-for-service Medicare claims or from Medicare Advantage claims. A new contribution to the Living Textbook of Pragmatic Clinical Trials published this month, Use of Medicare Data in PCTs , describes the important differences between these data. At the healthcare system level, differences in incentives for documenting diagnoses can affect the reliability and relevance of data used for pragmatic clinical trials.
XTalks
OCTOBER 30, 2024
Shorla Oncology recently received US Food and Drug Administration (FDA) approval to expand Jylamvo ’s (methotrexate) use for children with acute lymphoblastic leukemia and polyarticular juvenile idiopathic arthritis. Jylamvo, an oral liquid methotrexate, can now treat pediatric patients with acute lymphoblastic leukemia and polyarticular juvenile idiopathic arthritis.
Speaker: Simran Kaur, Co-founder & CEO at Tattva.Health
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!
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.
Drug Patent Watch
OCTOBER 30, 2024
The pharmaceutical industry is known for its complex regulatory environment and lengthy product development processes. One often overlooked aspect of this industry is the potential benefits of abandoned and expired patents. These patents can provide opportunities for companies to bring new products to market at a lower cost and with reduced development time.
Drug Discovery World podcast
OCTOBER 31, 2024
This is the latest episode of the free DDW narrated podcast, titled “How to streamline regulatory approval”, which covers two articles written for Volume 24 – Issue 1, Winter 2022/2023 of DDW. They are called: Quicker time to regulatory submission through improved data management and The three key stages to a successful specialty drug launch. In the first article, Ken Forman, Senior Director of Product Strategy, IDBS explains how robust digital workflows can reduce errors and time to compile dat
XTalks
NOVEMBER 1, 2024
Swiss pharmaceutical giant Roche shared new late-breaking data for its Elecsys Amyloid Plasma Panel, which shows the test can rule out Alzheimer’s-related amyloid pathology with good accuracy. The Elecsys Amyloid Plasma Panel is a minimally invasive blood test that detects both phosphorylated Tau (pTau) 181 protein and apolipoprotein E4 (APOE4) in plasma.
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.
Drug Patent Watch
OCTOBER 28, 2024
The pharmaceutical industry relies heavily on Contract Development and Manufacturing Organizations (CDMOs) to streamline the drug development and manufacturing process. CDMOs provide a wide range of services that cater to the diverse needs of pharmaceutical companies, from early-stage development to commercial manufacturing.
Bio Pharma Dive
OCTOBER 31, 2024
In an investor presentation, executives hinted at the possibility of seeking an accelerated approval of trontinemab if it can significantly lower levels of amyloid in a Phase 3 trial.
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
Speaker: Amie Phillips Pablo, VP, Corporate Compliance & Privacy Officer at Novo Nordisk
In today’s complex healthcare environment, navigating third-party relationships has become even more challenging—whether it’s vendor relationships, employee activities, or patient-facing interactions. Left unmanaged, these conflicts can compromise trust, regulatory compliance, and even organizational reputation. So, how can healthcare teams stay ahead?
Fierce Pharma
OCTOBER 31, 2024
Less than a month after the FDA removed Eli Lilly’s tirzepatide from its shortage list, the agency has done the same for Novo Nordisk’s rival GLP-1 semaglutide, potentially signaling the end of a d | The FDA this week revised its shortage list to note that the.25 mg starter dose of Novo’s semaglutide-based obesity med Wegovy is now available in the U.S.
Drug Patent Watch
OCTOBER 29, 2024
In the rapidly evolving landscape of biotechnology and pharmaceutical development, contract development and manufacturing organizations (CDMOs) have become essential partners for companies seeking to bring innovative medicines to market. However, navigating the complexities of these partnerships can be daunting, especially for smaller biotech companies.
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.
XTalks
OCTOBER 31, 2024
In this episode, Ayesha spoke with Robert Perkins, MD, Vice President, US Medical Affairs/Renal at Bayer who spoke about recent advancements in the heart failure (HF) treatment landscape. This includes new Phase III trial data for Kerendia (finerenone) in patients with heart failure that was presented recently at this year’s European Society of Cardiology (ESC) Congress 2024.
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Fierce Pharma
OCTOBER 30, 2024
Biopharma production efforts are set to receive a big boost in the U.K. thanks to a new budget rolled out by the Labour Party following this summer’s general election. | As part of the new budget presented Wednesday by the U.K.’s Chancellor of the Exchequer, Rachel Reeves, the country is debuting a new capital grants vehicle known as the Life Sciences Innovative Manufacturing Fund.
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.
XTalks
OCTOBER 31, 2024
Each year, TIME Magazine curates its “Best Inventions” list to showcase innovations that push the boundaries of technology, healthcare and everyday living. For the 2024 list , TIME collected nominations from editors, correspondents and industry experts using an open submission platform. Each nomination was evaluated on criteria including originality, effectiveness, ambition and impact.
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