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, 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
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.
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.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
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.
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 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
OCTOBER 30, 2024
Biogen and Neomorph have partnered to discover and develop molecular glue degraders for treating Alzheimer’s and other rare conditions.
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
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.
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.
Pharmaceutical Technology
OCTOBER 28, 2024
The US FDA has approved Iterum Therapeutics' NDA for ORLYNVAH to treat uncomplicated urinary tract infections (uUTIs).
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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
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
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.
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.
Pharmaceutical Technology
OCTOBER 30, 2024
GlaxoSmithKline (GSK) has entered an agreement to acquire Chimagen Biosciences’ CMG1A46 for $300m upfront.
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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.
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.
Fierce Pharma
OCTOBER 31, 2024
Bristol Myers’ $1.5 billion restructuring initiative that runs through 2025 may not be the end of the company’s ongoing efficiency push. | Bristol Myers' $1.5 billion restructuring initiative that runs through 2025 may not be the end of the company's ongoing efficiency push. The drugmaker is "exploring opportunities to further improve productivity and efficiency," CEO Chris Boerner said Thursday.
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.
Pharmaceutical Technology
OCTOBER 28, 2024
China's virtual monopoly on the supply of many APIs could be dangerous for the security of medicine supply to Western countries.
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
OCTOBER 31, 2024
Effective language training for healthcare teams within the NHS is crucial for providing quality care and communication with diverse patient populations. Learn why it is essential for healthcare professionals.
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 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
Green chemistry has the potential to revolutionise the pharmaceutical industry.
pharmaphorum
OCTOBER 31, 2024
The European Commission has delivered a hefty fine to Teva for abusing a dominant position in multiple sclerosis by artificially extending the patent protection for former blockbuster Copaxone.
Fierce Pharma
OCTOBER 30, 2024
Sales of Eli Lilly’s diabetes and weight loss drugs fell far short of expectations in the third quarter, leading the juggernaut company to reduce its annual revenue guidance and triggering speculat | Sales of Eli Lilly’s diabetes and weight loss drugs fell far short of analyst expectations in the third quarter, leading the juggernaut company to reduce its annual revenue guidance and triggering speculation that skyrocketing demand for the blood sugar modulating treatments has maxed out.
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
OCTOBER 28, 2024
The Pharmaceutical Automation and Digitalisation Congress (AUTOMA+) 2024 is a strategic platform for discussion and collaboration among decision makers, researchers and technologists who understand and follow this tendency.
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This new white paper defines and details the impact of Decentralized Clinical Trials on the Pharmaceutical industry and how the impact can be measured along with steps companies can take to ensure adoption.
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