Pharmaceutical Commerce
AUGUST 14, 2024
In this part of his Pharma Commerce video interview, Michael Rowe, Two Labs’ Senior Director of DSCSA/Serialization Compliance Services, describes the outcome of the joint public meeting held by the Partnership for DSCSA Governance and the FDA.
Pharmaceutical Technology
AUGUST 14, 2024
AstraZeneca and Daiichi Sankyo's Enhertu (trastuzumab deruxtecan), has received conditional approval in China for gastric cancer.
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Bio Pharma Dive
AUGUST 14, 2024
The company's new CEO announced layoffs that will affect about 7% of company’s workforce.
Worldwide Clinical Trials
AUGUST 14, 2024
By: Simran Padam, Medical Director, Medical Affairs Personalized treatment approaches have emerged as pivotal in improving outcomes for hematological cancers. Central to this advancement are biomarkers, which are measurable indicators that signal biological processes or pathological changes within the body. They play a crucial role in tailoring hematology oncology therapeutic strategies to individual patients and have transformed personalized medicine in oncology.
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
AUGUST 14, 2024
Less than two months after splitting from Illumina, the liquid biopsy maker is refocusing resources as it pursues an FDA submission for the Galleri multi-cancer early detection test.
Pharma Times
AUGUST 14, 2024
Heart failure with preserved ejection fraction makes up 50% of all UK heart failure cases
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Pharmaceutical Technology
AUGUST 14, 2024
IGNYTE-3 is a Phase III trial investigating Replimune’s flagship oncolytic treatment for advanced, treatment-resistant melanoma.
Fierce Pharma
AUGUST 14, 2024
Johnson & Johnson and Roche are at the top of S&P Global’s pharmaceutical industry power ratings, which assess the strength of the world’s top 17 drugmakers. | Johnson & Johnson and Roche are at the top of S&P Global’s pharmaceutical industry power ratings, which assess the strength of the world’s top 17 drugmakers.
Pharmaceutical Technology
AUGUST 14, 2024
Africa CDC’s director general Dr. Jean Kaseya stated the number of rising mpox cases in the continent has been “largely ignored”.
Rethinking Clinical Trials
AUGUST 14, 2024
In this Friday’s PCT Grand Rounds, Runar Solberg of the Norwegian Institute of Public Health will present “Methodological Insights and Lessons Learned From Conducting a Pragmatic Randomized Trial on Surgical Face Masks.” The Grand Rounds session will be held on Friday, August 16, 2024, at 1:00 pm eastern. Solberg is a research scientist in the Centre for Epidemic Interventions Research at the Norwegian Institute of Public Health.
Pharmaceutical Technology
AUGUST 14, 2024
Kezar plans to focus all efforts on zetomipzomib, which is being evaluated in two Phase II trials for lupus and autoimmune hepatitis.
pharmaphorum
AUGUST 14, 2024
Recent advancements in multi-omics, artificial intelligence (AI), deep learning (DL), ageing biomarkers, precision imaging, ageing clocks, robotics, and smart technologies have empowered researchers to pinpoint common pathways amenable to drug manipulation, with encouraging data now surfacing in early human clinical trials.
Pharmaceutical Technology
AUGUST 14, 2024
As part of pipeline reprioritisation, Acelyrin has dropped izokibep and will instead start Phase III trials for lonigutamab in Q1 2025.
pharmaphorum
AUGUST 14, 2024
CDMOs like Lannett play a critical role in tackling tech transfer challenges in the pharmaceutical industry. Learn how they navigate diverse challenges to ensure successful transfers.
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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
Pharmaceutical Technology
AUGUST 14, 2024
In 2021, the Centers for Disease Control and Prevention estimated that 49 percent of the U.S. population had either pre- or type 2 diabetes.
pharmaphorum
AUGUST 14, 2024
Otsuka and Click Therapeutics' first-in-class prescription digital therapeutic for depression launches in US through mobile app stores
Pharmaceutical Technology
AUGUST 14, 2024
The Ministry of Health and Prevention in the UAE has granted approval for BioArctic and Eisai’s Leqembi for Alzheimer's disease.
pharmaphorum
AUGUST 14, 2024
Baxter International has agreed to sell its kidney treatment division to private equity firm Carlyle Group in a $3.8 billion cash deal, continuing its efforts to streamline its operations and reduce debt.
Pharmaceutical Technology
AUGUST 14, 2024
Eli Lilly and Company has opened the Lilly Seaport Innovation Center (LSC), an R&D hub in Boston's Seaport district in the US.
pharmaphorum
AUGUST 14, 2024
Firefly Neuroscience lists on Nasdaq via a $45m merger with IT firm WaveDancer, as it rolls out an AI-powered platform for managing brain function.
Pharma Times
AUGUST 14, 2024
The findings could improve cancer treatment and drug delivery to treat tumours
pharmaphorum
AUGUST 14, 2024
AstraZeneca has claimed the first regulatory approval for an immunotherapy/PARP inhibitor combination for endometrial cancer.
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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.
Fierce Pharma
AUGUST 14, 2024
Bluebird Bio is making progress on the launch of its three approved gene therapies but appears to be trailing Vertex in its competition to attract patients to their respective treatments for sickle | Bluebird Bio is making progress on the launch of its three approved gene therapies but appears to be trailing Vertex in competition to attract patients to their respective treatments for sickle cell disease.
Pharmaceutical Commerce
AUGUST 14, 2024
The latest news for pharma industry insiders.
pharmaphorum
AUGUST 14, 2024
The rapid spread of a new variant of mpox – previously known as monkeypox – has prompted the Africa Centers for Disease Control and Prevention (Africa CDC) to declare a public health emergency.
Fierce Pharma
AUGUST 14, 2024
Incyte has expanded its graft-versus-host disease offerings beyond Jakafi. | Incyte has expanded its graft-versus-host disease offerings beyond Jakafi. The new addition comes from Syndax Pharma-partnered axatilimab, which received FDA approval as a third-line therapy.
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Planning on running clinical trials in Japan? How can you reliably supply these studies? Discover Catalent’s clinical supply packaging facility in Shiga, Japan. Strategically located between Tokyo and Osaka, and one of largest in Japan, this 6,000 square meter facility offers comprehensive services including primary and secondary clinical packaging and labelling, comparator sourcing, cold chain storage, local and global distribution, local language support and white glove service to support stud
Outsourcing Pharma
AUGUST 14, 2024
In an increasingly complex regulatory landscape, pharmaceutical companies face significant challenges in maintaining transparency and accountability across their global supply chains.
XTalks
AUGUST 14, 2024
In this episode, Ayesha spoke with Matthew Martinez, MD, a board-certified cardiologist and nationally recognized expert in hypertrophic cardiomyopathy (HCM). He serves as director of Atlantic Health System Sports Cardiology and director of the Chanin T. Mast Center for Hypertrophic Cardiomyopathy. Dr. Martinez is the Chair of ACC online “LEARNHCM” platform, which educates clinicians about HCM patient care.
Outsourcing Pharma
AUGUST 14, 2024
In the ever-evolving world of pharmaceutical logistics, nuVizz has emerged as a key player, delivering innovative solutions that streamline the delivery management process.
FDA Law Blog
AUGUST 14, 2024
By Alan M. Kirschenbaum & Michelle L. Butler & Faraz Siddiqui & Sophia R. Gaulkin — Enacted in 2022, the Inflation Reduction Act (IRA) amended the Medicare provisions of the Social Security Act to impose several discount requirements on pharmaceutical manufacturers. In addition to the widely publicized drug price negotiation program, the IRA established inflation rebate programs under Medicare Part B and Part D.
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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.
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