Pharmaceutical Technology
SEPTEMBER 20, 2024
In this issue: Solving adherence issues with prodrugs, examining whether PBMs are to blame for high drugs prices in the US, developing vaccines for Disease X, and more.
Bio Pharma Dive
SEPTEMBER 20, 2024
The decision against Syfovre’s approval follows efforts by Apellis to have reviewers reevaluate clinical evidence multiple times and, according to an analyst, will lead to a restructuring of the company’s operations in Europe.
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Pharmaceutical Technology
SEPTEMBER 20, 2024
The growth of AI in the healthcare sector is already having real-world impacts and promises a step-change in future care.
Bio Pharma Dive
SEPTEMBER 20, 2024
A pill Novo acquired produced modest weight loss but raised safety questions. Elsewhere, Sanofi detailed the silver lining it found in a recent study and a heart drug developer’s shares surged.
Pharmaceutical Technology
SEPTEMBER 20, 2024
The biotech has secured $65m in a Series A funding round led by Cormorant Asset Management and other investors.
Bio Pharma Dive
SEPTEMBER 20, 2024
The agency brought action against Caremark, Express Scripts and Optum Rx on Friday, and warned that all drug manufacturers “should be on notice” as well.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Fierce Pharma
SEPTEMBER 20, 2024
The hits just keep on coming for Bristol Myers Squibb staffers amid the company's cost-savings program. | Bristol Myers Squibb is laying off an additional 79 staffers in Lawrenceville, New Jersey. The cuts will be effective between Dec. 12 and May 30 of next year and are part of BMS's $1.5 billion cost reduction program.
Pharmaceutical Technology
SEPTEMBER 20, 2024
Pharmaceutical Technology has listed the leading pharmaceutical packaging companies and containment solutions suppliers. Download for free.
Drug Discovery World
SEPTEMBER 20, 2024
A new multinational clinical trial will investigate whether a novel treatment can help slow the progression of chronic kidney disease (CKD). The EASi-KIDNEY trial will evaluate whether vicadrostat, also known as BI 690517, improves clinical outcomes when it is given in combination with existing treatments. The trial will run in 15-20 countries around the world, with around 11,000 people expected to participate.
Pharmaceutical Technology
SEPTEMBER 20, 2024
The Outsourcing in Clinical Trials New England conference will gather pharma experts to discuss the current clinical trial landscape.
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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
pharmaphorum
SEPTEMBER 20, 2024
Astellas is ready to launch its first digital health product in the US, called Digitiva, which provides at-home monitoring of people with heart failure
Pharmaceutical Technology
SEPTEMBER 20, 2024
After missing primary endpoints in relapsing forms of MS, tolebrutinib has proved its efficacy in secondary progressive MS patients.
Fierce Pharma
SEPTEMBER 20, 2024
AstraZeneca has just scored big on the quest to make routine vaccinations less of a hassle. | The FDA signed off on AstraZeneca's influenza vaccine FluMist for self-administration by adults up to 49 years old and for administration by a parent or caregiver in kids between the ages of 2 and 17. With the green light, FluMist is now the only flu vaccine in the U.S. patients can give to themselves.
Pharmaceutical Technology
SEPTEMBER 20, 2024
The NHS England has announced the routine commissioning of Daiichi Sankyo's quizartinib for acute myeloid leukaemia (AML).
Fierce Pharma
SEPTEMBER 20, 2024
Amid a parade of regulatory endorsements in Europe, Apellis Pharmaceuticals’ ophthalmology prospect pegcetacoplan has been left in the cold once again. | Europe’s Committee for Medicinal Products for Human Use has confirmed its negative stance on pegcetacoplan in geographic atrophy, an advanced form of age-related macular degeneration that can lead to blindness.
Pharmaceutical Technology
SEPTEMBER 20, 2024
Data showed non-inferiority of immune response between adults and adolescents with Imvanex.
Fierce Pharma
SEPTEMBER 20, 2024
Approvals are coming fast and furious for Johnson & Johnson’s Rybrevant as it is lining up to challenge the dominance of AstraZeneca’s Tagrisso in non-small cell lung cancer (NSCLC). | Approvals are coming fast and furious for Johnson & Johnson’s Rybrevant as it is lining up to challenge the dominance of AstraZeneca’s Tagrisso in non-small cell lung cancer (NSCLC).
pharmaphorum
SEPTEMBER 20, 2024
J&J's target of $5bn in sales for Rybrevant has moved a step closer, after an FDA approval for second-line treatment of EGFR+ NSCLC
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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
SEPTEMBER 20, 2024
Since an initial FDA go-ahead in 2020, Sanofi’s Sarclisa has been specifically approved for patients with previously treated multiple myeloma. That changed Friday. | Since an initial FDA go-ahead in 2020, Sanofi’s Sarclisa has been specifically approved for patients with previously treated multiple myeloma. That changed Friday.
Drug Discovery World
SEPTEMBER 20, 2024
The DDW Fall issue asks if the gut microbiome can unlock new therapeutics for mental health disorders, places a spotlight on oncology, and includes an exclusive guide on the benefits and advances in cell line development. Other features in the Fall issue include: Beyond CRISPR–what anew tool offers gene editing How the UK could become a leader in cannabinoid research How mRNA’s tiny cousin could treat thousands of rare diseases DDW FALL 2024 The post DDW Fall 2024 appeared first on Drug Discover
Fierce Pharma
SEPTEMBER 20, 2024
For Zevra Therapeutics and its rare neurodegenerative disease med arimoclomol, the second time’s the charm. | The FDA approved Zevra’s arimoclomol capsules to treat the rare lysosomal storage disorder Niemann-Pick disease type C in conjunction with Johnson & Johnson’s enzyme inhibitor miglustat. Arimoclomol, which will fly under the brand name Miplyffa, is now the first FDA-approved therapy for NPC.
BioPharma Reporter
SEPTEMBER 20, 2024
Dandelion Health used its new clinical AI marketplace to analyze real-world data, showing that GLP-1 drugs may help prevent cardiovascular disease (CVD) for a seven times larger population than previously researched.
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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
Fierce Pharma
SEPTEMBER 20, 2024
Fierce Pharma Asia—Merck's collabs with Daiichi, Eisai deliver readouts; Granules hit with FDA manufacturing observations aliu Fri, 09/20/2024 - 09:21
Drug Discovery World
SEPTEMBER 20, 2024
Kyverna Therapeutics has revealed continued positive results for its CAR-T therapy KYV-101 in B cell-driven autoimmune diseases. The clinical trial results and case studies were presented in posters and a company-sponsored symposium at the 40 th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS). The case reports demonstrate disease modification across trials and durability in some patients extending beyond one year and a well-tolerated safety profile.
pharmaphorum
SEPTEMBER 20, 2024
Discover five effective patient travel strategies to improve diversity in clinical research enrolment. Learn how to enhance inclusivity and representation in your research studies.
Pharmaceutical Commerce
SEPTEMBER 20, 2024
In an interview with Pharma Commerce Editor Nicholas Saraceno, Kevin MacDonald, Bluesight’s Co-founder and CEO, discusses why mitigating the impact of rising costs is imperative, while explaining the benefit of advanced analytics tools.
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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.
Crucial Data Soutions
SEPTEMBER 20, 2024
The Challenge of Device Provisioning in Clinical Trials In clinical trials, gathering timely and accurate data from patients is essential. The post Simplifying ePRO Data Collection: The Benefits of BYOD with TrialKit appeared first on Crucial Data Solutions.
Intouch Solutions
SEPTEMBER 20, 2024
Predictive analytics is revolutionizing healthcare marketing by leveraging AI to make data-driven decisions. In this POV, we explore how the use of predictive models enhances engagement by targeting the right audiences, optimizing marketing strategies and best utilizing marketing dollars. We showcase real-world applications where AI-powered predictive analytics has led to significant increases in marketing effectiveness and patient care.
Drug Discovery World
SEPTEMBER 20, 2024
Hyundai Bioscience USA and the University of California San Diego (UCSD) have agreed to conduct a clinical trial to evaluate the efficacy of Xafty, a niclosamide-based antiviral, in treating long Covid. “This is an outstanding opportunity for UCSD and Hyundai Bioscience to partner together to tackle long Covid,” Professor Davey Smith, Director of the UCSD Altman Clinical and Translational Research Institute (ACTRI) of UCSD and an authority on viral illnesses, especially Covid, said
Drug Channels
SEPTEMBER 20, 2024
Today’s guest post comes from Josh Marsh, Vice President and General Manager, Sonexus™ Access and Patient Support at Cardinal Health Josh discusses challenges manufacturers may face when outsourcing patient support programs. He outlines a process that smoothly transitions hubs and minimizes disruptions for patients and healthcare providers. To learn more, download the 3-step guide to patient hub transitions.
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When selecting a clinical supply provider, consideration often focuses upon the manufacturing, packaging, storage and distribution capabilities available that will, at face-value, be sufficient to meet the needs of the sponsor and their trial. However, there are human-based and knowledge-driven factors that are often overlooked that go beyond these basic physical capabilities and are integral to the development and delivery of high performing clinical supply chains.
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