Fierce Pharma
MARCH 8, 2024
Novo Nordisk’s fast-growing weight loss med Wegovy just added a new cardiovascular FDA approval to its label, likely enabling the med's superstar status to reach new levels. | The drug is the first weight loss treatment to win FDA approval to reduce the risk of severe cardiovascular outcomes, giving it an edge over rival Zepbound from Eli Lilly.
MedCity News
MARCH 8, 2024
Amylyx Pharmaceuticals co-CEO Justin Klee previously said the company would withdraw ALS drug Relyvrio from the market if it failed its Phase 3 clinical trial. The biotech has set an eight-week timeline to evaluate its next steps.
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Fierce Pharma
MARCH 8, 2024
As President Joe Biden doubles down on the price negotiation meas | As President Joe Biden doubles down on the price negotiation measures in the Inflation Reduction Act, prominent industry lobbying group the Pharmaceutical Research and Manufacturers of America isn’t letting its legal challenge go down without a fight.
Pharmaceutical Technology
MARCH 8, 2024
Participants cannot remain blind to their treatment arm due to the properties of TauRx's drug, which causes urinary discoloration.
Fierce Pharma
MARCH 8, 2024
After reporting the failu | After reporting the failure of a confirmatory trial of its amyotrophic lateral sclerosis drug Relyvrio (AMX0035), Amylyx Pharmaceuticals is uncertain whether it will pull the treatment from the market in the U.S. and in Canada, where it is known as Albrioza.
MedCity News
MARCH 8, 2024
Bill Fera — a principal and head of AI at Deloitte — said that the generative AI frenzy holds incredibly promising opportunities for health systems. He noted that in order for hospitals to succeed in the era of generative AI, they need to establish the right metrics for their pilots early on so they can quickly nix or scale them.
Pharma Rep Focus brings together the best content for pharma rep professionals from the widest variety of industry thought leaders.
MedCity News
MARCH 8, 2024
Regardless of the path to market they ultimately take, DTx companies must be poised to harness and deploy data and information that can prove their products’ economic value. Without it, the innovative treatments that they produce will continue to struggle to find success.
European Pharmaceutical Review
MARCH 8, 2024
Headline results from Novo Nordisk AS’s kidney outcomes FLOW trial reveal that injectable semaglutide 1.0mg demonstrated a statistically significant and superior reduction in kidney disease progression as well as cardiovascular and kidney death of 24 percent. This was based on treatment policy estimand: treatment effect regardless of treatment adherence, Novo Nordisk confirmed.
Pharmaceutical Technology
MARCH 8, 2024
Johnson & Johnson (J&J) has concluded the acquisition of Ambrx Biopharma in a transaction valued at approximately $2bn.
European Pharmaceutical Review
MARCH 8, 2024
Researchers have described the impact of data integrity, GAMP 5 and quality by design (QbD) principles on pharmaceutical quality assurance (QA) , highlighting the importance of data integrity through various case studies. The authors explained first that “a robust quality assurance framework” is needed to ensure medicinal products are safe and efficient.
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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.
Pharmaceutical Technology
MARCH 8, 2024
The FDA has already granted accelerated approvals to several third-line treatments, with big pharma being prominent in the landscape.
pharmaphorum
MARCH 8, 2024
Amongst Novo Nordisk's comprehensive business update to investors, attention latched onto early data for an oral obesity therapy that outperformed the company’s big-selling GLP-1 agonist Wegovy in a clinical trial. The drug, called amycretin and codenamed NN9487, is a dual agonist that targets both GLP-1 and amylin and is being developed in both oral and subcutaneous injection formulations.
Pharmaceutical Commerce
MARCH 8, 2024
A proposed Senate bill is intended to protect citizens’ private health and genetic information.
pharmaphorum
MARCH 8, 2024
In another inflection point for the psychedelic medicines category, Mind Medicine (MindMed) has claimed breakthrough status from the FDA for its LSD-based treatment candidate MM120 as a treatment for anxiety.
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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
PharmaTimes
MARCH 8, 2024
The gamma treatment also shows potential for treating patients living with neurological diseases
pharmaphorum
MARCH 8, 2024
The UK government plans to link the NHS App to data generated by smart devices, including step counts and heart rate, according to Health Secretary Victoria Atkins.
MedCity News
MARCH 8, 2024
The boutique healthcare conference in Chicago is scheduled for May 21-22 at the Ritz Carlton hotel.
PharmaTimes
MARCH 8, 2024
The rare epileptic seizure disorder currently affects around one in 42,000 people in the UK
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Clinical research has entered a new era, one that requires real-time analytics and visualization to allow trial leaders to work collaboratively and to develop, at the click of a mouse, deep insights that enable proactive study management. Learn how Revvity Signals helps drug developers deliver clinical trial data insights in real-time using a fast and flexible data and analytics platform to empower data-driven decision-making.
MedCity News
MARCH 8, 2024
Check out news from Band Connect, Fijoya, Team8, and BrainCheck.
pharmaphorum
MARCH 8, 2024
BeiGene’s BTK inhibitor Brukinsa has become the first drug in the class to be approved in the US for follicular lymphoma, giving it the broadest label among its rivals
PharmExec
MARCH 8, 2024
FDA approves Wegovy (semaglutide) to lower the risk of major adverse cardiovascular events in adults with known heart disease and with either obesity or overweight, in addition to a reduced calorie diet and increased physical activity.
Clarivate
MARCH 8, 2024
Originally published October 20, 2016. Updated March 8, 2024 In the sprawling and complex world of research, attribution matters. Individual researchers, teams and institutions each deserve credit for their contributions and this credit underpins career advancement, research funding and trust in the scholarly record. However, with over 2.5 million research papers produced each year , keeping track of what happens where and who does it is no easy feat.
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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.
PharmExec
MARCH 8, 2024
In this Pharmaceutical Executive video interview, Daniel Ayala, Chief Security and Trust Officer, Dotmatics discusses how the data integrity landscape will evolve over the next five years and what extent bench scientists in the lab focused on data integrity.
Pharmaceutical Commerce
MARCH 8, 2024
In this Pharmaceutical Commerce video interview, Emma Banks, CEO of ramarketing, talks about what emerging scientific advancements will have the biggest impact on the future direction of the biotechnology industry.
PharmExec
MARCH 8, 2024
Because of the unique trial design of the Phase III TRAILBLAZER-ALZ 2 study, the FDA is seeking additional input regarding the safety and efficacy of donanemab for the treatment of early symptomatic Alzheimer disease.
ALULA
MARCH 8, 2024
International Women’s Day (IWD) is kicking off with local and global celebrations dedicated to the social, economic, cultural, and political achievements of women. This year’s theme is “ Inspiring Inclusion ,” and i t gives us an opportunity to recognize how everyone everywhere can take steps to inspire inclusion.
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Clinical development organizations face a wide array of challenges when it comes to data, many of which can impact the operational effectiveness of their clinical trials. In this whitepaper, experts from Revvity Signals explore how solutions like TIBCO® Spotfire® enable better, more streamlined studies. The whitepaper also features a success story from Ambrx, a leading biopharmaceutical company, detailing how it has leveraged Spotfire to tackle data quality and collaboration challenges in clinic
Rep-Lite
MARCH 8, 2024
Work/life balance is crucial for medical sales personnel, yet often elusive due to demanding schedules and intense job pressures. Balancing client meetings, product knowledge updates, and administrative tasks with personal life commitments can lead to burnout and strained relationships. It’s vital as it ensures overall well-being, productivity, and job satisfaction.
PharmExec
MARCH 8, 2024
BeiGene’s Brukinsa is a small molecule Bruton’s tyrosine kinase inhibitor indicated as a monotherapy and in combination with other treatments for various B-cell malignancies.
Pharmacy Times
MARCH 8, 2024
Semaglutide (Wegovy; Novo Nordisk) reduces the risk of cardiovascular death, heart attack, and stroke in adults with cardiovascular disease and either obesity or overweight when combined with the standard-of-care.
Pharmaceutical Commerce
MARCH 8, 2024
With out-of-pocket healthcare costs resulting in financial issues for patients, a cross-sectional study closely examines whether they are linked to more premature deaths.
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As the development pipeline for new drugs continues to grow, biopharmaceutical companies are re-evaluating how to best manage and balance resources across an increasing number of development projects and complex clinical trials. There are two approaches that can be used to speed a drug from development to clinic faster: timeline compression and parallel processing, but only one that considers the benefits of integrating clinical supply into the overall drug development process.
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