Sat.Aug 19, 2023 - Fri.Aug 25, 2023

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Creating the right foundations for omnichannel success

Dominic Tyer

Changing behaviours across commercial organisations will allow pharma to achieve true customer-centricity by delivering the customer experiences its stakeholders demand

Pharma 130
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What infeasible trial? Lilly shows Roche how it's done with positive Retevmo readout in thyroid cancer

Fierce Pharma

It was only a few weeks ago when Roche said a phase 3 study testing its RET inhibitor Gavreto in a type of thyroid cancer was not doable. | A few weeks ago, Roche said a phase 3 study testing its RET inhibitor Gavreto in a type of thyroid cancer was not doable. Now, Eli Lilly has revealed that a similar trial of its Retevmo was not only feasible but positive.

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Trending Sources

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Pharmaceutical migration study sampling procedure reported

European Pharmaceutical Review

A paper published in Molecules has detailed a strategy and evaluation approach for acceptable classification of species usually detected in migration studies. This can therefore support extractable and leachable (E&L) studies. Migration studies are one of the few domains of QA/QC pharmaceutical analysis employing wide-scope screening methodologies, the paper noted.

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Pfizer’s first-ever bispecific antibody Elrexfio holds promise in multiple myeloma

Pharmaceutical Technology

The US Food and Drug Administration's recent accelerated approval of Pfizer's Elrexfio for the treatment of adult patients with relapsed or refractory multiple myeloma (RRMM) has made a significant impact in the oncology community.

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AI Strategies for Sales Managers: How to Cut Down on Tedious Admin Work

What if you could help your sellers stop wasting 72% of their day on non-selling activities and focus on bringing in revenue? Incorporating AI in your enablement workflows can help you cut down on busy work, get projects done faster, and let your team (and you!) focus on making a bigger impact. We put together this guide to show you how to use AI to cut time and costs for projects, including collateral creation, development of training videos, and automating tedious processes.

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85,000 Kaiser Workers Will Soon Vote to Authorize What Could Be the Biggest Healthcare Strike in US History

MedCity News

The Coalition of Kaiser Permanente Unions announced that it will soon begin conducting strike authorization votes among its 85,000 members. The coalition’s chief concern is Kaiser’s dangerous staffing levels, which members say have led to excessively long wait times, patient neglect and mistaken diagnosis. If the coalition authorizes and implements the strike, it will become the largest strike of healthcare workers in the history of the U.S.

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Cabometyx study ends early after researchers see 'dramatic' benefits in neuroendocrine tumors, Exelixis says

Fierce Pharma

It's not always a good thing when a drug developer stops a cancer trial. But in a recent case for Exelixis, a Cabometyx trial ended early because of an undeniable efficacy showing. | Exelixis' drug proved its worth in treating advanced pancreatic and extra-pancreatic neuroendocrine tumors, so much so that an independent board unanimously recommended an early stop.

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When Does Healthcare Marketing Become Too Niche?

PM360

As healthcare advertisers work to maximize their promotional budgets, an ongoing shift is occurring from broad-based to niche market spending. The competition lies in having the best insights and access to first-party data to secure budgets and then creating opportunities with the reach to maximize these budgets. However, while hyper-targeting can ensure dollars are maximized, a catch-22 may be missing the most critical part of the patient journey: the first point of care—or primary care provide

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What the Success of “Barbie” Means for Women’s Health

Eversana Intouch

“Aside from the smashing success of ‘Barbie’ setting box office records, topping more than [$1 billion] and counting, the movie is also doing something much more important than sales – shining a spotlight on women’s health. In a time where there seems to be a war waged on women’s reproductive health and autonomy, Barbie (of all symbols!

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On a roll, Novo's star obesity drug Wegovy shows benefits in patients with heart failure

Fierce Pharma

Just a few short weeks after Wegovy posted a major cardio outcomes win, Novo Nordisk has chalked up another heart-related victory for its semaglutide star. | In a phase 3 study, semaglutide at the 2.4 mg dose bested placebo at reducing symptoms and physical limitations in patients with obesity and heart failure with preserved ejection fraction. The drug also led to greater improvements in exercise function and more weight loss versus a dummy drug, according to study results published in The New

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FDA grants first approval for multiple sclerosis biosimilar

European Pharmaceutical Review

The first US Food and Drug Administration (FDA)-approved biosimilar has been authorised to treat multiple sclerosis. Tyruko (natalizumab-sztn) is a biosimilar to Tysabri (natalizumab) injection for adults with relapsing forms of MS. Approval of Tyruko has been granted to Sandoz Inc. It is indicated for the following relapsing forms of MS: Clinically isolated syndrome – a single, first occurrence of MS symptoms Relapsing-remitting disease – in this type of MS, episodes of new neurological symptom

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From Diagnosis to Delivery: How AI is Revolutionizing the Patient Experience

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

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The PM360 Trailblazer Awards 2023 Finalists

PM360

The finalists are in for PM360’s 15 th annual Trailblazer Awards. Established in 2009, the Trailblazer Awards recognize and honor outstanding companies, marketers, marketing teams, brand managers, and initiatives that have demonstrated innovation and achieved incredible results in the life sciences. The awards honor achievements in eight overall categories, including Companies of the Year, CEOs of the Year, Products of the Year, Marketer of the Year, Marketing Team of the Year, Lifetime Ac

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CCC & GO FAIR Foundation Host Forum on Building AI Strategies with FAIR Data

Copyright Clearance Center

August 24, 2023 – Danvers, Mass. – CCC , a leader in advancing copyright, accelerating knowledge, and powering innovation, in partnership with the GO FAIR Foundation , will host its inaugural FAIR Forum on “The Evolving Role of Data in the AI Era” on 18 September at Poortgebouw , the University of Leiden, the Netherlands. With new AI services being introduced on an almost daily basis, the adoption of FAIR Data Principles ( F indable, A ccessible, I nteroperable, and R eusable) is more important

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Look out, Teva. Neurocrine's Ingrezza wins Huntington's disease FDA nod to rival Austedo

Fierce Pharma

With a new FDA approval to rival Teva's Austedo, Neurocrine Biosciences’ Ingrezza is debuting in a treatment area with hundreds of millions of dollars of revenue potential. | The FDA approved Ingrezza capsules to treat adult with chorea associated with Huntington’s disease. Ingrezza was first approved in tardive dyskinesia in 2017. With its second approval, the medication’s label now largely stacks up to Teva Pharmaceuticals’ Austedo.

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GSK shingles vaccine achieves 100 percent efficacy in China trial

European Pharmaceutical Review

GSK’s Shingrix (Recombinant Zoster Vaccine or RZV) vaccine has been shown to offer 100 percent efficacy against shingles in adults 50 years old and over in China. The Phase IV trial (ZOSTER-076) is the first-ever efficacy trial of the shingles vaccine Shingrix in China. Almost 6,000 participants were enrolled in the trial, which was conducted between 2021 and 2023.

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Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model

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FDA Offers GDUFA III Insight

PharmExec

The Generic Drug User Fee Amendments, designed to facilitate the delivery of safe and effective generic drugs to the public and improve the predictability of the ANDA assessment process, has undergone changes that will impact the pre-ANDA and ANDA approval process—and ultimately the path for generic drugs to approval.

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Harnessing the Power of Generational Diversity as a Competitive Advantage

PM360

For the first time in the history of business, up to five generations of employees are working together. Today’s workforce includes Traditionalists (born 1927-1945), Boomers (1946-1964), Gen X (1965-1980), Millennials (1981-1996), and Gen Z (1997-2015). Uniting people of different ages, perspectives, experiences, interests, and skillsets in shared goals is not without challenges, though multigenerational workforces are both valuable and critical to the future of work.

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After Regeneron scores FDA nod for high-dose Eylea, it’s game on in showdown with Roche’s Vabysmo

Fierce Pharma

Regeneron pulled off a rare double play on Friday afternoon as it scored two FDA approvals—one under the radar and the other highly anticipated. | With the FDA signing off on Regeneron and Bayer’s high-dose Eylea, the companies are set to take on Roche’s Vabysmo in a high-stakes battle for the massive eye disease market.

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New Parkinson’s drug formulation “nearly doubles” exposure

European Pharmaceutical Review

A new drug formulation of a protein kinase inhibitor therapeutic designed to modify the course of Parkinson’s diseas e has been developed. The Abelson Tyrosine Kinase (c-Abl) inhibitor risvodetinib (IkT-148009), “nearly doubles” drug exposure, according to Inhibikase Therapeutics’ CEO. Dr Milton Werner, President & CEO of Inhibikase explained that the company “recently completed characterisation of a novel tablet formulation that mimics the oral drug formulation we used to evaluate eff

Safety 98
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How Machine Learning Drives Clinical Trial Efficiency

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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Prioritizing SDOH for Patients Living with Chronic Diseases: Compassion, Coordination and Community

MedCity News

As the U.S. healthcare system works to focus on the move to preventive, personalized care for patients, it’s time to turn the tide on diabetes by addressing the three Cs of chronic disease care: compassion, coordination, and community.

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Building Patient Trust Through Authentic Imagery in Healthcare Marketing

PM360

With rapid advancements in healthcare and science, it is important that underrepresented communities don’t get left behind as new products are developed and brought to market. Visually representing diversity in marketing can help expose your brand to new and underserved audiences, which not only helps close that gap, but can increase impact and drive successful campaigns.

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AstraZeneca jumps on IRA litigation bandwagon, raising concerns over 'unintended consequences' in rare disease R&D

Fierce Pharma

With one week to go until the Centers for Medicare and Medicaid Services (CMS) releases its list of ten drugs up for the first round of pricing negotiations, AstraZeneca is jumping into the legal b | The company cited concerns with the law's consequences for orphan drug development. AstraZeneca becomes the sixth drugmaker to file suit against the IRA.

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Eli Lilly therapeutic shows potential in thyroid cancer

European Pharmaceutical Review

Eli Lilly and Company ’s highly selective and potent RET kinase inhibitor for advanced medullary thyroid cancer (MTC) has demonstrated superior progression-free survival (PFS) compared to approved multikinase inhibitors. These topline results are from an interim efficacy analysis of a Phase III study that compared Retevmo ® (selpercatinib) against multikinase inhibitors (MKIs) cabozantinib or vandetanib.

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How to Prove Marketing Value: Demonstrate Content ROI and Contribution to Sales

Every marketer knows how important it is to prove their efforts drive sales opportunities, but that’s easier said than done. When problems like sales and marketing misalignment, lack of data, and wasted efforts persist, marketers can’t measure, prove, or increase their impact on revenue at a time when demonstrating marketing value is critical. Using analyst and expert data, this guide to marketing impact and content attribution explains: How B2B buyers use content The most common types of conten

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An Inside Look into TransCelerate BioPharma

PharmExec

In this exclusive Q&A with Pharmaceutical Executive, Janice Chang, CEO of TransCelerate BioPharma, provides an inside look into her career journey, her work at the company, how the industry has changed in the last 10 years, as well as her thoughts on where the industry should put its efforts in clinical trials.

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Pharma Has a Pull-Through Problem—The Answer is Data

PM360

Most market access teams at pharmaceutical and biotech manufacturers have the same problem: evidence of clinical effectiveness isn’t always enough to affect prescribing behavior, often due to—accurate or misperceived—access and affordability concerns. The inability to “pull through” a prescription, despite healthcare provider (HCP) field team engagement and educational efforts, stubbornly remains a top client concern after 15 years of working in the market access space.

Pharma 98
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KRAS crisis? FDA will gather advisers to weigh full approval for Amgen's Lumakras

Fierce Pharma

First came doubts about the combinability of Amgen’s Lumakras with a standard PD-1 inhibitor. | The FDA will hold an advisory committee meeting to discuss confirmatory trial data for Amgen's Lumakras in KRAS-mutated lung cancer. This comes after a bumpy stretch for the medicine since its debut in 2021.

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Proposed non-animal derived reagent Chapter published

European Pharmaceutical Review

Chapter <86> Bacterial Endotoxins Test Using Recombinant Reagents, proposed by the USP Microbiology Expert Committee, is now published as a General Announcement. This is in advance of the official open comment period, according to USP. Comments are welcome from 1 November 2023 to 31 January 2024. The new standard was proposed by the committee earlier in 2023.

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How to Stay Competitive in the Evolving State of Martech

Marketing technology is essential for B2B marketers to stay competitive in a rapidly changing digital landscape — and with 53% of marketers experiencing legacy technology issues and limitations, they’re researching innovations to expand and refine their technology stacks. To help practitioners keep up with the rapidly evolving martech landscape, this special report will discuss: How practitioners are integrating technologies and systems to encourage information-sharing between departments and pr

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Innovaccer Unveils AI Suite With Automation Tools For Doctors, C-Suite Execs, Care Managers & More

MedCity News

Innovaccer announced a new suite of healthcare products. It comprises four different solutions — one for answering healthcare executives’ questions about their business metrics, one for automating care planning and documentation, one for generating clinical visit summaries, and one for streamlining workflows at contact centers.

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Embracing the Power of Generative AI in Clinical Research

PM360

In many respects, the arrival of generative artificial intelligence (AI) represents an entirely expected leap forward. It was always going to be simply a matter of time before we arrived here, technologists having assembled the necessary computing power to bring this new wave of technology to life. What is genuinely surprising is how soon it came. And with its arrival, AI is moving from the cutting edge into the mainstream of clinical research.

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UK pumps £13M into wide-ranging group of manufacturing projects

Fierce Pharma

Improved vaccines, cutting-edge mRNA medicines and accelerated drug production are at the heart of a new funding project in the U.K., where 17 companies have been selected for government grants to | Improved vaccines, cutting-edge medicines and accelerated drug production are at the heart of a new funding project in the U.K.

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AI/ML to drive bioprocess containers market

European Pharmaceutical Review

Between 2023-2028, the global bioprocess containers market is anticipated to see strong growth. A market report by Research and Markets considers this to be mainly due to the higher demand for automation and machine learning in the biopharmaceutical industry. Bioprocess containers are advantageous compared to traditional stainless-steel equipment. This is because they offer lower capital expenditures, reduced contamination risk, higher flexibility, and are more efficient.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time