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

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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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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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Skin Microbiome and Allergies: Understanding the Role of Microbes in Allergic Skin Conditions

MedCity News

Future research should focus on identifying the interactions between the immune system, microbes, and allergic responses; and exploring potential therapeutic strategies targeting the skin microbiome for allergy management.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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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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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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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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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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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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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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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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The Importance of Continuous Iteration in Health Equity Plans for REACH ACOs

MedCity News

Next year REACH ACOs will have to show success in developing and maintaining comprehensive health equity plans, and by kicking the can down the road they risk not knowing enough about their patient population in terms of what works better and what doesn’t. ACOs can pay in the effort of continuous iteration now or they can pay in poor health outcomes for their patients and the resulting increased costs.

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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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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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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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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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The Kids Are Not Alright: Why Pediatricians Need to Take Action to Prevent Medicaid Unwinding

MedCity News

Pediatricians and anyone who works with children should proactively reach out to their patients with resources and information about how to maintain coverage. Ask them to make sure their contact information is updated in state databases. Tell them to expect and respond to any communication from the state about their enrollment status.

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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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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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CVS Health enters biosimilar fray with launch of new subsidiary

Pharmaceutical Technology

The newly-launched business, called Corvardis, is already targeting the Humira biosimilar landscape with Hyrimoz via a planned Sandoz-partnered launch in Q1 2024.

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What the FDA's New Dosage Guidance Means for the Future of Clinical Research

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.

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Floridians Sue Florida Over Medicaid Redeterminations Process

MedCity News

Two Florida families allege that tens of thousands of Floridians are being terminated from Medicaid coverage without sufficient information as to why. This comes as the U.S. continues the unwinding of the Medicaid continuous enrollment requirement, which stopped states from disenrolling Medicaid enrollees during the Covid-19 public health emergency.

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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.

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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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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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Unlocking Excellence: How Catalent Is Transforming Japan’s Clinical Research

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

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5 Ways Patient Access Software Solutions Can Transform Mental Health Care

MedCity News

By leveraging sophisticated patient intake forms, robust patient-provider matching algorithms, self-scheduling features, calendar management tools, and telehealth capabilities, healthcare providers can bridge the gap between consumer expectations and the current state of healthcare access.

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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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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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mRNA Immunotherapy Targets Cancer

Medgadget

Researchers at the Mount Sinai Hospital have developed an mRNA-based treatment for cancer. The approach combines the delivery of mRNA therapy in lipid nanoparticles and also involves co-delivering dendritic cells that have also been primed through treatment with lipid-encased mRNA. The technology aims to overcome some of the immune evasive tricks that tumors use to circumvent the immune system, some of which can hamper more traditional immunotherapies.

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Deliver Fast, Flexible Clinical Trial Insights with Spotfire

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.

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FDA Clears New Surgical Platform Combining Robotics & Magnetics

MedCity News

The FDA cleared Levita Magnetics’ new abdominal surgery platform, which combines the company’s proprietary magnetic surgical technology with robotic assistance. The system is designed to deliver all the same patient benefits as its original magnetic surgery system — such as reduced incisions, less pain, fewer scars and speedier recovery — while also giving surgeons better control of their instruments.

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It’s GOAT Time: How Experts Are Changing the Game in Marketing’s New Digital Era

PM360

Michael Jordan, Ryan Reynolds, Mark Zuckerberg, Liz Moench …GOATs (or “greatest of all time” for those unfamiliar with the term). Greats play better than others. GOATs change the game. You know MJ. Great ball player. No, GREAT ball player. His game-changer: licensing his likeness as an icon and his name as a franchise. GOATs create new paths and then run down them.

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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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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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ABM Evolution: How Top Marketers Are Using Account-Based Strategies

In times of economic uncertainty, account-based strategies are essential. According to several business analysts and practitioners, ABM is a necessity for creating more predictable revenue. Research shows that nearly three-quarters of marketers (74%) already have the resources needed to build successful ABM programs.