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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Trending Sources

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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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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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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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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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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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More Trending

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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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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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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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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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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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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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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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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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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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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.

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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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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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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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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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ABM Success Recipe: Mastering the Crawl, Walk, Run Approach

Shifting to an account-based marketing (ABM) strategy can be both exciting and challenging. Well-implemented ABM motions build engagement with high-value accounts and drive impactful campaigns that resonate with your audience. But where do you begin, and how do you progress from crawling to running? Watch now as Demand Gen experts delve into the essentials of each stage of the ABM process.

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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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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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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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What Are the Highest-rated MA Plans Based on Customer Satisfaction?

MedCity News

Some of the highest-ranked Medicare Advantage plans are SCAN Health Plan, Humana, Excellus BlueCross BlueShield, UPMC for Life and Blue Cross Blue Shield of Texas, according to a new J.D. Power report.

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How Intent Data Helps Marketers Convert A-List Accounts

One of the biggest challenges for any B2B marketer is understanding your prospects’ next move — who is most likely to buy and when. Without these insights, marketing campaigns can feel more like guesswork, with high investment and little return. We’re here to tell you there’s a better way. By tracking buyers’ digital footprints and online activity, such as website visits, product reviews, and spikes in content consumption, you can engage prospects with a message that really resonates.

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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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Revised Annex 1 now effective

European Pharmaceutical Review

The European Commission (EC)’s revised Annex 1 – Manufacture of Sterile Medicinal Products is now effective in the EU. As of 25 August 2023, pharmaceutical manufacturers are required to implement the GMP regulation into cleaning and bio-decontamination procedures for these products. What is included in the new revision? According to the EC, revision to the document has been made to reflect changes in regulatory and manufacturing environments.

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Another Keytruda-Lenvima ambition is dashed as Merck, Eisai end head and neck cancer trial

Fierce Pharma

Add another failed trial to the list of setbacks for Merck and Eisai’s combination of Keytruda and Lenvima. | Add another failed trial to the list of setbacks for Merck and Eisai’s combination of Keytruda and Lenvima. The companies have decided to shut down a phase 3 study testing the PD-1/TKI combo in first-line head and neck cancer.

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3 Reasons Why The Biopharma M&A Market Is Ready For Takeoff

MedCity News

Healthcare M&A deals are expected to pick up over the next few months, and one expert is predicting that the biopharma sector in particular will see especially robust activity. M&A lawyer Matt Gardella said there are three sets of market circumstances that will lead to an influx of biopharma deals: a looming patent cliff, shrinking valuations and a weak IPO market.

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Solving the Biggest Tech Challenges in RevOps

In this eBook, we’ll run through real-world examples that show how RevOps teams can benefit from modern solutions for the access, management, and activation of their GTM data. Whether you need to improve lead response times, boost adoption of core tools, improve lead qualification, or target and automate your GTM motions, you’ll find examples of how revenue teams are solving some of the toughest problems in modern business.

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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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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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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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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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Drive GTM Efficiency with Tech Stack Consolidation

Consolidating your tech stack is an effective cost-saving measure that drives GTM efficiency and adds value to your enterprise. With a cohesive, integrated tech stack, your revenue teams can deliver an excellent customer experience that sets you up to win faster than your competitors.