Fierce Pharma

AUGUST 24, 2023

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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MedCity News

AUGUST 24, 2023

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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Fierce Pharma

AUGUST 24, 2023

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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PM360

AUGUST 24, 2023

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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Fierce Pharma

AUGUST 24, 2023

Royalty Pharma has built a niche by finding innovative products pre- and post-approval from companies that need an infusion of cash in exchange for future royalties. | Royalty Pharma has signed a deal with Ferring Pharmaceuticals to collect royalties on bladder cancer drug Adstiladrin. Royalty will pay $300 million up front and $200 million in a potential milestone tied to Ferring meeting certain manufacturing goals.

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PM360

AUGUST 24, 2023

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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PM360

AUGUST 24, 2023

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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Fierce Pharma

AUGUST 24, 2023

After the “extreme disappointment” of vadadustat’s anemia snub in March 2022—plus a partnership gone awry and a formal dispute with the FDA—Akebia Therapeutics has dusted itself off and readied for | After the “extreme disappointment” of vadadustat’s anemia snub in March 2022—plus a partnership gone awry and a formal dispute with the FDA—Akebia Therapeutics has dusted itself off and readied for a second bid at approval.

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PM360

AUGUST 24, 2023

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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Fierce Pharma

AUGUST 24, 2023

As the Federal Trade Commission tries to block Amgen’s $28 billion acquisition of Horizon Therapeutics with an injunction, Amgen has a lot to say in court filings. | The Federal Trade Commission is trying to block Amgen’s proposed $28 billion acquisition of Horizon Therapeutics. Amgen has a lot to say as the case plays out in court.

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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.

Safety

PM360

AUGUST 24, 2023

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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Copyright Clearance Center

AUGUST 24, 2023

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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PM360

AUGUST 24, 2023

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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European Pharmaceutical Review

AUGUST 24, 2023

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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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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PM360

AUGUST 24, 2023

The U.S. biosimilars market is evolving rapidly and pharma marketing programs need to evolve as well to better meet physician needs. The increased use of biosimilars has the potential to result in significant cost savings for the U.S. healthcare system but we haven’t seen widespread acceptance by doctors and patients. As we found in our latest physician survey, physicians are actively seeking more information on key topics such as patient affordability, patient eligibility, clinical results, for

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MedCity News

AUGUST 24, 2023

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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Patients 95

PM360

AUGUST 24, 2023

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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Pharmaceutical Technology

AUGUST 24, 2023

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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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.

Safety

MedCity News

AUGUST 24, 2023

For the sixth year in a row, the Medicare Shared Savings Program created overall savings, CMS announced. When compared to clinician groups of a similar size not participating in the program, participating ACOs performed better on quality measures, including measures for diabetes, breast cancer and colorectal cancer screenings, tobacco screenings and depression screenings.

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European Pharmaceutical Review

AUGUST 24, 2023

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

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MedCity News

AUGUST 24, 2023

In a new agreement, Interwell Health will provide care to Humana Medicare Advantage HMO and PPO members with chronic kidney disease in 13 states. It will also serve patients with end-stage kidney disease across the country.

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Patients 89

Pharmaceutical Technology

AUGUST 24, 2023

Dizal has received approval from China’s NMPA for sunvozertinib to treat adult patients with locally advanced or metastatic NSCLC

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Patients 98

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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.

Specialization

PharmaTimes

AUGUST 24, 2023

The drug is the first to be approved in Japan to treat children and adolescents with& generalised myasthenia gravis - News - PharmaTimes

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Patients 86

Pharmaceutical Technology

AUGUST 24, 2023

Japan has granted a new drug substance patent for BioArctic’s monoclonal antibody (mAb), BAN0805, to treat Parkinson’s disease.

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PharmaVoice

AUGUST 24, 2023

New variants drive a need for another round of shots, and biopharma companies are stepping up to the plate.

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Biopharma 98

PharmaTimes

AUGUST 24, 2023

The drug is currently being assessed in a phase 1b/2a clinical trial - News - PharmaTimes

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FDA 83

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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

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Cesare Ferrari

AUGUST 24, 2023

Small and mid-size MedTech enterprises (SMEs) contemplating entering international markets will need to develop knowledge, competencies, and expertise in some areas such as cultural sensitivity. Already, some sales managers think that international selling is challenging, while others think it is somewhat easy. However, most who have tried it, see international sales as simply different and no more demanding than selling in the home market.

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Impetus Digital

AUGUST 24, 2023

This is a guest article and does not necessarily reflect the views and values of Impetus Digital. Smart hospitals are elevating patient care and revolutionizing hospital operations like never before. They are about refining processes, reducing human error, and delivering more accurate, personalized care. So, how about we get into these game-changing solutions and the benefits they can bring?

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PM360

AUGUST 24, 2023

Press Release Contact: Andrew Matthius Senior Editor, PM360 646-300-8113 andrew.matthius@pm360online.com PM360 Announces 2023 Trailblazer Award Finalists Top Companies, Marketers, CEOs, Products, and Initiatives to be Honored During Gala on October 3 rd NEW YORK, NY, August 24, 2023— PM360 has announced the finalists for its 15 th annual Trailblazer Awards.

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Marketing Education Media Healthcare 52

PharmExec

AUGUST 24, 2023

In this Q&A, Matt Smith, Vice President Research Site Development, Slope discusses the competition pharma companies and trial sponsors face when trying to become a sponsor of choice and build trust with sites and patients.

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Competition Pharma Patients 52

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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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