Dominic Tyer
AUGUST 22, 2023
Changing behaviours across commercial organisations will allow pharma to achieve true customer-centricity by delivering the customer experiences its stakeholders demand
Fierce Pharma
AUGUST 25, 2023
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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European Pharmaceutical Review
AUGUST 25, 2023
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.
Pharmaceutical Technology
AUGUST 25, 2023
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.
Eversana Intouch
AUGUST 25, 2023
“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!
Fierce Pharma
AUGUST 25, 2023
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.
Pharma Rep Focus brings together the best content for pharma rep professionals from the widest variety of industry thought leaders.
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.
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
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
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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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.
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
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
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.
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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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
PharmExec
AUGUST 25, 2023
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.
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.
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.
European Pharmaceutical Review
AUGUST 23, 2023
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.
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.
MedCity News
AUGUST 21, 2023
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.
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.
Fierce Pharma
AUGUST 24, 2023
Moderna is considering pairing one of its mRNA cancer vaccine candidates with a CAR-T therapy from China's CARsgen. GSK's Shingrix showed 100% efficacy in a postmarketing trial in China. | Moderna is considering pairing an mRNA cancer vaccine candidate with a CAR-T therapy from China's CARsgen. GSK's Shingrix showed 100% efficacy in a Chinese post-marketing trial.
European Pharmaceutical Review
AUGUST 23, 2023
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.
MedCity News
AUGUST 22, 2023
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.
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.
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.
European Pharmaceutical Review
AUGUST 22, 2023
According to UK Research and Innovation ( UKRI ), £13 million is set to fund medicine manufacturing in the UK, through a focus on innovation in intracellular drug delivery, digitalisation and automation and nucleic acid medicines. The investment aims to improve vaccines and shorten the time it takes to produce medicines. Winners of a series of competitions centering on the aforementioned topics will obtain funding for UK medicines manufacturing.
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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
AUGUST 22, 2023
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.
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.
Fierce Pharma
AUGUST 25, 2023
Two months after a federal court in Delaware rejected Biogen’s patent infringement c | The FDA has endorsed Novartis' Tyruco as the first U.S. biosimilar to treat multiple sclerosis. The copycat will compete with Biogen's Tysabri, covering all of the original drug's indications for relapsing MS in addition to Crohn’s disease.
European Pharmaceutical Review
AUGUST 21, 2023
According to a market report , the global RNA therapy clinical trials market is anticipated to reach $3.5 billion by 2030 and grow at a CAGR of 3.84 percent from 2023 to 2030. The data stated that expansion of the market in emerging countries is due to factors such as the rising success rate of RNA-based COVID-19 vaccines, regulatory approval, as well as demand for personalised medicines.
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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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