Fri.Apr 12, 2024

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FDA advisers back new endpoint for myeloma approvals, paving way for faster introduction of new drugs

Fierce Pharma

After oncology experts reviewed arguments in favor of a surrogate endpoint to support multiple myeloma drug approvals, drug developers may soon have a new pathway in the R&D journey. | After oncology experts reviewed arguments in favor of a surrogate endpoint to support multiple myeloma drug approvals, drug developers may soon have a new pathway in the R&D journey.

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Why Hospitals Are Condemning CMS’ Proposed Inpatient Payment Rule

MedCity News

CMS released a proposed rule this week that would boost hospitals’ inpatient payment rates by 2.6%. Hospitals groups have swiftly denounced this plan, arguing that this payment update is insufficient and will jeopardize hospitals’ financial stability. The post Why Hospitals Are Condemning CMS’ Proposed Inpatient Payment Rule appeared first on MedCity News.

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Shareholders approve AstraZeneca's 2024 pay proposal for CEO Pascal Soriot despite proxy adviser discontent

Fierce Pharma

History is repeating for AstraZeneca CEO Pascal Soriot, who successfully dodged an executive pay revolt at the company’s annual meeting Thursday, echoing a similar situation that played out in 2021 | Out of more than 1.18 billion votes cast by AstraZeneca shareholders at the company's annual meeting this week, 64.43% of investors voted in favor of an updated pay policy that could see CEO Pascal Soriot earn upward of 18.7 million pounds sterling ($23.5 million) for his performance this year.

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EMA Says No Evidence for Link between Type 2 Diabetes Drugs and Suicidal Tendencies

PharmaTech

The agency’s risk assessment committee has concluded that available evidence has not been found that supports a causal association between glucagon-like peptide-1 receptor agonists and self-harming thoughts and actions.

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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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With 9% pay hike, Merck CEO Davis entered $20M compensation club in 2023

Fierce Pharma

Merck CEO Robert Davis has cracked the $20-million mark in annual pay for the first time, putting him in an exclusive club of biopharma heavy hitters. | Merck CEO Robert Davis has cracked the $20-million mark in annual pay for the first time, putting him in an exclusive club of biopharma heavy hitters. Davis, 57, received a 9% bump in pay in 2023 to $20.3 million, according to the company’s proxy filing.

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Bridging the Gap Between Physical and Mental Health

MedCity News

Prioritizing integration and accessibility is not just good practice, it’s a moral and strategic imperative. The post Bridging the Gap Between Physical and Mental Health appeared first on MedCity News.

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Kaiser Permanente Unveils Food is Medicine Center of Excellence

MedCity News

Kaiser Permanente’s new Food is Medicine Center of Excellence will “combine clinical services, research, education and community engagement,” according to the organization. The post Kaiser Permanente Unveils Food is Medicine Center of Excellence appeared first on MedCity News.

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Ex-broadcaster Paxman hands Parkinson’s wish list to UK PM

pharmaphorum

To mark World Parkinson’s Day, former broadcaster Jeremy Paxman has delivered a list of recommendations for improving how the disease is managed in the UK to Prime Minister Rishi Sunak.

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Another ADC Developer Lands a Mega Round of Financing for Cancer Clinical Trials

MedCity News

Torl BioTherapeutics’ $158 million Series B-2 financing will finance clinical testing of its pipeline of antibody drug conjugates in development for various types of cancer. Neuroscience and immunology are among the therapeutic areas represented in our roundup of other recent biotech financings. The post Another ADC Developer Lands a Mega Round of Financing for Cancer Clinical Trials appeared first on MedCity News.

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CRISPR technologies fuelling haematological innovations

European Pharmaceutical Review

There has been a “notable” rise in licensing agreements for innovator drugs incorporating clustered regularly interspaced short palindromic repeats (CRISPR)-based technology for gene therapies over the past five years, according to data and analytics firm GlobalData. These agreements have amassed a total deal value of $21 billion. Of note, between 2020 to 2022, there was a “remarkable surge” in deal worth.

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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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BioMarin’s Voxzogo shows promise in hypochondroplasia

pharmaphorum

BioMarin’s Voxzogo has been shown to increase growth rates in children with hypochondroplasia, a genetic cause of very short stature, in a phase 2 trial

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Study suggests tumour microenvironments could predict cancer progression

PharmaTimes

NSCLC is the most common type of lung cancer and is responsible for up to 85% of all cases

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TORL rakes in $158m for ADCs, and other bio financings

pharmaphorum

Our regular round-up of financings in the biotech sector features rounds for TORL BioTherapeutics, Nvelop Therapeutics, D3 Bio, and Century Therapeutics.

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Novel medicine could address short stature in children

European Pharmaceutical Review

The first-of-its-kind global Phase II study for vosoritide has demonstrated that children with hypochondroplasia, a genetic cause of short stature in children, achieved an increased average growth rate of 1.8 cm annually. [vosoritide] is the first medicine that has been developed to specifically target the pathway involved in hypochondroplasia” “This is the first medicine that has been developed to specifically target the pathway involved in hypochondroplasia,” commented Dr Andrew Dauber,

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Roles and Responsibilities of Specialized Clinical Supply Experts

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.

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Moderna pauses plans to build mRNA facility in Kenya

Pharmaceutical Technology

Moderna has announced the halt of its project to build a messenger ribonucleic acid (mRNA) manufacturing facility in Kenya.

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AZ shareholders back CEO Soriot’s pay package, amid dissent

pharmaphorum

Shareholders in AstraZeneca have voted to approve controversial increase in the salary and bonus package for CEO Pascal Soriot.

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KCL and McMaster University partner to advance nuclear medicine research

PharmaTimes

Both partners’ will leverage their nuclear research facilities and expertise to develop new health interventions

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3 big recent trial flops

PharmaVoice

Why these clinical setbacks impacted the companies, industry and patients.

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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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UK charities condemn continued drug shortages

Pharmaceutical Technology

As the UK tackles several drug shortages, UK charities and pharmacists called for urgent action to be taken.

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Pharma Pulse 4/12/24: The Road Ahead for GenAI-Enabled/Augmented Clinical Trials, The Health and Healthcare of Boomers & more

Pharmaceutical Commerce

The latest news for pharma industry insiders.

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Selling A Life Saving App With Military Veteran Bryan Lorden

Evolve Your Success

When Bryan Lorden’s life was touched by tragedy, it sparked a mission: to prevent others from experiencing the same heartache. That’s what led Bryan, a military veteran, to create Vesta Sleep, a life-saving app we dive into in our latest episode. This innovative tool, designed for wearable tech, doesn’t just track sleep—it also has the potential to alert users and their emergency contacts during critical medical situations, a feature born from the devastating loss of Bryan

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Does the Use of Hepatitis C Antivirals Surge Following an Easing of Medicaid Coverage Restrictions?

Pharmaceutical Commerce

A difference-in-differences analysis explores the correlation between direct-acting antiviral prescriptions for hepatitis C virus and the softening of state-level limitations.

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Accelerating Clinical Supply Through Integrated Drug Development

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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Supply Shortages in Weight Loss Drugs

PharmExec

In this Pharmaceutical Executive video interview, Currax Pharmaceuticals, CEO, George Hampton, discusses factors that are contributing to ongoing supply issues and if prices for these therapies are coming down anytime soon.

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FDA approves AstraZeneca’s FASENRA for asthma in children

Pharmaceutical Technology

The US FDA has granted approval for AstraZeneca's FASENRA in children aged six to 11 years with severe asthma and an eosinophilic phenotype.

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Trends in Continuing Medical Education

PharmExec

Elliott Yoo, Senior Media Strategist at epocrates, takes a closer look at the trends in CME consumption and what the future of medical education will be – from the priorities for physicians as they juggle learning with patient care, to what type of activities resonate most with prescribers.

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FDA approves new administration routes for Xcopri 

Pharmaceutical Technology

SK Life Sciences Xcopri (cenobamate) is approved as an oral suspension mixed with water for mouth administration or via a nasogastric tube.

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Clinical Data Like You´ve Never Seen It Before: Why Spotfire Is the Leading Tool for Clinical Analytics

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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Novartis, Arvinas Agree to Strategic Collaboration to Develop Treatment for Prostate Cancer

PharmExec

OncLive serves as the connection to oncology, including groundbreaking cancer news and interviews with top oncologists in multimedia formats.

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Eliem Therapeutics agrees to acquire Tenet

Pharmaceutical Technology

Eliem Therapeutics has announced an agreement for the acquisition of development-stage private biotechnology company Tenet Medicines.

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Latent Benefit of Access Restrictions for Rare Conditions

PharmExec

OncLive serves as the connection to oncology, including groundbreaking cancer news and interviews with top oncologists in multimedia formats.

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Fujifilm invests $1.2bn ramping up North Carolina facility

Pharmaceutical Technology

The site expansion is set to add 680 jobs to the site and expand Fujifilm’s contract research business and production capacity.

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The New Clinical Trial Supply Chain: Resilient, Flexible, and Patient-Centric

The global landscape of clinical trials is rapidly changing as studies become more complex. An increasing number of sponsors are seeking enhanced flexibility in their supply chains to address a variety of clinical supply challenges, including patient demand and reducing delays. Demand-led supply and direct-to-patient distribution are next-generation solutions that are helping to meet these growing needs, allowing for more streamlined processes and patient-centric studies.