Fierce Pharma
NOVEMBER 28, 2023
In a blow to CAR-T therapies, the FDA is investigating a “serious risk” of patients developing new cancers after treatment with these highly efficacious oncology drugs. | In a blow to CAR-T therapies, the FDA is investigating a “serious risk” of patients developing new cancers after treatment with these highly efficacious oncology drugs.
Dominic Tyer
NOVEMBER 28, 2023
Alongside my DT Consulting colleague Eleni Lee I'll be appearing at the BHBIA's 2023 Winter Seminar to present some of our customer experience data and discuss CX measurement best practices
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Fierce Pharma
NOVEMBER 28, 2023
As the pandemic eased earlier this year, officials in Poland became vocal critics of the financial obligations laid down by Pfizer’s large vaccine supply pact with the European Union. | As the pandemic eased earlier this year, officials in Poland became vocal critics of the financial obligations laid down by Pfizer’s large vaccine supply pact with the European Union.
MedCity News
NOVEMBER 28, 2023
Two of Philips’ most notable RSNA announcements were that its new cloud-based PACS is available and that its helium-free mobile MRI system will soon be deployed. More than 80 sites across the U.S. and Latin America have already migrated to Philips’ new PACS, and its mobile MRI system will be traveling to various cities next year.
Fierce Pharma
NOVEMBER 28, 2023
Gilead Sciences' Kite Pharma cell therapy unit is undergoing a business review that will result in layoffs to about 7% of the organization’s workforce. | Gilead’s Kite Pharma cell therapy unit is undergoing a business review that will result in layoffs to about 7% of the organization’s workforce. In a letter sent to staff this week that was obtained by Fierce Biotech, Kite Pharma Executive Vice President Cindy Perettie previewed a “refreshed business strategy” that would better align the un
MedCity News
NOVEMBER 28, 2023
CAR T-therapies for cancer are now under tighter FDA scrutiny as the agency opens an inquiry regarding reports that some patients who received these cell therapies went on to develop new cases of cancer. The FDA said benefits of these therapies still outweigh their risks, but it is evaluating the need for regulatory action.
Pharma Rep Focus brings together the best content for pharma rep professionals from the widest variety of industry thought leaders.
MedCity News
NOVEMBER 28, 2023
Hospitals that are able to transform what they are and how they operate can survive and serve the public well. They will still require investments from society in the interim, but that investment will be justified by the public good and eventually represent a windfall to taxpayers.
Fierce Pharma
NOVEMBER 28, 2023
Novartis is getting more optimistic about its midterm sales potential, thanks to bullish estimates for some blockbuster drugs. | Novartis is getting more optimistic about its midterm sales potential, thanks to bullish estimates for some blockbuster drugs, including Entresto and Kisqali.
MedCity News
NOVEMBER 28, 2023
If we can simplify nurses’ work by embracing technology that streamlines, automates, and integrates processes like scheduling, credentialing, and compliance management to enhance quality outcomes, we can give nurses time back to spend on the moments that matter most.
Fierce Pharma
NOVEMBER 28, 2023
Armed with a full FDA approval after four years supplying its anthrax vaccine under a pre-emergency use authorization, Emergent BioSolutions is expanding its countermeasure supply pact with the Uni | Armed with a full FDA approval after four years supplying its anthrax vaccine under a pre-emergency use authorization, Emergent BioSolutions is expanding its countermeasure supply pact with the United States.
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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.
MedCity News
NOVEMBER 28, 2023
SpringWorks Therapeutics drug Ogsiveo is now FDA-approved for treating desmoid tumors, a type of tumor affecting connective tissue. The regulatory decision makes the pill the first therapy approved specifically for treating this rare disorder.
Fierce Pharma
NOVEMBER 28, 2023
On a roll with Vyvgart—which is on its way to blockbuster sales in just its second year on the market for generalized myasthenia gravis (gMG)—argenx’s heat check in another indication has missed ba | On a roll with Vyvgart, argenx’s heat check in another indication has missed badly. On Tuesday, the Dutch company revealed that its subcutaneous formulation of the drug, Vyvgart Hytrulo, has flunked primary and secondary endpoints in a phase 3 study in a rare bleeding disorder, primary immune thromb
MedCity News
NOVEMBER 28, 2023
More precise and consumer-friendly biomarker detection technologies are coming to market at a pace that can help users gain rich insight into their health and well-being from anywhere and at any time. This is especially important when it comes to preventive healthcare.
Fierce Pharma
NOVEMBER 28, 2023
As drug shortages mount in the U.S. with little relief in sight, President Joe Biden has rolled out a slew of efforts to bolster the nation’s supply chains. | Monday, during the first meeting of the new White House Council on Supply Chain Resilience, President Biden unveiled nearly 30 actions to bolster production networks across industries. Among those actions, Biden intends to leverage the Defense Production Act (DPA) to make more essential medicines at home and thwart future drug shortages.
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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
MedCity News
NOVEMBER 28, 2023
By acquiring clinical assets from Wellory, Season Health will be able to greatly expand its provider network. The company will also gain national contracts with Aetna and Cigna.
Fierce Pharma
NOVEMBER 28, 2023
It’s the end of the road for one of Teva’s patent lawsuits against migraine competitor Eli Lilly. | The agreement comes after a patent board ruled that two Teva patents were invalid. Meanwhile, the companies continue to battle it out in a larger case relating to nine of Teva's Ajovy patents.
MedCity News
NOVEMBER 28, 2023
A higher share of Medicaid beneficiaries rate their physical and mental health as fair or poor compared to adults with Medicare, employer-sponsored insurance or Marketplace coverage, according to a new KFF report. However, 83% of Medicaid enrollees gave their health insurance a positive rating.
Pharmaceutical Technology
NOVEMBER 28, 2023
Venture financing for innovative radiopharmaceutical drugs witnessed an approximately 550% increase from $63m in 2017 to $408m in 2023 YTD (year-to-date) total deal value in the US.
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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
NOVEMBER 28, 2023
As IRA provisions are activated, the law’s impact on biologics and biosimilars will become more apparent. By using both the carrot and the stick, the IRA may finally bolster the market, increasing uptake of biosimilars to benefit patients and help lower costs.
Copyright Clearance Center
NOVEMBER 28, 2023
A selection of questions and answers from Copyright Clearance Center's response to the United States Copyright Office “Artificial Intelligence and Copyright" request for comment.
MedCity News
NOVEMBER 28, 2023
COPD is the sixth leading cause of death—but more than 50% of those impacted don’t even have a diagnosis. The so-called silent epidemic demands urgent action, as exorbitant costs and preventable deaths skyrocket. This four-point plan outlines a holistic strategy to address COPD.
European Pharmaceutical Review
NOVEMBER 28, 2023
Having been valued at $112 billion in 2022, the worldwide cold storage market is projected to witness a 12 percent compound annual growth rate (CAGR) between 2023 and 2032, according to a report by Towards Healthcare. Therefore, by the end of 2032, the market will value an estimated $383.05 billion, the research projected. Advancing cold storage for pharmaceuticals Temperature-sensitive pharmaceuticals requiring this type of storage include vaccines and biologics, the report explained.
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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.
MedCity News
NOVEMBER 28, 2023
Developed as part of the due diligence process for the disclosure of confidential documents, VDRs provide a secure repository for all types of confidential materials including merger and acquisition (M&A) documents, financial statements, contracts, intellectual property details, and legal agreements.
Pharmaceutical Technology
NOVEMBER 28, 2023
The US Food and Drug Administration (FDA) has accepted to review Orexo’s new drug application (NDA) for opioid overdose medication, OX124.
European Pharmaceutical Review
NOVEMBER 28, 2023
The US Food and Drug Administration (FDA) has approved the first drug for desmoid tumours (desmoid fibromatosis), an oral gamma secretase inhibitor. SpringWorks Therapeutics’ Ogsiveo (nirogacestat) tablets are authorised for adults with progressing desmoid tumours who require systemic treatment. A new treatment for desmoid tumours As a subtype of soft tissue sarcomas: “Desmoid tumours are rare [non-cancerous] tumours that can lead to severe pain and disability… [Ogsiveo is] the first approved tr
Pharmaceutical Technology
NOVEMBER 28, 2023
The emergency use listing is based on non-clinical data where the vaccine demonstrated immune responses against variants in SARS-CoV-2.
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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
PharmaTimes
NOVEMBER 28, 2023
Tafinlar and Mekinist led to a 56% overall response rate in children with BM-HGG - News - PharmaTimes
Pharmaceutical Technology
NOVEMBER 28, 2023
A Phase IIb/III trial studying the company’s immunotherapy izokibep, failed to achieve statistical significance for its primary endpoint
PharmaTimes
NOVEMBER 28, 2023
Around 3,000 new cases of mesothelioma are diagnosed in the US every year - News - PharmaTimes
Pharmaceutical Technology
NOVEMBER 28, 2023
Emergent’s Cyfendus was approved by the US FDA as a post-exposure prophylactic vaccine for anthrax in July.
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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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