Fierce Pharma
FEBRUARY 13, 2024
While Biogen’s financials are in rough shape now, the company’s CEO, Chris Viebacher, sees reason to be optimistic about the future. | With four new drug launches rolling and the majority of the company’s losses of exclusivity in the rearview, Biogen figures it could chart continued revenue growth over the next 10 years, CEO Chris Viehbacher said Tuesday.
MedCity News
FEBRUARY 13, 2024
Exscientia’s termination of CEO Andrew Hopkins is for cause and effective immediately. Grounds for termination include misconduct or behavior that brings Hopkins or the company into disrepute, according to his employment agreement.
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Fierce Pharma
FEBRUARY 13, 2024
It’s the approval Ipsen has been waiting for since buying up Onivyde in 2017. | It’s the approval Ipsen has been waiting for since buying up Onivyde in 2017. The FDA has approved Onivyde as part of a combination dubbed Nalirifox to treat patients with newly diagnosed metastatic pancreatic cancer.
MedCity News
FEBRUARY 13, 2024
Proper data collection, analysis, and utilization has the potential to address long-standing health disparities and propel our healthcare system forward to serve all communities.
Fierce Pharma
FEBRUARY 13, 2024
After introducing legislation targeting certain Chinese biopharma companies, a group of bipartisan lawmakers are taking their concerns to the White House—and upping the stakes. | After proposing a bill to revoke funding from certain Chinese biopharmas, a group of bipartisan legislators penned a letter to certain White House officials pressing for sanctions on the two companies based on alleged links to China's Communist Party and its military.
MedCity News
FEBRUARY 13, 2024
There is some acknowledgment by employers of their pain problem, but this awareness is not universal. This demonstrates a clear need for solutions that tackle not only health care costs, but absenteeism, the impact to presenteeism, and overall productivity.
Pharma Rep Focus brings together the best content for pharma rep professionals from the widest variety of industry thought leaders.
pharmaphorum
FEBRUARY 13, 2024
Biogen’s Skyclarys is the first approved medicine for the inherited neurological disease Friedreich’s ataxia (FA) in the EU, after getting a green light from the European Commission.
Fierce Pharma
FEBRUARY 13, 2024
It appears GSK won’t have to fork over extra Zejula royalties to AstraZeneca after all, thanks to an appeals court victory in the companies’ long-running U.K. legal dispute. | GSK was previously ordered to pay rival PARP inhibitor maker AstraZeneca a larger share of total sales on its cancer med Zejula. But an appeals court has overturned the decision.
Pharmaceutical Technology
FEBRUARY 13, 2024
The MHRA kicks off phase two of the Yellow Card biobank to explore the genetic link to side effects of direct oral anticoagulants.
Fierce Pharma
FEBRUARY 13, 2024
A federal judge has tossed a lawsuit by industry lobbying group PhRMA which challenged the legality of Medicare price negotiations.
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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
FEBRUARY 13, 2024
Headlight’s funding round was led by Matrix and EPIC Ventures. The company also hired new leadership, including CEO Geoff Swindle, who was formerly chief business officer at PillPack and Amazon Pharmacy.
European Pharmaceutical Review
FEBRUARY 13, 2024
The first CRISPR/Cas9 gene-edited therapy has been granted a marketing authorisation by the European Commission (EC). Vertex Pharmaceuticals’ CASGEVY ( exagamglogene autotemcel [exa-cel]) is conditionally approved individuals 12 years and over with severe sickle cell disease characterised by recurrent vaso-occlusive crises or transfusion-dependent beta thalassemia.
pharmaphorum
FEBRUARY 13, 2024
Researchers have used proteomics data from the UK Biobank to identify protein biomarkers in blood that could give warning of dementia years before diagnosis
European Pharmaceutical Review
FEBRUARY 13, 2024
In January, United States Pharmacopeia (USP) published revisions to previous drafts of chapters about using rapid microbiological methods (RMM), with a specific focus on short-life products. <72> Respiration-Based Microbiological Methods for the Detection of Contamination in Short-Life Products The changes for the proposed chapter the detection of contaminants in short-life products.
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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
Pharmaceutical Technology
FEBRUARY 13, 2024
The regulatory greenlight makes it the only gene therapy available in Europe for sickle cell disease and TDT.
pharmaphorum
FEBRUARY 13, 2024
Texas judge has thrown out the first lawsuit brought by PhRMA claiming Medicare negotiation of drug pricing is unconstitutional
Evolve Your Success
FEBRUARY 13, 2024
The biggest challenges in our lives should not stop us in our tracks, but rather open up new possibilities for a more meaningful life. Cancer survivor Rob Ciaramirato fully embraced this mindset, unleashing a more purposeful version of himself after going through one of his biggest tests. In this special episode for World Cancer Day, he joins Samuel Adeyinka in looking back how being diagnosed and surviving cancer made him realize the purposeful things he can do through medical sales.
pharmaphorum
FEBRUARY 13, 2024
Roche has turned to artificial intelligence specialist PathAI to accelerate its development of digital pathology technologies that can be used to match patients with drug treatments and support new drug development. The alliance is with Roche Tissue Diagnostics (RTD), a unit of the Swiss pharma group that is concerned with the development of tissue-based tools to improve the diagnosis of cancer and grew out of Roche’s acquisition of Venta Medical Systems in 2008.
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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
FEBRUARY 13, 2024
The conference is the premier boutique healthcare investment event in the U.S.
Clarify Health
FEBRUARY 13, 2024
In healthcare, the ability to predict future demand with precision is not just a competitive advantage. For many hospitals and healthcare systems, it’s a necessity for survival. Optimizing resources to meet the moment calls for strategic planning powered by healthcare data analytics and effective demand forecasting. Demand forecasting in the context of hospital systems is critical for aligning resources like staff, equipment, and beds with future patient care needs.
Pharmaceutical Commerce
FEBRUARY 13, 2024
Roche and Repare came to terms on a deal in June 2022 to develop and commercialize camonsertib, which included a $125 million upfront payment and could have reached up to $1.2 billion based on clinical, regulatory, commercial, and sales milestones.
PharmExec
FEBRUARY 13, 2024
Roche halts agreement with Repare Therapeutics to develop and commercialize camonsertib just weeks after triggering a $40 million milestone payment when the first patient was dosed with the novel cancer drug.
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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.
Pharmaceutical Commerce
FEBRUARY 13, 2024
BXCL701 combined with Keytruda (pembrolizumab) is being evaluated for patients with metastatic castration-resistant prostate cancer with small cell neuroendocrine and adenocarcinoma phenotypes.
PharmExec
FEBRUARY 13, 2024
Embracing business imperatives such as operational efficiency and a focus on a patient-centric approach can help pharma leaders provide a stable foundation amid lingering uncertainty.
Contrarian Sales Techniques
FEBRUARY 13, 2024
So, you've got your sights set on the pharmaceutical sales world for 2024, huh? It might be your smartest choice ever but don’t throw in the party yet. No doubt that this is a sector where you can really make a mark, not just in terms of a solid career but also in making a difference in people's lives. (Why choose pharma sales job? Here’s my thought ).
Tribeca Knowledge
FEBRUARY 13, 2024
I n our latest report, Launch Readiness 2024 , we look at the prospects and obstacles facing new medicines in markets still recovering from the COVID-19 pandemic. We consider the current state of companies’ R&D pipelines, where there are opportunities for launch excellence, and how launch planners can best negotiate the many and varied market-access challenges further complicated by the legacy effects of COVID-19.
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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
Pharmaceutical Commerce
FEBRUARY 13, 2024
In this video interview with Associate Editor Miranda Schmalfuhs, Dr. Jo Varshney, CEO & Founder of VeriSIMLife, discusses how artificial intelligence and machine learning can assist in the drug shortage problem.
Clarivate
FEBRUARY 13, 2024
At Clarivate we put sustainability at the heart of our business goals. Environment, social and governance issues are at the core of our global culture, serving as guiding principles for every decision we make. Our sustainability report is full of real-life examples of how we help our customers, colleagues and communities, with transparent, data-driven results and real insights on where we need to focus moving forward.
Pharmaceutical Commerce
FEBRUARY 13, 2024
Various considerations can help pharmaceutical manufacturers and suppliers provide a robust serialization solution based on the FDA's Drug Supply Chain Security Act.
Pharmaceutical Technology
FEBRUARY 13, 2024
Research indicates that designing clinical trials with the patient in mind reduces recruitment times and enhances trial performance.
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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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