Fierce Pharma
OCTOBER 25, 2023
After misconduct at a key trial site raised questions of | The FDA previously uncovered evidence of forged emails and trial misconduct in the company's phase 3 Alzheimer's disease agitation study. Now, with a third-party audit in hand, BioXcel looks to push forward with the drug.
PharmaVoice
OCTOBER 25, 2023
“They have the money,” and they’re using it to influence drug development, according to the executive director of the IQVIA Institute for Human Data Science.
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Fierce Pharma
OCTOBER 25, 2023
That didn’t take long. Roche has already settled a patent infringement lawsuit that it filed against Biogen in July. | Roche has already settled a patent infringement lawsuit that it filed against Biogen in July. The case surrounded Biogen’s biosimilar version of Roche’s blockbuster rheumatoid arthritis therapy Actemra.
MedCity News
OCTOBER 25, 2023
The healthcare industry must prioritize the development and implementation of universal tools that can efficiently navigate, interpret, and derive value from the growing wealth of health data.
Fierce Pharma
OCTOBER 25, 2023
Five months after becoming the first company to secure FDA approval for a respiratory syncytial virus (RSV) vaccine, GSK is taking steps toward expanding its label for Arexvy. | Five months after becoming the first company to secure FDA approval for a respiratory syncytial virus (RSV) vaccine, GSK is taking steps toward expanding its label for Arexvy.
PM360
OCTOBER 25, 2023
On August 30, the U.S. Department of Health and Human Services (HHS) made a recommendation to the U.S. Drug Enforcement Administration (DEA) that cannabis be moved from a Schedule I Controlled Substance to a Schedule III Controlled Substance under the federal Controlled Substances Act. While a great deal has been speculated about the potential impact of rescheduling on state licensed cannabis businesses, pharmaceutical companies, health plans, insurance companies, and federal agencies such as th
Pharma Rep Focus brings together the best content for pharma rep professionals from the widest variety of industry thought leaders.
MedCity News
OCTOBER 25, 2023
Johnson & Johnson released research this month showing that its system for robotic-assisted bronchoscopy helped physicians achieve an over 15% improvement in overall diagnostic yield compared to traditional bronchoscopy. This could mean that fewer patients will have to “wait and see” while their cancer potentially gets worse.
PM360
OCTOBER 25, 2023
Everyone’s buzzing about generative artificial intelligence (AI), and it’s true that technology like ChatGPT is already having an enormous impact on advertising and marketing. But other AI tools that our industry has been using for years have changed the face of media planning and buying. The examples below share how we have been utilizing AI for our pharma clients.
MedCity News
OCTOBER 25, 2023
HealthBook+ provides a way for individuals to aggregate and use their personal health information safely and securely to power AI engines that direct people to their next best health action. Importantly, it also gives employers predictive insights to help them provide the most relevant benefits for their employees.
PM360
OCTOBER 25, 2023
When it comes to healthcare decisions, patients are not the only ones calling the shots. Shared decision-making is a process where multiple parties work together to make decisions on testing, treatments, and care plans, among other things. This relationship between the patient and their provider is the backbone of modern healthcare, but we often overlook influential and extremely common stakeholders that medical brands sometimes miss: the patient’s family.
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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
OCTOBER 25, 2023
Servier drug Tibsovo is now approved for treating advanced cases of myelodysplastic syndrome that have an IDH1 mutation. It’s the first approval of a targeted therapy for this type of cancer.
PM360
OCTOBER 25, 2023
When launching a new digital product in pharma, one of the biggest challenges is global rollout and scaling. With a lot to be considered—local regulations, language and translations, capability and capacity, on-boarding regional teams—it can be overwhelming to know where to start to ensure your digital strategy is deployed efficiently, without compromising on quality.
MedCity News
OCTOBER 25, 2023
In the runup to the MedCity INVEST Digital Health conference, Christoph Besmer, a trade commissioner and head of investment promotion with Swiss Business Hub USA, talked about the “X Marks the Spot” campaign and how Switzerland Global Enterprise hopes to strengthen ties with U.S. health tech companies.
PM360
OCTOBER 25, 2023
The pharmaceutical industry is rapidly evolving its approach to strategic planning and decision-making. At the heart of this transformation is the role of medical affairs, which is undergoing something of a rebrand as it moves from supporting function to strategic partner within the broader pharma organization. According to a report by McKinsey & Company, the medical affairs function is on track to rise in importance, becoming the third strategic pillar alongside the research and development
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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
European Pharmaceutical Review
OCTOBER 25, 2023
SGS ISL forms part of an important biotechnology and pharmaceutical hub. The laboratory not only provides crucial support to manufacturing activities in Ireland but also leverages its rich history to contribute to global pharmaceutical operations and supply chains around the world. The facility underwent a successful inspection by the HPRA and transitioned onto the SGS network’s global LIMS and QMS platforms.
PM360
OCTOBER 25, 2023
This is the first in a three-part series examining the commercial dynamics surrounding combination therapy in oncology across the U.S. and Europe. In this article, we discuss the challenges and opportunities within the current landscape and key issues impacting pricing and access for combination therapy. Combination Therapy in Oncology Combination therapies comprising two or more therapeutic agents have become a cornerstone of oncology management and are increasingly a development focus for the
European Pharmaceutical Review
OCTOBER 25, 2023
Three key medicine regulatory bodies from the UK, US and Canada have collaborated to publish five guiding principles for machine learning-enabled medical devices MLMDs. The document by the Medicines and Healthcare products Regulatory Agency (MHRA), US Food and Drug Administration (FDA) and Health Canada, contains key guidance on predetermined change control plans (PCCPs) for MLMDs.
PM360
OCTOBER 25, 2023
Traditionally, when pharma marketers and their strategy, creative, and media agencies develop marketing plans, investment recommendations tend to focus on HCPs, patients, and managed care. On the HCP side, marketers tend to allocate the bulk of their investment on medical doctors as, historically, they have been the primary prescribers. However, as the shortage of MDs accelerates 1 the makeup of the healthcare provider landscape has significantly changed, and the role of the nurse practitioner (
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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.
European Pharmaceutical Review
OCTOBER 25, 2023
CPHI Barcelona has announced the winners of 2023 CPHI Pharma Awards. These recognise outstanding achievements and contributions from the global pharmaceutical industry and supply chain across 12 broad categories. Winners of the 2023 CPHI Pharma Award – highlights For spearheading Procos’ growth, the company’s CEO Enrico Zodio, won CEO of the Year award for enabling the contract development and manufacturing organisation (CDMO) to achieve a current turnover in excess of €200 million.
MedCity News
OCTOBER 25, 2023
Pair Team’s $9 million Series A funding round was led by Next Ventures and included participation from PTX Capital, Create Health Ventures, OCA Ventures, CHCF Innovation Fund, Kapor Capital and other investors. In total, Pair Team has raised about $20 million.
PharmaTimes
OCTOBER 25, 2023
The APPG has called for urgent improvements in rural and ethnically diverse-areas - News - PharmaTimes
Pharmaceutical Technology
OCTOBER 25, 2023
The AD and PD drug aims to reduce the level of neurotoxic proteins, thereby improving information flow across the axonal transport
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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.
PharmaTimes
OCTOBER 25, 2023
The company will launch a clinical investigation of EA-2351 for geographic atrophy - News - PharmaTimes
MedCity News
OCTOBER 25, 2023
Elevance Health is finding ways to connect with the community in order to achieve better health equity.
PharmExec
OCTOBER 25, 2023
Amy West, Head of US Digital Health & Innovation Strategy at Novo Nordisk, shares her insights on fostering collaboration, embracing change, and her compelling vision to revolutionize digital transformation and innovation in the field of healthcare.
Pharmaceutical Commerce
OCTOBER 25, 2023
Parties will establish a Center of Excellence in CMIC’s NJ plant.
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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 Technology
OCTOBER 25, 2023
iCARE4CVD is coordinated by Novo Nordisk and aims to collect and analyse data from 1 million people to validate personalized treatments.
pharmaphorum
OCTOBER 25, 2023
ESMO: J&J’s Tagrisso challenge, and other highlights Phil.
Clarify Health
OCTOBER 25, 2023
Value-based payment agreements are becoming more popular and widespread. According to a 2022 report, 60% of healthcare payments were tied to value and quality in 2021. However, the impact of a value-based payment agreement is dependent on which metrics are used to measure performance. As the saying goes, you can’t manage what you don’t measure. Choosing which metrics to measure in value-based payment programs is the critical first step toward success.
Pharma Marketing Network
OCTOBER 25, 2023
Digital marketing has become an essential part of the pharmaceutical industry. It allows companies to reach potential customers, build relationships, and promote their products. To measure the success of their campaigns, pharmaceutical companies need to track and monitor key performance indicators (KPIs). In this article, we will discuss the importance of KPIs for pharma digital marketing campaigns and how they can be used to optimize 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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