Fierce Pharma
MAY 17, 2024
After Moderna last year suffered a loss in its heated patent fight against Pfizer and BioNTech, the mRNA drugmaker can now celebrate a win. | The win comes after a prior decision from the European Patent Office that invalidated Moderna's other asserted patent.
MedCity News
MAY 17, 2024
Amgen’s Imdelltra has FDA approval in extensive-stage small cell lung cancer, making it the first bispecific T cell engager approved for treating this type of cancer. Analysts project the new Amgen drug will become a blockbuster seller. The post Amgen Drug for Aggressive Type of Lung Cancer Wins Accelerated FDA Approval appeared first on MedCity News.
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Fierce Pharma
MAY 17, 2024
Seven months after Amgen’s chief medical officer referred to trial | Seven months after Amgen’s chief medical officer referred to trial results for the company's investigational lung cancer immunotherapy as a “watershed moment,” the FDA has signed off on Imdelltra (tarlatamab) to treat patients with extensive-stage small-cell lung cancer (ES-SCLC).
MedCity News
MAY 17, 2024
Uber Health launched Uber Caregiver on Wednesday. The solution allows caregivers to coordinate rides and deliveries on the behalf of the ones they’re caring for. The post Uber Health Launches Solution for Caregivers appeared first on MedCity News.
Fierce Pharma
MAY 17, 2024
Following a controversy over Covis’ preterm birth drug Makena in the U.S. last year, the European Medicines Agency (EMA) is cracking down on hydroxyprogesterone caproate therapies across the pond. | A committee of the European Medicines Agency on Friday called for the withdrawal of preterm birth drugs containing 17-hydroxyprogesterone caproate (17-OHPC), citing safety and efficacy concerns.
pharmaphorum
MAY 17, 2024
Brainomix gets FDA approval for e-Lung, an AI tool that assists in the diagnosis and assessment of patients with interstitial lung diseases (ILDs) from medical images.
Pharma Rep Focus brings together the best content for pharma rep professionals from the widest variety of industry thought leaders.
Scott Burrows
MAY 17, 2024
As a keynote inspirational speaker, I’ve had the privilege of addressing audiences from various industries and backgrounds, but there’s something uniquely invigorating about speaking at sales and leadership conferences. Recently, I had the opportunity to kick off a sales conference for a broker dealer that had just been acquired by the largest independent broker dealer in the U.S.
MedCity News
MAY 17, 2024
Increasingly, nurse practitioners and physician assistants are joining cardiology, dermatology, and other specialty practices, broadening their skills and increasing their income. This development worries some people who track the health workforce, because current trends suggest primary care, soon might not be able to rely on them to mitigate the physician shortage.
Pharmaceutical Technology
MAY 17, 2024
The US Senator took another swipe at the US prices of Novo Nordisk’s blockbuster GLP-1 receptor agonist drugs Ozempic and Wegovy.
MedCity News
MAY 17, 2024
Watershed Health closed a $13.6 million funding round this week. The New Orleans-based company seeks to improve care coordination by connecting providers of all types across the healthcare system. The post Watershed Health Raises $14M For Its Care Coordination Platform appeared first on MedCity News.
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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.
Pharmaceutical Commerce
MAY 17, 2024
Business strategies and top news in the biotech / biopharma industry, including market access, supply chain distribution and more.
MedCity News
MAY 17, 2024
In-home hospice care, which gives them ample opportunities to engage with family and friends in the comfort of their own homes, allows providers to give dementia patients the daily contact they deserve. The post Hospice — The Best Way to Alleviate Loneliness for Middle-Stage Dementia Patients appeared first on MedCity News.
European Pharmaceutical Review
MAY 17, 2024
The US Food and Drug Administration (FDA) has approved Amgen’s Imdelltra (tarlatamab-dlle), a bispecific T-cell engager, for the treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC). The drug received accelerated regulatory approval based on the “encouraging response rate and duration of response (DoR) observed in clinical studies,” Amgen said.
pharmaphorum
MAY 17, 2024
Amgen gets FDA approval for Imdelltra as a treatment for small cell lung cancer, becoming the first DLL3-targeted drug and the company's second BiTE therapy.
European Pharmaceutical Review
MAY 17, 2024
Everything in the pharmaceutical industry now seems to rely increasingly heavily on effective organisation and handling of data. But what needs to happen so that users/process owners can fully trust data’s quality, integrity, reliability, etc? Steve Gens (SG): The more critical data becomes to regulatory procedures, to safety processes, to clinical research, to manufacturing, and ultimately connecting all of those parts of the value chain more seamlessly, the greater the need for formal and cons
pharmaphorum
MAY 17, 2024
Johnson & Johnson has agreed a $850m deal to acquire Proteologix that will give it a pair of early-stage bispecific antibodies for atopic dermatitis and asthma.
PharmaTimes
MAY 17, 2024
Areas include health research across life stages, from paediatrics to health ageing and resilience
pharmaphorum
MAY 17, 2024
An artificial intelligence-driven WhatsApp messaging platform for scheduling cervical cancer screening appointments is being piloted in London to see if it can improve take-up rates. The pilot of the Asa AI assistant – cleared by the NHS North Central London Integrated Care Board (ICB) – will take place at the Islington GP Federation in London.
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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.
PharmaTech
MAY 17, 2024
A combination of rapid sterility methods with the industry standard compendial method should ensure maximum safety.
European Pharmaceutical Review
MAY 17, 2024
EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) has recommended the suspension of the marketing authorisations for medicines containing 17-hydroxyprogesterone caproate (17-OHPC) in the European Union. The recommendation follows a review by the PRAC , which concluded that there is a “possible but unconfirmed risk of cancer in people exposed to 17-OHPC in the womb.
pharmaphorum
MAY 17, 2024
Bernie Sanders says high prices being charged for new obesity therapies like Novo Nordisk’s Wegovy could end up bankrupting US healthcare systems
PharmaTimes
MAY 17, 2024
The mosquito-borne disease affected around 249 million people globally in 2022
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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
PharmaTech
MAY 17, 2024
Ken Keller, president and CEO, Daiichi Sankyo, discusses the foundation of partnership and takes a look at the future of biotech partnerships at the US Pharma and Biotech Summit.
Contrarian Sales Techniques
MAY 17, 2024
When I first entered the field of medical sales, the idea of artificial intelligence (AI) playing a role in our work seemed like science fiction. Back then, our tools were simple: a laptop loaded with presentation slides, a stack of brochures, and a phone for endless cold calls. But as the years have passed, I've witnessed a technological revolution that has reshaped the landscape of medical sales in ways I could never have imagined.
Rep-Lite
MAY 17, 2024
In the world of medical sales, attracting not just good, but high-performing talent, stands as a formidable challenge. It’s a world where the quality of your workforce can directly influence success, given the competitive and evolving nature of the industry. Think of your job listings as your first sales pitch to potential candidates. If it resonates, they’re engaged; if not, they’re scrolling past.
pharmaphorum
MAY 17, 2024
In summary, the PDURS framework aims to integrate digital health technologies into drug labeling, providing a pathway for pharmaceutical companies to enhance information dissemination related to their products while maintaining regulatory oversight.
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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
PharmExec
MAY 17, 2024
In an interview with Pharm Exec Associate Editor Don Tracy, Carmen Villar, VP, ESG & Corporate Citizenship, Gilead Scienes discusses the changes expected in the pharma industry that will come with the entry of younger professionals.
Contrarian Sales Techniques
MAY 17, 2024
When I first started as a pharmaceutical sales rep a decade ago, training was a rigorous but straightforward affair. We’d gather in a conference room for hours, listening to presentations, taking notes, and role-playing various sales scenarios. I remember my first training session vividly – it was intense, informative, and somewhat intimidating. As a male rep entering this competitive field, I felt the pressure to absorb every bit of information and perfect my pitch to stand out.
PharmExec
MAY 17, 2024
A Q&A with Professor Frances Frei of the Harvard Business School, who discusses how leaders create the conditions for organizations and individuals to thrive by designing for excellence in operations, strategy, and culture.
Pharmaceutical Commerce
MAY 17, 2024
Chip Davis recaps the organization’s Distribution Management Conference and addresses distributors’ preparedness for DSCSA implementation.
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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.
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