Fierce Pharma

DECEMBER 15, 2023

About a year after Arcutis Biotherapeutics unveiled positive data on roflumilast foam at the European Academy of Dermatology and Venereology congress 2022, the company has clinched a second FDA OK. | About a year after Arcutis Biotherapeutics unveiled positive data on roflumilast foam at the European Academy of Dermatology and Venereology congress 2022, the company has clinched a second FDA OK.

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MedCity News

DECEMBER 15, 2023

WeightWatchers’ new GLP-1 program offers daily nutritional and activity targets, recommended foods, recipes, food and activity tracking, a digital community, virtual workshops and access to coaches 24/7.

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Fierce Pharma

DECEMBER 15, 2023

Since Merck secured approval for kidney cancer pill and blockbuster hopeful Welireg (belzutifan) in August of 2021, sales have grown slowly but surely. | Since Merck secured approval for kidney cancer pill and blockbuster hopeful Welireg (belzutifan) in August of 2021, sales have grown slowly but surely. With a second FDA nod for a much larger patient population, the company can anticipate a more pronounced upswing in revenue from the hypoxia-inducible factor-2 alpha (HIF-2a) inhibitor.

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MedCity News

DECEMBER 15, 2023

By prioritizing patient care and adapting our business models to meet the demands of our patients, we can ensure that the telehealth industry continues to provide meaningful and lasting benefits to all those who need it.

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Fierce Pharma

DECEMBER 15, 2023

Over the years, shareholders at the Interfaith Center on Corporate Responsibility (ICCR) have repeatedly voiced concerns on a variety of subjects to top pharma companies. | Once again, shareholders with the Interfaith Center on Corporate Responsibility are raising access concerns in proposals to several top drugmakers.

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Pharma 183

MedCity News

DECEMBER 15, 2023

To harness the best parts of AI — and avoid its worst possible outcomes — you need an AI strategy that not only includes technical implementation tactics but also prioritizes efforts to minimize bias, address ethical considerations, and build consumer trust and confidence.

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Ethics 103

MedCity News

DECEMBER 15, 2023

Elation Health released results of a survey it conducted to learn more about how primary care physicians feel about AI scribes. It found that they haven’t really experienced the benefits of these tools yet, but they hope AI scribes can lead to time savings, reduced cognitive burden, improved job satisfaction, better patient focus and more time for care coordination.

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PharmExec

DECEMBER 15, 2023

CDC data show hospitalizations among all age groups spiked by 200% for influenza, 51% for COVID-19, and 60% for respiratory syncytial virus over the past four weeks, emphasizing the need for improved outreach efforts among at-risk populations.

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pharmaphorum

DECEMBER 15, 2023

MSD and Moderna’s individualised cancer vaccine mRNA-4157 has shown impressive efficacy in a phase 2b trial in skin cancer melanoma, leaving the partners speculating about a possible regulatory filing.

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PharmExec

DECEMBER 15, 2023

In clinical trials, Padcev (enfortumab vedotin-ejfv) plus Keytruda (pembrolizumab) produced a statistically significant improvement in survival compared to platinum-based chemotherapy alone in patients with locally advanced or metastatic urothelial cancer.

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FDA Patients 98

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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.

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MedCity News

DECEMBER 15, 2023

As we advocate for healthier aging, proficiency in technology emerges as not just an optional skill, but as a fundamental pillar of holistic healthcare for older adults.

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Healthcare Healthcare 91

European Pharmaceutical Review

DECEMBER 15, 2023

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for the conditional approval of Vertex’s gene-editing therapy Casgevy for the treatment of severe sickle cell disease and transfusion-dependent beta thalassemia. Casgevy (exagamglogene autotemcel) is a CRISPR/Cas9 gene-edited cell therapy.

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Medicine Food and Drug Administration Food Patients 91

PharmaVoice

DECEMBER 15, 2023

Markups for generics can be as high as 7,000%, the researchers said.

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European Pharmaceutical Review

DECEMBER 15, 2023

Alkermes has agreed to sell its pharmaceutical development and manufacturing facility in Athlone, Ireland to Novo Nordisk for $92.5 million. “The acquisition of the Athlone facility represents an expansion of Novo Nordisk’s global manufacturing setup and will provide Novo Nordisk with additional development and manufacturing capacity for current and future oral products,” commented Thilde G.

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Manufacturing Engineering Pharmaceutical 84

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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

Distribution

PharmaTimes

DECEMBER 15, 2023

The funding builds on AstriVax’s €30m in seed funding for its vaccine platform - News - PharmaTimes

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MedCity News

DECEMBER 15, 2023

This week, check out news from Alpha Sophia, Encellin, CalmWave, Essential AI, and MATTER.

Healthcare 101

Healthcare Healthcare 101

PharmaTimes

DECEMBER 15, 2023

The combined system works to detect and eliminate airborne pathogens - News - PharmaTimes

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pharmaphorum

DECEMBER 15, 2023

MSD claims 2nd FDA approval for Welireg, in kidney cancer Phil.

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FDA 95

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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.

Safety

PharmaTimes

DECEMBER 15, 2023

The funding builds on AstriVax’s €30m in seed funding for its vaccine platform AstriVax has announced that it has been awarded a total of €3m in funding from Flanders Innovation & Entrepreneurship (VLAIO) for its therapeutic vaccine targeting chronic hepatitis B. The new funding will bring the company closer to revolutionising therapeutic vaccine development and creating a long-lasting impact in the hepatitis B field.

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Patients 73

Spotio

DECEMBER 15, 2023

The wholesale distribution industry is huge, measuring $10 trillion in the US alone. To put that number in context, the retail industry measures $5.63 trillion, the finance and insurance industry measures $4.97 trillion, and the construction industry measures 2.29 trillion. Obviously, wholesalers are a critical part of the economy, which is why there are so many businesses in this sector.

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PharmaTimes

DECEMBER 15, 2023

The combined system works to detect and eliminate airborne pathogens A new air-filtering system developed by the University of Glasgow and Pinpoint Medical aims to detect and eliminate airborne pathogens to combat the spread of infections in hospitals. Funded by the UK Research and Innovations’ (UKRI) Engineering and Physical Sciences Research Council (EPSRC), the platform will decontaminate the air of pathogens and measure air quality to ensure a safer and healthier environment.

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Engineering Medical Manufacturing Patients 55

Clarify Health

DECEMBER 15, 2023

Beyond Theory: Harnessing Incentives to Drive Value-Based Care Initiatives Healthcare Unbound episode recap: On this episode of the Healthcare Unbound podcast , behavioral economics expert Dr. Zeke Emanuel discusses how to create physician incentives to control costs and improve outcomes in healthcare. Physician incentives should be real, substantial, and timely to get the desired positive response from doctors and drive value-based care payment models.

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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.

Specialization

Pharmaceutical Commerce

DECEMBER 15, 2023

The FDA previously granted the application for Padcev (enfortumab vedotin-ejfv) plus Keytruda (pembrolizumab) with priority review and breakthrough designation for patients with locally advanced or metastatic urothelial cancer.

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FDA Patients 52

PharmExec

DECEMBER 15, 2023

Erasca will initiate the pivotal SEACRAFT-2 trial in the first half of 2024 to evaluate naporafenib in combination with trametinib in adults with unresectable or metastatic melanoma with an NRAS mutation.

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FDA 52

pharmaphorum

DECEMBER 15, 2023

As conversations surrounding Equality, Diversity, and Inclusion (EDI) in health and care research participation continue to broaden, we are also expanding our scope of involvement and inclusivity. However, achieving the ambitious goal of EDI remains a challenge. In this interactive webinar, brought to you by the National Institute for Health and Care Research (NIHR), we delve beneath the surface of EDI in research to unpick common challenges in offering equal participation opportunities in the U

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Pharmaceutical Commerce

DECEMBER 15, 2023

Creating a meaningful digital transformation requires pharmaceutical manufacturing companies to incorporate the right technologies, processes, and systems to reach their fullest potential.

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Pharmaceutical manufacturing Pharma Manufacturing Pharmaceutical 52

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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

Leads

Contrarian Sales Techniques

DECEMBER 15, 2023

Buckle up, bookworms! Did you know the children's book market is a literary behemoth, raking in billions of dollars each year? Homeschooling's rise and engaged parents have fueled this explosion, creating a golden opportunity for aspiring authors and illustrators. But what if there was a way to tap into this market without years of writing and drawing?

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Pharmaceutical Commerce

DECEMBER 15, 2023

The FDA based the approval Merck’s Welireg (belzutifan) on findings from the randomized, open-label, Phase III LITESPARK-005 trial, which compared Welireg to Afinitor for the treatment of advanced RCC that has progressed after prior treatment with PD-1/L1 and VEGF-TKI therapies.

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FDA Patients 52

Contrarian Sales Techniques

DECEMBER 15, 2023

"Passive income," "huge commissions," "lifestyle business" - these are the siren calls of countless online marketing schemes, promising riches with minimal effort. But before you dive headfirst into the latest "secret system," let's shed some light on the reality of affiliate marketing , particularly the red flags you should be wary of. The Glimmering Myth: The email you received paints a picture of affiliate marketing as a magic money machine, where commissions roll in effortlessly while you sl

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Marketing Sales Education 52

PharmExec

DECEMBER 15, 2023

Adjuvant treatment with Moderna’s mRNA-4157 (V940) in combination with Merck's Keytruda lowered the risk of recurrence or death by 49% compared with Keytruda monotherapy.

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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.

Management