Thu.Aug 01, 2024

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Another IRA lawsuit bites the dust with ruling on Novo Nordisk case; company pledges to appeal

Fierce Pharma

Like clockwork, another lawsuit challenging the constitutionality of the Inflation Reduction Act's (IRA's) price-setting measures has been shot down in the courts. | The ruling from the New Jersey federal court marks the latest in a string of rejections as various drugmakers have taken to the courts to fight the drug pricing legislation.

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Nearly Every Large Healthcare Organization Uses Microsoft Active Directory: Here’s How to Secure It to Safeguard Against Escalating Ransomware Attacks

MedCity News

Healthcare organizations can significantly improve their resilience against ransomware attacks by implementing proactive protection, continuous monitoring, and rapid recovery strategies. Proactive protection, continuous monitoring, and rapid recovery strategies are key. The post Nearly Every Large Healthcare Organization Uses Microsoft Active Directory: Here’s How to Secure It to Safeguard Against Escalating Ransomware Attacks appeared first on MedCity News.

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Kyowa Kirin looks to cut small molecule research and manufacturing jobs, slims down in Asia

Fierce Pharma

Like many other biopharma companies, Kyowa Kirin is in restructuring mode. | Kyowa Kirin is planning “a significant reduction” in its small molecule drug discovery research activities and will trim certain manufacturing roles. The company is also divesting its Chinese operations as part of a larger restructuring in the Asia-Pacific region.

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Huma’s Evolution From Patient Monitoring Apps to Cloud Platform With AI Chops

MedCity News

Huma has spent 10 years perfecting its technology stack and now it wants others to build off of its expertise, says the company’s chief medical officer. The post Huma’s Evolution From Patient Monitoring Apps to Cloud Platform With AI Chops appeared first on MedCity News.

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Increase Revenue With Better, Faster Sales Onboarding

Quotas need to be hit. Revenue goals need to be met. This reality makes shortening sales onboarding time a top priority. Organizations with a standard onboarding process boost employee retention by 58% and increase productivity by 50%. Unfortunately, many companies struggle with inefficient processes that lead to high turnover and missed revenue opportunities.

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After series of patent lawsuits, Novartis doubles down in Entresto defense with FDA complaint

Fierce Pharma

Two weeks ago, Novartis CEO Vas Narasimhan referred to the initial wave of drug pricing effects tied to the Inflation Reduction Act (IRA) as “manageable.” | Novartis has filed a lawsuit against the FDA, claiming that the U.S. regulator’s approval of a generic version of Entresto is unlawful. The complaint comes a week after the FDA approved an Entresto generic from MSN Laboratories.

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5 Notable Health Tech Funding Announcements in July

MedCity News

Here is a list of some of the biggest funding rounds from health tech companies that were announced in July. The post 5 Notable Health Tech Funding Announcements in July appeared first on MedCity News.

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More Trending

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Providers’ Finances Are Steady, But Cost Pressures Still Loom

MedCity News

A new report showed that financial margins have leveled off for both hospitals and physician groups in recent months. However, costs for drugs and labor continue to climb. The post Providers’ Finances Are Steady, But Cost Pressures Still Loom appeared first on MedCity News.

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Regeneron touts launch of Eylea HD—and warns of manufacturing issue with linvoseltamab

Fierce Pharma

With U.S. sales of $304 million during the second quarter, Regeneron’s high-dose version of Eylea came up just short of analyst projections. | The launch of Regeneron's Eylea HD has helped the Eylea franchise to a rebound after U.S. sales had declined in each of the previous three quarters. Additionally, Regeneron reported that its FDA decision date on its application for approval of multiple myeloma therapy linvoseltamab is likely to be delayed because of a manufacturing issue.

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Read to lead: 6 books pharma execs swear by

PharmaVoice

From an epic, alternative reality fantasy to a ‘biography of cancer,’ these six reads have stuck with pharma execs as they navigate how to lead.

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Eli Lilly, after tirzepatide's late-stage cardio win, plots regulatory filings this year

Fierce Pharma

Eli Lilly, after tirzepatide's late-stage cardio win, plots regulatory filings this year esagonowsky Thu, 08/01/2024 - 09:40

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Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model

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NICE recommends BeiGene’s MZL tablet for NHS use

Pharmaceutical Technology

The UK NICE has recommended BeiGene’s Zanubrutinib for marginal zone lymphoma (MZL) for use on the National Health Service (NHS).

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Moderna takes axe to '24 sales guidance, sending shares lower

Fierce Pharma

The post-pandemic period has posed serious challenges for financial forecasters at the top mRNA vaccine makers, as evidenced by Pfizer's

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Valneva, LimmaTech ally on quest for first Shigella vaccine

pharmaphorum

Valneva has bolstered its vaccines pipeline with a shot designed to protect against shigellosis – a major global health threat – licensed from LimmaTech Biologics.The French pharma company – best known for its COVID-19 jab and recent approval for the world's first chikungunya vaccine Ixchiq – is paying €10 million upfront for a stake in LimmaTech's S4V vaccine candidate, and promising undisclosed regulatory, development and sales-based milestone payments.

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Agios, looking to expand blood disorder med Pyrukynd, misses the mark in 1st pediatric study

Fierce Pharma

Despite missing the primary endpoint in a pediatric study, Agios says it remains steadfast in working to grow the reach of its pyruvate kinase (PK) activation franchise. | The trial in PK-deficient children who receive regular transfusions didn't meet its primary endpoint based on an analysis that incorporated response data from a prior adult study.

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Using Generative AI in Sales: Pros, Cons, and Considerations According to Sellers

Are your sellers unsure about using AI in their day-to-day workflows? Or are they eager to try but uncertain where to start? They might be asking: Which tasks are best suited for AI? How will using AI affect my relationship with my customers? With so many tools available, which ones are the most useful to me? To help answer these and other common questions about using AI during the sales cycle, we surveyed B2B sellers who were early adopters to get their insight and advice about how to use gen A

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Otsuka snaps up Jnana with its phenylketonuria drug for $800m

Pharmaceutical Technology

The acquisition is expected to conclude in Q3 this year and will see Otsuka adding Jnana’s phenylketonuria therapy to its portfolio.

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Otsuka Commits $800M in M&A Deal Bringing a Phase 3-Ready Metabolic Disorder Drug

MedCity News

Otsuka Pharmaceutical is acquiring Jnana Therapeutics, whose lead drug is a potential treatment for the rare metabolic disorder phenylketonuria (PKU). Jnana’s drug could provide an alternative to two FDA-approved PKU medicines from BioMarin Pharmaceutical. The post Otsuka Commits $800M in M&A Deal Bringing a Phase 3-Ready Metabolic Disorder Drug appeared first on MedCity News.

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Bayer files first application of menopause drug elinzanetant

pharmaphorum

Bayer files elinzanetant as a non-hormonal treatment for menopausal symptoms, with Astellas' first-to-market Veozah in its sights

Marketing 101
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Takeda’s revenue climbs by 14.1% in Q1 FY2024

Pharmaceutical Technology

Takeda has reported a revenue of Y1,208bn for Q1 FY2024, a 14.1% increase from Y1,058bn in the corresponding period of FY2023.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Oxford Nanopore rises on Novo Holdings equity stake

pharmaphorum

UK DNA/RNA sequencing specialist Oxford Nanopore raises £80m in a share issue backed with £50m from Novo Holdings

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Valneva and LimmaTech partner for shigellosis vaccine development

Pharmaceutical Technology

Valneva and LimmaTech have signed a deal to potentially develop the first marketed shigellosis vaccine.

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Drug Digest: Delving into Biopharmaceutical Development and Manufacturing

PharmaTech

In this exclusive Drug Digest video interview, Felicity Thomas, Associate Editorial Director, Pharmaceutical Technology Group, interviews experts from Biosynth and the University of Maryland about biopharmaceutical drug development and manufacturing.

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Study finds ovarian cancer-treated women less likely to develop breast cancer

PharmaTimes

Combined, ovarian and breast cancer affect over 60,000 women in the UK every year

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How Machine Learning Drives Clinical Trial Efficiency

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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EVERSANA Unveils TEDAVI, the Breakthrough Content Creation Hub to Transform Agency Marketing Models and Maximize Brand Impact

PM360

CHICAGO – Aug. 1, 2024 – EVERSANA , a leading provider of global commercial services to the life sciences industry, today introduced TEDAVI , the pharmaceutical and life science industry’s premier content transformation hub built to streamline content production, enable personalization at scale and accelerate time-to-market for brand assets while ensuring compliance.

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NHS Scotland, AZ and Scottish universities partner for kidney health research

PharmaTimes

The collaboration aims to develop new medicines to reduce chronic kidney disease in Scotland

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Tirzepatide Shows Statistically Significant Improvements in Reducing Heart Failure Risk, Enhanced Symptoms

PharmExec

Data from the SUMMIT clinical trial demonstrated that tirzepatide lowered the risk of negative heart failure outcomes and enhanced symptoms and physical limitations when tested with three different doses.

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AAIC 2024: MCI patient reflects on Leqembi trial experience

Pharmaceutical Technology

During a session at the 2024 Alzheimer’s Association International Conference (AAIC), which concludes today, Ralph Carmona shared his experience of being diagnosed with Mild Cognitive Impairment (MCI) due to Alzheimer’s disease.

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Unlocking Excellence: How Catalent Is Transforming Japan’s Clinical Research

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

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Achieving VLP continuous production with digital twins

European Pharmaceutical Review

A study has illustrated the development and validation steps for a digital twin “combining a physical-chemical-based mechanistic model for all unit operations with a process analytical technology (PAT) strategy” for bioprocessing. According to Hengelbrock et al. , developing and incorporating digital twins for Quality-by-Design (QbD)-based process approaches is a major challenge in modern biotechnology.

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Self-Talk: The Olympic-Grade Mental Hack for Business Success

ALULA

Imagine a high-stakes business negotiation. Your palms are sweaty, your mind racing. How you talk to yourself in that moment can dramatically impact the outcome. Research shows that the words we use internally can influence everything from decision-making to stress levels.

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Addressing Maternal Health Disparities and Driving Change

PharmExec

In this part of her Pharmaceutical Executive video interview, Charlotte Owens, MD, FACOG, Head of Medical Affairs and Outcomes Research at Organon, identifies Organon's efforts to invest in research, education, and its pipeline to focus on critical areas of need in maternal health.

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The Evolution of Temperature-Sensitive Biologics

Pharmaceutical Commerce

In an interview with Pharma Commerce Editor Nicholas Saraceno, Dan Gagnon, UPS Healthcare’s VP of Global Strategy & Acquisition Integration, discusses the development of frozen/cold biologics when it comes to the logistics space, along with how the companies themselves have changed over the years.

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Deliver Fast, Flexible Clinical Trial Insights with Spotfire

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.