Thu.Jun 27, 2024

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Billionaire Sackler family can't get legal immunity as part of Purdue bankruptcy deal, Supreme Court rules

Fierce Pharma

Years of negotiations and legal proceedings surrounding a high-dollar opioid settlement for Purdue Pharma have reached a dead end at the U.S. Supreme Court. | Years of negotiations and legal proceedings surrounding a high-dollar opioid settlement for Purdue Pharma have reached a dead end at the U.S. Supreme Court.

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What Do Experts Make of Risant Health’s Newest Acquisition?

MedCity News

While it it’s too early to judge the success of Kaiser Permanente’s Risant Health, the company’s first two acquisitions show a commitment to adjoining organizations with a strong focus on population health — as well as a dedication to spreading Kaiser’s value-based care delivery models across the country. The post What Do Experts Make of Risant Health’s Newest Acquisition?

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In bispecific rivalry, AbbVie’s Epkinly follows Roche’s Lunsumio into follicular lymphoma

Fierce Pharma

With Regeneron’s treatment delayed, AbbVie is expanding its T-cell engager competition against Roche in blood cancer with a new FDA approval. | With Regeneron's treatment delayed, AbbVie is expanding its T-cell engager competition against Roche in blood cancer with a new FDA approval.

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Verona’s first-in-class COPD drug ‘could transform market’

pharmaphorum

Verona Pharma has claimed FDA approval for its chronic obstructive pulmonary disease (COPD) drug ensifentrine, which has been tipped as a future blockbuster.The first-in-class dual phosphodiesterase (PDE) 3/4 inhibitor – now given the somewhat tongue-twisting brand name of Ohtuvayre – is the first inhaled product with a novel mechanism of action available for the maintenance treatment of COPD in more than 20 years, according to Verona.

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

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Fierce Pharma Asia—Daiichi, Merck's FDA rejection; Wegovy's expansion; Takeda CEO's hunt for China deals

Fierce Pharma

The FDA rejected Daiichi Sankyo and Merck's HER3 antibody-drug conjugate. Novo Nordisk's weight loss star Wegovy secured approval in China. | The FDA rejected Daiichi Sankyo and Merck's HER3 antibody-drug conjugate. Novo Nordisk's weight-loss star Wegovy secured approval in China. After two large licensing deals, Takeda's CEO is open to more partnerships with Chinese biotechs.

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Blue Shield of California Launches New Way for Members to Interact with Health Info

MedCity News

Blue Shield of California unveiled its new Member Health Record on Wednesday. It allows members to access their health information in one place within the insurer’s app or website. The post Blue Shield of California Launches New Way for Members to Interact with Health Info appeared first on MedCity News.

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The Impact of GI Disorders on Women’s Mental Health

MedCity News

GI disorders are complex, disruptive, and immensely stressful, with physiological, psychological, and sociological implications. The post The Impact of GI Disorders on Women’s Mental Health appeared first on MedCity News.

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Novo Nordisk’s ocedurenone Phase III flop costs company $816m

Pharmaceutical Technology

NovoNordisk acquired the hypertension and kidney disease drug ocedurenone from KBP Biosciences in 2023 as part of a $1.3bn deal.

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Biden’s ‘March-In-Rights’ Proposal Undermines 40-Year-Old Policy, and Endangers Life-Saving Innovation

MedCity News

It is crucial that we preserve the unique public-private partnership framework that drives innovation in our country by ensuring that the Bayh-Dole Act remains intact. The post Biden’s ‘March-In-Rights’ Proposal Undermines 40-Year-Old Policy, and Endangers Life-Saving Innovation appeared first on MedCity News.

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England, Denmark back CSL’s haemophilia B gene therapy

pharmaphorum

CSL Behring's gene therapy Hemgenix for haemophilia B has been backed for reimbursement in England and Denmark.

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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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McKesson, Independent Pharmacy Cooperative Reach Drug Supply Agreement

Pharmaceutical Commerce

The deal offers member pharmacies two pricing options, which will take effect Aug. 1.

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Purdue’s bankruptcy plan in tatters as SCOTUS says no

pharmaphorum

SCOTUS rejects bankruptcy deal that would settle opioid litigation against Purdue Pharma, but also protect the Sackler family from liability.

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2seventy bio completes $40m haemophilia A program deal with Novo Nordisk

Pharmaceutical Technology

US-based 2seventy bio has completed an asset purchase agreement (APA) to divest its haemophilia A candidate to Novo Nordisk.

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FDA turns down MSD, Daiichi Sankyo HER3 ADC for lung cancer

pharmaphorum

FDA rejects MSD, Daiichi Sankyo’s HER3-targeted ADC patritumab deruxtecan because of problems at a third-party manufacturer

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Exploring the societal impact of digital health research and innovation

Clarivate

Discover how our combination of data-driven insights and analysis in digital health research and innovation highlight global societal impact in our latest report Digital health encompasses the use of digital technologies such as mobile apps, wearables and telemedicine, to improve health and healthcare delivery. The digital health landscape is evolving rapidly.

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Drug approval roundup – May/June 2024

European Pharmaceutical Review

Considering recent EU and US approvals, there has been a continued trend of exciting innovative therapies reaching market, demonstrating promise for a range of hard-to-treat-diseases. In May and June, regulatory approvals have so far included treatments for rare disorders as well as in oncology, such as blood, endometrial and colorectal cancers. Looking back briefly to 2023, within the cell and gene therapy space, the US Food and Drug Administration (FDA) approved marketing authorisations for se

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Addressing Sales Enablement Pain Points with AI Solutions

Quantified

Introduction In the ever shifting landscape of sales, enablement is crucial for business success. Sales enablement provides sales teams with the tools, resources, and information they need to engage buyers and close deals effectively. However, several pain points can hinder these efforts. Leveraging artificial intelligence (AI) can significantly mitigate these challenges, transforming sales enablement into a more efficient and effective process.

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Pharma Pulse 6/27/24: Pharmacy Deserts & Underserved/Rural Communities, GoodRx Launches New “Prescription Cost Tracker” & more

Pharmaceutical Commerce

The latest news for pharma industry insiders.

Pharma 101
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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.

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European Commission Approves Metastatic Colorectal Cancer Monotherapy

PharmaTech

Fruzaqla was previously approved for use in patients with metastatic colorectal cancer in the US in November 2023.

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FDA Issues Complete Response Letter to Merck and Daiichi Sankyo for Patritumab Deruxtecan for Advanced, Metastatic EGFR-Mutated Non-Small Cell Lung Cancer

PharmExec

The Complete Response Letter was issued as a result of inspection findings at a third-party manufacturing facility, unrelated to patritumab deruxtecan’s efficacy or safety in patients with advanced or metastatic EGFR-mutated non-small cell lung cancer.

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Novo Nordisk Aims to Invest $4.1 Billion to Expand Manufacturing Capacity in US

PharmaTech

This $4.1 billion investment to build a second fill/finish manufacturing facility in Clayton, N.C., boosts Novo Nordisk's current 2024 investments in production to $6.8 billion.

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FDA Approves Genmab’s Epkinly to Treat Adults with Relapsed or Refractory Follicular Lymphoma After Two or More Lines of Systemic Therapy

PharmExec

Approval of Epkinly was based on results from the Phase I/II EPCORE trial in patients with relapsed or refractory follicular lymphoma who have already completed two or more lines of systemic therapy.

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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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The Association Between 340B Program Involvement and Availability of Hospital Services

Pharmaceutical Commerce

A longitudinal observational study examined whether the program was related to access to hospital-based services, while determining if that association differs by hospital ownership.

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Empowering Financial Advisors: Scott Burrows, Inspirational Business Keynote Speaker

Scott Burrows

In the fast-paced world of financial services, where each day presents fresh challenges and intense competition, I stand as a beacon of inspiration and expert guidance. My journey of resilience and triumph empowers financial service organizations and their teams to cultivate a belief system that conquers any obstacle while embracing change. Through compelling storytelling and practical insights, I vividly illustrate how enduring principles such as Vision, Mindset, and Grit lead to remarkable ach

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Citius Pharmaceuticals Co-Founder and CEO Talks Promising Results from a Phase III Clinical Trial for Mino-Lok, a Treatment Designed to Salvage Catheters in Patients with Central-Line Associated Infections

PharmExec

In an interview with Pharm Exec Associated Editor Don Tracy, Leonard Mazur, Co-Founder, CEO, Citius Pharmaceuticals, discusses recent topline results from the pivotal Phase III Clinical Trial of Mino-Lok, which works to salvage catheters infections.

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Kite to Evaluate Cellares’ Manufacturing Platform for Wider Use

PharmaTech

No timetable was given for the length of the planned evaluation or when data would be available, but Kite intends to use the information to expand its manufacturing options.

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Clinical Data Like You´ve Never Seen It Before: Why Spotfire Is the Leading Tool for Clinical Analytics

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

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Pharmacy Closure Contributors & Long-Term Consequences

PharmExec

In this part of his Pharmaceutical Executive video interview, Michael Abrams, Managing Partner, Numerof & Associates, identifies the main factors contributing to closures of pharmacies big and small and some potential long-term consequences for public health if they continue.

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Don’t call it a comeback: Biotech’s CNS resurgence forges Big Pharma connections

PharmaVoice

Neuroscience pipelines are reawakening as biotechs prove to the pharma giants that the field is still worth the investment.

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National HIV Testing Day 2024: Level Up Your Self Love, Check Your Status

PharmExec

As a part of National HIV Testing Day, the Centers for Disease and Control Prevention encourages testing as a part of taking charge of individual health and wellness.

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FDA reveals diversity action plan guide for clinical trials

pharmaphorum

FDA reveals diversity action plan guide for clinical trials Phil.

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Roles and Responsibilities of Specialized Clinical Supply Experts

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.