Thu.Aug 03, 2023

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As sales crater, Moderna sees hope in private COVID vaccine market and RSV launch

Fierce Pharma

Even as Moderna chugs through another post-pandemic year, the biotech has raised its COVID-19 vaccine revenue projection in the expectation that it can deliver a strong showing in the private marke | The company raised its forecast for COVID-19 sales to between $6 billion and $8 billion, up from a prior estimate of $5 billion. Elsewhere, an RSV clash with pharma giants nears.

Sales 235
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‘A Criminal Justice Approach to a Public Health Problem’: How the Justice System Can Improve SUD Support

MedCity News

There is inadequate substance use disorder support for people who are incarcerated or are leaving incarceration. But there are opportunities to make improvements, experts say.

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Novo Nordisk, Eli Lilly face injury lawsuit from user of popular GLP-1 medicines

Fierce Pharma

As Novo Nordisk and Eli Lilly rack up significant sales from their GLP-1 diabetes and obesity drugs, the companies also must gear up for defense against lawsuits from new users. | A Louisiana woman is suing Novo Nordisk and Eli Lilly, alleging that her use of Ozempic and Mounjaro caused her to vomit so much that some of her teeth have fallen out. Jaclyn Bjorklund, 44, says that she also has been hospitalized on "several" occasions and that the companies failed to warn patients of “seve

Medicine 230
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New European monograph for Cannabis flower adopted

European Pharmaceutical Review

The Danish Medicines Agency (Lægemiddelstyrelsen) has announced the European Pharmacopoeia Commission has adopted a new European monograph, which describes quality requirements for the raw material Cannabis flower. EPC’s new Cannabis flower monograph The new monograph Cannabis flower (Cannabis flower, monograph 3028) will be available next year in January 2024 with publication of the supplement 11.5.

Medical 98
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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Bavarian Nordic locks up $120M BARDA deal to replenish US stock of smallpox and mpox vaccine

Fierce Pharma

After coming to the rescue during the mpox outbreak in 2022, vaccine maker Bavarian Nordic has agreed to help replenish U.S. stores of its smallpox/mpox shot. | The U.S. Biomedical Advanced Research and Development Authority is handing Bavarian Nordic a new $120 million contract, primarily to cover the production of new bulk vaccine product.

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Driving for Results: 3 Key Benefits of Telehealth [Sponsored]

MedCity News

Explore the myriad benefits telehealth offers to healthcare providers and patients alike. From enhanced convenience and improved privacy to streamlined workflows and elevated patient satisfaction, find out how telehealth is reshaping the future of healthcare delivery.

More Trending

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What We Can Learn From Health Systems Around the World

MedCity News

I am a practicing UK general practitioner and in this article, I take a magnifying glass to quality indicators including access, affordability, healthcare inequalities and population health, staffing and equipment, and patient and provider experience to discuss how we can shape up.

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'The Top Line': How to support patients during a drug shortage, plus this week's headlines

Fierce Pharma

In this episode of "The Top Line," Zoey Becker talks with Dr. | This week on "The Top Line," we discuss how to support patients during the cancer drug shortage, plus this week's headlines.

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Signify Health Unveils Chronic Kidney Disease Evaluation

MedCity News

Home care company Signify Health announced Tuesday that it added an in-home kidney health evaluation to its platform. Based on the results of the evaluation, the company can refer patients to their primary care physician or a specialist if they’re in need of further treatment.

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Merck KGaA suffers CDMO slump after 'sharp drop' in COVID-related sales, CFO says

Fierce Pharma

Merck KGaA’s forecast for a tough 2023 is coming true, as the Darmstadt, Germany-based company’s contract manufacturing division took a major hit from production timing and COVID-related sales down | Merck KGaA’s life science services business unit, which offers contract manufacturing and contract testing services, logged a “strong organic sales decline” in the second quarter, the company said.

Sales 173
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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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Novartis Pays Ionis $60M to Expand Alliance on a Hot Target for Cardio Drugs

MedCity News

Novartis and Ionis, already partners in cardiovascular disease R&D, are expanding their alliance to see if they can develop a next-generation therapy offering efficacy and dosing advantages. But competitors are already in the mix with programs addressing the same cardiovascular disease target.

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Fierce Pharma Asia—BMS, BeiGene strike settlement; Sumitomo, Otsuka suffer trial failures; AZ's CEO talks China

Fierce Pharma

Bristol Myers Squibb and BeiGene have settled their Abraxane feud by terminating their three-drug licensing deal altogether. | Bristol Myers Squibb and BeiGene decided to terminate their three-drug licensing deal. Sumitomo Pharma's Otsuka-partnered schizophrenia candidate ulotaront failed in two phase 3 trials. AstraZeneca CEO responded to a report about the company's plan to spin out its China business.

Pharma 130
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Pharma Marketing in the Age of AI: A New Era Begins

PharmExec

This podcast companion to our roundtable feature explores the transformative power of AI in pharmaceutical marketing, six months after the arrival of ChatGPT.

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Bristol Myers, BeiGene end legacy Celgene deal with settlement years after China ban

Fierce Pharma

Back in 2020, a surprise manufacturing shortfall led to an import ban of Bristol Myers Squibb’s Abraxane, sold by BeiGene, in China. | Back in 2020, a surprise manufacturing shortfall led to an import ban of Bristol Myers Squibb’s Abraxane, sold by BeiGene, in China. Legal finger-pointing ensued, and now the two companies have decided to scrap their three-drug partnership altogether.

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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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New Alzheimer’s treatments are the tip of the iceberg in a long-stymied area of medicine

PharmaVoice

A smaller player in the Alzheimer’s space, Prothena is approaching the next phase of treatments, including prevention and clinical trial evolution.

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TytoCare Rakes In $49M for Its Virtual Care Platform

MedCity News

Virtual care company TytoCare recently raised $49 million in growth financing, taking its total funding to date to $205 million. CEO Dedi Gilad declared that his company was founded to solve a fundamental problem with traditional telehealth services: people do not trust them, so they do not use them.

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Waters Launches SEC Columns for Gene Therapy Applications

PharmaTech

Waters XBridge Premier GTx BEH size exclusion chromatography (SEC) columns are designed to improve analysis while lowering the cost of gene therapies.

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Rush Launches Program to Scale RPM for Chronic Conditions Management

MedCity News

Chicago-based Rush University System for Health recently struck a partnership with Cadence — the health system is beginning an RPM pilot using the startup’s technology platform and clinicians. Rush will enroll Medicare and Medicaid patients who have one or more of the following chronic conditions: hypertension, congestive heart failure and type 2 diabetes.

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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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Generative AI has the potential to revolutionise drug discovery

Pharmaceutical Technology

The impact of artificial intelligence has been profoundly felt in the drug discovery space, with increased interest in AI in recent years.

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GSK Patent Suit Aims to Halt Pfizer’s RSV Vaccine for Adults, But Not Infants

MedCity News

GSK claims that Pfizer’s FDA-approved vaccine for respiratory syncytial virus infringes on four patents protecting its own approved vaccine, Arexvy. The patent suit comes with the RSV season approaching.

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Seattle institute lands $18m funding to develop RNA vaccine for chikungunya

Pharmaceutical Technology

AAHI is developing a novel RNA vaccine that overcomes manufacturing and storage limitations to increase accessibility.

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FDA Clearance Spotlight: UltraSight

MedCity News

UltraSight, based in Israel, recently received a nod from the FDA to market its UltraSight AI Guidance product that can assist medical professionals without sonography experience in acquiring cardiac ultrasound images and allow for more widespread detection of heart diseases.

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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.

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ABM Therapeutics receives FDA orphan drug status for GBM therapy

Pharmaceutical Technology

ABM Therapeutics has received ODD from the US FDA for ABM-1310 to treat patients with glioblastoma (GBM) harbouring the BRAF V600 mutation.

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Is the COVID-19 market crashing?

PharmaVoice

Pfizer’s recent earnings report could foretell major trouble in the market for pandemic products.

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Theriva Biologics reveals positive VCN-01 study results

PharmaTimes

The candidate is a stroma-degrading oncolytic adenovirus for the treatment of pancreatic cancer - News - PharmaTimes

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Scripta, Mark Cuban Cost Plus Drug Company Partner Up on Drug Price Transparency

Pharmaceutical Commerce

The agreement provides Scripta patients with another option when purchasing medication.

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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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Metrion Biosciences boosts hERG screening service 

PharmaTimes

MHRA has made the company a member of the UK GLP compliance monitoring programme - News - PharmaTimes

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Vyera Pharmaceuticals, Phoenixus AG Announce Agreement to Sell Daraprim and Vecamyl Rights

PharmExec

Deal comes amid companies’ bankruptcy filings.

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Building a Winning Sales Team: The Importance of a Strong Bench

Rep-Lite

In the dynamic world of sales, having a high-performing team is crucial to achieving business success. However, building such a team requires careful planning and strategic foresight. A vital component of an effective sales strategy is building a strong bench – a pool of talented and skilled sales professionals ready to step in and drive results when needed.

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A Guide to Long-Acting Injectables and Implantables

PharmaTech

Long-acting products, such as Long-Acting Injectables (LAIs) and implantables, have gained significant traction in recent years, revolutionizing patient treatment and medication adherence. By reducing the number of doses required, long-acting products improve patient compliance and eliminate the risk of missed doses. Moreover, they minimize toxicity and side effects, offering a more comfortable patient experience.

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Accelerating Clinical Supply Through Integrated Drug Development

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.