Mon.Oct 09, 2023

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Gates Foundation spends $40M to boost mRNA vaccine production in Africa and beyond

Fierce Pharma

Following similar initiatives to bolster mRNA vaccine production and access in Africa, the Bill & Melinda Gates Foundation is providing new funding to a clutch of drugmakers. | Following similar initiatives to bolster mRNA vaccine production and access in Africa, the Bill & Melinda Gates Foundation is providing new funding to a clutch of drugmakers.

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From Promise to Impact: The Evolution of AI in Medical Imaging for Population Health and ROI

MedCity News

The ultimate challenge for the broader adoption of AI in medical imaging remains the same: demonstrating to healthcare institutions that it provides a clear ROI.

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GSK strikes $3B Shingrix partnership with China powerhouse Zhifei. Is a deal for RSV shot next?

Fierce Pharma

GSK has forged a partnership with vaccine powerhouse Chongqing | GSK has forged a partnership with vaccine powerhouse Chongqing Zhifei Biological Products to distribute Shingrix in China. Zhifei will pay £2.5 billion ($3.05 billion) for exclusive rights to distribute the shingles shot in China from 2024 through 2026. The deal could be a precursor to similar arrangement between the companies for GSK’s new respiratory syncytial virus (RSV) vaccine Arexvy, the London-based drugmaker said.

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Digital Health Consolidation Is Meant To Happen, VCs say

MedCity News

Endless digital health solutions have emerged over the last few years. But eventually, they’ll have to consolidate — and that’s part of the cycle, investors said during a panel discussion on Sunday.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Pharma marketing: Getting personalized with Fingerpaint Group

Fierce Pharma

Marketers operating in every sector are seeking ways to offer personalized, high-quality experiences to their target audiences. | How much influence will AI exert over pharma marketing? Is it a silver bullet solution to productivity and personalization challenges? Fingerpaint Group’s Paul Hagopian sits down with Fierce Pharma to discuss what has become a hotly contested topic.

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Venture Capital Firm Shares Ambitious Value-Based Care Strategy: Buy a Health System [Sponsored]

MedCity News

The opening day of the HLTH 2023 event offered a surprising announcement from venture capital firm General Catalyst. Weight Watchers CEO called for a change in how we talk about obesity. ENGAGE at HLTH offered compelling discussions around retail health, prescription drug prices and investment trends.

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How Can LLMs Be Deployed Safely in Healthcare?

MedCity News

Healthcare technology experts have confidence that the industry will put the right guardrails up around LLMs as it continues to develop and deploy these AI tools, they said Sunday during a panel discussion at Engage at HLTH.

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Navigating a fragmented marketing landscape with DeepIntent

Fierce Pharma

The way we consume and engage with content is changing all the time. | How can marketers leverage AI to make sense of the masses of data they have access to? Chris Paquette, Founder and CEO of DeepIntent, explores the issues of fragmentation and outlines some of the tools designed to overcome it.

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Bristol Myers Squibb Bolsters Its Cancer Presence With $4.8B Mirati Acquisition

MedCity News

Acquiring Mirati Therapeutics brings Bristol Myers Squibb Krazati, one of two FDA-approved therapies addressing a KRAS cancer mutation. The deal comes as BMS looks to add revenue-generating products as patent expirations loom for several of its cancer products.

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Roche preps for filings after subcutaneous Ocrevus matches up to IV formulation in phase 3 study

Fierce Pharma

Roche preps for filings after subcutaneous Ocrevus matches up to IV formulation in phase 3 study zbecker Mon, 10/09/2023 - 18:07

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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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FDA Rejection Is a Delay, Not a Detour for Alnylam’s Aim to Treat Heart Disorder

MedCity News

Despite an affirmative FDA advisory committee vote, the agency declined to approve Alnylam Pharmaceuticals’ Onpattro for treating the heart complications caused by a rare, inherited protein disorder. But Alnylam has other drugs candidates for the disease, including one expected to post Phase 3 data in the first half of 2024.

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The Path Toward Digital CPV: Why and How to Take It

Fierce Pharma

The pharmaceutical and biopharmaceutical industries are currently underutilizing their manufacturing data, with a significant portion of the collected data either non-actionable or of insufficient | Discover how implementing digital continued process verification (CPV) elevates product quality assurance and drives operational excellence.

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How AI Can Fix the Broken Clinical Trial Process

MedCity News

By combining AI with human expertise and oversight, we have the potential to revolutionize the clinical trial process—and most importantly, extend and save lives.

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Effective pharma marketing: Engaging with the patient journey

Fierce Pharma

Dorothy Gemmel, the Chief Commercial Officer for manufacturer solutions business within GoodRx, identifies two exciting opportunities in pharma marketing today: personalization and partnerships. | GoodRx connects patients with pharmaceutical brands through personalization, data utilization, and strategic partnerships - necessities in modern pharma marketing.

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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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Novel anti-epileptic drug demonstrates efficacy

European Pharmaceutical Review

A new drug, part of a class of chemicals called potassium-channel openers, has demonstrated potential in offering relief to patients with focal epilepsy. Key data from a clinical trial, published in a report in JAMA Neurology, has revealed that adding the drug XEN1101 to a patient’s current antiseizure treatments saw a 33 percent to 53 percent drop in monthly seizures, depending on dose.

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GSK and Zhifei sign deal for shingles vaccine in China

Pharmaceutical Technology

GSK and Chongqing Zhifei have signed an exclusive agreement for co-promoting the former’s shingles vaccine, Shingrix, in China.

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Bristol Myers Squibb agrees nearly $6bn oncology merger

European Pharmaceutical Review

Bristol Myers Squibb ( BMS ) has agreed to acquire Mirati Therapeutics for a total of $4.8 billion. This merger deal entitles BMS to add KRAZATI (adagrasib), a best-in-class KRAS G12C inhibitor to its portfolio. The medicine is approved in the US for advanced KRAS G12C -mutated non-small cell lung cancer (NSCLC) in patients who have received at least one prior systemic treatment.

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Islet transplantation for type 1 diabetes: Do regulators have it right?

Pharmaceutical Technology

Diabetes researchers oppose the regulation of islet transplantation as a biologic, following the approval of CellTrans’ Lantidra.

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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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MSD medicine accepted for use in Scotland

European Pharmaceutical Review

MSD’s WELIREG ® (belzutifan) has been accepted for use within NHS Scotland in adults who have von Hippel-Lindau (VHL) disease. This decision by the Scottish Medicines Consortium (SMC) relates to these patients who require therapy for VHL-associated renal cell carcinoma (RCC), central nervous system (CNS) hemangioblastomas, or pancreatic neuroendocrine tumours (pNETs), and for whom localised procedures are unsuitable or undesirable.

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FDA Approves Novartis’ New Rheumatic Disease Treatment

PharmExec

Cosentyx is the first intravenous formulation interleukin-17A antagonist to focus on disease.

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New University of Bristol study to aid strep A vaccine development

PharmaTimes

The study will offer new insights into the immune system's response to iGAS - News - PharmaTimes

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Convert More Healthcare Consumers with Modern Conversion Rate Optimization Techniques

Healthcare Success

Healthcare consumers demand better, more personalized experiences at every touchpoint. According to Google, approximately 77% of people use search engines to start their patient journey. Listen to the podcast: So, it makes sense for healthcare businesses to focus their attention on their websites, landing pages, and paid search campaigns. But what happens after your ads have captured their attention—especially with a PPC or display ad?

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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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Elligo Health Research expands Study Marketplace with Syneos Health

PharmaTimes

The agreement builds on the companies’s existing partnership - News - PharmaTimes

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AstronauTx Raises $61M in Series A Financing for New Alzheimer’s Treatments

PharmExec

Supporters include Novartis Venture Fund, Brandon Capital, and more.

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A biotech ‘tuning’ the genome for a potentially safer gene therapy

PharmaVoice

Tune Therapeutics is hoping to overcome the pitfalls of CRISPR-style treatments with epigenetic editing.

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FDA Awards HistoSonics Clearance of its First-of-a-Kind Edison® Histotripsy System

Legacy MEDSearch

HistoSonics ® , ( www.histosonics.com ), the manufacturer of the Edison ® System and novel histotripsy therapy platforms, announced today the marketing authorization of its “Breakthrough” platform via the U.S. Food and Drug Administration’s (FDA) De Novo Classification Request process, a rigorous pre-market review pathway for medical devices with no existing predicate.

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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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The Era of Digital Data in Bio/Pharma Manufacturing

PharmaTech

Laks Pernenkil, principal and practice leader, US Life Sciences Product & Supply Operations, Deloitte, discusses the impact that digitalization is having on data generation and data integrity in bio/pharma manufacturing.

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Populus Announces Corporate Re-branding and the Launch of HCP Reach

PM360

Populus Media Inc., a pioneer in digital pharma marketing and patient acquisition solutions leveraging virtual care, today announced that the company has re-branded as Populus Health Technologies concurrent with the official launch of HCP Reach , its physician-facing virtual care channel. The rebranding reflects the company’s broader data-driven product line built to empower pharmaceutical brands with the tools to bolster brand awareness and leverage new virtual tactics for acquiring, activating

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Preetesh Sood

Curzon Consulting

Consultant Contact me Preetesh is a management consultant and technology expert with over 6 years of experience driving digital transformation and innovation initiatives at global corporations. He began his career at Cisco Systems, where he managed the development and delivery of smart manufacturing solutions. By spearheading the global synchronisation of smart manufacturing platforms, Preetesh enabled significant cost savings through operational efficiency.

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Semaglutide: a price and HTA comparison between US and top European markets

Pharmaceutical Technology

Semaglutide: compared to key European markets, its higher price and that of other diabetes/obesity drugs in the US could impact on healthcare

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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.