Sat.Apr 22, 2023 - Fri.Apr 28, 2023

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A physician’s perspective on health equity, diversity and inclusion

PharmaVoice

Dr. Preeti Parikh sees parallels between promoting health equity and current DE&I challenges in the workplace.

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What Will it Take for the U.S. to Modernize its Public Health Systems?

PM360

How can countries be better prepared for the next pandemic? How do they need to change their public health infrastructure to ensure they don’t face similar challenges as posed by COVID-19? What can countries learn from each other to get these more modernized systems in place to improve their ability to exchange public health data across the globe? These questions were at the heart of many discussions during the 2023 Healthcare Information Management System Society (HIMSS) Global Health Conferen

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Apellis hits setback in ALS trial after pair of pegcetacoplan approvals

Fierce Pharma

Apellis hits setback in ALS trial after pair of pegcetacoplan approvals fkansteiner Mon, 04/24/2023 - 10:56

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Healthcare Leaders Must Come Together to Mitigate ChatGPT Risks, Experts Urge

MedCity News

The healthcare sector has been notoriously slow to adopt new technologies in the past, but Chat-GPT has already begun to enter the field. Technology experts at the HIMSS conference in Chicago said that while the AI model is certainly exciting, the healthcare sector must establish an accountability framework for it’s going to address the risks of new technologies like ChatGPT moving forward.

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

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Breathing easy: How digital inhalers are changing asthma treatment

Pharmaceutical Technology

AstraZeneca , Teva Pharmaceuticals , and Novartis , and other companies, are expanding their reach in the asthma space by capitalizing on digital technologies to enhance the patient experience. But experts say the complete integration of these devices and platforms into the healthcare system remains to be seen. Dr. Amy Chan, senior clinical research fellow at the School of Pharmacy, University of Auckland, says digital inhalers have existed for almost 30 years.

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Pioneering malaria vaccine gains regulatory clearance

European Pharmaceutical Review

The R21/Matrix-M malaria vaccine, developed by the University of Oxford , has been approved for use in Ghana (13 April 2023) and was authorised for use in Nigeria on 17 April. [Regulatory] approval of the [R21/Matrix-M ] malaria vaccine in Ghana was the first in the world” Approval of the malaria vaccine in Ghana was the first in the world. Granted full national licensure by the country’s Food and Drugs Authority (FDA Ghana), it is authorised for children aged 5 to 36 months.

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Report: Firearm-related Injuries Cost US Healthcare $1B Annually

MedCity News

In just 2020, deaths from gun violence cost the U.S. healthcare system $290 million, or about $6,400 per patient, according to a report from the Commonwealth Fund. These costs are mostly covered by Medicaid and other government insurance programs.

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Discussing Sterile Aseptic Connectors with Todd Andrews (INTERPHEX 2023)

PharmaTech

Todd Andrews, global director of Applications and Business Development at CPC, discusses sterile aseptic connectors, flexibility in manufacturing, and more in an interview held at INTERPHEX 2023.

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Editas grabs orphan drug status for sickle cell disease CRISPR therapy

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has granted an Orphan Drug Designation to Editas Medicine’s gene therapy EDIT-301 in sickle cell disease, based on an April 27 announcement. The US agency previously granted the Orphan Drug Designation to EDIT-301 for its study in beta thalassemia, in May 2022. The company is studying EDT-301 in sickle cell disease in a Phase I/II RUBY study (NCT04853576), and is on track to provide a clinical update by mid-2023.

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FDA awards Biogen's ALS drug Qalsody an accelerated approval, following its experts' feedback this time

Fierce Pharma

FDA awards Biogen's ALS drug Qalsody an accelerated approval, following its experts' feedback this time aliu Tue, 04/25/2023 - 14:16

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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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Kaiser Permanente to Acquire Geisinger, Along with 5-6 More Health Systems in the Near Future

MedCity News

Kaiser Permanente announced that it expects to acquire Pennsylvania-based Geisinger Health. Kaiser’s move is part of a larger plan — Geisinger will be the first health system to join Risant Health, a new company Kaiser launched to operate nonprofit health systems under value-based care models. Kaiser said it expects to invest $5 billion in Risant and fold five or six health systems into the company over the next five years.

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Exploring the impact of globalization on research in the United States

Clarivate

Our latest Global Research Report from the Institute for Scientific Information (ISI) , “U.S. research trends: The impact of globalization and collaboration,” raises important questions about how well past investment has prepared the U.S. scientific enterprise to achieve its goals. Our findings suggest that while the U.S. remains a leading science and technology power, it must acknowledge its shrinking domestic research capacity and work collaboratively with resourceful competitors to maintain i

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EC announces EU pharma reform that cuts market exclusivity

Pharmaceutical Technology

The European Commission’s (EC) long-anticipated pharma reform plans in the European Union have finally been unveiled , indicating a focus on improving access to medicines across the bloc while cutting down on market exclusivity. Described as the largest reform in over 20 years, the proposed revision touches on multiple topics ranging from unequal access to innovative medicines across the EU to new environmental protections.

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FDA approves first oral microbiome therapy Vowst. Will Nestlé be around to help Seres with the launch?

Fierce Pharma

FDA approves first oral microbiome therapy Vowst. Will Nestlé be around to help Seres with the launch?

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How to Stay Competitive in the Evolving State of Martech

Marketing technology is essential for B2B marketers to stay competitive in a rapidly changing digital landscape — and with 53% of marketers experiencing legacy technology issues and limitations, they’re researching innovations to expand and refine their technology stacks. To help practitioners keep up with the rapidly evolving martech landscape, this special report will discuss: How practitioners are integrating technologies and systems to encourage information-sharing between departments and pr

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In Which Areas of Healthcare Do Investors Want More Startup Activity?

MedCity News

While the digital health sector might feel a little cramped in some areas, there are wide open spaces in others — and investors are ready to funnel money into companies looking to innovate these lesser-discussed aspects of care delivery and healthcare technology. Some of these areas include Medicaid, generative AI and patient-to-patient support.

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Immunotherapy to become standard treatment for infants with ALL

European Pharmaceutical Review

Immunotherapy treatment blinatumomab will now become standard treatment worldwide for babies with acute lymphoblastic leukaemia (ALL). This decision is based on new results from an international trial published in the New England Journal of Medicine. Blinatumomab significantly improved survival, with the rate increasing from 66 percent to 93 percent, compared to individuals just given prior chemotherapy.

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Ethnopharmacology: traditional medicine and modern drug discovery

Pharmaceutical Technology

Traditional medicine refers to the knowledge, skills and practices that indigenous and different cultures use to maintain health, encompassing forms such as herbal medicine, Traditional Chinese Medicine (TCM) and acupuncture. While 80% of the world’s population practices some form of traditional medicine, according to the World Health Organization (WHO), the practice is regularly discredited due to a lack of scientific support and regulation as well as evidence of negative side effects with cert

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UPDATED: Gearing up for key approvals, GSK projects 'Shingrix-like' sales for its RSV vaccine

Fierce Pharma

UPDATED: Gearing up for key approvals, GSK projects 'Shingrix-like' sales for its RSV vaccine fkansteiner Wed, 04/26/2023 - 09:52

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What the FDA's New Dosage Guidance Means for the Future of Clinical Research

Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist

What will the future hold for clinical research? A recent draft from the FDA provides valuable insight. In "Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases," the FDA notes that "targeted therapies demonstrate different dose-response relationships compared to cytotoxic chemotherapy, such that doses below the Maximum Tolerated Dose (MTD) may have similar efficacy to the MTD but with fewer toxicities.

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Achieve Precision Medicine Through AI and Analytics Solutions [Sponsored]

MedCity News

MedCity News connected with Integra Connect’s COO, Cory Wiegert at ViVE 2023 to discuss how their new platform will go beyond the “one size fits all” approach to data curation.

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From “Fake News” to “News You Can Use”

PM360

No one disputes how much the media landscape has evolved over the last two decades. What has been discussed, at times very passionately, is the role and reputation of media in today’s environment. As marketing and communications professionals, we wanted to take a deeper look into how media is perceived, how social media has changed the game, and how we can best adapt to this ever-evolving dynamic.

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Seres and Nestlé Health receive FDA approval for Vowst microbiome therapy

Pharmaceutical Technology

Seres Therapeutics and Nestlé Health Science have received approval from the US Food and Drug Administration (FDA) for Vowst (faecal microbiota spores, live-brpk) for preventing the recurrence of C difficile infection (CDI) in adults. Vowst is an orally administered microbiota-based therapeutic, previously known as SER-109, and is indicated for the prevention of recurrence of CDI in people aged 18 years and above following an antibacterial treatment for recurrent CDI (rCDI).

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Pascal Soriot deflects shareholder discord over AstraZeneca's legal battles amid 'very encouraging' start to the year

Fierce Pharma

Pascal Soriot deflects shareholder discord over AstraZeneca's legal battles amid 'very encouraging' start to the year fkansteiner Thu, 04/27/2023 - 09:39

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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With Halo Shutdown, Amazon Has Now Closed 3 of Its Healthcare Divisions Since 2021

MedCity News

Amazon recently announced that it is shuttering its Halo division, a line of wearable health and fitness devices. This marks the third time in about two years that the e-commerce giant has closed one its healthcare businesses — Amazon Care failed last year, and Haven failed in 2021.

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Innovative Contracting in Europe—A Double Hurdle to Value?

PM360

In many markets around the world, but particularly in Europe, there have always been post-regulatory hurdles for pharmaceutical companies to achieve their price and access ambitions. In most of the developed markets, there are rigorous health technology assessment (HTA) processes that ascribe a particular benefit to a drug in the context of current therapeutic options.

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NICE publishes draft nod for Darzalex combo to treat multiple myeloma

Pharmaceutical Technology

The National Institute for Health and Care Excellence (NICE) has published a final draft guidance recommending the use of Darzalex (daratumumab) with bortezomib and dexamethasone (DVd) for adults with previously treated multiple myeloma. The draft guidance is open for feedback from consultees after which the document and its recommendations will be used to establish the organization’s guidance on the use of this combination regimen for patients in the UK’s National Health Services.

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Quitting Lilly's obesity drug tirzepatide may be difficult for many patients, exec says

Fierce Pharma

Quitting Lilly's obesity drug tirzepatide may be difficult for many patients, exec says kdunleavy Thu, 04/27/2023 - 15:08

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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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The Public Health Emergency Expiring, So What Is the Future of Covid-19 Vaccines?

MedCity News

The FDA will decide this summer which strains the next Covid-19 vaccines should address. But companies are also taking a longer view, developing shots for the future that offer different features than the current ones and potentially broader protection against a wider range of pathogens.

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Medspoke Launches as a New Audio Platform Geared Toward Physicians

PM360

In January 2021, Watzan saw the rise of podcasts and wanted to develop an audio platform that mixed social media and talk and allowed users to listen to short, 15-second audio clips about any of their favorite subjects posted by other users. Now, they are taking the tech behind that platform, which was called ililli , and spinning it off into a similar, but entirely medically focused platform called Medspoke.

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European Pharmaceutical Review Issue 2 2023

European Pharmaceutical Review

Included in this issue of European Pharmaceutical Review : FOREWORD New quality requirements for tobacco products David Elder, David P Elder Consultancy QA/QC MASS SPECTROMETRY The benefits of mass spectrometry for expediting biologics to patients Ian Anderson, Mostafa Zarei and Qifeng Zhang, Lonza IN-DEPTH FOCUS: Bioprocessing/Bioproduction Realising the potential of AAV gene therapies Rajiv Vaidya, Andelyn Biosciences What gene therapy manufacturers can gain from collaboration Neil Almstead,

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Bristol's multiple new launches won't stop it from scouting for M&A deals, CEO says

Fierce Pharma

Bristol's multiple new launches won't stop it from scouting for M&A deals, CEO says aliu Thu, 04/27/2023 - 10:16

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ABM Evolution: How Top Marketers Are Using Account-Based Strategies

In times of economic uncertainty, account-based strategies are essential. According to several business analysts and practitioners, ABM is a necessity for creating more predictable revenue. Research shows that nearly three-quarters of marketers (74%) already have the resources needed to build successful ABM programs.