Sat.Dec 17, 2022 - Fri.Dec 23, 2022

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Life sciences faces a battle with sustainability, but let’s not forget its successes

pharmaphorum

We know that the global healthcare sector is a contributor to the warming of our planet. It is responsible for 4.4% of annual carbon emissions; if the sector were a country, it would be the world’s fifth biggest global carbon emitter. 1. Recent research also found that, as of 2022, the sector had one of the lowest proportions of Net Zero targets of all industries.

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Pfizer, Sanofi settle first California Zantac case slated for trial: report

Fierce Pharma

Pfizer, Sanofi settle first California Zantac case slated for trial: report. zbecker. Thu, 12/22/2022 - 12:38.

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Moderna and UK government sign deal to establish mRNA facility

Pharmaceutical Technology

Moderna and the UK government have entered a ten-year strategic collaboration to build a messenger ribonucleic acid (mRNA) research, development and manufacturing facility in the country. The latest development comes after the parties announced an agreement in principle in June this year. This Moderna Innovation and Technology Centre (MITC) is expected to offer access to a locally produced future mRNA vaccine portfolio against respiratory viruses, subject to regulatory evaluation and licensure.

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Moderna finalises plans for UK mRNA vaccine manufacturing centre

European Pharmaceutical Review

Moderna, Inc. has finalised a strategic partnership with the UK government to establish a state-of-the-art mRNA vaccine research, development, and manufacturing facility in the UK. This milestone follows the agreement in principle between Moderna and the UK Government, announced in June 2022. The Moderna Innovation and Technology Centre (MITC) is intended to provide access to a UK-made supply of COVID-19 jabs.

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AI Strategies for Sales Managers: How to Cut Down on Tedious Admin Work

What if you could help your sellers stop wasting 72% of their day on non-selling activities and focus on bringing in revenue? Incorporating AI in your enablement workflows can help you cut down on busy work, get projects done faster, and let your team (and you!) focus on making a bigger impact. We put together this guide to show you how to use AI to cut time and costs for projects, including collateral creation, development of training videos, and automating tedious processes.

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UK digital health project aims to tackle dysfunctional breathing

pharmaphorum

A collaboration between academic centres in the UK has won government funding for a digital approach to dysfunctional breathing or dyspnoea, a symptom that affects around 10% of the population. The Engineering and Physical Sciences Research Council (EPSRC) has set aside £400,000 (almost $490,000) for the project, which will help fund work at the Universities of Plymouth, Salford and Stirling, and the Glasgow School of Art.

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Atara makes history with world-first nod for allogeneic T-cell therapy Ebvallo

Fierce Pharma

Atara makes history with world-first nod for allogeneic T-cell therapy Ebvallo. fkansteiner. Mon, 12/19/2022 - 14:06.

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Health Tech Innovation: How to Advance Data Security To Support Healthcare Accessibility

MedCity News

As with most industries, healthcare should consider adopting a zero-trust approach. This security measure can help decrease an organization’s attack surface, create accurate response automation and prevent the compromise.

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Could ketamine-assisted therapy help treat alcoholism?

European Pharmaceutical Review

A new £2.4 million Phase III trial will determine if ketamine-assisted therapy can help those with severe alcohol use disorder to stay off alcohol for longer. Led by the University of Exeter and funded by the Medical Research Council (MRC) and the National Institute for Health and Care Research (NIHR), “[t]his is the largest trial of its kind in the world and builds on our earlier, smaller positive trial,” stated Professor Anne Lingford-Hughes, Professor of Addiction Biology at Imperial College

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2023 forecast: With Novo's Wegovy on a supply rebound, 2023 offers course correction and obesity showdown with Lilly

Fierce Pharma

2023 forecast: With Novo's Wegovy on a supply rebound, 2023 offers course correction and obesity showdown with Lilly. fkansteiner. Tue, 12/20/2022 - 10:26.

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EMA CHMP recommends Moderna’s Covid-19 booster for children

Pharmaceutical Technology

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended granting variation to the marketing authorization (MA) for Moderna ’s Spikevax bivalent Original/Omicron BA.1 (mRNA-1273.214) booster for usage in children aged six to 11 years. The 0.25mL dose of the booster vaccine could potentially be used in the European Union (EU) following authorisation in these children a minimum of three months following a previous Covid-19 vaccination.

Medicine 121
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From Diagnosis to Delivery: How AI is Revolutionizing the Patient Experience

Speaker: Simran Kaur, Founder & CEO at Tattva Health Inc.

The healthcare landscape is being revolutionized by AI and cutting-edge digital technologies, reshaping how patients receive care and interact with providers. In this webinar led by Simran Kaur, we will explore how AI-driven solutions are enhancing patient communication, improving care quality, and empowering preventive and predictive medicine. You'll also learn how AI is streamlining healthcare processes, helping providers offer more efficient, personalized care and enabling faster, data-driven

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Financial Management: The Next Area for Innovation in Serving Seniors

MedCity News

Some financial management service companies have earned the patronage of local governments and prestigious funders, including the National Institutes of Health and AARP. It is time for health plans, particularly MA plans, to pay attention as well.

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Belt Monitors Heart Failure Patients

Medgadget

Researchers at Florida Atlantic University have developed a belt that can monitor heart failure patients for signs of disease progression. The wearable device measures heart rate, thoracic impedance, electrocardiogram, and motion, all of which can provide information on a heart failure patient’s status and potentially enable early detection of disease exacerbation.

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After overcoming vial issue, Gilead wins FDA approval for long-acting HIV injectable Sunlenca

Fierce Pharma

After overcoming vial issue, Gilead wins FDA approval for long-acting HIV injectable Sunlenca. zbecker. Wed, 12/21/2022 - 17:50.

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mRNA therapeutics: a limitless revolution in medicine

European Pharmaceutical Review

The success of mRNA vaccines against SARS-CoV-2 has quickly catapulted mRNA therapeutics as a disruptive, expanding drug category” The term ‘mRNA’ has become commonplace globally. mRNA technologies have emerged as an innovative and effective approach to developing new drugs that can potentially transform existing therapies or target difficult‑to‑treat indications including respiratory, cardiac, metabolic and autoimmune diseases, as well as cancer.

Medicine 116
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Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model

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2023: The Year of the Healthcare Cloud

MedCity News

The ability to adapt has proven paramount over the past few years and it is fundamentally reshaping healthcare IT. In 2023, that shape will increasingly form around the cloud.

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FDA approves Adstiladrin as first gene therapy for NMIBC

pharmaphorum

The US Food and Drug Administration (FDA) has approved Swiss drugmaker Ferring Pharmaceuticals’ Adstiladrin (nadofaragene firedenovec-vncg) for the treatment of adult patients with high-risk Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle-invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), with or without papillary tumours. Bladder cancer is one of the more common forms of cancer.

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2023 forecast: An 'inflection point' for biopharma, fueled by a flood of AI and machine learning products

Fierce Pharma

2023 forecast: An 'inflection point' for biopharma, fueled by a flood of AI and machine learning products. kdunleavy. Tue, 12/20/2022 - 13:39.

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Whole genome sequencing and analysis of live biotherapeutic products

European Pharmaceutical Review

The US Food and Drug Administration (FDA) created live biotherapeutic products (LBP) as a new category in the 2012 guidelines. 1 It defined LBPs as drug products containing live microorganism(s) to be used to prevent, treat or cure a disease or condition in human beings. 1 The European Directorate for the Quality of Medicines & Healthcare (EDQM) also accepted LBP as a new category of medicinal products for the European market in 2019. 2.

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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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Eliminate Lab Test Panel Stuffing To Support Value-Based Care

MedCity News

With the projection that the U.S. may spend up to $27.9 billion annually on low-value screening, testing, and procedures considered waste, there needs to be a new approach to how the lab industry develops test menus from which physicians order labs.

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Fentanyl: a horrifyingly disruptive drug

Pharmaceutical Technology

Fentanyl is a powerful opioid (a narcotic analgesic that is at least partly synthetic) that is being trafficked in increasing quantities from Mexico to the US by cartels. The Drug Enforcement Administration (DEA) recently announced that it had seized 10,000 pounds of illicit fentanyl in 2022 and pointed out that this volume represented enough fentanyl to kill every American.

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Novartis prunes nearly 300 jobs in Garden State as corporate slimdown rolls on

Fierce Pharma

Novartis prunes nearly 300 jobs in Garden State as corporate slimdown rolls on. fkansteiner. Mon, 12/19/2022 - 10:53.

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Lynparza combination approved in EU for advanced prostate cancer

European Pharmaceutical Review

The European Commission (EC) has approved Lynparza (olaparib) in combination with abiraterone and prednisone or prednisolone for metastatic castration-resistant prostate cancer (mCRPC) in male adults in the European Union for whom chemotherapy is not clinically indicated, making it the first approved PARP inhibitor to demonstrate clinically meaningful benefits in combination with a new hormonal agent.

Medicine 110
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How to Prove Marketing Value: Demonstrate Content ROI and Contribution to Sales

Every marketer knows how important it is to prove their efforts drive sales opportunities, but that’s easier said than done. When problems like sales and marketing misalignment, lack of data, and wasted efforts persist, marketers can’t measure, prove, or increase their impact on revenue at a time when demonstrating marketing value is critical. Using analyst and expert data, this guide to marketing impact and content attribution explains: How B2B buyers use content The most common types of conten

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How We Can Speed up our Aid to Nurses with Substance Use Disorders

MedCity News

I write this because of my own personal experience with stealing prescription drugs while employed as a nurse, which led to me serving a four-month jail sentence and losing the career of my dreams.

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Sanofi and Innate Pharma extend cancer therapeutics partnership

Pharmaceutical Technology

Sanofi has extended the partnership with Innate Pharma for natural killer (NK) cell therapeutics in oncology. With the latest development, Sanofi will licence a NK cell engager programme that acts on B7H3 from the antibody-based NK cell engager therapeutics (ANKET) platform of Innate. Under the latest licence deal, Sanofi will make an upfront payment of $26.4m (€25m) to Innate.

Pharma 105
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2023 forecast: FDA revamps cancer drug approvals, and Big Pharma is willing to fall in line

Fierce Pharma

2023 forecast: FDA revamps cancer drug approvals, and Big Pharma is willing to fall in line. aliu. Sun, 12/18/2022 - 17:18.

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FDA approves first gene therapy for high-risk early bladder cancer

European Pharmaceutical Review

The US Food and Drug Administration (FDA) has approved Adstiladrin (nadofaragene firadenovec-vncg) as the first gene therapy for non-muscle-invasive bladder cancer (NMIBC) in adults with high-risk Bacillus Calmette-Guérin (BCG)-unresponsive with carcinoma in situ (CIS) with or without papillary tumours. Dr Peter Marks, PhD, Director of the FDA’s Center for Biologics Evaluation and Research observed that Adstiladrin, the non-replicating adenoviral vector-based therapy provides “… an innovative tr

FDA 110
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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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How UnitedHealthcare Is Supporting Americans’ Travel

MedCity News

UnitedHealthcare has recently introduced a set of three travel protection plans called SafeTrip, which offer healthcare insurance and trip cancellation coverage for Americans.

Insurance 108
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From chemistry to canvas: What the pharma world can learn from art

PharmaVoice

Art and science are often viewed as diametric opposites, but these industry insiders say their passion for painting blends into their pharma work.

Pharma 110
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AstraZeneca, Merck's Lynparza wins EU nod in advanced prostate cancer right after FDA delay

Fierce Pharma

AstraZeneca, Merck's Lynparza wins EU nod in advanced prostate cancer right after FDA delay. kdunleavy. Wed, 12/21/2022 - 09:08.

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Clinical innovation: using digital solutions to deliver the next wave of medicines

European Pharmaceutical Review

The ambition is to use technological and digital solutions to reduce the burden for patients and trialists, so that clinical trial participation ultimately becomes part of daily practice” In a typical year, AstraZeneca conducts over 240 global clinical trials , involving more than 123,000 patients in around 60 countries. For clinical innovation to deliver life-changing and potentially curative new medicines to patients as quickly and safely as possible, diverse digital and other technologi

Medicine 105
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European Clinical Supply Planning: Balancing Cost, Flexibility and Time