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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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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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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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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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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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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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.

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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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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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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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UK, Moderna formalise 10-year vaccines alliance

pharmaphorum

Construction will start early next year of a new manufacturing centre in the UK with the capacity to produce 250 million vaccine doses per year, the centrepiece of a 10-year alliance between the government and US biotech Moderna. The government said today it has finalised the partnership – agreed in principle earlier this year and estimated to be worth in the region of $1.2 billion – although it is not revealing the financial details, as these are “commercially sensitive.” The overar

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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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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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Psychedelic research: evaluating the fast-evolving regulatory roadmap

European Pharmaceutical Review

Fluoxetine was approved to treat depression 35 years ago. Since then, there have been few breakthrough innovations in treating neuropsychiatric diseases such as anxiety, depression, substance use disorders (SUDs), and post-traumatic stress disorder (PTSD). For many indications, progress has been incremental. Psychedelic research, in particular, is gaining momentum. .

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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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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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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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Report: Telehealth programs increase workload for nurses and support staff

MedCity News

Many providers think their telehealth program increases the workload for nurses and support staff, according to a recent report. In 2023, hospitals and physician practices will have to focus on making their telehealth workflows more efficient, which may involve partnering with third-party administrators.

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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.

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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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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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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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7 Pet Peeves of a Healthcare Tech Reporter

MedCity News

Healthcare journalists source a significant amount of the stories they write from emailed pitches. To make the media relations process more fruitful for everyone involved, I laid out my top seven pet peeves as a healthcare technology reporter so public relations representatives have a better understanding of which behavior to avoid.

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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: 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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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.

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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 Battle Between Primary Care and Time: The Doctors are Losing

MedCity News

With most doctors spending less than 15 to 20 minutes with their patients per visit, there is not much time for fact-finding, let alone education for the doctor to learn what preventive screening resources are available for their patients, even if that care is reimbursable by Medicare/Medicaid, such as a lung cancer screening.

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Breakthrough gene therapy gives hope for Artemis-SCID

European Pharmaceutical Review

Ten young children all under the age of 5, who born with immunodeficiency disorder Artemis-SCID, have been able to return to normal life, thanks to a new gene therapy which allows diagnosed babies to be treated with their own cells, a significant milestone since the condition is normally treated via bone marrow transplant from a donor. A breakthrough treatment for Artemis-SCID.

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AbbVie's Vraylar, carrying $4B sales target, wins FDA label expansion in depression

Fierce Pharma

AbbVie's Vraylar, carrying $4B sales target, wins FDA label expansion in depression. zbecker. Mon, 12/19/2022 - 11:13.

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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.

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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.