Wed.Jun 29, 2022

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Enabling the next wave of innovative drug therapies with speciality enzymes

Pharmaceutical Technology

Approximately 75,000 enzymes are thought to exist in the human body as vital catalysts for biochemical reactions or conversions. For hundreds of years, we have found myriad uses for microbial enzymes in manufacturing – from food, drink, and household products to a range of industrial applications. The pharmaceutical industry often relies on enzymes to perform a process known as biocatalysis, which facilitates the cost-effective and sustainable production of small molecule drugs at scale.

Drugs 295
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5 FDA decisions to watch in the third quarter

Bio Pharma Dive

Between July and September, the regulator could approve a first-of-its-kind autoimmune drug and two gene therapies as well as decide how COVID-19 vaccines should be updated.

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AI hiring levels in the pharmaceutical industry rose in May 2022

Pharmaceutical Technology

The proportion of pharmaceutical companies hiring for AI related positions kept relatively steady in May 2022 compared with the equivalent month last year, with 39.3% of the companies included in our analysis recruiting for at least one such position. This latest figure was higher than the 39% of companies who were hiring for AI related jobs a year ago but a decrease compared to the figure of 43.6% in April 2022.

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Novartis details plans to lay off up to 8,000 amid sweeping restructuring

Bio Pharma Dive

The Swiss pharma confirmed it will cut as many as 1,400 jobs in Switzerland and thousands more globally under a reorganization plan first announced in early April.

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The New Age of Decentralized Clinical Trials

White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations

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Terumo and GenCure sign agreement for cell and gene therapies

Pharmaceutical Technology

Terumo Blood and Cell Technologies and BioBridge Global subsidiary, GenCure, have entered a new partnership agreement to expand and integrate cell and gene therapy manufacturing solutions. In a bid to meet the growing demand for automated and closed smart systems across the cell and gene therapy (CGT) industry, the companies entered the deal to merge technologies and capabilities.

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Bayer, Amgen back ReCode's plan to broaden genetic medicine's reach

Bio Pharma Dive

The two drugmakers joined a long list of investors, including Pfizer and Sanofi, that have been funding the startup’s plan to develop a new type of lipid nanoparticle technology.

Genetics 255

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Social Media is dangerous for patients

World of DTC Marketing

Suppose you’re on Facebook or Instagram, and Meta has determined you may be interested in cancer treatments. In that case, you may have seen an ad for a dangerous cancer treatment, or one of the 20 or so others recently running from the CHIPSA hospital in Mexico near the US border, all of which are publicly listed in Meta’s Ad Library. They are part of a pattern on Facebook of ads that make misleading or false health claims targeted at cancer patients.

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Arch brings in another $3B for biotech startup investing

Bio Pharma Dive

The venture firm’s largest-ever haul comes about a year and a half after it raised another $2 billion and amidst an historic downturn for the sector.

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Japan’s MHLW accepts GSK’s submission for shingles vaccine in adults

Pharmaceutical Technology

The Japanese Ministry of Health, Labour and Welfare (MHLW) has accepted GlaxoSmithKline’s (GSK) regulatory application for recombinant, adjuvanted Zoster vaccine, Shingrix, for preventing shingles (herpes zoster) in at-risk adults of the age 18 years and above. The submission also comprises the use of the vaccine to prevent shingles in people with immunodeficiency or immunosuppression caused by known disease or treatment.

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June 29, 2022: Pragmatic Trials Experienced Significant Impacts of COVID-19 on Trial Activities

Rethinking Clinical Trials

Lead author Dr. Emily O’Brien. Pragmatic clinical trials experienced significant impacts of COVID-19 on trial activities, according to a survey of NIH Pragmatic Trials Collaboratory Demonstration Projects published last month in Trials. Since the beginning of the COVID-19 pandemic in March 2020, many of the NIH Collaboratory’s Demonstration Projects have had to postpone recruitment, alter methods of participant engagement, and modify tools for research assessment and intervention delivery.

Trials 100
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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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Bayer launches digital AI platform for radiology specialists

pharmaphorum

Bayer has stepped up the digital capabilities of its radiology business with the launch of artificial intelligence-based apps for X-ray, MRI and CT imaging. The cloud-hosted platform – called Calantic Digital Solutions – has tools to help radiologists detect and quantify disease lesions in medical images and select patients for treatment in order of priority, improving their productivity.

Radiology 111
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June 24, 2022: FDA Draft Guidance on Real-World Evidence (John Concato, MD, MS, MPH)

Rethinking Clinical Trials

? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ?. Speaker. John Concato, MD, MS, MPH. Associate Director for Real-World Evidence Analytics. Office of Medical Policy (OMP). Center for Drug Evaluation and Research (CDER). Food and Drug Administration (FDA). Slides. Keywords. Big data; Real-word evidence; Real-world data; 21st Century Cures Act; FDA Draft Guidance.

Big Data 130
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Avacta announces escalation in clinical study of AVA6000

Pharma Times

AVA6000 is a novel form of doxorubicin that has been modified using Avacta’s delivery platform to improve safety

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New patent for Teva Branded drug AUSTEDO

Drug Patent Watch

Annual Drug Patent Expirations for AUSTEDO Austedo is a drug marketed by Teva Branded Pharm and is included in one NDA. It is available from one supplier. There are seven…. The post New patent for Teva Branded drug AUSTEDO appeared first on DrugPatentWatch - Make Better Decisions.

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The New Age of Decentralized Clinical Trials

This new white paper defines and details the impact of Decentralized Clinical Trials on the Pharmaceutical industry and how the impact can be measured along with steps companies can take to ensure adoption.

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Pfizer seeks to overturn three RSV vaccine patents held by GSK

pharmaphorum

Already competing to bring the first vaccine against respiratory syncytial virus (RSV) to market, Pfizer and GSK are also fighting a patent infringement battle in the courts. Earlier this month, Pfizer filed a lawsuit (HP-2022-000016) in the Royal Courts of Justice in London, seeking to invalidate three GSK patients covering its RSVPreF3 shot, according to a report on the Law360.com website.

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New patent for Abbvie Inc drug ORILISSA

Drug Patent Watch

Annual Drug Patent Expirations for ORILISSA Orilissa is a drug marketed by Abbvie Inc and is included in one NDA. It is available from one supplier. There are five patents…. The post New patent for Abbvie Inc drug ORILISSA appeared first on DrugPatentWatch - Make Better Decisions.

Drugs 98
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NHS App could offer video consultations by 2024

pharmaphorum

The NHS App will be updated over the next couple of years to include a series of new features, including the ability to offer remote video consultations between patients and GPs, according to the Department of Health and Social Care. The update to the app is part of a series of measures unveiled in the Plan for Digital Health and Social Care that describes how technologies will be used to “drive efficiency, free up hospital space and clinician time, and bust the Covid backlogs.” From

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New patent for Amicus Therap drug GALAFOLD

Drug Patent Watch

Annual Drug Patent Expirations for GALAFOLD Galafold is a drug marketed by Amicus Therap Us and is included in one NDA. There are thirty-five patents protecting this drug. This drug…. The post New patent for Amicus Therap drug GALAFOLD appeared first on DrugPatentWatch - Make Better Decisions.

Drugs 98
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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.

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Next Gen CAR T Cell could Enable Large-Scale Deployment Against Cancer

BioSpace

???????Cellectis shared how its novel immune-evasive universal CAR T cells may potentially deploy large amounts of T-cell product candidates to target multiple malignancies.

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Romantic partners can influence each other’s beliefs and behaviors on climate change, new Yale study finds

Scienmag

Few would argue that romantic partners have the potential to shift each other’s beliefs and behaviors, but what about their views on climate change specifically? Up until now there’s been little analysis of the dynamics of climate change conversations in romantic relationships and how the beliefs of one partner can influence the other. Credit: Courtesy […].

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Despite Threat of Omicron, World Shifts Focus Away from COVID-19

BioSpace

There’s quite a bit of movement on the Omicron-specific booster shot and updated supply deals, despite world leaders shifting their attention away from the COVID-19 pandemic.

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Targeting a human protein to squash SARS-CoV-2 and other viruses

Scienmag

More than two years into the COVID-19 pandemic, people are realizing that the “new normal” will probably involve learning to co-exist with SARS-CoV-2. Some treatments are available, but with new variants emerging, researchers are looking toward new strategies. In ACS Infectious Diseases, scientists now report that apratoxin S4, an anticancer drug candidate that targets a […].

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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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First treatment for ‘broken heart syndrome’ trialled

Pharma Times

Scientists will trial a programme of exercise conditioning and psychological therapy for people diagnosed with the condition

Scientist 103
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How Facebook clickbait draws users into engaging with posts

Scienmag

A study of 4,000 Facebook posts by news organizations provides unique insights into clickbait and user engagement. The study, published in the open access journal PLOS ONE by Anna-Katharina Jung, of the University of Duisburg-Essen, and colleagues, suggests both headlines and the text used in the posts can ‘bait’ users into interacting with a post, […].

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Biogen Community Lab 2.0 Reveals Wonders of Science to Thousands of Students

BioSpace

Biogen's Chirfi Guindo discusses the launch of the company's next-generation approach to teaching STEM to even more students, leading to potential careers in the field.

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Clashes of inference and perspective explain why children sometimes lose the plot in conversation

Scienmag

Children who suddenly appear to lose the thread of an otherwise obvious conversation often do so because they cannot combine two key communicative skills until surprisingly late in their development, researchers have found. Credit: Elspeth Wilson, Faculty of Education, University of Cambridge. Children who suddenly appear to lose the thread of an otherwise obvious conversation […].

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The New Clinical Trial Supply Chain: Resilient, Flexible, and Patient-Centric

The global landscape of clinical trials is rapidly changing as studies become more complex. An increasing number of sponsors are seeking enhanced flexibility in their supply chains to address a variety of clinical supply challenges, including patient demand and reducing delays. Demand-led supply and direct-to-patient distribution are next-generation solutions that are helping to meet these growing needs, allowing for more streamlined processes and patient-centric studies.

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AstraZeneca Touts China Expansion, Positive CHMP Opinions

BioSpace

???????AstraZeneca had a very busy week of international news, with progress being shown in China, positive recommendations for two drugs in Europe and a positive clinical trial update.

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The world’s rivers are changing, here’s how

Scienmag

The way rivers function is significantly affected by how much sediment they transport and where it gets deposited. River sediment — mostly sand, silt, and clay — plays a critical ecological role, as it provides habitat for organisms downstream and in estuaries. It is also important for human life, resupplying nutrients to floodplain agricultural soils, […].

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Big Pharma not Likely to Bail Out Battered Biotech Industry

BioSpace

The biotech industry has been looking for multiple sources of financing, and there has been speculation that big pharma might come to the rescue. But a recent report says that's unlikely.

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Shining some light on the obscure proteome

Scienmag

Histone deacetylase (HDAC) inhibitors are a class of drugs used in oncology. An international research team involving scientists at the Technical University of Munich (TUM), Cornell University in Ithaca (USA), the German Cancer Research Center (DKFZ) in Heidelberg and Martin Luther University of Halle-Wittenberg has now investigated the effects of some HDAC drugs in more […].

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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.