Mon.Nov 07, 2022

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FDA halts Verve plans to test gene editing therapy for heart disease in US

Bio Pharma Dive

Verve didn’t say what led to the FDA’s decision, but claimed it hasn’t observed any safety issues in an ongoing trial in New Zealand and the U.K, where enrollment will continue.

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The pharmaceutical industry found it easier to fill artificial intelligence vacancies in Q3 2022

Pharmaceutical Technology

Artificial intelligence related jobs that were closed during Q3 2022 had been online for an average of 36.5 days when they were taken offline. This was a decrease compared to the equivalent figure a year earlier, indicating that the required skillset for these roles has become easier to find in the past year. Artificial intelligence is one of the topics that GlobalData, our parent company and from whom the data for this article is taken, have identified as being a key disruptive technology force

Marketing 211
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Amgen to test new way to lower heart risk with large drug trial

Bio Pharma Dive

Buoyed by strong mid-stage study results, the biotech will soon start a cardiovascular outcomes trial of a drug designed to target a genetic risk factor called lipoprotein(a).

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Care-Keralam plans multi-pronged strategy to boost Ayush SMEs with special focus on marketing companies

AuroBlog - Aurous Healthcare Clinical Trials blog

The Ayush cluster in Kerala, Care-Keralam Ayurvedic Resource Centre at Koratty in Thrissur, is planning to adopt a multi-pronged strategy to support the small and medium ayurvedic drug manufacturing enterprises (SMEs) by focusing on their production growth and marketing of products. Similar support will be provided to other streams of the Ayush like Siddha and […].

Marketing 153
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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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GSK myeloma drug comes up short in confirmatory test

Bio Pharma Dive

The drug, Blenrep, did not outperform a standard treatment in relapsed or refractory multiple myeloma, setting back GSK's plans to confirm the conditional approval it received in 2020.

Drugs 269
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Mouse Study Suggests a Surprising Link Between Nose-Picking And Alzheimer’s

AuroBlog - Aurous Healthcare Clinical Trials blog

A new study has revealed a tenuous but plausible link between picking your nose and increasing the risk of developing dementia. In cases where picking at your nose damages internal tissues, critical species of bacteria have a clearer path to the brain, which responds to their presence in ways that resemble signs of Alzheimer’s disease. […].

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UK pharma industry IT recruitment activity rises 38.2% in October 2022

Pharmaceutical Technology

The UK’s pharma industry registered a 38.2% rise in IT hiring activity in October 2022 when compared with the previous month, according to GlobalData’s Job Analytics database. The industry’s overall hiring increased by 63.93% in October 2022 when compared with September 2022. Out of the pharma industry’s total hiring activity, IT jobs claimed a 1.37% share in October 2022, recording a decrease of 2.04% over the last three-month average share.

Genome 130
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Viatris to buy two eye drug developers in deals worth up to $750M

Bio Pharma Dive

The generics company is acquiring Oyster Point Pharma and the privately held Famy Life Sciences in a move aimed at creating an ophthalmology business.

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US pharma industry IT recruitment activity drops 10.% in October 2022

Pharmaceutical Technology

The US’s pharma industry registered a 10.% drop in IT hiring activity in October 2022 when compared with the previous month, according to GlobalData’s Job Analytics database. The industry’s overall hiring is decreased by 5.4% in October 2022 when compared with September 2022. Out of the pharma industry’s total hiring activity, IT jobs claimed a 1.65% share in October 2022, recording a decrease of 0.17% over the last three-month average share.

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Cell line characterization and selection made easy

Bio Pharma Dive

Build confidence and efficiency into your research with traceable and reliable cell line 'omics data.

Research 246
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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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AstraZeneca’s IT hiring activity declines 1.4% in October 2022

Pharmaceutical Technology

UK-based company AstraZeneca’s IT hiring declined 1.4% in October 2022 when compared with the previous month, according to GlobalData’s Job Analytics database. The company’s overall hiring activity declined by 7.03% in October 2022 when compared with September 2022. IT jobs claimed an 8.8% share in the company’s total hiring activity in October 2022, and recorded a 0.36% growth over the last three-month average share.

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Modular plug-and-produce facilities for cell therapies

Bio Pharma Dive

Commercial-scale production is pivotal for the success of cell therapy. Is modularity the solution?

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Eurofins Scientific’s IT hiring activity rises 11.4% in October 2022

Pharmaceutical Technology

Luxembourg-based company Eurofins Scientific’s IT hiring rose 11.4% in October 2022 when compared with the previous month, according to GlobalData’s Job Analytics database. The company’s overall hiring activity declined by 0.56% in October 2022 when compared with September 2022. IT jobs claimed a 5.84% share in the company’s total hiring activity in October 2022, and recorded a 0.35% growth over the last three-month average share.

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‘We’re sick of watching women die’: In Michigan, doctors rally to protect abortion access

STAT News

GRAND RAPIDS, Mich. — Doctors are on the frontlines of a political battle raging across the country, as abortion rights are added to the ballot in the first election since the Supreme Court overturned Roe v. Wade. Michigan is at the heart of the struggle. “Doctors fought hard for these rights because we’re sick of watching women die,” Melissa Bayne, an OB-GYN in Fremont, Mich., told the audience at a rally Saturday in Grand Rapids.

Doctors 145
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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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F. Hoffmann-La Roche’s IT hiring activity rises 19.8% in October 2022

Pharmaceutical Technology

Switzerland-based company F. Hoffmann-La Roche’s IT hiring rose 19.8% in October 2022 when compared with the previous month, according to GlobalData’s Job Analytics database. The company’s overall hiring activity increased by 14.74% in October 2022 when compared with September 2022. IT jobs claimed a 7.48% share in the company’s total hiring activity in October 2022, and recorded a 0.09% decline over the last three-month average share.

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Cholesterol and diabetes drugs may lessen risk of degenerative eye disease associated with aging

Medical Xpress

Regular use of drugs to lower cholesterol and control type 2 diabetes may lessen the risk of the degenerative eye disease associated with aging, known as AMD, finds a pooled data analysis of the available evidence, published online in the British Journal of Ophthalmology.

Drugs 136
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MerckInc’s IT hiring activity declines 5.2% in October 2022

Pharmaceutical Technology

US-based company MerckInc’s IT hiring declined 5.2% in October 2022 when compared with the previous month, according to GlobalData’s Job Analytics database. The company’s overall hiring activity increased by 2.8% in October 2022 when compared with September 2022. IT jobs claimed a 4.86% share in the company’s total hiring activity in October 2022, and recorded a 0.95% decline over the last three-month average share.

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Study points to potential new treatment for inflammatory bowel diseases

Medical Xpress

People with inflammatory bowel diseases develop inflammation of the intestine that can cause thickening of the gut wall and life-threatening blockage of the intestinal tube. Twenty to 50 percent of people with Crohn's disease and ulcerative colitis are affected over their lifetime by this poorly understood condition, called "fibrosis.".

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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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Parexel International’s IT hiring activity rises 27.9% in October 2022

Pharmaceutical Technology

US-based company Parexel International’s IT hiring rose 27.9% in October 2022 when compared with the previous month, according to GlobalData’s Job Analytics database. The company’s overall hiring activity declined by 3.1% in October 2022 when compared with September 2022. IT jobs claimed a 12.5% share in the company’s total hiring activity in October 2022, and recorded a 0.27% growth over the last three-month average share.

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Could this cheaper, more climate-friendly perennial rice transform farming?

NPR Health - Shots

A promising, less labor-intensive perennial rice is beginning to take off in China, but whether this success can be replicated in other crops like wheat or corn remains to be seen.

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Meeting global demand for patient independence: SHL Medical expands production in Charleston, US

Pharmaceutical Technology

SHL Medical is a world-leading solutions provider for advanced drug delivery systems with a unified purpose to further enable patient independence. As a vertically integrated company, SHL Medical prides itself on being an end-to-end partner, offering in-house capabilities at every stage – from design, development and production to final assembly, labelling and packaging.

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First human trials of lab-grown red blood cells start in UK

pharmaphorum

Blood cells grown in a laboratory have been given to people for the first time in a clinical trial being carried out by researchers in the UK, in the hope that plentiful supplies of rare blood groups can be manufactured to order. A team from the universities of Bristol and Cambridge, NHS trusts and NHS Blood and Transplant (NHSBT) have started giving small quantities of the lab-grown red blood cells – a couple of teaspoons full – to two healthy volunteers to see if they are safe.

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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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Health Canada grants authorisation for Moderna’s Omicron-based booster

Pharmaceutical Technology

Health Canada has granted authorisation for Moderna ’s BA.4/BA.5 Omicron-targeting bivalent Covid-19 booster vaccine, mRNA-1273.222, for people aged 18 years and above. The 50µg vaccine is indicated for usage as a booster shot for active immunisation against Covid-19. It comprises 25µg of messenger ribonucleic acid (mRNA) encoding for the SARS-CoV-2 virus BA.4/BA.5 Omicron variants’ spike protein and 25µg encoding for the virus’ initial strain.

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Opinion: Trying to quit my job as an ER doctor gave me reasons to stay

STAT News

The morning was crisp and still dark as I sat in my car in the hospital lot, summoning the will to open the door and leave for my shift in the emergency department. Like many frontline providers in early 2021, I felt pancaked by the two pandemic surges — emotionally and morally. Not getting out of the car wasn’t an option. Responsibility to others demanded I get moving.

Doctors 111
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Spain’s pharma industry IT recruitment activity rises 6.7% in October 2022

Pharmaceutical Technology

Spain’s pharma industry registered a 6.7% rise in IT hiring activity in October 2022 when compared with the previous month, according to GlobalData’s Job Analytics database. The industry’s overall hiring increased by 1.86% in October 2022 when compared with September 2022. Out of the pharma industry’s total hiring activity, IT jobs claimed a 10.06% share in October 2022, recording an increase of 0.62% over the last three-month average share.

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A brain stimulator powered by breath instead of batteries

Medical Xpress

Implantable deep brain stimulators can help many people with neurological and psychiatric disease when traditional treatments fail. But surgery every time the batteries need to be changed is a major drawback. Now, UConn researchers report in Cell Reports Physical Sciences a new way to charge the devices using a person's own breathing movements.

Research 111
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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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The ins and outs of the life sciences: top hires for October 2022 

pharmaphorum

In this new segment from pharmaphorum, we collect the most significant hirings, firings, and recruitment stories from across the industry. This month, we highlight new appointments from Lumeris, Lineage Cell Therapeutics, 1910 Genetics, and ADC Therapeutics. . Ben Grabski, Lumeris. Lumeris, a value-based care managed services operator for health systems, has appointed Ben Grabski as chief financial officer.

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Study shows that adaptive immune responses can cause cellular loss in the aging brain

Medical Xpress

Past neuroscience studies have consistently demonstrated that the aging of the mammalian nervous system is liked with a decline in the volume and functioning of white matter, nerve fibers found in deep brain tissues. Although this is now a well-established finding, the mechanisms underpinning the decline of white matter and associated pathologies are poorly understood.

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STAT+: J&J’s Mammen out of the running for Biogen CEO post

STAT News

Biogen is mulling new options in its search for a CEO after talks with a senior research executive from Johnson & Johnson reached an impasse, STAT has learned. Mathai Mammen, a well-regarded scientist and head of R&D at pharmaceutical giant J&J, had been a frontrunner to become Biogen’s next leader as late as last month. But more recently, talks between Mammen and the company’s board broke down, according to a person familiar with the situation.

Scientist 105
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Sugar molecules as a target in cancer therapy

Medical Xpress

Cancer cells use sugar molecules on their surfaces to disable attacks by the body's immune system. Researchers at the University of Basel now report on how this mechanism can be neutralized.

Research 105
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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.