December, 2022

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Four ways Biogen is tackling digital innovation in neurological disease

pharmaphorum

Digital transformation in pharma is not a singular endeavour. It can mean everything from patient-facing disease management apps and wearables to background AI dramatically altering drug discovery or radiological imaging. So, when a life sciences company embarks on a project of digital transformation or innovation, it’s really embarking on multiple projects that span the wide world of pharmaceutical operations.

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2022 in review: Regulation starts to catch up with AI in pharma

Pharmaceutical Technology

Artificial intelligence (AI) continued to stay in the news with several high-profile deals this year, as the pharmaceutical industry readily took to adopting AI models to improve drug discovery. But as the field grows in leaps and bounds, many authorities have prioritised the release of new guidelines, frameworks, and regulations to keep pace with these advances.

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Ferring wins FDA approval for bladder cancer gene therapy

Bio Pharma Dive

The OK caps a long development journey for the treatment, which was previously turned back by the agency. Ferring doesn’t expect it to be available until the second half of next year, however.

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In Afghanistan, coal mining relies on the labor of children

NPR Health - Shots

Since the return of the Taliban, Afghanistan's coal exports have increased — and so has child labor. At a coal mine in Baghlan province, boys earn between $3 and $8 for a day's work.

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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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‘One needs to feel safe’: Racism can put sleep — and its health benefits — out of reach

STAT News

Lots of people struggle to get enough sleep — and the responsibility for fixing the problem tends to fall on the individual. Experts offer advice like reducing screen time, exercising more, or just going to bed earlier in the evening. But many restless nights can’t be solved with blackout curtains, ear plugs, or other typical suggestions.

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Developing a digital marker for coronary artery disease

Medical Xpress

Using machine learning and clinical data from electronic health records, researchers at the Icahn School of Medicine at Mount Sinai in New York constructed an in silico, or computer-derived, marker for coronary artery disease (CAD) to better measure clinically important characterizations of the disease.

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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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Biotech veteran Jeff Jonas on leaving Sage, guiding new biotechs and his ‘personal odyssey’

Bio Pharma Dive

In an interview with BioPharma Dive, the longtime industry executive discussed becoming a biotech investor and his plans for Abio-X, a new incubator with $150 million to spend on startups.

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COVID spreading faster than ever in China. 800 million could be infected this winter

NPR Health - Shots

Scientists predict China will see the largest COVID surge of the pandemic this winter, with hundreds of millions of people infected. But some experts say that it could have been even worse.

Scientist 145
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Opinion: Hospice care needs saving

STAT News

Hospice in America is gravely ill. An extensive investigation jointly published by The New Yorker and ProPublica documented outright fraud, predatory practices, and flagrant mistreatment by specific publicly traded and private equity-owned hospice companies.

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Commercial Drug Sourcing for Clinical Trials

The sourcing of commercial drugs for use in clinical trials either as a comparator, rescue or co-medication can be a complex process. Sponsors can face a number of challenges when trying to obtain these critical supplies for their studies, including addressing product lead times, availability, expiry limitations, safety and cost, among others. Choosing the right partner with global sourcing, regulatory, quality and clinical packaging expertise can provide the necessary guidance to help sponsors

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Adults who neglect COVID-19 health recommendations may also neglect basic road safety, study finds

Medical Xpress

Reasons underlying hesitancy to get vaccinated against COVID-19 may be associated with increased risks of traffic accidents according to a new study in The American Journal of Medicine. Researchers found that adults who neglect these health recommendations may also neglect basic road safety. They recommend that greater awareness might encourage more COVID-19 vaccination.

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CSL closes on EU approval for haemophilia B gene therapy

pharmaphorum

CSL’s gene therapy for haemophilia B has been recommended for approval by the EMA’s human medicine committee, setting up a decision by the European Commission early next year. The positive opinion for etranacogene dezaparvovec – which was approved as Hemgenix by the FDA last month – raises the prospect of the first one-time therapy in the EU for the bleeding disorder, which affects around 1 in 50,000 of the population, according to the European Haemophilia Network (EUHANET).

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Lilly and ProQR to expand genetic medicine development agreement

Pharmaceutical Technology

Eli Lilly and Company has expanded a licencing and partnership agreement with ProQR Therapeutics to discover, develop and market new genetic medicines. The companies entered the initial agreement in September last year. This alliance is utilising the Axiomer ribonucleic acid (RNA) editing platform of ProQR to address ailments affecting the liver and nervous system.

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Amgen to buy Horizon Therapeutics in year’s biggest biotech deal

Bio Pharma Dive

After outlasting rival suitors Sanofi and J&J in deal talks, Amgen agreed to a deal that values the Ireland-based maker of rare and inflammatory disease drugs at about $28 billion.

Drugs 343
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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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You can order free COVID tests again by mail

NPR Health - Shots

People are gathering indoors for the holidays, and there's been an uptick in COVID-19 cases. The federal government says you should test often to try to prevent the spread of the virus.

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STAT+: Nine in 10 health care companies with financial stress are owned by private equity

STAT News

Almost 90% of the health care companies deemed to be under financial stress by a leading credit rating agency are owned by private equity , a stark indicator of the toll financial investors have taken on a vital sector. The striking finding is part of a new Moody’s Investors Service report released this week that shows broad turbulence throughout an industry weakened by private equity’s practice of loading companies with debt, making them less resilient to challenges like Covid-19,

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Probiotic bacteria found in fermented foods might help dispel bad breath

Medical Xpress

Probiotic bacteria usually found in fermented foods, such as yogurt, sourdough bread, and miso soup, might help dispel the embarrassment of persistent bad breath (halitosis), finds a pooled data analysis of the available evidence, published in the open access journal BMJ Open.

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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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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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Looking back at 2022: The top healthcare stories

Pharmaceutical Technology

The healthcare industry saw its share of ups and downs in 2022. Our response to the worldwide pandemic evolved over time, and so did the needs of the sector and the people relying on healthcare companies to deliver solutions. Along the way, mergers and acquisitions continued to happen, new drugs and devices got approved, and innovations in the clinical trial industry were introduced.

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Dantari emerges with a new way to make cancer drug conjugates

Bio Pharma Dive

As the success of drugs like Enhertu catalyzes new investment in antibody-drug conjugates, the California startup is launching with plans to develop more potent versions of the targeted cancer medicines.

Drugs 328
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Medical bills remain inaccessible for many visually impaired Americans

NPR Health - Shots

When health bills aren't legible — via large-print, Braille or other adaptive technology — blind patients can't know what they owe, and are too often sent to debt collections, an investigation finds.

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STAT+: Bone marrow transplant patients could be spared from ‘bland’ diet, study finds

STAT News

Whenever a hematopoietic cell transplant patient tries to get a family member to sneak food in past the nurses, Federico Stella, a resident hematologist at the University of Milan, remembers. One was a girl who tried to get her sister to bring her a panettone, a Milanese sweet bread usually eaten around the holidays. A week before Christmas, the sister tried to hide the panettone in a bag.

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2022 Research: The Rapid Rise of Ocean Freight Visibility

A research study conducted by The Journal of Commerce and FourKites surveyed hundreds of international shippers, exploring how their usage of global supply chain visibility technology has evolved since the onset of global disruptions caused by COVID-19. For international shippers, ocean freight visibility has evolved from optional to essential and satisfaction with visibility varies greatly depending on how it is obtained and delivered.

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Good social relations promote active and healthy aging in Europe, finds researcher

Medical Xpress

In the older European population, men, as well as those with lower socioeconomic status, weak social ties, and poor health, might experience more difficulties getting informal support and are considered to have a higher risk of worsening frailty state and lower quality of life. This reality is shown in a new doctoral thesis at Umeå university.

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Investigation launched into alleged animal welfare violations at Neuralink

pharmaphorum

Elon Musk’s brain computer interface (BCI) company Neuralink is being investigated by law enforcement authorities in the US amid allegations of animal welfare violations in its testing facilities. Neuralink’s BCI is intended to treat conditions like blindness and spinal cord injury, as well as provide a way to interact with digital devices using the brain and, according to Musk, is on the brink of moving into the human testing stage.

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Kite and Daiichi Sankyo update cell therapy licensing agreement

Pharmaceutical Technology

Kite Pharma and Daiichi Sankyo have updated a partnership agreement signed in 2017 for the former’s CAR T-cell therapy, Yescarta (axicabtagene ciloleucel). Under the prior deal, Daiichi Sankyo acquired exclusive rights for the development, manufacturing and commercialisation of Yescarta in Japan. Subsequently, in the same year, Gilead Sciences acquired Kite.

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FDA approves first microbiota-based treatment

Bio Pharma Dive

The regulatory OK, a milestone for microbiome-based drug research, is for a medicine from Ferring Pharma that treats a recurrent type of gut infection.

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An Innovative & Creative Problem Solver Approach to Selling in the Medical Device Space

Speaker: Steve Goldstein, Sales Leader

Are you currently in sales, or involved in a business that depends on strong sales results? What about the extremely competitive world of medical device sales? What are some of the top challenges your customers face and how do you approach understanding what’s most important to them? Join Steve Goldstein, Sales Success Coach, Motivational Speaker and Medical Device Sales Leader from Gold Selling LLC., to discover critical strategies and approaches you can take to engage your customers, achieve g

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China has stopped publishing daily COVID data amid reports of a huge spike in cases

NPR Health - Shots

China's National Health Commission said in a statement it would no longer publish daily data and that "from now on, the Chinese CDC will release relevant COVID information for reference and research.

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Opinion: Artificial intelligence: crossing the border between health care and tech

STAT News

There’s been significant investment in companies creating artificial intelligence (AI) applications for health and health care over the last decade. But while there have been successes, notably in the area of medical imaging, the industry is known more for not yet living up to its potential — think IBM Watson. The slow pace of AI adoption in health care stems from the fact that health AI sits on the border between two large industries, health care and tech.

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Subcutaneous fat emerges as a protector of females' brains

Medical Xpress

Females' propensity to deposit more fat in places like their hips, buttocks and the backs of their arms, so-called subcutaneous fat, is protective against brain inflammation, which can result in problems like dementia and stroke, at least until menopause, scientists report.

Scientist 141
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WHO/PAHO launch free digital health assistant to cut alcohol-related diseases

pharmaphorum

A digital health assistant that can help people at risk of becoming dependent on alcohol has been launched in Belize, its first country, by the World Health Organisation (WHO) and Pan-American Health Organisation (PAHO). The artificial intelligence-powered assistant – called Pahola and available as a free online chat-based site – is designed to provide information and guidance to help people reduce their alcohol consumption, helping to prevent more than 200 health conditions linked to excessive

Drugs 122
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Mandatory COVID Vaccination Policy Template

New vaccine mandates and testing policies will affect employers with more than 100 workers. Get Paycor’s free, customizable vaccination policy template to communicate critical details and new requirements to your employees. Get Paycor’s Template today!