Fri.Feb 18, 2022

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BioMarin says gene therapy hold will endure as FDA questions cancer risk

Bio Pharma Dive

According to BioMarin, the regulator has requested additional data to assess the "theoretical" cancer risk to the treatment, information that will take "several quarters" to collect.

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When it comes to telehealth it’s not numbers

World of DTC Marketing

Business Insider formed a relationship with eMarketer for so-called “intelligence.” Their report on telehealth has numbers, but that’s not what’s important. We need to understand “why” people are using telehealth and for what purposes versus an in-office visit. In-office visits also have more benefits. Here is a quote from the report that is debatable at best “over the next few years, telehealth will remain the domain of the younger digital natives.

Doctors 247
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Citing safety signal, GSK pauses some trials of new RSV vaccine

Bio Pharma Dive

As RSV vaccine development heats up, the drugmaker said it will delay work on its shot for pregnant women, although separate studies in older adults remain on track.

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QED Environmental Systems Ltd MD becomes Co-Chair of CoGDEM Industry Subgroup

Pharma Mirror

Dean Kavanagh, Managing Director of QED Environmental Systems Ltd in the UK, has been appointed Co-Chair of the Council of Gas Detection and Environmental Monitoring (CoGDEM) Industry Subgroup. Dean will chair the Sub-group with Rob White, Sales Director of DD Scientific, with both chairs taking up their appointments early in 2022. The CoGDEM Industry Subgroup is one of the most influential steering groups, with meetings scheduled three times a year.

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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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With drug approval, Agios hits first key milestone after major shakeup

Bio Pharma Dive

The biotech, which recently narrowed its research focus to rare blood disorders, is now cleared by the FDA to start selling the first medicine for a rare form of anemia.

Medicine 169
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7 Problems with Using Borosilicate Glass to Package Drugs

Pharma Mirror

By Christopher Weikart, Chief Scientist, SiO2 Materials Science Even though drugs are meant to save lives, the primary packaging used for delivering drug therapies and vaccines may actually be putting us in danger. The pharmaceutical industry works hard to create cutting-edge drugs to save lives and keep people healthy. From research to clinical trials, to go-to-market, drug makers are constantly seeking out new drug technologies and approaches to treat everyday illnesses and to end global pande

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Data day: Trial results deliver hope for prostate cancer patients

Pharma Times

New combination treatment can significantly reduce the risk of death among prostate cancer patients

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Dupixent falls short in phase 3 chronic spontaneous urticaria trial

pharmaphorum

Sanofi and Regeneron have reported disappointing results in a trial of Dupixent in people with chronic spontaneous urticaria (CSU) who don’t respond to the only approved biologic treatment, Novartis/Roche’s Xolair. . CSU is a severe form of hives that affects around 1% of the global population, causing severe itching and swelling that can last for weeks at a time and resist even very high doses of antihistamines, the standard, first-line therapy for the condition.

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Dig Restaurant Group is Introducing the Four-Day Workweek to the QSR Industry

XTalks

Dig Restaurant Group, a chain of locally farm sourced restaurants, is taking a page from the corporate world and introducing four-day workweeks to the quick service restaurant (QSR) industry. While salaried office workers tend to be the most popular cohort trialing the four-day workweek, hourly workers at some of Dig’s locations will be getting the same perk.

Trials 98
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Bayer triples sales forecast for prostate cancer drug Nubeqa

pharmaphorum

Bayer now says it expects to make €3 billion in sales for its prostate cancer treatment Nubeqa, up from an earlier estimate of €1 billion, after reviewing new data for the drug in metastatic hormone-sensitive tumours. The optimistic assessment of the revenue potential for androgen receptor inhibitor Nubeqa (darolutamide) follows the publication of the results of the phase 3 ARASENS trial in the New England Journal of Medicine.

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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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Pharma Franchise Business Is Beneficial For the Indian Pharmaceutical Market

Fossil Remedies

PCD Pharma Franchise Business. Why are more aspirants willing to make a career in the field of pharmaceuticals? It is because the business is not only promising, but it is going to remain profitable for many years. People have become health conscious and they want to maintain fitness. Also, the recent Covid-19 outbreak has also changed the scenario.

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New AI technology sheds light on drug development

Scienmag

Will artificial intelligence (AI) change the traditional trial–and–error drug development process and become a revolutionary force in the pharmaceutical sector? Active learning and interpretable AI are the two critical paradigms that lead to the positive answer, according to a perspective article recently published in Health Data Science, a Science Partner Journal.

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Why China Doesn’t Have an mRNA Vaccine for Covid

NY Times

Beijing once said it had two mRNA shots within reach and ready for approval — one homemade and one produced by a foreign company. Today, neither are available.

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How racialized trauma functions as a barrier to enjoying nature

Scienmag

COLUMBUS, Ohio – The closure of a gate at a national wildlife refuge in Denver about a decade ago ensured protection for bison, bald eagles and other wildlife inside, but also created a physical and metaphorical barrier for people living in diverse communities just outside the fence. The case of the fence and closed gate […].

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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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Vertical Integration: Strategies to Align Care

Drug Channels

Today’s guest post comes from Garry Marshall, Senior Director of Business Strategy at Wolters Kluwer, Health. Garry discusses healthcare business vertical integration and its effect on care quality for patients and on providers' work experiences. To learn more, download the Wolters Kluwer Expert Insight article Vertical Integration Strategies: Using Data to Align Partners and Reduce Variation in Care.

Drugs 80
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Hepatitis C patients cured with antiviral medicines are less likely to be hospitalized, need ER care for liver, other health-related issues

Scienmag

DETROIT (February 18, 2022) – Researchers at Henry Ford Health System, as part of a national hepatitis C collaborative, report that patients with chronic hepatitis C who are treated with direct-acting antiviral medicines are less likely to be hospitalized or seek emergency care for liver and non-liver related health issues. Credit: Henry Ford Health System […].

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All trades: Syncona announces sale of portfolio company to Novartis

Pharma Times

Company focused on founding and building global leaders in life science sold to Novartis

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Onset of modern sea level rise began in 1863, international study finds

Scienmag

An international team of scientists including Rutgers researchers has found that modern rates of sea level rise began emerging in 1863 as the Industrial Age intensified, coinciding with evidence for early ocean warming and glacier melt. Credit: Shutterstock An international team of scientists including Rutgers researchers has found that modern rates of sea level rise […].

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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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¿Por qué China no ha aprobado o desarrollado una vacuna de ARNm?

NY Times

El país había dicho que tenía dos vacunas con esta tecnología a su alcance y listas para ser aprobadas: una nacional y otra producida por una empresa extranjera. Hoy, ninguna de las dos está disponible.

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nTIDE January 2022 COVID Update: Rise in January unemployment reflects omicron surge

Scienmag

East Hanover, NJ. February 18, 2022. Unemployment rose for people with and without disabilities as the surge in the omicron variant affected the labor market in January, according to today’s National Trends in Disability Employment (nTIDE) COVID Update. Credit: Kessler Foundation East Hanover, NJ. February 18, 2022. Unemployment rose for people with and without […].

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What do we know about lab automation? 

Drug Discovery World podcast

The latest episode of the free DDW podcast is titled “ What do we know about lab automation? ”. It covers two narrated articles written for Volume 22, Issue 3 – Summer 2021 of DDW, read by Megan Thomas. . The articles are “What has 2020 taught us about lab automation?” and “Enhancing drug discovery with laboratory informatics and automation”. .

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Steroid treatments for Duchenne muscular dystrophy may depend on the clock

Scienmag

Each year, about 20,000 children are diagnosed with Duchenne muscular dystrophy, a rare genetic condition that causes progressive muscle weakness and other systemic damage. Credit: Cincinnati Children’s Each year, about 20,000 children are diagnosed with Duchenne muscular dystrophy, a rare genetic condition that causes progressive muscle weakness and other systemic damage.

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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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New patent for Therapeuticsmd Inc drug IMVEXXY

Drug Patent Watch

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

Drugs 52
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MicroQuin to launch cancer research to space station on Northrop Grumman CRS-17

Scienmag

An investigation from biotechnology startup MicroQuin launching to the International Space Station (ISS) on Northrop Grumman’s 17th Commercial Resupply Services (CRS) aims to better understand the onset and progression of cancer. The project will use 3D cell culture to examine cell signaling pathways involved in tumorigenesis (the process by which normal cells transform into cancer […].

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New patent for Jazz Pharms drug DEFITELIO

Drug Patent Watch

Annual Drug Patent Expirations for DEFITELIO Defitelio is a drug marketed by Jazz Pharms Inc and is included in one NDA. It is available from one supplier. There is one…. The post New patent for Jazz Pharms drug DEFITELIO appeared first on DrugPatentWatch - Make Better Decisions.

Drugs 52
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UMass Amherst research advances knowledge of the battle between viruses and human cells

Scienmag

In the long-term battle between a herpesvirus and its human host, a University of Massachusetts virologist and her team of students have identified some human RNA able to resist the viral takeover – and the mechanism by which that occurs. Credit: UMass Amherst In the long-term battle between a herpesvirus and its human host, 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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New patent for Vifor Fresenius drug VELPHORO

Drug Patent Watch

Annual Drug Patent Expirations for VELPHORO Velphoro is a drug marketed by Vifor Fresenius and is included in one NDA. It is available from one supplier. There are nine patents…. The post New patent for Vifor Fresenius drug VELPHORO appeared first on DrugPatentWatch - Make Better Decisions.

Drugs 52
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Network models may help us understand the spread of new variants in a pandemic

Scienmag

Tokyo, Japan – Researchers from Tokyo Metropolitan University have performed numerical simulations based on network theory which show how numbers of infections in a pandemic change when a new variant emerges. They found a non-linear dependence between how infectious the new variant is compared to the existing one, an effect not seen in previous work. […].

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New patent for Biocryst drug ORLADEYO

Drug Patent Watch

Annual Drug Patent Expirations for ORLADEYO Orladeyo is a drug marketed by Biocryst and is included in one NDA. There are five patents protecting this drug. This drug has forty-eight…. The post New patent for Biocryst drug ORLADEYO appeared first on DrugPatentWatch - Make Better Decisions.

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Hiddenite: a new AI processor for reduced computational power consumption based on a cutting-edge neural network theory

Scienmag

A new accelerator chip called “Hiddenite” that can achieve state-of-the-art accuracy in the calculation of sparse “hidden neural networks” with lower computational burdens has now been developed by Tokyo Tech researchers. By employing the proposed on-chip model construction, which is the combination of weight generation and “supermask” expansion, the Hiddenite chip drastically reduces external memory […].

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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.