Fri.May 06, 2022

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Novartis suspends production of two radiopharmaceutical drugs over quality concerns

Bio Pharma Dive

Due to potential issues in manufacturing, the pharma is halting deliveries of two cancer drugs, Lutathera and Pluvicto, in the U.S. and Canada, a setback for a business in which the company has invested heavily.

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Clinical Data Management Experts Share Insights on Modern Digital Clinical Trials

XTalks

In this interview, Xtalks spoke with experts from eClinical Solutions , Katrina Rice, Chief Delivery Officer, Data Services; and Diane Lacroix, Vice President, Clinical Data Management, about clinical data management for modern day digital clinical trials. They discussed current challenges and solutions that life science companies and clinical development organizations have with the management of clinical data.

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FDA places stricter limits on J&J's COVID-19 vaccine after review of rare side effect

Bio Pharma Dive

The agency is limiting use to adults who either can't or won't take another authorized vaccine after collecting more data on a rare and unusual clotting syndrome that has weighed on the shot's uptake.

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Matica Bio opens new Texas cell and gene therapy facility

BioPharma Reporter

CDMO Matica Bio has opened a new 45,000-square-foot facility dedicated to the production of viral vectors and cell-based products used in cell and gene therapies, vaccines, oncolytic therapies and other genetic medicines.

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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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University launches hub for pregnant women with pre-existing medical conditions

Pharma Times

Norfolk and Norwich University Hospitals Foundation Trust opens centre to increase survival rate among pregnant women managing other conditions

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When diversity, equity and inclusion are more than just buzzwords

pharmaphorum

Throughout my 30-year career, there have been many times it was obvious I stood out just because of my gender. I was often the only woman in the room, the meeting, or on the committee. Many colleagues had never worked with a woman leader before, let alone reported to a female boss. I’ve certainly faced barriers – sometimes literally. Exclusive behavior has many faces.

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WHO recommends Veklury for high-risk patients

Pharma Times

WHO have stated that Veklury recommendation is being updated following compelling new evidence of hospital reductions

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New review highlights innovative catalysts: Design and application

Scienmag

Nano-catalysis provides many opportunities for chemical transformations, ranging from chemical manufacturing to energy conversion and storage. By far, mainly due to the recovery aspect, heterogeneous catalysis has received a significant research attention, with its application covering approximately 80% of all catalytic processes. Credit: Chinese Journal of Catalysis Nano-catalysis provides many opportunities for chemical transformations, ranging […].

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FDA sets limits on the use of the Janssen COVID-19 vaccine in US

BioPharma Reporter

The FDA has limited the authorized use of the Janssen COVID-19 vaccine to individuals 18 years of age and older who cannot access other approved COVID-19 shots for various reasons.

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Wireless self-powered ammonia leakage monitor system developed for ammonia-energy ships

Scienmag

Due to its zero carbon, safe storage, and high energy density, liquid ammonia is a promising marine fuel in shipping industry. Credit: Nano Energy Due to its zero carbon, safe storage, and high energy density, liquid ammonia is a promising marine fuel in shipping industry. However, ammonia is a common toxic gas that can cause irritation to the mucous […].

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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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Beyond numbers: database brings to light quality of care for women and their babies at a national scale

The Pharma Data

New paper on database and programme in Nigeria shows enormous potential for helping to improve quality of care for women and babies. Quality, standardized data on the health of women and girls who are pregnant or have recently given birth, and their babies, is crucial to inform the design of interventions to help to safeguard their lives and well-being.

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United States, France cooperation advances international weather research

Scienmag

NORMAN, OKLA. – The University of Oklahoma and several research universities in France have signed a memorandum of understanding to facilitate cooperation between scientists to advance observations and studies of the atmosphere and radar technologies that will lead to improved weather, climate and air quality forecasts worldwide. Credit: None NORMAN, OKLA. – The University of […].

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WHO launches first ever global report on infection prevention and control

The Pharma Data

Reveals that good IPC programmes can reduce health care infections by 70%. The COVID-19 pandemic and other recent large disease outbreaks have highlighted the extent to which health care settings can contribute to the spread of infections, harming patients, health workers and visitors, if insufficient attention is paid to infection prevention and control (IPC).

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Research paper co-authored by City, University of London’s Dr Martin Nyx Brain wins Best Tool Paper Award at the European Joint Conference on the Theory & Practice of Software (ETAPS)

Scienmag

A research paper co-authored by City, University of London’s software reliability academic Dr Martin Nyx Brain in the Department of Computer Science, has won the Best Tool Paper Award at the recent European Joint Conference on the Theory & Practice of Software (ETAPS). Credit: Martin Nyx Brain, City University of London A research paper co-authored by City, […].

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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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New patent expiration for Gw Res drug EPIDIOLEX

Drug Patent Watch

Annual Drug Patent Expirations for EPIDIOLEX Epidiolex is a drug marketed by Gw Res Ltd and is included in one NDA. It is available from one supplier. There are twenty-one…. The post New patent expiration for Gw Res drug EPIDIOLEX appeared first on DrugPatentWatch - Make Better Decisions.

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Book on the management landscape an essential guide for business leaders.

Scienmag

Toronto – Over a stellar career, Professor Emeritus Roger Martin, a former Dean at the University of Toronto’s Rotman School of Management, has advised the CEOs of some of the world’s most successful companies. From the beginning, he noted that almost every executive he talked to had a “model”—a framework or way of thinking that […].

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Nurturing biotech in Europe: EuropaBio sets out recommendations

BioPharma Reporter

EU systems need to become more streamlined to help bring novel technologies to market - which would in turn encourage investment and activity in healthcare biotech, says EuropaBio as it publishes key policy recommendations for the sector.

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Researchers find superconductors can carry magnetic information to much longer distances than conventional metals

Scienmag

A group of theoretical physicists from the University of Jyväskylä and Tampere University, Finland, and the Materials Physics Center in San Sebastian, Spain, explain how superconductors can carry magnetic information to much longer distances than can conventional metals. The finding could be useful in information processing that uses magnetic materials at low temperatures.

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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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Big Health DTx improves sleep in stroke rehabilitation patients

pharmaphorum

A digital therapeutic (DTx) developed to help people suffering from insomnia has been shown to improve sleep and mental health in people recovering from a stroke in a clinical trial. The use of the Sleepio app improved sleep quality in 48% of patients enrolled into the study, which was conducted with the University of Oxford. The study found Sleepio users experienced less depression and anxiety after eight weeks follow-up, according to the results, which were presented this week at the European

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Paid leave mandates reduce likelihood of decreasing paid work hours after a spouse’s health shock, study shows

Scienmag

The 2022 Economic Report of the President cited Associate Professor of Health Administration and Policy Priyanka Anand’s research on the impact of paid family leave mandates on labor supply and caregiving decisions following a spousal disability or health shock. Credit: George Mason University The 2022 Economic Report of the President cited Associate Professor of Health […].

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Biogen grabs MS music therapy from MedRhythms in $120m deal

pharmaphorum

Biogen has licensed rights to a digital therapeutic (DTx) developed by MedRhythms which combines sensors, software, and music to help people with multiple sclerosis tackle mobility problems. The biopharma company – which is one of the top players in MS drug therapies – is paying $3 million upfront to claim rights to the DTx, known as MR-004, and is also on the hook for an additional $117.5 million in development and commercial milestones plus royalties on any eventual sales.

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Rotman School professor named to the Canadian Accounting Hall of Fame.

Scienmag

Toronto – A professor of accounting at the University of Toronto’s Rotman School of Management is among the second class of inductees to the Canadian Accounting Hall of Fame. Credit: Rotman School of Management Toronto – A professor of accounting at the University of Toronto’s Rotman School of Management is among the second class of […].

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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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PING Conference 2022 – The Golden Age for Life Sciences Innovation

pharmaphorum

The PING Conference 2022 is back in person this year, with opportunities to network face-to-face with people from right across the life sciences ecosystem. We will be going back to the future…with a historic twist! Be informed and be inspired from leading speakers, be networked, be fed, and be entertained! We are delighted to bring you this year’s PING Conference 2022 with a high calibre of inspirational and informative speakers taking part in an entertaining in person format at The Old Palace

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Almost 1 in 4 physicians experience workplace mistreatment, mostly from patients and visitors

Scienmag

BOSTON – According to new research from Boston Medical Center and Stanford University School of Medicine, almost a quarter of physicians who responded to a survey at Stanford Medicine experienced workplace mistreatment, with patients and visitors being the most common source. The research, published in JAMA Network Open, found mistreatment was common among all physicians, but […].

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Deep Dive: Market Access

pharmaphorum

For life science companies around the world, enabling faster access to innovative drugs and therapies is a complicated challenge. As this issue’s contributors discuss, changes in technologies and processes across the industry are disrupting traditional market access solutions and creating opportunities for companies to explore new avenues for innovation.

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nTIDE April 2022 Jobs Report: Economic recovery for people with disabilities holds strong  

Scienmag

East Hanover, NJ – May 6, 2022 – The post-pandemic economic recovery of people with disabilities remained strong in April and continued at historic highs, according to today’s National Trends in Disability Employment – Monthly Update (nTIDE), issued by Kessler Foundation and the University of New Hampshire’s Institute on Disability (UNH-IOD). Looking ahead, nTIDE experts […].

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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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WHO estimates true COVID death toll is nearly 15 million

pharmaphorum

Forget the number of deaths worldwide from COVID-19 estimated by the various trackers of around six million. The true figures is much higher, at nearly 15 million, according to the World Health Organisation (WHO). The agency believes many countries have underestimated the number of deaths that can be directly or indirectly attributed to the coronavirus, in some cases by a massive margin.

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Business intelligence acts as a precursor to strategy

Scienmag

Business Intelligence (BI) and analytics play a key role in strategy work. However, business intelligence is not just a data mass that supplements strategy or a self-evident prop, but, together with the predictions generated by new algorithms and computational models, it can even act as a driving force or “prime mover” in strategy formation, according […].

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Manufacturing foul-up hits Novartis’ radioligand business

pharmaphorum

Novartis has shut down production of its radioligand therapies – one of its key growth areas – at facilities in Europe and the US after discovering potential quality issues at the plants. The suspension affects sites at Ivrea in Italy and Millburn in New Jersey, and will affect both commercial and clinical trial supplies of its Lutathera for neuroendocrine tumours (NET) and recently-approved prostate cancer therapy Pluvicto.

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Chirped pulse driven cavity soliton dynamics

Scienmag

Researchers led by Prof. Tianye Huang at China University of Geosciences (Wuhan), China, are interested in the passive Kerr-resonators-based dissipative cavity solitons. The pulsed driving is an effective method to increase the temporal overlap between cavity soliton (CS) and pump field, thereby increasing the pump-to-comb conversion efficiency. The amplitude-modulated inhomogeneity of the background wave causes […].

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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.