Thu.Jun 02, 2022

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Upstream Bio, a richly funded startup, reveals its lead drug and research plans

Bio Pharma Dive

Backed by $200 million in funding and led by biotech veteran Samantha Truex, Upstream is developing a clinical-stage inflammatory disease drug acquired from Astellas last year.

Drugs 336
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Azelis inaugurates state-of-the-art Regional Innovation Center for Food & Nutrition in Singapore 

Pharma Mirror

SINGAPORE, Azelis, a leading innovation service provider in the specialty chemicals and food ingredients industry, announces the opening of its Regional Innovation Center (RIC) for Food & Nutrition (F&N) in Singapore, further demonstrating the Group’s commitment to continuously invest in its innovation capabilities. The RIC will generate a wealth of possibilities for food innovation towards healthier and tastier solutions through pioneering, ready-to-use formulations with advance

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Former AbbVie executive Severino joins Flagship-backed startup as CEO

Bio Pharma Dive

Severino left the pharma company in April after eight years as its chief scientist and then president. He'll lead Tessera Therapeutics, a well-funded genetic medicine startup.

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Monkeypox: The vaccine landscape

BioPharma Reporter

Interest in vaccines against monkeypox is growing as the outbreak spreads around the world. The arsenal includes existing smallpox vaccines and potential new monkeypox specific mRNA vaccines.

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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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Regeneron buys control of cancer drug Libtayo from Sanofi

Bio Pharma Dive

The biotech, which has been partnered with Sanofi for years, will pay $900 million upfront to gain sole control of the cancer immunotherapy.

Drugs 177
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Jubilant wins US government $150m funding into vaccine manufacture

BioPharma Reporter

The agreement, which was made in coordination between the US army and BARDA, will see Jubilant expand its injectable filling production capacity to prepare for future pandemics.

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Freestyle Libre 3 By Abbott Gets FDA Clearance and Becomes the Affordable Continuous Glucose Monitor

XTalks

A person riding an exercise bike while wearing the FreeStyle Libre 3 and using the phone app with Bluetooth connection to this continuous glucose monitor. © Abbott. All rights reserved. The circular shape of the sensor, housing, FreeStyle, Libre, and related brand marks are marks of Abbott. In this fast-paced world, the dietary changes of the human population have led to the rise of diet-related diseases such as diabetes, obesity, cardiovascular diseases and more.

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Scientists show that at least 44 percent of earth’s land requires conservation to safeguard biodiversity and ecosystem services

Scienmag

New research published in the June 3, 2022 journal Science reveals that 44 percent of Earth’s land area – some 64 million square kilometers (24.7 million square miles) requires conservation to safeguard biodiversity. Credit: Max Melesi on behalf of Koobi Carbon New research published in the June 3, 2022 journal Science reveals that 44 percent […].

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The Case for Data Unity, Sharing, and Usability

Drug Channels

Today’s guest post comes from Bonnie Briggs, Associate Director of Clinical Effectiveness at Wolters Kluwer, Health. Bonnie describes how pharmaceutical care would benefit from standard medical record identification. She then discusses the practical issues behind implementing and adopting such a system. To learn more, download the Wolters Kluwer free ebook: Drug Data Unity: Realistic and Idealistic Futures for Information Exchange.

Drugs 85
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Immune therapy targets cells that cause leukemia relapse

Scienmag

Genetically engineered immune cells successfully target the specific cancer cells that may be responsible for relapse of acute myeloid leukemia (AML), a type of blood cancer, and proved effective in animal models of the disease, according to a preclinical study by investigators at Weill Cornell Medicine. The new cell therapy, now being tested in phase […].

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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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Numinus CEO: Psychedelic-assisted Psychotherapy Still Driven by Perceptions

BioSpace

BioSpace spoke with Payton Nyquvest, co-founder and CEO of Numinus about changing perceptions around psychedelic-assisted psychotherapy and the company's work in this space.

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A 50% reduction in emissions by 2030 can be achieved. Here’s how

Scienmag

The United States has set an ambitious goal to reduce greenhouse gas (GHG) emissions by at least 50% by 2030. Are we on track to succeed? Credit: choochart choochaikupt/iStock The United States has set an ambitious goal to reduce greenhouse gas (GHG) emissions by at least 50% by 2030. Are we on track to succeed? A new […].

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FDA Expresses Concern Over Myocarditis Ahead of Novavax Adcom

BioSpace

The FDA has expressed worries over four cases of heart inflammation, or myocarditis, that were observed in pivotal clinical trials of Novavax's COVID-19 vaccine.

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This parasite will self-destruct: researchers discover new weapon against drug-resistant malaria

Scienmag

A new method to combat malaria which sees the disease turn against itself could offer an effective treatment for the hundreds of millions of people infected globally each year, as the efficacy of current antimalarial drugs weakens. Credit: Image generated by Leann Tilley and Riley Metcalfe A new method to combat malaria which sees the […].

Drugs 82
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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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Aeglea Stumbles in First BLA Attempt as FDA Issues RTF

BioSpace

???????The FDA requested more data on effectiveness, particularly evidence that shows plasma arginine and metabolic reduction can predict clinical benefit in patients living with ARG1-D.

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Cancer increases the risk of developing diabetes

Scienmag

Cancer patients are at a greater risk for developing diabetes, according to a new study by the Steno Diabetes Center Copenhagen, Rigshospitalet, and the University of Copenhagen. The study also concludes that cancer patients who develop diabetes die sooner than survivors without diabetes. Credit: Jakob Helbig / University of Copenhagen Cancer patients are at a […].

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Novo Scores Phase III Insulin Win, Potentially Strengthening Market Position

BioSpace

The results showed that insulin icodec is as non-inferior to Sanofi’s insulin glargine, Lantus, potentially bringing another major competitor into the insulin space.

Insulin 79
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Iron catalyst could make important chemical reactions cheaper and more eco-friendly

Scienmag

A catalyst is a key ingredient for many chemical reactions. It facilitates a molecule to change into another molecule, without being changed itself, meaning it can be used multiple times. However, many catalysts are made of precious metals, making them expensive and potentially harmful to the environment. Now, researchers have designed a catalyst made of […].

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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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Athersys Culls 70% of Staff in Effort to Prioritize MultiStem Programs

BioSpace

Shares of Cleveland-based Athersys, Inc. are plunging Friday after the company announced a strategic restructuring that will result in the slashing of 70% of its workforce.

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Study reveals COVID-19 mortality rate five times higher among labor, retail and service workers

Scienmag

TAMPA, Fla. (June 2, 2022) – A new study reveals that 68 percent of COVID-19 deaths during the first year of the pandemic were adults in low socioeconomic positions (SEP) employed in labor, service and retail jobs that require on-site attendance and prolonged close contact with others. Credit: University of South Florida TAMPA, Fla. (June 2, 2022) […].

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Sanofi and Immunocore Pair High Potential Molecules for Metastatic Skin Cancers

BioSpace

Sanofi will study its SAR444245 in combination with Immunocore’s KIMMTRAK in HLA-A*02:01 positive patients with advanced unresectable or metastatic skin cancers.

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Neurobiological model to better understand creative processes

Scienmag

Creativity is understood as the creation of novel, useful and surprising solutions. The researchers argue that the associated cognitive processes, such as the ability to abstract, improvise, or think divergently, involve different brain areas that are interconnected. These areas include the cerebellum, hippocampus, prefrontal cortex, and basal ganglia (see figure).

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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 Biogen/Ionis Data Suggests ALS Drug Effective Upon Earlier Initiation

BioSpace

Biogen and Ionis Pharmaceuticals have announced results from the Phase III VALOR trial and an open-label extension (OLE) trial of tofersen.

Trials 83
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Salmonella vaccine for poultry contributed to rise of antibiotic-resistant bacteria

Scienmag

An investigation into the evolution of Salmonella bacteria infecting Brazilian poultry shows that the introduction of a Salmonella vaccine, combined with increasing antibiotic usage by Brazilian farmers, has led to the rise of strains that are more antibiotic-resistant, but less likely to cause disease in humans. Andrea Micke Moreno of the University of São Paulo, […].

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FDA Extends Review for Amylyx ALS Drug to September

BioSpace

Amylyx Pharmaceuticals shared news that the FDA has extended the review period for AMX0035, a combination drug treatment with the potential to treat patients with ALS.

Drugs 73
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Saha legacy continues with establishment of Aortic Research Center at the University of Kentucky

Scienmag

LEXINGTON, Ky. (June 2, 2022) — On Monday, May 25, the faculty and administration of the University of Kentucky College of Medicine announced the creation of the Saha Aortic Center, a new research center focused on aortic disease. This new center was established thanks to a generous $1 million gift from the Saha Foundation. Credit: University of Kentucky LEXINGTON, Ky. […].

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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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Scientists Reset the Clock on Aging through Gene Manipulation

BioSpace

While tools to reverse age-related cellular dysfunction haven’t yet reached the masses, two research studies have emerged this week that hint at progress.

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JNM supplement explores opportunities for molecular imaging of neurodegeneration

Scienmag

In response to the ongoing paradigm shift in how neurodegenerative diseases are defined and diagnosed—as well as the new hope for a breakthrough in disease-modifying drugs—The Journal of Nuclear Medicine has issued a supplement on molecular imaging of neurodegeneration. The supplement provides an up-to-date overview on the different aspects of molecular imaging in neurodegeneration and a […].

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How to Keep Top Talent During Inflation

BioSpace

In order to stay afloat while maintaining a competitive edge, many life science companies are going to have to get creative in order to keep up with rising salaries and inflation.

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New discoveries in lupus research

Scienmag

Two separate findings by a University of Houston nationally recognized expert in systemic lupus erythematosus (SLE or lupus), a chronic autoimmune disease that affects multiple organs including the kidneys, skin, joints and heart, are being reported in scientific and medical journals. Credit: University of Houston Two separate findings by a University of Houston nationally […].

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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.