Wed.Oct 20, 2021

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Gates Foundation pledges $120M to bring Merck COVID-19 drug to lower-income countries

Bio Pharma Dive

Anticipating regulatory clearance of the pill, the group aims to speed access by investing in the manufacturing of generic versions of the drug.

Drugs 257
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These Dairy Innovations Meet Personal and Planetary Health Targets

XTalks

Despite major accomplishments in the plant-based dairy space over the last few years, the animal-based dairy sector is proving there is still room for innovation. Taking notes from the VegTech sector , the dairy industry is diversifying to meet personal and planetary health targets, prioritizing nutrition and sustainability, along with flavor and accessibility. .

Protein 105
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FDA authorizes additional Moderna, J&J shots, broadening booster rollout

Bio Pharma Dive

The agency also cleared booster shots of all three currently available vaccines to be used interchangeably, a so-called mix-and-match approach that recent study results showed could boost immune responses.

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Cacaofruit is a New Ingredient in Barry Callebaut’s Elix Nutraceutical Beverage

XTalks

Barry Callebaut, a manufacturer of high-quality chocolate and cocoa products, is introducing a nutraceutical fruit drink made with the cacaofruit itself, called Elix. The new beverage has a zesty, fruity flavor that claims to promote circulatory health. In addition, the company created a product that keeps all the nutrients of the cacaofruit intact in order to provide the consumer with a nutraceutical beverage.

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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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Biogen's Alzheimer's drug is struggling, and a turnaround might not be coming soon

Bio Pharma Dive

Sales of Aduhelm during the third quarter totaled only $300,000, falling well below expectations amid controversy over its approval and physician reluctance to prescribe it.

Sales 161
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Manufacturing Issues Deliver More Delays for Novavax's COVID-19 Vaccine

BioSpace

Novavax is having problems getting its COVID-19 vaccine to the finish line. Shares plunged more than 23% in premarket trading today after reports that it is having manufacturing problems.

More Trending

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Federal Court finds Minister of Health’s refusal to grant CSP based on the “Timely Submission Requirement” unreasonable

Pharma in Brief

SUMMARY. The Federal Court has granted Merck Canada Inc.’s ( Merck ) application for judicial review of a decision of the Minister of Health ( Minister ) denying a Certificate of Supplementary Protection ( CSP ) for Canadian Patent No. 2,670,892 ( 892 Patent ) and the drug BELSOMRA (suvorexant). BACKGROUND. A CSP provides patent-like rights and is intended to compensate patentees for a period of patent term lost while innovative pharmaceutical products undergo research and regulatory approval. [

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COVID Update: New Delta Subtype Rising and Ivermectin Continues to Cause Problems

BioSpace

A subtype of the Delta variant might be rising, although it’s not yet clear if it’s more transmissible or lethal than the original Delta variant. Read on for that and more COVID-19 news.

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Humans did not cause woolly mammoths to go extinct — climate change did

Scienmag

For five million years, woolly mammoths roamed the earth until they vanished for good nearly 4,000 years ago – and scientists have finally proved why. Credit: Daniel Eskridge For five million years, woolly mammoths roamed the earth until they vanished for good nearly 4,000 years ago – and scientists have finally proved why. The hairy […].

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AstraZeneca Cancer Trial Hit with Clinical Hold Following Cardiac Issues

BioSpace

An experimental AstraZeneca cancer drug trial has been placed on hold due to safety concerns. This news comes two years after Amgen was also forced to pause a study of a drug within the same class.

Trials 98
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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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Scientists show plasma technology can safely clean disposable PPE for reuse

Scienmag

A new study from the University of Southampton has demonstrated a new method to safely clean and reuse facemask respirators with advanced low-temperature plasma technology. The discovery could help future pandemic responses by providing contingency options should a shortage of personal protective equipment (PPE) for frontline healthcare staff occur again.

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Merck Recalls 22,000 Vials Of Cubicin After Discovering Glass Particles

BioSpace

?The entire lot of CUBICIN (daptomycin), numbered 934778, which has an expiry date of June 2022, will be recalled from the user level, including administering institutions and hospitals.

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The transformation of brain implants

pharmaphorum

Nicolas Vachicouras, CEO of Neurosoft Bioelectronics, tells us how Neurosoft’s electrode implant aims to reduce inflammation and scar tissue for patients, provide higher quality brain recordings for surgeons and neurologists, and potentially administer medication where needed most in the body. “Electrodes have been on the market for many years and are used for a lot of applications.

Drugs 93
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Life Sciences Industry in California Defies Pandemic-Driven Employment Downturn

BioSpace

Although California is already a well-known hotbed for science and technology, the pandemic still precipitated a surge of activity in the life sciences industry.

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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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Psychoactive compound to advance research in treatment of depressive disorders

Pharma Times

Lucid-PSYCH is a psychoactive compound potentially viable for the treatment of major depressive disorders

Research 117
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Pfizer COVID Vaccine Contributor Saama Lands $430 Million Investment

BioSpace

Saama Technologies secured a $430 million investment from the Carlyle Group and venture funds from some of the pharmaceutical industry’s biggest companies.

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Scientists design nanoparticles that communicate with cancer cells

Scienmag

NEW YORK, October 20, 2021 — A multi-institutional research team has designed nanoparticles that can communicate with and slow the development of cancer cells. The work — detailed in a newly published paper in Advanced Materials — has uncovered a novel framework for the potential development of drug-free cancer therapies. Credit: Richard Huang and Ye […].

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Eisai-backed trial will assess Altoida’s digital test for early Alzheimer’s

pharmaphorum

A software platform developed by Altoida that uses augmented reality and artificial intelligence to diagnose neurological diseases in their earliest stages is being tested in a five-year trial involving thousands of patients. The trial – which will be supported by pharma company Eisai and Ionian University in the US – will see if the test can identify people who have mild cognitive impairment (MCI) due to Alzheimer’s disease.

Trials 78
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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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New galaxy images reveal a fitful start to the Universe

Scienmag

New images have revealed detailed clues about how the first stars and structures were formed in the Universe and suggest the formation of the Galaxy got off to a fitful start. Credit: SHARDS research team New images have revealed detailed clues about how the first stars and structures were formed in the Universe and suggest the formation of the Galaxy got off to a fitful start.

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DrugPatentWatch Ranked Best Biopharmaceuticals Commercial Business Intelligence Platform

Drug Patent Watch

DrugPatentWatch has been ranked the “Best Biopharmaceuticals Commercial Business Intelligence Platform” by Global Health & Pharma News This award is dedicated to honoring the innovation, determination and outstanding levels of…. The post DrugPatentWatch Ranked Best Biopharmaceuticals Commercial Business Intelligence Platform appeared first on DrugPatentWatch - Make Better Decisions.

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National study aims to document relationship between language and cognition in childhood language disorders

Scienmag

The University of Massachusetts Amherst will be one of two sites for a national study that aims to better understand language and cognition in two groups of children affected by language disorders. Credit: UMass Amherst The University of Massachusetts Amherst will be one of two sites for a national study that aims to better understand […].

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UCB licenses AI tech for spinal fracture detection to ImageBiopsy

pharmaphorum

An artificial intelligence-based tool for identifying hard-to-detect spinal fractures, developed by Belgian drugmaker UCB, has been licensed out to ImageBiopsy Lab for further development. The digital health tool, known as BoneBot, applies machine learning to X-rays to detect ‘silent’ or asymptomatic fractures in the vertebrae of the spine, a feature of the bone-wasting disease osteoporosis that can remain undiagnosed in more than two-thirds of cases.

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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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Unique dinosaur-era fossil bridges a gap in the evolution of crabs

Scienmag

During the dinosaur era, a crab wandering near a coastal forest was buried alive in tree resin and became fossilized. 100 million years later, Javier Luque, a former predoctoral fellow at the Smithsonian Tropical Research Institute and currently a Research Associate at Harvard University, became aware of the crustacean trapped in amber thanks to Lida […].

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Biotage acquires DNA synthesis and purification company ATDBio

Pharma Times

ATDBio adds important platform solutions to Biotage within DNA and RNA oligonucleotide synthesis and purification

DNA 89
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Some of the world’s oldest rubies linked to early life

Scienmag

While analyzing some of the world’s oldest coloured gemstones, researchers from the University of Waterloo discovered carbon residue that was once ancient life, encased in a 2.5 billion-year-old ruby. Credit: University of Waterloo While analyzing some of the world’s oldest coloured gemstones, researchers from the University of Waterloo discovered carbon residue that was once ancient […].

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ReCode Scores $80 Million to Advance mRNA-Based Cystic Fibrosis, PCD Programs

BioSpace

ReCode is aiming to advance its lead candidates for cystic fibrosis and primary ciliary dyskinesia (PCD).

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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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ISS National Lab releases research announcement focused on in-space production applications in biomanufacturing

Scienmag

KENNEDY SPACE CENTER, FL. October 20,2021 – The International Space Station (ISS) National Laboratory has unveiled a research announcement seeking proposals to demonstrate biomanufacturing activities in microgravity. Targeted fields such as tissue engineering and biomanufacturing provide use cases for how ISS National Lab-sponsored research may lead to new biological products and tools that benefit humankind and […].

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Gates Foundation Pledges $120 Million to Help Get Covid Pills Quickly to Poor Countries

NY Times

Regulatory hurdles and supply chain issues could slow efforts to produce generic versions of Merck’s antiviral molnupiravir for developing nations, despite licensing agreements.

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Crab found in 100-million-year-old amber is oldest modern-looking crab ever found

Scienmag

Looking at the ancient piece of amber, Javier Luque’s first thought wasn’t whether the crustacean trapped inside could help fill a crucial gap in crab evolution. He just, more or less, wondered what the heck is a crab doing stuck in fossilized tree resin? Credit: Artwork by Franz Anthony, courtesy of Javier Luque (Harvard University). […].

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Genetika+ CEO Talia Cohen Solal Brings Precision Medicine to Brain Health

BioSpace

Depression is the first indication, but other neurological conditions are being planned.

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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.