Fri.Apr 09, 2021

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Sanofi buys an mRNA startup in another bet on 'off-the-shelf' cell therapy

Bio Pharma Dive

Tidal Therapeutics is the second biotech developing more convenient cell therapies that the French pharma has recently acquired, part of a broader expansion in oncology.

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Social media and prescription drugs: A study

World of DTC Marketing

QUICK READ: A two-month analysis of social media and prescription drugs found the number one reason online health seekers use social media is to share and ask questions about medication side effects. I also found an abundance of medication misinformation based on personal experiences and hearsay. In conjunction with leading consumer magazine I worked on a study to determine why people were using social media for information on prescription drugs and to examine and quantify what they were sharing

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Researchers lay out hypothesis for rare side effect linked to AstraZeneca vaccine

Bio Pharma Dive

The EMA has reiterated the benefits of the shot outweigh the risks, but the safety concerns are another hurdle to the vaccine's rollout in Europe.

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A Guide to Isolation Gown Selection

Pharma Mirror

Isolation gowns are essential equipment for infection-control strategies. They are the second most used PPE items after gloves. They were originally designed for health workers but can also be worn by random people to protect them from infections when they come in contact with infected people or substances. The different types of isolation gowns There are two major types of isolation gowns made for healthcare purposes: Surgical gowns: A surgical gown is a personal protective garment that is used

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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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Provention Bio latest drugmaker flagged for 'deficiencies' in FDA approval application

Bio Pharma Dive

While Provention executives think they can clear up the issues in a timely manner, shares in the biotech company slid sharply in response.

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Fine, We’re Humble-Bragging Again

Intouch Solutions

Three Intouchers recently garnered industry attention, and we thought it would be wrong to not talk about it. Learn more about who they are and what makes them exceptional. The post Fine, We’re Humble-Bragging Again appeared first on Intouch Solutions.

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Provention faces delay in FDA review of diabetes prevention antibody

pharmaphorum

The FDA says it has uncovered “deficiencies” in the marketing application for Provention Bio’s much-anticipated drug teplizumab for the prevention of type 1 diabetes (T1D) that could delay its review. The issues are holding up discussions between the agency and company about labeling and post-marketing requirements for teplizumab, and are concentrated around the pharmacokinetics data for the antibody, and whether it is comparable to the drug that its original developer Eli Lill

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UNT Health Science Center leads health literacy outreach in seven states

Scienmag

The Gibson D. Lewis Health Sciences Library works to improve access to authoritative health information for communities in Arkansas, Kansas, Louisiana, Missouri, Nebraska, Oklahoma and Texas. Credit: HSC Federal funding from the National Institutes of Health (NIH) will allow The University of North Texas Health Science Center at Fort Worth (HSC) to serve as a […].

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EU watchdog evaluates possible link between Johnson & Johnson jab and blood clots

BioPharma Reporter

The European Medicines Agency (EMA) is evaluating a possible link between blood clots and Johnson & Johnsonâs COVID-19 vaccine, while also reviewing reports of a bleeding condition in some individuals who received AstraZenecaâs COVID-19 shot.

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A new international consortium to promote stem cell-based therapy for Huntington’s disease

Scienmag

Credit: SC4HD The Stem Cells for Huntington’s Disease (SC4HD) is a new international consortium created to promote advanced therapy medicinal product (ATMP) through cell transplantation studies on Huntington’s Disease. The entity, made up of twenty-eight renowned researchers from ten countries, has been officially presented in a recent publication in the Journal of Huntington’s Disease.

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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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Astaxanthin for Dogs: Three Key Benefits

XTalks

Antioxidants have long been known to have risk-mitigating and disease-preventing properties when consumed by humans, but could they also be beneficial for man’s best friend? One such antioxidant, astaxanthin, may play a key role in not only maintaining but enhancing mobility and recovery in dogs. Before understanding why astaxanthin for dogs can be advantageous, we first have to delve into the antioxidant itself.

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Balancing between build-up and break-down of bone

Scienmag

Researchers at Osaka University define the complex role of SLPI, a secretory leukocyte protease inhibitor, in coordinating the biphasic action of parathyroid hormone on the metabolism of bone Credit: Osaka University Osaka, Japan – Despite what some people think, bone is not merely a passive component of the body. The skeleton is structurally dynamic and […].

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Human trials for world's first AI-designed immuno-oncology drug

Pharma Times

The drug was discovered through an AI-design platform within just eight months of project initiation

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Study finds to increase nurse practitioners prescribing buprenorphine falls short

Scienmag

Credit: Indiana University Since 2016, a federal regulation has allowed nurse practitioners and physician assistants to obtain a waiver to prescribe buprenorphine, a medication used to treat opioid use disorder as a medication assisted treatment. But a recent study by Indiana University researchers found the bill, called the Comprehensive Addiction and Recovery Act (CARA), has […].

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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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NICE 'no' for Opdivo/Yervoy lung cancer combo

Pharma Times

The combination is not considered to be a cost-effective use of NHS resources in this setting

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Antibody binding-site conserved across COVID-19 virus variants

Scienmag

The structural revelation could have implications as a therapeutic target in all SARS-CoV-2 variants Credit: Kelly Lab/Penn State A tiny protein of SARS-CoV-2, the coronavirus that gives rise to COVID-19, may have big implications for future treatments, according to a team of Penn State researchers. Using a novel toolkit of approaches, the scientists uncovered the […].

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EU nod for new formulation of Biogen's Tysabri

Pharma Times

A subcutaneous formulation will now be available to treat relapsing-remitting multiple sclerosis

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Exploration of ocean currents beneath the ‘Doomsday Glacier’

Scienmag

For the first time, researchers have been able to obtain data from underneath Thwaites Glacier, also known as the “Doomsday Glacier” They find that the supply of warm water to the glacier is larger than previously thought, triggering concerns of faster m Credit: Filip Stedt For the first time, researchers have been able to obtain […].

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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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BeiGene gains commercial manufacturing approval for Guangzhou biologics facility

BioPharma Reporter

BeiGene has announced approval from the China National Medical Products Administration (NMPA) to begin manufacturing its anti-PD-1 antibody, tislelizumab, at its biologics facility in Guangzhou, China.

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University of Tartu scientists develop materials for future fusion reactor

Scienmag

Credit: Wikipedia.org The energy source of the Sun and other stars is determined by the fusion reaction between two hydrogen nuclei. Imitating this process in a reactor would enable to produce so much energy that satisfy the world’s energy needs forever. It would not cause hazardous environmental pollution and the fuel supply would be unlimited. […].

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Plunging Johnson & Johnson Vaccine Supply Dents State Inoculation Efforts

NY Times

With supplies from Johnson & Johnson set to fall 86 percent, a White House official warned that the vaccine would be scarce until a troubled Baltimore plant gains regulatory approval.

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Treating sleep apnea may reduce dementia risk

Scienmag

A new study finds older adults who received positive airway pressure therapy prescribed for obstructive sleep apnea may be less likely to develop Alzheimer’s disease and other kinds of dementia. Researchers from Michigan Medicine’s Sleep Disorders Centers analyzed Medicare claims of more than 50,000 Medicare beneficiaries ages 65 and older who had been diagnosed with […].

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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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Healx deploys its AI in hunt for Friedreich’s ataxia therapies

pharmaphorum

UK artificial intelligence specialist Healx has begun a partnership with two medical charities that aims to uncover new therapies for the neurodegenerative disease Friedreich’s ataxia (FA). . Healx has joined forces with Ataxia UK and the US-based Friedreich’s Ataxia Research Alliance (FARA) on the project, and will use its AI-powered drug discovery platform Healnet to try to find already used drugs that could be repurposed as treatments for FA.

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New research reveals secret to Jupiter’s curious aurora activity

Scienmag

Auroral displays continue to intrigue scientists, whether the bright lights shine over Earth or over another planet. The lights hold clues to the makeup of a planet’s magnetic field and how that field operates. New research about Jupiter proves that point — and adds to the intrigue. Peter Delamere, a professor of space physics at […].

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Lilly, Incyte's Olumiant fails in COVID-19 trial

Pharma Times

The drug failed to significantly reduce progression to ventilation or death in patients hospitalised with COVID-19

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UCI’s Adriana Darielle Mejía Briscoe is named a 2021 Guggenheim Fellow

Scienmag

Renowned biologist is among 184 diverse recipients of prestigious award this year Irvine, Calif., April 9, 2021 — Adriana Darielle Mejía Briscoe, an acclaimed biologist known for her work on the evolution of vision in butterflies, has been awarded a 2021 Guggenheim Fellowship. The University of California, Irvine professor of ecology & evolutionary biology is […].

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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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Adlib Adds Contract Analytics to its AI Content Intelligence Platform

XTalks

Adlib Solutions, an emerging global leader in content intelligence, has announced the launch of its expanded AI-driven content intelligence platform to include enhanced contract analytics capabilities. Content intelligence combines the powers of AI systems and software to process, mine and analyze data to gain insights into the effectiveness of content and help guide content strategies for businesses.

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Glass injection molding

Scienmag

Credit: Photo: Neptun Lab/University of Freiburg Glass is ubiquitous, from high-tech products in the fields of optics, telecommunications, chemistry and medicine to everyday objects such as bottles and windows. However, shaping glass is mainly based on processes such as melting, grinding or etching. These processes are decades old, technologically demanding, energy-intensive and severely limited in […].

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Merck’s Keytruda demonstrates adjuvant use in kidney cancer

pharmaphorum

Merck & Co has announced interim data from its pivotal Phase 3 KEYNOTE-564 trial evaluating immunotherapy Keytruda for the potential adjuvant treatment of patients with renal cell carcinoma (RCC) following surgery. . The interim analysis carried out by an independent data monitoring committee, revealed Keytruda showed a statistically significant and clinically meaningfully improvement in disease free survival compared with placebo.

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Childhood diet and exercise creates healthier, less anxious adults

Scienmag

Study in mice shows lasting effects of early-life habits Credit: Marcell Cadney/UCR Exercise and a healthy diet in childhood leads to adults with bigger brains and lower levels of anxiety, according to new UC Riverside research in mice. Though diet and exercise are consistently recommended as ways to promote health, this study is the first […].

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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.