Wed.Jun 15, 2022

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Pfizer study results show Paxlovid benefit less clear in lower-risk patients

Bio Pharma Dive

A closely watched study missed its goal, failing to prove the antiviral pill’s benefit in a broader population than the high-risk individuals for which it’s currently cleared.

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?5 Things You Need to Know from Our Recent Gene Therapy Webinar

Worldwide Clinical Trials

At the end of May, we hosted a webinar titled “ Changing Times, Changing Therapies: Keeping Up with Advancements in Cell and Gene Therapies ” to provide a quick update on the latest advancements and ongoing in development of these advanced therapeutics. In case you missed it, you can watch the full webinar, here , or check out the top five things you missed: 1.

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FDA advisers recommend Pfizer, Moderna COVID-19 vaccines for youngest children

Bio Pharma Dive

Independent experts unanimously supported use of both shots in children aged 6 months to 5 years old, clearing the way for an FDA decision.

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Opioid use disorder: Flexible treatment at home proves effective

Scienmag

Did you know that more than 26,500 Canadians died from opioid intoxication between January 2016 and September 2021? Or that more than 350,000 people who used drugs containing opioids to relieve their pain did so problematically? Credit: CHUM Did you know that more than 26,500 Canadians died from opioid intoxication between January 2016 and September […].

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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 biotech in retreat, Third Rock raises $1B for life sciences investing

Bio Pharma Dive

The fund, Third Rock’s sixth, comes amid a significant downturn in the biotech stock market, which has raised questions about the viability of young drug startups.

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2nd NSCLC Drug Development Summit

pharmaphorum

The 2nd NSCLC Drug Development Summit returns for its second year to unite biopharma and academic leaders during an exciting era of personalized medicine. The industry is uniting to address mechanisms of drug resistance, spearhead progress in molecular subtyping and define practice-changing drug sequencing and combinations for the largest solid tumor indication, NSCLC.

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Co-existing mangrove-coral habitats have a new global classification system

Scienmag

On any given day between 2016 and 2019, Heather Stewart could be found snorkeling in between mangroves in the Bocas del Toro archipelago along Panama’s Caribbean coast. For years she visited these forests at the interface between land and sea, trying to understand what drove corals to grow inside them. Corals and mangroves often grow […].

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Boehringer Ingelheim Signs Option to Acquire Immunology Partner, Trutino Biosciences

BioSpace

Boehringer Ingelheim signed an option to acquire Trutino Biosciences for an undisclosed amount if certain milestones under its existing partnership are achieved.

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Jazz and Redx in milestone inhibitor agreement

Pharma Times

Jazz Pharmaceuticals and Redx announce that pan-RAF inhibitor will enter clinical development

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How to Get an Internship in Biopharma

BioSpace

Applying to your first biopharma internship may feel overwhelming, but it doesn't have to be. Discover how to find, prepare for and be successful in a biopharma internship in our guide.

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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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Olive trees were first domesticated 7,000 years ago

Scienmag

A joint study by researchers from Tel Aviv University and the Hebrew University unraveled the earliest evidence for domestication of a fruit tree. The researchers analyzed remnants of charcoal from the Chalcolithic site of Tel Zaf in the Jordan Valley and determined that they came from olive trees. Since the olive did not grow naturally […].

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ImmunityBio’s Patrick Soon-Shiong Discusses Quest to Orchestrate NK and T Cells

BioSpace

Dr. Soon-Shiong and ImmunityBio are on the final leg of what they hope will be the FDA approval of their drug N-803 (anktiva) for the treatment of bladder cancer.

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New study finds human echolocators can better locate targets from sideways rather than straight ahead

Scienmag

-With pictures and videos- Novel research conducted by scientists from Durham University, UK, University of Birmingham, UK, Eindhoven University of Technology, Netherlands and Placentia, USA have discovered for the first time that human echolocators have better acuity in localising a target from 45° off to the side as compared to from straight ahead at 0°. […].

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Digital operating room developer Proximie raises $80m

pharmaphorum

Tech startup Proximie has raised $80 million in third-round financing that will be used to further develop its augmented reality platform, which allows surgeons to share best practices with other clinicians anywhere in the world. The London, UK-based company’s connected operating room (OR) platform means doctors can physically show each other where to make an incision – in real-time – or use physical gestures to illustrate a technique.

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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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Trial Automation, Education Lapse Consequences of COVID-19 for Cancer Research

BioSpace

Frederick National Laboratories, the American Cancer Society and other leaders are picking up the pieces - both good and bad - as COVID-19 becomes endemic.

Trials 91
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In people with HIV, treating precancerous anal lesions cuts risk of anal cancer by more than half

Scienmag

A large clinical trial of people living with HIV has found that treating anal precancerous growths known as high-grade squamous intraepithelial lesions, or HSIL, reduces the chance that anal cancer will develop by more than half. Credit: The ANCHOR study A large clinical trial of people living with HIV has found that treating anal precancerous […].

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ADC Space Continues to Thrive with Four More Companies Linking Up

BioSpace

This week sees Exelixis, BioInvent, ImmunoGen and Oxford BioTherapeutics coming together to develop antibody-based therapies for cancer.

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Willingness to give away money among older adults linked to cognitive profile of early Alzheimer’s disease

Scienmag

To help protect older adults from financial exploitation, researchers are working to understand who is most at risk. New findings from the Keck School of Medicine of USC, published this week in the Journal of Alzheimer’s Disease, suggest that willingness to give away money could be linked to the earliest stages of Alzheimer’s disease. Credit: Ricardo […].

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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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Keensight Capital invests in AstraZeneca spin-out

Pharma Times

The deal will boost CatSci’s ability to deliver best-in-class medicines to patients worldwide

Medicine 101
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Wildfire smoke exposure negatively impacts dairy cow health

Scienmag

Philadelphia, June 16, 2022 – Increasing frequency and size of wildfires in the United States over the past several decades affect everything from human life and health to air quality, biodiversity, and land use. The US dairy industry is not exempt from these effects. The Western states, where wildfires are especially prevalent, are home to […].

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Biogen Halts ALS Asset Agreement with Karyopharm

BioSpace

Biogen has terminated its asset purchase agreement with Karyopharm Therapeutics, putting a halt to the development of KPT-350 (BIIB100), which was being evaluated as a treatment for ALS.

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UGA study asks: Did democracy have a separate origin in the Americas?

Scienmag

Democracy is widely understood to have arisen in the Mediterranean world about 2,500 years ago before spreading through cultural contact to other parts of the globe. But new research from the University of Georgia Laboratory of Archaeology, together with its partners in the Muscogee Nation, indicates that inhabitants of the Americas may have been practicing […].

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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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Emulate's Colon Intestine-Chip Assay Helps Predict Therapeutic Efficacy in IBD

BioSpace

The model has been validated against clinically relevant IBD therapies to demonstrate efficacy and mechanism of action, enabling drug developers to gain more accurate therapeutic insights.

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Fecal transplants show promise for protecting newborns receiving antibiotics

Scienmag

Antibiotics are among the most powerful superheroes of medicine. From the introduction of penicillin in the 1930s to the dramatic rescues that occur today when doctors use strong antibiotics like vancomycin to combat “superbugs,” many people know that bacteria-slaying antibiotics have saved uncounted lives from deadly infections. Credit: Cincinnati Children’s Antibiotics are among the most […].

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What’s Next on Moderna and Pfizer Vaccines for Very Young Kids?

NY Times

As eagerly anticipated as the shots are for some parents, the committee’s meeting is just one step in a process federal regulators must follow before the vaccines could become available to children as young as 6 months old.

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Dog-owner relationship appears similar for dogs born in Canada versus imported there

Scienmag

Contrary to some beliefs about internationally sourced dogs, a new survey analysis has found no evidence for a poorer relationship between Canadian dog owners and dogs born outside of Canada versus in Canada. Kai von Rentzell of the University of British Columbia in Vancouver, Canada, and colleagues present these findings in the open-access journal PLOS […].

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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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Roche Therapy for Rare Form of Alzheimer's Falls Short in Phase III

BioSpace

The trial evaluated crenezumab’s ability to slow Alzheimer’s disease in cognitively unimpaired people with a specific gene mutation that causes early-onset Alzheimer’s disease.

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Qatar Omicron-wave study shows slow decline of natural immunity, rapid decline of vaccine immunity

Scienmag

A recent Pfizer or Moderna mRNA-vaccine booster provided good but temporary protection against infection by the SARS-CoV-2 Omicron variant, according to a study from researchers at Weill Cornell Medicine—Qatar. In the study, published June 15 in the New England Journal of Medicine, the researchers analyzed the Omicron wave in Qatar last winter, comparing prior infections, vaccine […].

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The top 5 barriers to type 2 diabetes patient recruitment, and how to overcome them

Clairnes

The post The top 5 barriers to type 2 diabetes patient recruitment, and how to overcome them appeared first on Clinical Trial Recruitment & Management Services.

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Giving metal to microbes could reduce greenhouse gas

Scienmag

Like you and me, microbes need some metals in their diet to stay healthy. The metals help the microbes fully “digest” food. After a good meal, the microbes that gain energy by chemically reducing nitrate release a harmless byproduct: nitrogen, the gas that makes up 78% of Earth’s atmosphere. Credit: Kenneth Kemner/Argonne National Laboratory Like […].

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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.