Sun.Mar 14, 2021

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Russia Sees Opportunity in Europe as AstraZeneca’s COVID-19 Vaccine Falters

BioSpace

With more European countries pausing dosing of AstraZeneca’s COVID-19 vaccine over concerns about potential blood clotting side effects, Russia is seeking to fill in the gaps with its Sputnik V vaccine.

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Effect of Osteopathic Manipulative Treatment on Activity Limitations in Patients With Low Back Pain

JAMA Internal Medicine

This randomized clinical trial compares the efficacy of standard vs sham osteopathic manipulative treatment for reducing activity limitations at 3 months in patients with nonspecific subacute or chronic low back pain.

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HIV Leaders Merck and Gilead to Team Up on Potential Game-Changer

BioSpace

Two of the biggest drugmakers in the HIV space are teaming up on a combination therapy that has the potential to be a game-changer for patients diagnosed with the dangerous virus for which there is no known cure.

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Psychotropic Drug Prescribing Among Nursing Home Residents During the COVID-19 Pandemic

JAMA Internal Medicine

This cross-sectional study uses data from the Ontario Drug Benefit database to assess prescribing patterns of psychotropic drugs among nursing home residents in Ontario, Canada during the coronavirus disease 2019 pandemic.

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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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FDA Action Alert: Karyopharm, FibroGen and Kiniksa

BioSpace

The second half of March is a busy month for the U.S. Food and Drug Administration (FDA), with quite a few PDUFA dates scheduled. Here’s a look at this week’s target action dates.

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Testing of primary school pupils promotes culture of division, say experts

Scienmag

Study shows children are removed from normal lessons or playtime to plug gaps in their learning and be ‘fixed’ academically, ready for SATS A fear of poor SATs results is driving headteachers to separate pupils by ability despite the impact on children’s self-esteem and confidence, according to a study by researchers from UCL published in […].

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National poll: Pandemic has negatively impacted teens’ mental health

Scienmag

Nearly half of parents have noticed a new or worsening mental health condition in their teen since the pandemic started; 3 in 4 say COVID-19 has negatively affected teens’ social interactions. Credit: C.S. Mott Children’s Hospital National Poll on Children’s Health at Michigan Medicine. ANN ARBOR, Mich. – For teens, pandemic restrictions may have meant […].

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At-Home, Prescription-free COVID-19 Dx Tests Enter the Real Marketplace: Amazon

BioSpace

EmpowerDX, a Eurofins subsidiary, just launched its direct-to-consumer COVID-19 Home Collection Kit in the U.S. through Amazon, making it one of a miniscule number of at-home and over-the-counter kits that are putting detection of the SARS-CoV-2 virus in the hands of patients.

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Should I Get a Coronary CT Scan?

JAMA Internal Medicine

This JAMA Patient Page describes the 2 different types of coronary computed tomography scans, as well as their benefits and risks.

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AVEO Reclaims Full Global Rights to Antibody Drug from CANbridge

BioSpace

Nearly five years to the day after striking the deal, AVEO Oncology and CANbridge Life Sciences announce the termination of their collaboration and licensing agreement for AVEO’s AV-203.

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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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Study finds high tumor mutation burden predicts immunotherapy response in some, but not all, cancers

Scienmag

Further research is needed to identify predictive biomarkers for certain cancers, results suggest Credit: MD Anderson Cancer Center HOUSTON ? A high rate of genetic mutations within a tumor, known as high tumor mutation burden (TMB), was only useful for predicting clinical responses to immune checkpoint inhibitors in a subset of cancer types, according to […].

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Clinical Catch-Up: March 8-12

BioSpace

It was another busy week for clinical trial announcements. Here’s a look including trials for COVID-19, migraine, Parkinson's disease, Alzheimer's, HIV and more.

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Sweden’s quantum computer project shifts up a gear

Scienmag

Knut and Alice Wallenberg Foundation is almost doubling the annual budget of the research initiative Wallenberg Centre for Quantum Technology, based at Chalmers University of Technology, Sweden Credit: Johan Bodell/Chalmers University of Technology Knut and Alice Wallenberg Foundation is almost doubling the annual budget of the research initiative Wallenberg Centre for Quantum Technology, WACQT, based […].

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Sanofi and Regeneron Halt Cervical Cancer Trial Early Due to Dazzling Results, Plan to Submit to.

BioSpace

Sanofi and Regeneron Pharmaceuticals’ checkpoint inhibitor Libtayo (cemiplimab) performed so well in the companies’ Phase III clinical trial in cervical cancer that the Independent Data Monitoring Committee (IDMC) recommended the trial be halted early. They plan to use the data for regulatory sub.

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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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Update on the safety of COVID-19 Vaccine AstraZeneca

The Pharma Data

Following a recent concern raised around thrombotic events, AstraZeneca would like to offer its reassurance on the safety of its COVID-19 vaccine based on clear scientific evidence. Safety is of paramount importance and the Company is continually monitoring the safety of its vaccine. A careful review of all available safety data of more than 17 million people vaccinated in the European Union (EU) and UK with COVID-19 Vaccine AstraZeneca has shown no evidence of an increased risk of pulmonary e

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Lilly's Donanemab for Alzheimer's: Promising Primary Results, Mixed Secondary Data, Some Safety C.

BioSpace

Many drugs for Alzheimer’s disease have demonstrated promise in early and mid-stage clinical trials, but then go on to fail in larger late-stage trials. It’s too early to know if that will be the case with Eli Lilly’s donanemab, but it showed unusually good primary results in a Phase II trial, wi.

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Calls to poison centers about high-powered magnets increased by 444% after ban lifted

Scienmag

Findings reflect the urgent need to protect children through preventive efforts and government action (COLUMBUS, Ohio) – High-powered magnets are small, shiny magnets made from powerful rare earth metals. Since they started showing up in children’s toys in the early 2000s and then later in desk sets in 2009, high-powered magnets have caused thousands of […].

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Former Five Prime CEO Aron Knickerbocker Named CEO of Aulos Bioscience

BioSpace

Aron Knickerbocker, former Chief Executive Officer (CEO) of RayzeBio and Five Prime Therapeutics, has taken the helm of Aulos Bioscience, a relatively new biotech company focused on the development of highly differentiated interleukin-2 (IL-2)-binding monoclonal antibodies the treatment of solid.

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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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These Covid Vaccines Are Now in the U.S. Others May Be Coming.

NY Times

Two vaccines are in wide use, a third is getting there, and there may soon be more alternatives. Here is a rundown.

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Three Biotechs Obtain Millions in New Financing Rounds Announced Monday

BioSpace

Several biotech companies have announced closings of million-dollar financing rounds Monday, with Cambridge, Mass.-based cell and gene therapy company ElevateBio leading the pack. ElevateBio announced it raised $525 million in a Series C financing round, which the company says should help expand.

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School closures ‘sideline’ working mothers

Scienmag

In states where elementary schools primarily offered remote instruction, the gender gap between parents in workforce surpassed 23 percentage points in 2020 Decades of feminist gains in the workforce have been undermined by the COVID-19 pandemic, which has upended public education across the United States, a critical infrastructure of care that parents — especially mothers […].

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Biocon Launches Bifunctional Antibody IO Subsidiary Bicara with $40 Million

BioSpace

Cambridge-based Bicara Therapeutics launched with a $40 million investment from its parent company, Biocon, to advance its bifunctional antibodies targeting both tumors and the immune system in cancer patients who are refractory to checkpoint inhibitors.

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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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Doctor communication key to pandemic vaccine adoption

Scienmag

PULLMAN, Wash. – People who talk with their doctors are more likely to get vaccinated during a pandemic, according to a study of evidence collected during the “swine flu,” the last pandemic to hit the U.S. before COVID-19. Researchers from Washington State University and University of Wisconsin-Madison surveyed patients about the vaccine for the H1N1 […].

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Conversiobot Review – AI-Powered Chatbot for Skyrocketing your Sales – Product Review by Mike Vaughn

BioTech 365

Conversiobot Review – AI-Powered Chatbot for Skyrocketing your Sales – Product Review by Mike Vaughn Conversiobot Review – AI-Powered Chatbot for Skyrocketing your Sales – Product Review by Mike Vaughn Conversiobot is an AI chatbot designed to help website owners … Continue reading →

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Is your child afraid of the dentist? CBT could help

Scienmag

Around one in three children are scared of going to the dentist and end up with poor oral health, more toothache, dental infections and tooth decay as a result Children with dental anxiety are frequently referred to specialist services for general anaesthetic which has additional challenges The new study, led by the University of Sheffield, […].

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Newron and Zambon Sign Agreement for Potentially Pivotal Study with safinamide in Parkinson’s Disease Patients

BioTech 365

Newron and Zambon Sign Agreement for Potentially Pivotal Study with safinamide in Parkinson’s Disease Patients Newron and Zambon Sign Agreement for Potentially Pivotal Study with safinamide in Parkinson’s Disease Patients Global study to evaluate the reduction of levodopa-induced dyskinesia (PD … Continue reading →

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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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Intervening early for infant brain health

Scienmag

CNS 2021 Virtual In the world of neurodevelopment, one thing is clear: the earlier the intervention the better. Infancy is a critical time in brain development, and neuroscientists are increasingly identifying factors that can negatively impact cognition and ones that can improve cognition early in life. At the annual meeting of the Cognitive Neuroscience Society […].

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Drug Patent Expirations for the Week of March 14, 2021

Drug Patent Watch

TWIRLA (ethinyl estradiol; levonorgestrel) Agile Patent: 7,045,145 Expiration: Mar 14, 2021 See More … For more information on how DrugPatentWatch can help with your pharmaceutical business intelligence needs, contact admin@DrugPatentWatch.com…. The post Drug Patent Expirations for the Week of March 14, 2021 appeared first on DrugPatentWatch - Make Better Decisions.

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One Thousand New Vaccine Appointments Available This Week in Orem via Nomi Health

BioTech 365

One Thousand New Vaccine Appointments Available This Week in Orem via Nomi Health One Thousand New Vaccine Appointments Available This Week in Orem via Nomi Health Appointments Also Available at Additional Nomi-Operated Larry H. Miller Megaplex Sites via GetMyShot.Utah.

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Which pharmaceutical companies have the most liquid dosed drugs?

Drug Patent Watch

This chart shows the pharmaceutical companies with the most liquid dosed drugs. For a different perspective, see the most popular dosage types. The companies with the most liquid dosed drugs…. The post Which pharmaceutical companies have the most liquid dosed drugs? appeared first on DrugPatentWatch - Make Better Decisions.

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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.