Mon.Feb 15, 2021

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DTC Review: Nucala

World of DTC Marketing

THE SHORT: According to Medical News Today “in the United States (U.S.), an estimated 25.7 million people have some form of asthma , and 15 percent of these people have severe asthma that is difficult to control with standard medications. In the population as a whole, eosinophilic asthma is rare, affecting only 5 percent of adults with asthma or about 1.2 million people.

Doctors 205
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AstraZeneca/Oxford to trial COVID-19 vaccine in children

BioPharma Reporter

A new trial for the AstraZeneca/Oxford COVID-19 vaccine will investigate the efficacy of the vaccine in children aged six and over.

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CureVac’s COVID-19 vaccine begins rolling review with EMA

Pharma Times

CureVac’s CVnCoV is currently being investigated in a randomised, placebo-controlled Phase IIb/III clinical trial

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Scientific breakthroughs, approvals: Latest CAR T-cell therapy related developments

BioPharma Reporter

From new research offering promise for children's cancer to FDA registrations, we track the progress made in the past few weeks in terms of advancing CAR T-cell therapy in a number of markets.

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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 Places Partial Clinical Hold on Cortexyme’s Alzheimer’s Drug Trial

BioSpace

According to a statement made by Cortexyme, the partial hold was placed on the development program for atuzaginstat after an FDA review of the trial data identified hepatic adverse events.

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Kidney Research UK pledges support to Accelerate@Babraham initiative

Pharma Times

Accelerate@Babraham supports early-stage life sciences ventures within the Babraham Research Campus’ community

More Trending

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AstraZeneca CEO Pascal Soriot Took Home $21.4 Million in 2020

BioSpace

AstraZeneca Chief Executive Officer Pascal Soriot is seeing a significant return on the fruits of his company’s labor in 2020. Soriot’s annual compensation jumped a bit from the previous year to $21.4 million.

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Does Access to 100 Million Patients Lead to Patient-Led Research?

XTalks

If identifying and including patients is one of the biggest hurdles of a clinical trial, what do you think access to 100 million patients would do? Although it’s not the panacea for all patient recruitment challenges, having access to millions of patients offers an opportunity to provide study designers with the ability to transform clinical trials by focusing on the real-world needs of the patient population in a way unlike ever before.

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North Korea Implicated in Another COVID-19 Hacking Attempt

BioSpace

Pfizer’s COVID-19 vaccine data has once again been threatened by hackers. The alleged theft of intellectual property has been laid at the feet of North Korea’s government.

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New skin patch brings us closer to wearable, all-in-one health monitor

Scienmag

Credit: Wang lab/UC San Diego Engineers at the University of California San Diego have developed a soft, stretchy skin patch that can be worn on the neck to continuously track blood pressure and heart rate while measuring the wearer’s levels of glucose as well as lactate, alcohol or caffeine. It is the first wearable device […].

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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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Should Employers Require COVID-19 Vaccination Before Returning to the Office?

BioSpace

As COVID-19 vaccine rollouts intensify across the country, employers across all industries are trying to decide whether they should implement a mandatory vaccine policy before they let employees back into the office.

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Insight about tumor microenvironment could boost cancer immunotherapy

Scienmag

Credit: UPMC, created with BioRender.com PITTSBURGH, Feb. 15, 2021 – A paper published today in Nature shows how chemicals in the areas surrounding tumors–known as the tumor microenvironment–subvert the immune system and enable cancer to evade attack. These findings suggest that an existing drug could boost cancer immunotherapy. The study was conducted by a team […].

Drugs 98
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Healthware and Italian cancer institute partner on digital health drive

pharmaphorum

Healthware Group has partnered with the National Cancer Institute of Naples in Italy to develop and roll out digital health platforms to support research and clinical practice in the treatment of people with cancer. The overall aim of the alliance – which will see Healthware work alongside the NCI’s Pascale Hospital – is to develop digital health tools that will deliver “more precise and accessible treatments to patients”, said the partners in a statement.

Doctors 95
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Comet or asteroid: What killed the dinosaurs and where did it come from?

Scienmag

New theory explains possible origin of the Armageddon-causing object. Credit: Credit not required. This is a public domain image. It forever changed history when it crashed into Earth about 66 million years ago. The Chicxulub impactor, as it’s known, left behind a crater off the coast of Mexico that spans 93 miles and runs 12 […].

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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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Why starting an innovation journey isn’t sexy

pharmaphorum

Chugai Pharmaceutical’s UK innovation lead, Martin Ellgood explores the challenges pharma companies face when devising innovation strategies. On a hot July morning, our managing director called me aside for a “quick word”. Five minutes later I emerged smugly with a new job title: UK innovation lead. I got ready to update my LinkedIn profile. I must confess that in that moment, the image of a golden chalice was floating in my mind.

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Moiré patterns facilitate discovery of novel insulating phases

Scienmag

UC Riverside-led study observed unexpected insulating phases by placing electrons on stacked monolayers of 2D semiconductors Credit: Microwave Nano-Electronics Lab, UC Riverside. RIVERSIDE, Calif. — Materials having excess electrons are typically conductors. However, moiré patterns — interference patterns that typically arise when one object with a repetitive pattern is placed over another with a similar […].

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US increases Pfizer and Moderna COVID-19 vaccine orders

BioPharma Reporter

The US Government has announced the purchase of 100 million additional doses from Pfizer and 100 million from Moderna.

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New physics rules tested on quantum computer

Scienmag

Simulation of non-Hermitian quantum mechanics using a quantum computer goes beyond centuries old conventions Credit: Aalto University Aalto researchers have used an IBM quantum computer to explore an overlooked area of physics, and have challenged 100 year old cherished notions about information at the quantum level. The rules of quantum physics – which govern how […].

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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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2021 Biopharma Update on the Novel Coronavirus: February 16

BioSpace

Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for February 16, 2021.

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CO2 dip may have helped dinosaurs walk from South America to Greenland

Scienmag

Climate shift may have aided herbivores on a 6,500-mile trek Credit: Lars Clemmensen A new paper refines estimates of when herbivorous dinosaurs must have traversed North America on a northerly trek to reach Greenland, and points out an intriguing climatic phenomenon that may have helped them along the journey. The study, published today in Proceedings […].

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Merck gets a leg-up for Keytruda in first-line kidney cancer

pharmaphorum

New phase 3 data have shored up the position of Merck & Co’s cancer immunotherapy Keytruda in the increasingly competitive first-line kidney cancer market. . The data from the KEYNOTE-581/CLEAR study reveal that the combination of PD-1 inhibitor Keytruda (pembrolizumab) with Eisai’s targeted tyrosine kinase inhibitor Lenvima (lenvatinib) reduced the risk of disease progression of death by 61% compared to Pfizer’s Sutent (sunitinib) in previously-untreated patients with renal cell carcinoma (

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Study questions whether pubs can effectively prevent COVID-19 transmission risk

Scienmag

Credit: University of Stirling A new first-of-its-kind study has questioned whether pub operators can effectively and consistently prevent COVID-19 transmission – after researchers observed risks arising in licensed premises last summer. Led by the University of Stirling, the research was conducted in May to August last year in a wide range of licensed premises which […].

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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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The Path to Novel Antibiotics

BioSpace

Those magic bullets that save thousands of lives each year – antibiotics – aren’t as resilient or effective as they once were, thanks to resistant bacteria.

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Higher elevation birds sport thicker down “jackets” to survive the cold

Scienmag

Study of Himalayan songbirds in museum collections is first step toward using feathers to predict the effects of climate change for birds in extreme environments Credit: Suniti Bhushan Datta Feathers are a sleek, intricate evolutionary innovation that makes flight possible for birds, but in addition to their stiff, aerodynamic feathers used for flight, birds also […].

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UK expands COVID-19 vaccinations to over-65s after 15 million receive first dose

Pharma Times

People aged 65 to 69 and the clinically vulnerable will be offered the jab from today

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New immunotherapy target discovered for malignant brain tumors

Scienmag

Credit: Dana-Farber Cancer Institute Scientists say they have discovered a potential new target for immunotherapy of malignant brain tumors, which so far have resisted the ground-breaking cancer treatment based on harnessing the body’s immune system. The discovery, reported in the journal CELL, emerged from laboratory experiments and has no immediate implications for treating patients.

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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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Cellectis Stock Jumps Following Natural Killer Cell Deal with Cytovia

BioSpace

Shares of Cellectis Therapeutics were up nearly 10% in premarket trading after the company forged a deal with Cytovia Therapeutics to develop immunotherapies based on gene-edited allogeneic CAR T-cells.

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Improved use of databases could save billions of euro in health care costs

Scienmag

Billions of euro in health care costs – arising from osteoporosis-related bone fractures – could be saved by improved use of existing databases Years of suffering and billions of euro in global health care costs, arising from osteoporosis-related bone fractures, could be eliminated using big data to target vulnerable patients, according to researchers at Lero, […].

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NICE rejects Lilly’s Verzenios for advanced breast cancer

Pharma Times

CDK4 & 6 inhibitor has been available as part of a Cancer Drugs Fund (CDF) managed access agreement

Drugs 75
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Ageism and sexism barring grandmothers from initiatives to save newborn lives in Global South

Scienmag

This is despite published research suggesting they have key roles in many cultures Ageism, sexism, and Western ideals of the nuclear family have excluded grandmothers from national and international policy initiatives to save newborn lives in the Global South, suggests an analysis published in the online journal BMJ Global Health. This is despite published research […].

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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.