Thu.Feb 04, 2021

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J&J asks FDA for emergency clearance of coronavirus vaccine

Bio Pharma Dive

With J&J's application filed, the FDA will start reviewing study results which the company says show its shot to be 66% effective against moderate or severe COVID-19.

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Thursday pharma headlines

World of DTC Marketing

SUMMARY: The industry is facing several challenges on several fronts. Amgen is laying off people because of their poor financial outlook. Merck’s old drugs are under more scrutiny, and anti-vaxxers are causing problems by cherry-picking unreliable information. Amgen announced that it’s laying off a significant number of people, most from the salesforce, under the guise that they’re going “digital.” Let’s be honest: this is a way to inflate a company’s st

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Ken Frazier to step down as Merck CEO

Bio Pharma Dive

Frazier, who's retiring after a three-decade career at Merck, will hand the reins to CFO Robert Davis at the end of June. While Frazier's tenure was framed by the success of Keytruda, his leadership extended far beyond Merck's walls.

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Olympus Supports Dissemination of Endoscopic Procedures for Colorectal Cancer in Russia

Pharma Mirror

Olympus Corporation (Director, Representative Executive Officer, President and CEO: Yasuo Takeuchi) announced today that it has been selected(1) by Japan’s Ministry of Health, Labour and Welfare (MHLW) to implement the Japan-Russia Medical Cooperation Promotion Project in the field of endoscopy for the fiscal year ending March, 2021. Under the project, Olympus will promulgate gastrointestinal endoscopic/laparoscopic techniques in support of a five-year oncology plan launched by the Russian

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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UK to start study testing Pfizer, AstraZeneca vaccines together

Bio Pharma Dive

The government-funded trial will evaluate the effects of mixing vaccines and varying timing between shots.

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Two Immigrants, One Unique Plan For A Biopharma

Pharma Mirror

The American Dream is why the United States is considered the “land of opportunity,” and why for centuries immigrants have flocked to our shores seeking their fortunes. Guo-Liang Yu, Ph.D., (China), and Sanjeev Redkar, Ph.D., (India), came to the U.S. in the 1980s. By anyone’s reasonable measure, both have achieved the American Dream.

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I Holland to Deliver a Free Tooling Maintenance Webinar Series

Pharma Mirror

Ensuring punches and dies are kept in optimum condition is essential to produce high quality tablets. As the demand for pharmaceutical tablets increases, the importance for proficient tool maintenance becomes even more important. To help companies understand the processes involved, I Holland, leaders in the manufacture of tablet tooling, will launch a free seven month webinar series, with the first presentation taking place at 2pm GMT on 25th February 2021.

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Not every cough is COVID – MSD UK’s lung cancer campaign

pharmaphorum

For World Cancer Day, David Long, business unit director of Oncology at MSD UK tells pharmaphorum about the company’s ‘Do It Yourself’ campaign launched in the North East to raise awareness of lung cancer symptoms. As COVID cases surged last year, lung cancer referrals dropped in the UK, causing alarm to the UK Lung Cancer Coalition (UKLCC), an alliance of the UK’s leading lung cancer experts, senior NHS professionals, charities, and healthcare companies.

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Olympus Supports Dissemination of Endoscopic Procedures for Colorectal Cancer in Russia

Pharma Mirror

Olympus Corporation (Director, Representative Executive Officer, President and CEO: Yasuo Takeuchi) announced today that it has been selected(1) by Japan’s Ministry of Health, Labour and Welfare (MHLW) to implement the Japan-Russia Medical Cooperation Promotion Project in the field of endoscopy for the fiscal year ending March, 2021. Under the project, Olympus will promulgate gastrointestinal endoscopic/laparoscopic techniques in support of a five-year oncology plan launched by the Russian

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Family cancer experience informs eHealth company

Outsourcing Pharma

The founder of Andaman7âs leukemia diagnosis, and his sonâs experience with bone cancer, have helped inform the firm's tech and patient-centric approach.

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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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A Message to Pharma CIOs: Optimizing Salesforce Improves Security and Compliance

pharmaphorum

By Jennifer Mercer , CEO of Metazoa. Jennifer Mercer is Co-founder and CEO of Metazoa, developers of Snapshot, an admin and developer tool for companies with complex Salesforce orgs that is used by over 60% of Fortune 100 companies. . Salesforce org management is usually not the headliner for CIOs and CTOs looking to catch up on executive-level trends and issues pertaining to technology.

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New Study Shows How SARS-CoV-2 Evolves Into New, Antibody-Evading Variants

BioSpace

A new study report in Science suggests SARS-CoV-2 and its mutated new variants can evade immune responses via the selective deletion of small sections of the virus’s genetic sequence.

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UK trial explores impact of combining different COVID-19 vaccines

BioPharma Reporter

An Oxford University trial, a world first, is looking at whether inoculating volunteers with doses of different combinations of two currently approved COVID-19 vaccines is effective.

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Switzerland Delays AstraZeneca Vaccine Approval, Wanting More Data

BioSpace

The Swiss health authority Swissmedic rejected AstraZeneca’s rolling authorization application for its COVID-19 vaccine a few days ago, saying more data is needed “to obtain more information about safety, efficacy, and quality.

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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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Five Super Bowl LV Food Ads to Watch This Year

XTalks

Super Bowl LV will be played on February 7, 2021 at the Raymond James Stadium in Tampa, Florida where the Kansas City Chiefs and the Tampa Bay Buccaneers will compete to win the 55 th Super Bowl. The Super Bowl is watched by 102 million people, and the advertisements are just as highly anticipated as the outcome of the game itself. A Super Bowl commercial in 2019 cost between $5.1 and $5.3 million for a 30-second slot, according to Bloomberg.

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Belgian trial to evaluate potential of genomic profiling of a patient’s cancer to guide personalized treatment options

BioPharma Reporter

Illumina, a DNA sequencing and array-based technology specialist, is supporting the Belgian Society of Medical Oncology (BSMO) in a pilot study examining the use of comprehensive genomic profiling (CGP) in 864 patients with advanced metastatic cancer.

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Webinar Recap – Video, Voice, and Virtual: Applying New Digital Technology to Enhance Customer Experience with PMN

Pharma Marketing Network

Moderator and Panelists: Amy Turnquist , EVP, Digital, eHealthcare Solutions (Moderator). Ryan Billings , U.S. Oncology Digital Marketing & Customer Experience at GSK. Desiree Priestley , Director, Patient Support Strategy & Insights at Otsuka America Pharmaceutical. Kristen Palmer Winters , Customer Experience (CX), Americas Hub, Digital & Commercial Innovation, Bayer.

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Sanofi Succeeding with Blue-Chip Asset, Dupixent, While Other Programs Fall Away

BioSpace

Over the course of 2020, Sanofi saw significant growth in its specialty care sales primarily driven by its blue-chip asset, Dupixent, as well as an increase in vaccine sales that were driven by demand for differentiated influenza vaccines, the company announced in its year-end financial report.

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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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Scientists optimized technology for production of optical materials for microelectronics

Scienmag

Credit: Denis Kosyanov, FEFU PI REC for Advanced Ceramic Materials Research Scientists of Far Eastern Federal University (FEFU) have advanced the technology of high-speed sintering for optical ceramics (Nd3+:YAG), i.e. active elements generating laser emission in the near-infrared wavelength range (1.06 ?m) for cutting the edge microelectronics and medicine.

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Lung cancer community severely impacted by COVID: report

Outsourcing Pharma

A report from the World Economic Forum and Lung Ambition Alliance outlines the impacts the pandemic is having on lung cancer diagnoses and treatment.

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Mapping hotspots of undersized fish and crustaceans may aid sustainable fishing practices

Scienmag

Credit: G. Milisenda and coathors A new study in Frontiers in Marine Science provides a first-of-its-kind evaluation of which regions of southern European seas are in the most need of fishing restrictions. These areas have persistently shown high numbers of undersized fish and crustaceans, which are typically discarded because they are below the allowable size […].

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New Zealand authorizes its first COVID-19 vaccine

BioPharma Reporter

New Zealandâs regulator Medsafe has given the Pfizer/BioNTech vaccine provisional approval, with border workers the first to be offered the vaccine.

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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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Deadly white-nose syndrome changed genes in surviving bats

Scienmag

Study has big implications for management of bat populations Credit: Sarah Gignoux-Wolfsohn Scientists have found genetic differences between bats killed by white-nose syndrome and bats that survived, suggesting that survivors rapidly evolve to resist the fungal disease, according to a Rutgers-led study with big implications for deciding how to safeguard bat populations.

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AstraZeneca and UCL to collaborate on two immuno-oncology projects

Pharma Times

Projects will investigate immune checkpoints and contribute to the development of new cancer treatments

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SSRgenotyper: A new tool to digitally genotype simple sequence repeats

Scienmag

Credit: Lewis, D. H., D. E. Jarvis, and P. J. Maughan. 2020. SSRgenotyper: A simple sequence repeat genotyping application for whole-genome resequencing and reduced representational sequencing projects. Applications in Plant Sciences… SSRgenotyper is a newly developed, free bioinformatic tool that allows researchers to digitally genotype sequenced populations using simple sequence repeats (SSRs), a task that […].

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Super Bowl player donates to help fund cancer research

Outsourcing Pharma

William Gholston, with the Tampa Bay Buccaneers football team, is donating to the Moffitt Cancer Center to fund research into cancer treatment disparities.

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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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Comb-like etching regulated growth for large-area graphene nanoribbon arrays

Scienmag

Credit: @Science China Press The rapid development of silicon-based transistors leads to its integration getting closer to the limit of Moore’s law. Graphene is expected to become the next generation of mainstream chip materials due to its ultra-high carrier mobility. However, it is difficult to obtain a high on/off current ratio for intrinsic graphene-based transistor […].

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Novavax Initiates Rolling Review for Vaccine & Other COVID News

BioSpace

Less than one week after posting a positive first-look at Phase III vaccine data, Maryland-based Novavax began the rolling review process for authorization of NVX-CoV2373 in the United Kingdom, Canada and the United States.

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Scripps Research and Tempus collaborate to study how individual blood sugar levels vary

Scienmag

The study will leverage genomics and digital technologies to better understand factors that contribute to obesity and type 2 diabetes LA JOLLA, CA–Scripps Research, a globally recognized nonprofit biomedical research institute, today announced a collaborative research program with Tempus, a leader in precision medicine and artificial intelligence, to develop a predictive model of glucose responses […].

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Gilead’s Inhaled COVID-19 Treatment, Remdesivir, Requires More Adequate Testing Before Regulatory.

BioSpace

Foster City-based Gilead Sciences says its inhaled version of remdesivir, which has been increasingly used in research and practice to combat COVID-19 in hospitalized patients, won’t be available any time soon as it needs more testing in clinical research.

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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.