Mon.Mar 22, 2021

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Roche immunotherapy notches a win in early lung cancer, pressuring Merck

Bio Pharma Dive

New results could make Tecentriq the first immunotherapy available in the post-surgery setting, adding pressure on Merck & Co.'s Keytruda to succeed as well.

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The right balance in DTC: Tv versus digital ads

World of DTC Marketing

SUMMARY: Television remains the most important medium for healthcare advertising , accounting for 54.7% of all spend in 2018, far higher than television’s 30.8% share of the advertising market as a whole. However, recent trends indicate that healthcare marketers are shifting more dollars to digital ads. The shift to digital advertising doesn’t make sense when pharma product websites don’t meet consumers’ needs.

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AstraZeneca, Oxford vaccine prevents COVID-19 in big US study amid controversy overseas

Bio Pharma Dive

A two-shot regimen was 79% effective at protecting people from COVID-19, which should support the fourth clearance of a vaccine in the U.S. and calm safety concerns abroad.

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‘A critical and very exciting milestone’: Approval of domestically manufactured COVID-19 vaccine boosts Australia’s vaccination campaign

BioPharma Reporter

Australiaâs Therapeutic Goods Administration (TGA) has approved manufacture of the AstraZeneca COVID-19 vaccine by CSL â Seqirus: reducing the country's dependence on limited supply from abroad and allowing a wider vaccination campaign to begin.

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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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Technological adoption and human connection. Finding the balance in clinical trials

Bio Pharma Dive

While technology can push trials ahead, in-person interactions and site relationships are, and always will be, the key to success in delivering patient-centric trials on time.

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The 4 Biggest Cancer Biotech Acquisitions of 2021 So Far

XTalks

As a growing number of pharmaceutical companies set their sights on stepping into the burgeoning oncology space, major moves continue to be made with key cancer biotech acquisitions. And as big pharma works on developing and growing their oncology portfolios, the rising trend of such mergers and acquisitions won’t be slowing down any time soon. In the past few weeks alone, the industry saw four major cancer biotech acquisitions: Agilent Technologies’ takeover of precision oncology liquid biopsy

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CureVac on track to apply for COVID-19 vaccine market authorization in Q2 2021

BioPharma Reporter

CureVac is expanding its late-stage clinical trials for its COVID-19 vaccine candidate; while confirming it is on schedule to apply for formal market authorization in the EU in Q2 2021.

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José Baselga, prominent cancer researcher, dies at 61

Bio Pharma Dive

The head of AstraZeneca's oncology R&D changed the paradigm of breast cancer care by helping bring the targeted treatments Herceptin and Perjeta to patients.

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Shock as AstraZeneca’s charismatic cancer R&D chief José Baselga dies

pharmaphorum

AstraZeneca is mourning the loss of one of its top scientists after eminent cancer researcher José Baselga passed away at the age of just 61. . Baselga was a heavyweight in oncology research, pursuing a career that saw him serve as physician-in-chief at Memorial Sloan Kettering Cancer Centre in the US and also hold the position as president of the American Association of Cancer Research (AACR) before joining AZ to lead the drugmaker’s cancer R&D in January 2019.

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How to navigate Health Canada XML PM requirements

Bio Pharma Dive

Learn the latest about XML PM mandates and timelines from structured labeling experts.

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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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AstraZeneca’s Covid-19 Vaccine Is Found to Be 79% Effective in U.S. Study

NY Times

The company is preparing to apply for emergency authorization from the Food and Drug Administration. But the shot may not be needed in the United States.

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Solving the “information challenge” of rare disease diagnosis

pharmaphorum

Getting a diagnosis is often the biggest challenge facing a rare disease patient in the UK. We take a look at efforts from charities, the government and digital innovators to boost awareness of rare conditions among GPs and make the clinical pathway smoother for patients. There are more than 150,000 people living with a rare neurological condition in the UK, which taken together means that these conditions aren’t actually that rare at all – and that’s just for one slice of the wider rare disease

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Good News for Pfizer and Regeneron in Fight Against COVID-19

BioSpace

With widespread distribution of various vaccines against COVID-19 vaccine ongoing, companies are still refining their vaccines and therapies and generating new data. Here’s a look at two recent updates.

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Raft of Indian pharma firms set to produce Sputnik V vaccine

BioPharma Reporter

The RDIF, Russiaâs sovereign wealth fund, and India based, Virchow Biotech Private Limited, have today announced a partnership to produce and supply a minimum of 200 million doses of the Russia developed Sputnik V vaccine against COVID-19.

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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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Food industry lobbying was intense on failed bill to limit marketing to Canadian children

Scienmag

Credit: Christine Mulligan, courtesy of Nutritional Sciences, University of Toronto Researchers at the University of Toronto have found that food industry interactions with government heavily outnumbered non-industry interactions on Bill S-228, also known as the Child Health Protection Act, which died in the Senate of Canada in 2019. The researchers looked at more than 3,800 […].

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GoodSport Milk-Based Sports Drink Upcycles Dairy Byproduct

XTalks

GoodSport Nutrition has introduced a line of milk-based sports drinks that is innovating in this crowded category. This sports drink is made from the goodness of milk and provides consumers with hydration that is clear and thirst quenching. The beverage, GoodSport, uses milk as its main ingredient because it is an essential and natural source of electrolytes and carbohydrates.

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Sealing fistulas with regenerative immiscible bioglue

Scienmag

Credit: POSTECH A Korean research team has recently developed an innovative vesico-vaginal fistula treatment method using the mussel adhesive protein (MAP) that can effectively seal fistulas in organs even when exposed to urine. Professor Hyung Joon Cha, Dr. Hyo Jeong Kim (currently at Korea Research Institute of Chemical Technology), and Dr. Tae Yoon Park of […].

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Some Nations Could Wait Years for Covid Shots. That’s Bad for Everyone.

NY Times

While richer places, such as the U.S., hope to vaccinate most of their citizens within months, poorer countries, like Kenya, expect to reach just small fractions of their populations in that time.

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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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Deluge of DNA changes drives progression of fatal melanomas

Scienmag

Credit: WEHI, Australia Melbourne researchers have revealed how melanoma cells are flooded with DNA changes as this skin cancer progresses from early, treatable stages through to fatal end-stage disease. Using genomics, the team tracked DNA changes occurring in melanoma samples donated by patients as their disease progressed, right through to the time the patient died. […].

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Four More Biopharma Companies Set Sights on IPOs

BioSpace

This week, four companies set sights on listing their shares on the stock market in hopes of raising significant funds to support the development of their pipelines and businesses.

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UNM study: As more are vaccinated, it makes economic sense to gradually open the economy

Scienmag

Credit: UNM School of Engineering A University of New Mexico research team conducted a data analysis that has found that as a larger portion of the population gets vaccinated against COVID-19, it becomes economically advantageous to start relaxing social distancing measures and open businesses. Francesco Sorrentino, associate professor of mechanical engineering, is lead author of […].

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AstraZeneca’s Covid-19 Vaccine Found to Be 79% Effective in U.S. Study

NY Times

The vaccine maker is preparing to apply for emergency authorization from the Food and Drug Administration. But the vaccine may not be needed in the United States.

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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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US trial data shows Oxford-AstraZeneca vaccine is ‘safe and highly effective’

BioPharma Reporter

The Oxford-AstraZeneca vaccine was 79% effective in preventing symptomatic COVID-19, according to the findings of the Phase 3 study in the US, Chile and Peru, says AstraZeneca.

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Fruit fly egg takes an active hand in its own growth, highlighting parallels to mammals

Scienmag

Credit: (c) Simons Foundation A cast of so-called ‘nurse cells’ surrounds and supports the growing fruit fly egg during development, supplying the egg — or ‘oocyte’ — with all the nutrients and molecules it needs to thrive. Long viewed as passive in this process, the Drosophila egg actually plays an active role not only in […].

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FDA nod for Kiniksa’s Arcalyst in recurrent pericarditis

Pharma Times

Recurrent pericarditis is an autoinflammatory cardiovascular disease

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Cancer research benefits from harnessing real-world data

Outsourcing Pharma

A leader from oncologist-founded trial tech specialists COTA shares how advanced data analysis can benefit cancer researchers and patients alike.

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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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News Brief – FDA Slapdown, Patent Approval, Funding News and More

BioSpace

The life sciences industry is a bustling beehive of activity. Here’s a quick compilation of some of today’s newsworthy announcements.

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Roche’s Tecentriq improves disease-free survival in early lung cancer

Pharma Times

Tecentriq is approved in five lung cancer indications currently

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Novartis' Radioligand Therapy Lives Up to Hype in Phase III Prostate Cancer Trial

BioSpace

Targeted radioligand therapy 177Lu-PSMA-617 from Novartis significantly improved overall survival (OS) and radiographic progression-free survival (rPFS) in patients with PSMA-positive metastatic castration-resistant prostate cancer.

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Machine learning shows potential to enhance quantum information transfer

Scienmag

Credit: Courtesy: LSU RESEARCH TRIANGLE PARK, N.C. – Army-funded researchers demonstrated a machine learning approach that corrects quantum information in systems composed of photons, improving the outlook for deploying quantum sensing and quantum communications technologies on the battlefield. When photons are used as the carriers of quantum information to transmit data, that information is often […].

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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.