Mon.Nov 23, 2020

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AstraZeneca, Oxford coronavirus vaccine prevents COVID-19, though study results raise questions

Bio Pharma Dive

Data from two late-stage trials showed the shot to be, on average, 70% effective against COVID-19, an encouraging finding. The lower dose tested, however, outperformed a higher dose.

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Pfizer’s ad first step in restoring trust

World of DTC Marketing

SUMMARY: Pfizer’s ad in newspapers around the U.S. shows that they are ready to lead the fight against COVID-19 and in the process establish that their vaccine is safe and has been well tested. Pfizer ran an ad today that is superb. The ad, for it’s COVID-19 vaccine, has a headline that says “courage” and details that 43,661 people tested their vaccine and ends with “science will win” This ad send out a reassurance to vaccine skeptics who have come to believe

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Amgen cuts Cytokinetics loose after heart drug disappointment

Bio Pharma Dive

The smaller biotech vowed to push forward, although the pill's inability to prevent heart failure death may complicate its plans to win approval.

Drugs 303
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Comparing COVID-19 Vaccines: Timelines, Types and Prices

BioSpace

As the Pfizer-BioNTech COVID-19 vaccine is being evaluated by the U.S. FDA and the Moderna vaccine is soon to follow, here’s a look at several of the top COVID-19 vaccine candidates and where they stand as of today.

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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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Merck, expanding coronavirus work, buys a small biotech and its COVID-19 drug

Bio Pharma Dive

The large drugmaker will pay $425 million to acquire OncoImmune, which is developing a treatment for severe coronavirus disease.

Drugs 326
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Bill Gates, the Virus and the Quest to Vaccinate the World

NY Times

The billionaire is working with the W.H.O., drugmakers and nonprofits to defeat the coronavirus everywhere, including in the world’s poorest nations. Can they do it?

More Trending

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Chinese Government Arrests GenScript and Legend Biotech Founder for Smuggling

BioSpace

Two months after he was stepped down from the role of chief executive officer of Legend Biotech, Fangliang “Frank” Zhang has been arrested for smuggling genetic resources from the People’s Republic of China.

Genetics 119
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COVID-19 vaccine hope for older adults: following release of AstraZeneca, Pfizer, Moderna clinical trial data

BioPharma Reporter

Study data from leading COVID-19 vaccine candidates suggests they may be effective in older people.

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New Class of Drugs Harnesses Gold Nanocrystals to Heal and Protect the Brain

BioSpace

Clene Nanomedicine is trying to set a new “gold standard” in neurodegenerative diseases through the development of a new class of drugs called bioenergetic nanotherapeutics that harnesses the properties of gold nanocrystals.

Drugs 114
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AZ preps filings for COVID-19 jab, UK nears decision on Pfizer rival

pharmaphorum

AstraZeneca is preparing to file its COVID-19 vaccine with regulators after phase 3 trial results showed it is up to 90% effective. AZ made the announcemen t as the UK regulator reportedly gears up to make a decision on the rival vaccine from Pfizer and BioNTech, ahead of counterparts in the US and Europe. Results from trials conducted in the UK and Brazil showed an efficacy of 90% in 2,741 patients receiving the vaccine as a half dose, followed by a full dose at least one month apart.

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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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Antitrust Panel Sets Sights on Big Pharma for Next Target

BioSpace

Following a year-long probe into tech giants Amazon, Apple, Facebook, and Google, the House Judiciary antitrust subcommittee has its next target in its sights – big pharma.

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AstraZeneca Releases Promising Data on Its Coronavirus Vaccine

NY Times

The drug maker said its vaccine candidate was 70 percent effective on average, and potentially up to 90 percent effective, at preventing Covid-19 in an early analysis.

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Eyeing the Future, Novartis Plans for Growth with Share Buyback

BioSpace

To support its long-term goals, the Swiss pharma giant is initiating a share-buyback program of up to $2.5 billion that is expected to be carried out over the next few months.

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European Commission approves Sanofi’s MenQuadfi

BioPharma Reporter

Sanofiâs MenQuadfi becomes the first quadrivalent meningococcal conjugate vaccine available in Europe in a fully liquid presentation, avoiding the need for vaccine reconstitution.

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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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Will Thanksgiving Cause Another Round of Food Shortages? Here’s How Retailers Are Preparing

XTalks

With Thanksgiving just around the corner and COVID-19 cases continuing to rise, grocers and retailers are bracing once again for customer stockpiling. But this time around, some grocery chains are implementing previously used tactics to curb the inevitable shortages of Thanksgiving staples and other food items. While many national chains, including Kroger, Publix and H-E-B, have already limited purchasing quantities for some home essentials, they are looking ahead to see which food products migh

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Pooled efficacy of 70% for AstraZeneca and University of Oxford COVID-19 vaccine: 'It will have an immediate impact on this public health emergency'

BioPharma Reporter

AstraZeneca says interim analysis of clinical trials in the UK and Brazil of its candidate COVID-19 vaccine being developed in partnership with the University of Oxford - AZD1222 - showed the vaccine was highly effective in preventing COVID-19, the primary endpoint.

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Carbon nanocomposites are now one step closer to practical industrial

Scienmag

Credit: The image was taken in the Laboratory of Micro and Nano Mechanics, CDMM at Skoltech. A research team from the Center for Design, Manufacturing and Materials at Skoltech has recently published a study focusing on multifunctional materials created through the addition of carbon nanoparticles to polymer matrices, designed to allow self-diagnostic monitoring through an […].

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Regeneron’s COVID-19 antibody cocktail receives EUA from FDA

BioPharma Reporter

Regeneronâs casirivimab and imdevimab antibody cocktail (formerly known as REGN-COV2 or REGEN-COV2), has received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA).

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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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Siberian primrose has not had time to adapt to climate change

Scienmag

Credit: Maria Hällfors Siberian primrose, a species protected under the Habitats Directive of the European Union, spread northward from southern areas to the current Bothnian Bay as well as, through another route, to northern Norway with the gradually receding ice after the Ice Age. Compared to today, the warming of the climate was very slow […].

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Novartis taps smartpatient for app to support wet AMD patients

pharmaphorum

German digital health company smartpatient is adding a new section of its MyTherapy app providing information on wet age-related macular degeneration (AMD), a leading cause of blindness. The Munich-based company is launching the educational See What’s Next app in collaboration with Novartis, which sells the wet AMD medicines Beovu (brolucizumab) and Lucentis (ranibizumab), and has also been a big proponent of digital health technologies.

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Impressive impact: ONR executive director lauded for career achievements

Scienmag

Credit: (U.S. Navy photo by Corey Egler) ARLINGTON, Va.–The American Society of Naval Engineers (ASNE) has awarded its most prestigious accolade–the Harold E. Saunders Award for Lifetime Achievement–to E. Anne Sandel, the executive director of the Office of Naval Research (ONR), for outstanding contributions to the Navy and nation over her career.

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AstraZeneca-Oxford COVID-19 Vaccine Shows High Efficacy

XTalks

Adding to recent announcements from Pfizer and Moderna on the efficacy of their COVID-19 vaccine candidates, AstraZeneca and Oxford revealed today that their vaccine contender is 70 percent effective, and could be as high as 90 percent. In an interim, pooled analysis of Phase II/III clinical trials for the vaccine (AZD1222 or ChAdOx1 nCoV-2019) being conducted in the UK and Brazil (in the COV002 Phase II/III trial in the UK and the COV003 Phase III trial in Brazil, respectively), the vaccine was

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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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Bite-size view of brain space

Scienmag

How ancient fish may have prepared for life on land Credit: Dr Alice Clement, Flinders University A new study adds another layer to the remarkable evolutionary transition of life from water to land on Earth. The international study of the prehistoric ‘relic’ tetrapods, including salamander and lobe-finned lungfish and coelacanths, adds another perspective to the […].

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Bristol Myers Squibb, Noxopharm to partner on immunotherapy pilot

Outsourcing Pharma

The pharma giant and the clinical-stage drug developer will join on a pilot study investigating a candidateâs potential in overcoming resistance of a cancer drug.

Drugs 94
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Professor works to bring new brain implant for the blind closer to reality

Scienmag

UTD team will play key role in device test, study response to electrodes Credit: University of Texas at Dallas Implanting a device into the brain to generate a rough perception of sight for people with blindness may sound like the stuff of science fiction, but researchers from The University of Texas at Dallas and partner […].

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Widespread Vaccine Uptake Will Likely Require Full Transparency on Side Effects

BioSpace

Physicians are worried that a lack of transparency about side effects might prevent people from going back for a second dose, or even getting the first one.

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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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Study: Early, late stages of degenerative diseases are distinct

Scienmag

Two-phase theory applies to diseases like Alzheimer’s, Parkinson’s, muscle atrophy Credit: Jeff Fitlow/Rice University HOUSTON – (Nov. 23, 2020) – Rice University biochemists Michael Stern and James McNew have studied how neurodegeneration kills cells. They’ve conducted countless experiments over more than a decade, and they’ve summarized all they’ve learned in a simple diagram they hope […].

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Annual pharma R&D spending in UK climbed 6.9% in 2019

Pharma Times

R&D spending in the sector last year represents an eight-year high

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Understanding frustration could lead to better drugs

Scienmag

Rice scientists’ atomic resolution protein models reveal new details about protein binding Credit: Illustration by Mingchen Chen/Rice University HOUSTON – (Nov. 23, 2020) – Knowing precisely where proteins are frustrated could go a long way toward making better drugs. That’s one result of a new study by Rice University scientists looking for the mechanisms that […].

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AZ/Oxford University’s COVID-19 vaccine shows average efficacy of 70%

Pharma Times

Effectiveness ranges from 62% to 90% depending on dosing regimen

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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.