Tue.Jul 28, 2020

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COVID 19 vaccine means big money and greed

World of DTC Marketing

QUICK READ : Pharma had a chance to earn some goodwill with a very skeptical public but it’s become obvious that the rush to develop a vaccine is about profit, executive stock, and Wall Street despite potential huge investments from the government. Moderna, which has received a ton of money from the government, told lawmakers it would not sell its vaccine at cost.

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Indegene: e-labeling could make paper inserts obsolete

Outsourcing Pharma

A leader from the life-sciences solutions firm explains how electronic drug labels and inserts offer widespread benefits to various stakeholders.

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Look Back – Drug Approvals First Half of 2020 Amidst the COVID Challenge

Eye on FDA

As the year began, no one really thought that within a few months, the systems upon which we rely on for just about everything would be so severely disrupted and tested by the presence of something we cannot even see with the naked eye. But of course, that is what happened. By March we were remaining at home, including people who worked at FDA who assess new drugs for approval.

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Remdesivir Could Be in Short Supply. Here’s a Fix.

NY Times

The federal government must work to ensure adequate supply of the coronavirus drug — and distribute it evenly and transparently.

Drugs 64
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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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AZ, Daiichi inks an oncology deal; Moderna begins Phase III trial of its COVID-19 vaccine; No good news for Solid’s DMD gene therapy trial

Delveinsight

AZ, Daiichi put their trust into TROP2-based drugs, inks an oncology deal to together develop and commercialize DS-1062. AstraZeneca has inked an oncology deal with Daiichi Sankyo to jointly develop and commercialize an antibody-drug conjugate DS-1062 (trastuzumab deruxtecan), worldwide except in Japan. Daiichi holds exclusive rights to the drug in Japan.

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Ensuring Quality in Risk-Based Monitoring and Data Protection

Forte Research Systems®

Protecting participant data is of the utmost importance in clinical research. This article breaks down risk-based monitoring, as well as other data protection terms falling underneath it.

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Thermo Fischer Scientific backs 200+ COVID-19 projects globally

Outsourcing Pharma

The company is offering technology and support to projects around the world seeking to discover and produce vaccines and therapeutics.

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Cancer Research UK, University of Southampton and Touchlight Genetics Partner to Develop Head and Neck Cancer Vaccine

Drug Discovery Today

Cancer Research UK, the University of Southampton and Touchlight Genetics, a London based biotechnology company, today (Wednesday) announce a new clinical development partnership to progress a therapeutic DNA vaccine, TGL-100, into an early phase clinical trial targeting head and neck squamous cell carcinoma (HNSCC).

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Colorcon expands pH range of enteric coatings

Outsourcing Pharma

The new Acryl-Eze II coatings line increases the pH range offered for delayed-release oral solid-dosage drugs and other items.

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Are All Excipients Truly Inert? Maybe Not, Suggests New Study

XTalks

For decades, formulation scientists have relied on the assumption that common pharmaceutical excipients are biologically inert. Now, results from a new study conducted by researchers at the UC San Francisco (UCSF) School of Pharmacy and the Novartis Institutes for BioMedical Research (NIBR), have challenged drugmakers’ understanding of the effects of excipients.

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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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‘Nobody Likes Me,’ Trump Complains, Renewing Defense of Dubious Science

NY Times

The president lamented that his poll numbers were lower than those of his top science advisers. “It can only be my personality,” he said.

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How Trump’s Canadian Drug Importation Executive Order Changes Things

Pharmacy Checkers

Originally published on PharmacyChecker.com. Three executive orders were signed by President Donald Trump last week. One of them is all about drug importation : measures already underway and new actions to help Americans buy more affordable prescription drugs from other countries. It has the potential to help many millions of Americans who are sick and tired of high drug prices or can’t even afford the medications prescribed to them.

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