XTalks

JANUARY 8, 2021

The US Food and Drug Administration (FDA) released a statement this week about dosing schedules for COVID-19 vaccines, saying that any dose changes would be premature. In the statement , the FDA said that it wants to “remind the public about the importance of receiving COVID-19 vaccines according to how they’ve been authorized by the FDA in order to safely receive the level of protection observed in the large randomized trials supporting their effectiveness.”.

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Vaccination Vaccine Clinical Trials Clinical Trials 144

Bio Pharma Dive

JANUARY 29, 2021

The vaccine's efficacy was higher in the U.S., but lower in Latin America and South Africa, where new, more infectious virus variants are circulating.

Vaccination 353

Vaccination Vaccine Trials 353

BioSpace

JANUARY 25, 2021

An in vitro study conducted by scientists from Northwestern University and Utah State University concluded that components found within the Xlear nasal spray, particularly grapefruit seed extract and xylitol, were successful in statistically reducing the amount of SARS-CoV-2 in a patient.

In-Vitro 145

In-Vitro Scientist 145

World of DTC Marketing

JANUARY 4, 2021

KEY TAKEAWAY: Consumer behavior has changed due to the pandemic, and DTC marketers should be aware of how consumers will evaluate and choose prescription drugs. Many organizations have postponed market research due to the pandemic but knowledgeable DTC marketers should be aware of the progressive trends in healthcare. Here’s my list: 1ne: DTC should focus more on providing health information about advertised medications and less on “selling.” The overwhelming majority of consum

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Marketing Branding Engineer Doctors 271

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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

Clinical Research

pharmaphorum

JANUARY 29, 2021

Genome editing is an exciting but still nascent field, and companies in the area face as many obstacles as they do opportunities. Sangamo CEO Sandy Macrae told us how his company is being cautious about the hype and finding ways to be financially viable in an emerging space. ‘Cutting edge’ is, for once, a truly apt description when it comes to gene editing – both because the field is pushing medicine into areas we might never have dreamed possible, and because these technologies involve literall

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Gene Editing Gene Gene Therapy In-Vivo 143

NY Times

JANUARY 22, 2021

After the surprise discovery of an extra dose in every vial, Pfizer executives successfully lobbied the F.D.A. to change the vaccine’s formal authorization language. The company charges by the dose.

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Vaccination Vaccine Drugs 144

Bio Pharma Dive

JANUARY 5, 2021

By March, the FDA expects to conclude reviews of key drugs for heart failure, Duchenne's and multiple myeloma, as well as decide on whether to clear Biogen's controversial Alzheimer's treatment.

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FDA Approval Drugs 359

BioSpace

JANUARY 18, 2021

One approach that is being developed by researchers at Stanford University leveraged nanoparticles. Preclinical research was recently published on it in the journal ACS Central Science.

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Vaccination Vaccine Research Development 141

World of DTC Marketing

JANUARY 8, 2021

SUMMARY: Pfizer and Moderna will sell $28 billion of Covid-19 vaccines this year. Pharma companies will make an estimated $40 billion on the global COVID-19 vaccine market this year, which will be split between Johnson & Johnson, AstraZeneca, Novavax, and others. Wall Street has been speculating for a long time on which pharma company is going to make the most from the development of a Covid-19 vaccine.

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Vaccination Vaccine Pharma Companies Development 266

pharmaphorum

JANUARY 7, 2021

The European Union has approved the coronavirus vaccine from Moderna, leaving the UK trailing because of changes to post-Brexit drug approval rules. With the UK reeling from one of the worst outbreaks of the disease, it’s a worrying situation for one of the countries worst hit by the pandemic that is relying on vaccines to bring the virus under control.

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Vaccination Vaccine Regulation Medicine 141

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White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations

Clinical Trials

Pharmacy Checkers

JANUARY 27, 2021

This week, the Colorado Department of Health Care Policy and Financing issued a request for proposals, called an Invitation to Negotiate, to operate a state wholesale drug importation program as permitted under federal law and the administrative final rule issued by HHS last year, referred to as the Section 804 rule. Colorado’s proposal request is chock full of details, with many regulatory and legal issues addressed, quite ably predicting pushback from drug companies who virulently oppose impo

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Drugs Pharmacy 125

NY Times

JANUARY 26, 2021

President Biden said the amount of coronavirus vaccines reaching the states would rise next week and a deal was near to provide enough shots to vaccinate nearly all Americans by the end of summer.

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Vaccination Vaccine Drugs 124

Bio Pharma Dive

JANUARY 4, 2021

With no decision from the FDA on approval of an experimental cancer cell therapy, an agreement by Bristol Myers to pay out more money as part of its Celgene acquisition fell apart.

Drugs 350

Drugs 350

BioSpace

JANUARY 21, 2021

Despite the rising number of COVID-19 cases reported across the globe, rates of influenza have virtually flatlined across the Northern Hemisphere, leading many doctors and researchers to wonder how this could be replicated in non-pandemic times.

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Doctors Doctor Research 140

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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.

Clinical Trials

BioPharma Reporter

JANUARY 26, 2021

AstraZeneca along with its scientific partners at the University of Oxford have rejected German media reports that their vaccine against COVID-19 had low efficacy in people aged over 65.

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Vaccination Vaccine Regulation Marketing 122

pharmaphorum

JANUARY 22, 2021

Gilead Sciences says its antiviral Veklury should be effective against the new, more contagious COVID-19 variants discovered in the UK and South Africa. According to the US biopharma company, genetic analyses of publicly available sequences for the new variants of SARS-CoV-2 suggest the mutations in the viral spike protein that have made them more transmissible shouldn’t affect the way Veklury (remdesivir) works.

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In-Vitro RNA Licensing Licensing 140

Outsourcing Pharma

JANUARY 25, 2021

Two leaders from the clinical technology solutions company discuss how digital tools like eCOAs have been invaluable in facing pandemic-related challenges.

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Trials Clinical Development Development 120

NY Times

JANUARY 12, 2021

In their first abortion case since Justice Amy Coney Barrett joined the court, the justices reinstated a requirement that women seeking medication abortions pick up a pill in person.

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Drugs 119

Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist

What will the future hold for clinical research? A recent draft from the FDA provides valuable insight. In "Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases," the FDA notes that "targeted therapies demonstrate different dose-response relationships compared to cytotoxic chemotherapy, such that doses below the Maximum Tolerated Dose (MTD) may have similar efficacy to the MTD but with fewer toxicities.

Clinical Research

Bio Pharma Dive

JANUARY 25, 2021

The drugmaker, one of the largest vaccine developers globally, won't move forward with either of two candidates it's been testing after disappointing data in early trials.

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Vaccination Vaccine Development Trials 350

BioSpace

JANUARY 7, 2021

Biotech growth in China continued at a rapid pace in 2020, despite COVID-19, which emerged from that country to become a global pandemic. Opportunities in China remain good and are expected to continue.

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BioPharma Reporter

JANUARY 22, 2021

The World Health Organizationâs Global Advisory Committee on Vaccine Safety says it has not seen any unexpected or untoward increase in fatalities in frail and elderly individuals who have received the Pfizer/BioNTech vaccine.

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Vaccination Vaccine Regulation Marketing 116

pharmaphorum

JANUARY 26, 2021

From telehealth to digital trials, customer engagement to healthcare data, Healthware Group outlines the key trends that are expected to shake up digital health this year. Well, it goes without saying, COVID-19 has resulted in a rapid adoption of digital technologies across all industries, most notably in healthcare. There are several important aspects to these shifts for pharma, biotech and medical device companies, so what can we expect to see over the next 12 months and beyond?

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Clinical Trials Clinical Trials Sales Life Science 138

Advertiser: FourKites

A research study conducted by The Journal of Commerce and FourKites surveyed hundreds of international shippers, exploring how their usage of global supply chain visibility technology has evolved since the onset of global disruptions caused by COVID-19. For international shippers, ocean freight visibility has evolved from optional to essential and satisfaction with visibility varies greatly depending on how it is obtained and delivered.

Research

Scienmag

JANUARY 4, 2021

Welcome to the World of Hyperautomation Credit: World Scientific Two centuries ago, the Industrial Revolution began to automate “blue-collar” work, allowing higher profits and wider societal improvements like the reduction of famine and the increase in living standards. Today, Intelligent Automation has the ability to automate “white-collar” work, also called office work, in a shift […].

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Engineer 108

NY Times

JANUARY 11, 2021

Participants with the disease still declined, but much more slowly than those receiving a placebo, investigators say.

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Trials Drugs Clinical Trials Clinical Trials 144

Bio Pharma Dive

JANUARY 26, 2021

The French drugmaker, having hit delays with its own coronavirus shot, agreed to manufacture over 100 million doses of Pfizer and BioNTech's vaccine for supply in Europe.

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Vaccination Vaccine Manufacturing 355

BioSpace

JANUARY 15, 2021

Janet Lambert, CEO of the Alliance for Regenerative Medicine (ARM), painted a rosy picture despite a few challenges at the 2021 Cell & Gene State of the Industry Briefing during this year’s Biotech Showcase, held virtually January 11-15.

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Gene Therapy Gene Medicine 133

Speaker: Steve Goldstein, Sales Leader

Are you currently in sales, or involved in a business that depends on strong sales results? What about the extremely competitive world of medical device sales? What are some of the top challenges your customers face and how do you approach understanding what’s most important to them? Join Steve Goldstein, Sales Success Coach, Motivational Speaker and Medical Device Sales Leader from Gold Selling LLC., to discover critical strategies and approaches you can take to engage your customers, achieve g

Sales

BioPharma Reporter

JANUARY 6, 2021

AstraZeneca officially announced today the Serum Institute of India, had obtained emergency use authorization in India for its COVID-19 vaccine. It also confirmed the vaccine has been granted emergency use authorization in Argentina, Dominican Republic, El Salvador, Mexico and Morocco.

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Vaccination Vaccine Regulation Marketing 115

pharmaphorum

JANUARY 18, 2021

Public health authorities in California are seeking a halt on dosing of one lot of Moderna’s COVID-19 vaccine after reports of allergic reactions at one immunisation clinic. According to state epidemiologist Dr Erica Pan, there were a higher-than-expected number of suspected allergic reactions at a community clinic being used to administer the shot, with some people needing medical attention in a 24-hour period.

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Vaccination Vaccine Allergies Scientist 136

XTalks

JANUARY 6, 2021

Researchers at the National Institutes of Health (NIH) in the US have isolated small antibodies called “nanobodies” from a llama named Cormac that can block the SARS-CoV-2 coronavirus. One nanobody in particular, called NIH-CoVnb-112, was shown to be able to prevent COVID-19 infection from the novel coronavirus by targeting both the spike protein on SARS-CoV-2, as well as the angiotensin converting enzyme 2 (ACE2) receptor that it binds to on human cells.

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Antibody Protein Bacteria In-Vitro 105

NY Times

JANUARY 31, 2021

Rich countries are cornering the market on coronavirus vaccines, leaving poorer regions as potential breeding grounds for variants, like one found in South Africa, that could make vaccines less effective.

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Vaccination Vaccine Marketing Drugs 105

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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.

Clinical Supply