2020

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How biotech and pharma companies pay their CEOs, and their workers

Bio Pharma Dive

The median CEO of 231 drug companies analyzed by BioPharma Dive earned 50% more last year than in 2017, a leap that far outpaced the more modest pay gains among employees.

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Moderna Vaccine Is Highly Protective and Prevents Severe Covid, Data Show

NY Times

The positive review likely ensures that the F.D.A. will grant emergency authorization for a second coronavirus vaccine this week for millions of Americans.

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Could a COVID-19 breath test help UK out of lockdown?

pharmaphorum

A potential COVID-19 breath test has been unveiled in the UK, as the country desperately searches for alternatives to crippling lockdown measures to prevent the disease from spreading. The breath test has been developed by Integumen in collaboration with Modern Water, Avacta and Aptamer Group, which had been working on test that identifies the SARS-CoV-2 coronavirus in waste water.

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First trial participant gets GSK's 5-in-1 meningitis jab

Pharma Times

The Phase III study is evaluating the safety, tolerability and immunogenicity of GSK’s MenABCWY vaccine candidate compared to Bexsero and Menveo

Trials 176
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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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Singapore Halts Dosing of Two Flu Shots After 59 Deaths in South Korea

BioSpace

South Korea, on the other hand, indicated they would continue their state-run vaccination program because they did not find a direct link between the deaths and the vaccinations.

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Third Plasma Donation Drive from Shincheonji Church Expected to Gather 4,000 Donors

The Pharma Data

DAEGU, KOREA, November 09, 2020 /24-7PressRelease/ — South Korean religious group Shincheonji Church of Jesus has announced their third convalescent plasma donation drive to take place for 3 weeks starting November 16th at an Indoor Athletics Center in Daegu. Approximately 4,000 members of the group are expected to participate. This comes after two previous donation drives that took place in July and September.

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J&J launches Phase 3 trial for 2-dose COVID-19 vaccine

BioPharma Reporter

Johnson & Johnson has launched a second global Phase 3 trial for its Janssen COVID-19 vaccine candidate: this time exploring a 2-dose regimen (its existing Phase 3 trial explores a 1-dose regimen).

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Ivory Coast creates first marine protected area

Scienmag

Credit: CEM Ivory Coast has announced the creation of its first Marine Protected Area (MPA). The MPA will cover 2,600km2 (1,000 square miles) of pristine ocean off the coast of Grand-Béréby, protecting marine biodiversity including threatened shark and turtle species. The announcement is the culmination of years of work by the Ivorian government, the Abidjan […].

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Researchers Discover Genetic Errors and Rogue Antibodies in Cases of Severe COVID-19 Infection

XTalks

While it remains unclear why some people become more gravely ill than others when infected with the SARS-CoV-2 virus that causes COVID-19, researchers have found that an immune deficiency may be part of it. Two recent studies have shown that individuals who lack an important immune factor may have reduced ability to fight the virus. The two studies were recently published online in the journal Science, both of which were led by Jean-Laurent Casanova, an infectious disease geneticist at Rockefell

Antibody 135
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DNA analysis could pinpoint ‘long haulers’ among COVID-19 patients

Outsourcing Pharma

The analytical tool, developed via Bionano Genomics, maps structural variations in DNA that are known to cause disease and are tied to symptom severity.

DNA 145
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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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Pfizer strikes a deal with newly formed China biotech

Bio Pharma Dive

The deal, which has Pfizer paying as much as $70 million, is the latest in a series of moves by big pharma companies to forge a stronger position in the world's second-largest drug market.

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McKinsey Proposed Paying Pharmacy Companies Rebates for OxyContin Overdoses

NY Times

Court filings reveal consultants’ talk of a records purge during the opioid crisis, and shed new light on sales advice given to the billionaire Sackler family and their drug company, Purdue Pharma.

Pharmacy 145
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MHRA looks to AI to hunt for COVID-19 vaccine side effects

pharmaphorum

The UK drugs regulator has awarded a £1.5 million tender to a software company for an artificial intelligence tool that will be used to process “the expected high volume of COVID-19 vaccine adverse drug reactions (ADRs).”. The tender awarded to Maidenhead, Berkshire-based GenPact UK aims to “ensure that no details from the ADRs…are missed” as the UK prepares to start rolling out COVID-19 vaccines – assuming their safety and efficacy is supported in late-stage trials.

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Clinical Course and Molecular Viral Shedding Among Patients With SARS-CoV-2 Infection

JAMA Internal Medicine

This cohort study quantitatively describes molecular viral shedding in asymptomatic and symptomatic patients with SARS-CoV-2 infection.

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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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SARS-CoV-2, the COVID-19 Virus, is Mutating, But So Far, Slowly

BioSpace

Viruses mutate, and SARS-CoV-2, the virus that causes COVID-19, is not different. Luckily, it appears to mutate relatively slowly. Meanwhile, researchers are beginning to get a grip on the virus’s evolution.

Research 145
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Colchicine added to UK’s COVID-19 ‘RECOVERY’ trial

Pharma Times

Commonly used anti-inflammatory drug added to list of potential treatments

Trials 173
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Thinking of signing your company up for DrugPatentWatch?

Drug Patent Watch

We prefer simple flat-rate unrestricted subscriptions — we’ll work on your terms, and with your favorite subscription contract template, to find a solution that fits. If your colleagues would like to…. The post Thinking of signing your company up for DrugPatentWatch? appeared first on DrugPatentWatch - Make Better Decisions.

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New Zealand secures COVID-19 vaccines from Novavax and AstraZeneca

BioPharma Reporter

New Zealand now has enough COVID-19 vaccines for everyone in the country, says the government, as it announces two new supply agreements with Novavax and AstraZeneca today.

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What the FDA's New Dosage Guidance Means for the Future of Clinical Research

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.

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What cold lizards in Miami can tell us about climate change resilience

Scienmag

Credit: Photo courtesy Day’s Edge Productions It was raining iguanas on a sunny morning. Biologist James Stroud’s phone started buzzing early on Jan. 22. A friend who was bicycling to work past the white sands and palm tree edges of Key Biscayne, an island town south of Miami, sent Stroud a picture of a 2-foot […].

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The meeting that could change Alzheimer's treatment

Bio Pharma Dive

On Friday, a panel of experts and FDA staff will weigh in on a closely watched Alzheimer's drug from Biogen. Their feedback could affect how the disease is treated for years to come.

Drugs 363
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Merck signs $356M deal to supply US with experimental coronavirus drug

Bio Pharma Dive

The drugmaker spent $425 million a month ago to acquire the biotech developer of the treatment, which tamps down on the body's inflammatory response to viral infections.

Drugs 364
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A cure for hemophilia is closer than ever. For many patients, it could be just out of reach.

Bio Pharma Dive

Approval of BioMarin's Roctavian, should it come as expected this week, would deliver on decades of unfulfilled hopes for a gene therapy fix to one of the earliest identified inherited diseases.

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2022 Research: The Rapid Rise of Ocean Freight Visibility

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.

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Intellia, beginning treatment in CRISPR study, secures Gates Foundation backing

Bio Pharma Dive

The biotech won a grant from the foundation two days after dosing the first patient in a study of an in vivo CRISPR medicine, a milestone for the company and the technology.

In-Vivo 364
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Pfizer says coronavirus vaccine study still on track for October readout

Bio Pharma Dive

Importantly, the study committee hasn't had reason to pause vaccinations in the trial, something AstraZeneca and the University of Oxford recently reported in tests of their vaccine.

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US backs AstraZeneca COVID-19 antibody drug with $486M in funding

Bio Pharma Dive

Days after President Donald Trump was treated with a similar antibody therapy from Regeneron, his administration is backing another candidate being tested by British drugmaker AstraZeneca.

Antibody 355
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Biogen's all-important Alzheimer's drug enters the review gauntlet

Bio Pharma Dive

On Nov. 6, aducanumab will go before a panel of experts who will review it and make recommendations to the FDA. Meanwhile, the drug has also caught the attention of a powerful cost watchdog group.

Drugs 354
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An Innovative & Creative Problem Solver Approach to Selling in the Medical Device Space

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

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Stem cell therapy for ALS fails a large clinical trial

Bio Pharma Dive

The therapy's developer, Brainstorm Therapeutics, blamed the setback on better-than-expected results from placebo-treated patients. The biotech still sees a path forward, however.

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Pfizer and BioNTech's coronavirus vaccine works. Here's what we still don't know.

Bio Pharma Dive

An early analysis found the companies' shot more than 90% effective in preventing COVID-19. Beyond that highly encouraging number, however, there were few other details.

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Moderna says it won't enforce coronavirus vaccine patents during pandemic

Bio Pharma Dive

The biotech, a frontrunner in the coronavirus vaccine race, said it won't tie up resources defending the intellectual property covering its experimental shot as long as the pandemic continues.

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5 FDA approval decisions to watch in the 4th quarter

Bio Pharma Dive

The world's attention will be on the FDA as it considers initial data from coronavirus vaccine developers. But several other important drugs, including a CAR-T therapy and an Ebola antibody, will also be on the agency's agenda.

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Mandatory COVID Vaccination Policy Template

New vaccine mandates and testing policies will affect employers with more than 100 workers. Get Paycor’s free, customizable vaccination policy template to communicate critical details and new requirements to your employees. Get Paycor’s Template today!