Sat.Nov 07, 2020 - Fri.Nov 13, 2020

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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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Optimism on Pfizer COVID vaccine is unwarranted

World of DTC Marketing

SUMMARY : Pfizer’s 90 percent effectiveness is very impressive, but the rate is based on a relatively small number of people and the data has not been peer-reviewed but today headlines rule the news, not content. You need to ask yourself why in the hell Pfizer’s CEO would say that their vaccine is 90% effective when there is a lot more testing and review of data needed.

Vaccine 286
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In the News: October Regulatory and Development Updates

Camargo

Each month, Camargo’s “In the News” series highlights important changes and advancements in the regulatory and development space and explores how those changes could impact your program. Unpacking the (Black) Box: Antares Licenses Urology Product with Boxed Warning. When the FDA requires a product’s labeling to include a boxed warning (also called a “black box warning” because the text is surrounded by black border), the potential market value of the drug often drops severely.

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SSRI Antidepressants May Be Effective Early Treatments for COVID-19

BioSpace

Researchers at Washington University School of Medicine in St. Louis published the results of a clinical trial evaluating an antidepressant, fluvoxamine, for early treatment for COVID-19.

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From Diagnosis to Delivery: How AI is Revolutionizing the Patient Experience

Speaker: Simran Kaur, Founder & CEO at Tattva Health Inc.

The healthcare landscape is being revolutionized by AI and cutting-edge digital technologies, reshaping how patients receive care and interact with providers. In this webinar led by Simran Kaur, we will explore how AI-driven solutions are enhancing patient communication, improving care quality, and empowering preventive and predictive medicine. You'll also learn how AI is streamlining healthcare processes, helping providers offer more efficient, personalized care and enabling faster, data-driven

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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.

Vaccine 356
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Social media and DTC

World of DTC Marketing

SUMMARY: Social media continues to be used by online health seekers, but there is also a high level of health misinformation. Using social media for DTC can be effective if you have a story to tell in short messages. Still, DTC marketers should be aware of what’s being said around certain health conditions via social media. BMS has been running an ad for Optivio on Twitter that makes no sense because of FDA guidelines.

Marketing 195

More Trending

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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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Coronavirus vaccine from Pfizer, BioNTech prevents COVID-19, early results show

Bio Pharma Dive

An interim analysis conducted after 94 cases of COVID-19 in Pfizer and BioNTech's large study found their vaccine to be more than 90% effective.

Vaccine 345
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Hope is not a reason to approve a drug

World of DTC Marketing

GOOD MORNING: The future of Biogen’s potential blockbuster Alzheimer’s treatment was thrown back into doubt on Friday when an unusually combative scientific panel contradicted the positive conclusions of staff at the US drug regulator. This drug may be nothing but a lifesaver to Alzheimer’s patients. More than 5 million Americans of all ages have Alzheimer’s.

Drugs 186
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Sunshine Vitamin Could Help Boost Immunity in Fight Against COVID-19

BioSpace

A recent study found that Vitamin D deficiency may be associated with an increased COVID-19 risk.

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Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model

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AI implementation for pharma and healthcare

pharmaphorum

Abid Rahman from Intouch Group tells pharmaphorum how AI-based technology is solving challenges across healthcare systems, pharmaceutical companies, and patient treatment. With AI already the key engine for a growing list of consumer devices, the trend has created exciting opportunities for pharma and healthcare. “We have now entered a new phase of AI implementation where AI-based technology is expected to be foundational and not just a novel technology,” Abid Rahman, vice president, innovation,

Engineer 139
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Pfizer invests in Homology and adds to its gene therapy ambitions

Bio Pharma Dive

Along with an equity investment, Pfizer will get first dibs on any potential transaction involving Homology's lead programs, which the biotech is developing for a rare metabolic disorder.

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Wego health’s self-serving survey

World of DTC Marketing

SUMMARY: Patient influencers trust social media groups more than pharma websites for health information, according to a survey from Wego Health. Imagine a survey like this from a company that specializes in patient influencers. Over the years, I am very proud to say that I’ve been involved in a LOT of qual and quant research. I’ve seen that, while people will turn to social media for health information, they seldom make treatment decisions based on what they find.

Doctor 180
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AI speeds adapting to post-COVID ‘new normal’: WhizAI

Outsourcing Pharma

A leader from the AI technology firm discusses how life-sciences pros are harnessing AI to help continue their work in the face of the pandemic.

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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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BREAKING NEWS: early data indicates Pfizer/BioNTech’s COVID-19 vaccine is 90% effective

Pharma Times

Phase III study of vaccine candidate involved 43,538 participants

Vaccine 136
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Eli Lilly wins FDA emergency clearance for COVID-19 antibody drug

Bio Pharma Dive

The Food and Drug Administration cleared the company's synthetic antibody treatment, but short supplies and logistical challenges could limit its initial impact.

Antibody 338
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Big, bureaucratic pharma

World of DTC Marketing

SUMMARY: Big pharma is still using outdated bureaucratic processes for everything from hiring to implementing marketing tactics to the point the industry is becoming more bloated. Unless employees challenge the status quo, DTC marketing will continue down a path to irrelevance. How long does it take to hire a new pharma employee? Would you believe the answer is between 4.5 and 6 weeks?

Marketing 155
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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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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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EU secures 300 million doses of BioNTech, Pfizer’s COVID-19 vaccine

Pharma Times

Agreement follows positive phase III data announcement

Vaccine 135
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AstraZeneca cancer drug found ineffective for treating COVID-19

Bio Pharma Dive

The setback follows disappointing results from companies like Novartis and Sanofi, which have also sought to repurpose existing drugs for COVID-19.

Drugs 321
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Moderna’s Personalized Cancer Vaccine Shows Promise in Early-Stage Trial

BioSpace

Moderna released interim data from the expansion cohort of its ongoing Phase I trial of its mRNA personalized cancer vaccine, mRNA-4157.

Vaccine 134
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Recommended Drugs to Undergo Incineration Process

Pharma Mirror

Contributing factors such as the excessive carbon dioxide in the atmosphere and burned fossil fuels wounds the earth at large. Highly dangerous pollutants from agricultural runoffs, industrial junks, and even pharmaceutical waste can decrease human life expectancy by three years. Pharmaceutical Pollution This type of pollution is practically a form of water pollution.

Drugs 130
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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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Waylivra, Tecentriq and more accepted by SMC

Pharma Times

Akcea’s Waylivra approved via ultra-orphan pathway

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5 takeaways from the FDA's high-stakes meeting for Biogen's Alzheimer's drug

Bio Pharma Dive

The decidedly negative vote at Friday's meeting on aducanumab raises questions about the drug's future, as well as the credibility of the FDA.

Drugs 321
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France’s Medicine Watchdog Indicted Over Sanofi’s Birth Defect-Causing Drug

BioSpace

Sanofi was formally charged over Depakine, its epilepsy drug, for not taking action when they first discovered the fetal risks when taken by pregnant women.

Medicine 132
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Pharma brands must ‘up the ante’ in their digital presence

pharmaphorum

Since Covid-19 hit, many industries have shifted a heavier weighting of their business into the online world, relying on e-commerce and digital engagement to counterbalance the reduced ability for physical interactions. The pharma world is no exception, and this year both small and large players have made the transition – partly out of necessity – from a world that relied predominantly on the face-to-face side of doing business, into a new digital world.

Branding 124
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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Russian says its ‘Sputnik V’ COVID-19 vaccine is 92% effective

Pharma Times

Interim data analysis comes from phase III clinical trials in the Russian Federation

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Pfizer, with vaccine results positive, readies plans to ship coronavirus shot

Bio Pharma Dive

Twelve trucks and 20 planes would be used each day to distribute the vaccine, should approvals follow Pfizer and partner BioNTech's positive study results.

Vaccine 306
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Biden Taps BARDA Whistleblower Rick Bright for COVID-19 Advisory Board

BioSpace

President-elect Joe Biden hit the ground running this morning with the announcement of his transition team’s COVID-19 advisory board.

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Russia claims 92% efficacy for Sputnik COVID-19 shot

pharmaphorum

In the second positive piece of COVID-19 vaccine news in a week, Russia’s Sputnik V candidate has been shown to be 92% effective at the interim point of a 40,000-patient study. The preliminary assessment is based on 20 coronavirus cases split between the vaccinated and placebo arms of the study at 21 days, according to a press statement issued this morning by the Gamaleya Institute which developed the shot and the Russian Direct Investment Fund (RDIF).

Vaccine 116
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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.