November, 2020

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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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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.

Vaccine 344
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Moderna Applies for Emergency F.D.A. Approval for Its Coronavirus Vaccine

NY Times

The first shots could be given as early as Dec. 21, if authorization is granted.

Vaccine 145
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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percent effectiveness is very impressive, but the rate is based on a relatively small number of people and the data has not been peer-reviewed but today headlines rule the news, not content.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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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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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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Colchicine added to UK’s COVID-19 ‘RECOVERY’ trial

Pharma Times

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

Trials 170

More Trending

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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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Health misinformation online abounds

World of DTC Marketing

SUMMARY : In a 2019 Pew Research Center poll, more Americans said they consider made-up news a bigger problem than terrorism, illegal immigration, racism, and sexism. And 68% said disinformation greatly impacts people’s confidence in government institutions. No matter the form, inaccurate health information is a danger to public health. While psychological factors leave people unguarded against misinformation, people in the U.S. are particularly vulnerable to health misinformation because the l

Scientist 277
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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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Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model

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NHS to trial innovative cancer blood test

Pharma Times

It is hoped that the test will help detect cancer at a much earlier stage

Trials 157
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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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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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New Pfizer Results: Coronavirus Vaccine Is Safe and 95% Effective

NY Times

The company said it planned to apply for emergency approval from the Food and Drug Administration “within days.

Vaccine 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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So much for pharma earning trust back

World of DTC Marketing

SUMMARY: Business by press release has made pharma executives a lot of money but we still haven’t seen any over reviewed data on COVID 19 vaccines. A report released Thursday by the University of California at Los Angeles researchers said that 66 percent of Los Angeles health-care workers who responded to an online questionnaire (not a randomized sample) said they would delay taking a vaccine.

Vaccine 208
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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.

Vaccine 145
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New study assessing antibiotics for COVID-19 sepsis

Pharma Times

It is hoped that findings from the NIHR-funded trial will help better inform treatment decisions

Trials 146
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SARS-CoV-2 Causes Heart Damage in 20% of People with Mild or No COVID-19 Symptoms

BioSpace

COVID-19 is a cardiac condition as much as it is a pulmonary or respiratory disease. This knowledge is so recent that it often is overlooked by non-cardiologists, according to physicians speaking at Demy-Colton Virtual Salon, “COVID-19: Surprising Cardiac Findings & Concern about the Potential Im.

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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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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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The Husband-and-Wife Team Behind the Leading Vaccine to Solve Covid-19

NY Times

The German company BioNTech, founded by two scientists, has teamed up with Pfizer on a vaccine that was found to be more than 90 percent effective.

Vaccine 145
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My thoughts this Thanksgiving

World of DTC Marketing

SUMMARY: This Thanksgiving, my thoughts turn to families who are going to have an empty seat at the table because of COVID-19. Over 2100 people died from COVID-19 yesterday as the void in leadership continues. Maybe I’m too empathetic, but these people are someone’s dad, father, son, or daughter, and many of these deaths could have been prevented if only we had leadership who put as much emphasis on prevention as they did on “fake news.” On Facebook, local newspaper feeds

Vaccine 204
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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).

Vaccine 141
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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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Novo Nordisk’s Saxenda bags NICE recommendation

Pharma Times

Obesity management treatment recommended following confidential discount

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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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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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Politics, Science and the Remarkable Race for a Coronavirus Vaccine

NY Times

The furious race to develop a coronavirus vaccine played out against a presidential election, between a pharmaceutical giant and a biotech upstart, with the stakes as high as they could get.

Vaccine 144
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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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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
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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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Symkevi/Kalydeco cleared for use in young CF patients

Pharma Times

The combination is the first available to treat the underlying cause of CF in this patient group.

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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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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