Sat.Dec 05, 2020 - Fri.Dec 11, 2020

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J&J study shows multiple myeloma cell therapy to be strongly effective

Bio Pharma Dive

The company plans to submit an approval application to the FDA in the next few weeks, chasing a rival Bristol Myers therapy that's now under review.

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A new normal for digital health?

World of DTC Marketing

SUMMARY : According to Harvard Business Review, “digital health solutions and technology will play a crucial role in the difficult work of optimizing processes and systems for greater efficiency, financial viability, and enhanced outcomes. While this is true digital health won’t go anywhere unless there is a renewed effort on the user experience.

Doctor 245
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Gilead’s CAR T therapy Yescarta shows potential in new indication

Pharma Times

ZUMA-12 phase II study is evaluating therapy as a first-line treatment for high-risk large B-cell lymphoma

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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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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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A CRISPR gene editing treatment continues to show promise for two blood diseases

Bio Pharma Dive

Results from 10 patients with beta thalassemia or sickle cell disease show CRISPR Therapeutics and Vertex's pioneering treatment to be effective, building on earlier study data.

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Consumers fall into three COVID-19 vaccine adoption segments

World of DTC Marketing

(Mckinsey) Much of the prevailing market research on COVID-19 vaccination frames sentiment as “likely,” “unlikely,” or “neutral.” McKinsey’s research is designed to uncover a more granular continuum of sentiments and to account for the fact that many consumers may take a “wait and see” approach to their decision about vaccination. Their research has found that consumers’ attitudes towards receiving a COVID-19 vaccine fall into three primary segments.

Vaccine 227

More Trending

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COVID-19 Vaccine Shelved After False HIV Positives Affirms Need for Multiple Vaccines

BioSpace

A COVID-19 vaccine being developed by CSL Ltd., and the University of Queensland was scrapped this week after numerous vaccine recipients reported receiving false positives on certain HIV tests.

Vaccine 142
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Researchers of the Year: The RECOVERY team

Bio Pharma Dive

The U.K.'s RECOVERY trial proved a cheap steroid could keep COVID-19 patients from dying, and showed two other widely considered drugs didn't work — crucial findings in a sprawling and sometimes messy global hunt for coronavirus treatments.

Research 338
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It’s time to bring emarketing expertise in house

World of DTC Marketing

SUMMARY: Pharma has been relying on digital agencies for too long but agencies can’t begin to understand your audience like brand team members. Having a brand digital marketer constantly communicating with digital agencies is a waste of time and money. Pharma brands have come to rely too heavily on digital marketing agencies for a range of services, from paid media to actual website development.

Branding 154
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MHRA issues allergy warning for Pfizer/BioNTech COVID-19 jab

Pharma Times

Updated guidance warns people with a history of allergic reactions not to receive the shot

Allergies 146
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Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model

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Pfizer's Covid Vaccine and Allergies: How Concerned Should You Be?

NY Times

British health officials recommended that people with severe allergy reactions not be given the vaccine. Such reactions to vaccines are rare, even in people who have allergies to food or bee stings.

Allergies 140
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FDA advisers meet to review Pfizer, BioNTech's coronavirus vaccine

Bio Pharma Dive

A panel of vaccine and infectious disease experts will publicly vet the drugmakers' study results on Thursday. Follow the discussion along with BioPharma Dive reporters here.

Vaccine 328
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In the News: November Regulatory and Development Updates

Camargo

Remote Document Review Leads to CRL: Be Careful What You Wish for? The FDA’s halt of onsite inspections has created a wealth of problems. Camargo is currently involved with no less than three product applications that are stalled because the FDA is requiring inspections before the application can be approved (assuming a satisfactory outcome). Needless to say, the sponsors of these applications are anxious to pursue all possible alternatives to simply waiting for an indeterminate period for inspe

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Winners shine bright at PharmaTimes Awards

Pharma Times

Meet the winners of the 2020 PharmaTimes Marketer of the Year, Communications Awards and Sales Awards

Sales 146
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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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Sinopharm’s COVID-19 Vaccine Shows 86% Efficacy, UAE Health Agency Says

BioSpace

The COVID-19 vaccine under development by China’s Sinopharm is showing efficacy of 86%, health authorities from the United Arab Emirates reported this morning.

Vaccine 139
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Bayer strikes a deal with Atara, wading deeper into cell therapy

Bio Pharma Dive

A pact for two Atara programs continues the German pharma's efforts to use dealmaking to build a gene and cell therapy division.

Gene 328
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AstraZeneca Missteps Undermined U.S. Faith in Coronavirus Vaccine

NY Times

The Oxford-AstraZeneca effort held great promise to help arrest the pandemic. But a series of miscues caused it to fall behind in the U.S.

Vaccine 136
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World first as UK launches COVID-19 vaccination programme

Pharma Times

A 90 year-old woman in Coventry has become the first person in the UK to be given the vaccine

Vaccine 139
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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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AstraZeneca Hopes COVID-19 Vaccine Will Take Off in Combination with Sputnik V

BioSpace

AstraZeneca, which is jointly developing a COVID-19 vaccine with the University of Oxford, plans to begin clinical trials testing its vaccine in combination with Russia’s Sputnik V vaccine by the end of the year.

Vaccine 130
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Viatris to lay off staff, shutter plants in major restructuring

Bio Pharma Dive

The company created by a merger of Mylan and Pfizer's Upjohn unit is dramatically cutting costs, shedding jobs and closing or divesting up to 15 plants worldwide.

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Telstar strengthens its activity in Bangladesh and relocates its office in Dhaka

Pharma Mirror

Terrassa (Barcelona) 2020. The Telstar subsidiary in Dhaka, Bangladesh, has relocated to a new installation reacting to the ongoing growth of demand for Life Sciences service & product solutions in the region. Under the leadership of Parvez Hashim, Country General Manager, Telstar’s office has consolidated a professional and specialized service in Asia’s pharmaceutical market in consultancy, engineering, construction and manufacturing processes for development of turnkey plants and installat

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Novartis signs AI ophthalmology pact with RetinAI

Pharma Times

Agreement will utilise RetinAI's IT solutions and artificial intelligence tools to support projects in ophthalmology

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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 HCPs think about COVID-19’s impact on cancer

pharmaphorum

COVID-19’s knock-on effect on cancer patients is of concern by HCPs, with delayed or decreased diagnosis seen as a key worry. CREATION.co’s Lara Meyer explores why HCPs need more support. The COVID-19 pandemic has been mainstream headline news throughout 2020 and continues to have a profound impact on all our lives. A key concern that has emerged from the crisis is how COVID-19 will affect other areas of healthcare, particularly cancer diagnosis and treatment.

Nurses 124
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Sanofi, GSK coronavirus vaccine delayed after early study results disappoint

Bio Pharma Dive

The experimental shot produced a weak immune response in adults over 49, leading the partner drugmakers to change plans and push back their development timelines.

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CO2 Safety Monitors for Dry Ice Vaccination

Pharma Mirror

Ormond Beach, FL – CO2Meter, Inc. has partnered with a national pharmacy chain to keep their customers and employees safe from the potential hazardous effects for CO2 exposure from the dry ice that is keeping the COVID-19 vaccines cold. A national pharmacy chain contacted CO2Meter on December 1st asking about devices to detect the release of CO2 when dry ice sublimates.

Vaccine 130
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CR UK makes further cuts in COVID's wake

Pharma Times

The charity is slashing £45 million from its research budget

Research 133
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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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RWE key to boosting trial diversity: Verantos

Outsourcing Pharma

An expert from the clinical research technology specialist discusses how trial teams can use real-world evidence to improve study inclusivity.

Trials 119
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In multiple myeloma, cell therapies lead but antibody drugs could follow fast

Bio Pharma Dive

Two cell therapies might soon be approved for the blood cancer. But a growing group of antibody drugs, several of which were showcased at ASH, aren't far behind.

Antibody 306
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What next for AstraZeneca's 'intriguing' half-dose COVID-19 vaccine?

BioPharma Reporter

AstraZeneca and the University of Oxford's COVID-19 vaccine candidate threw up a surprise last month when a lower initial dose of the two-dose vaccine showed higher efficacy. More detailed results from this interim analysis, now peer-reviewed and published in The Lancet this week, shed some light on this 'intriguing' efficacy.

Vaccine 119
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FDA set to review GSK’s Nucala for nasal polyps

Pharma Times

Submission is based on data from the pivotal SYNAPSE study

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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.