Sat.Feb 20, 2021 - Fri.Feb 26, 2021

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FDA lays out shortened path for testing vaccines against new coronavirus variants

Bio Pharma Dive

Lengthy trials won't be needed for updating shots against emerging viral strains, the agency told developers in newly published guidance.

Vaccine 362
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Jazz Pharma uses flying pig for huge grey area DTC

World of DTC Marketing

SUMMARY: One of the biggest complaints people have about their health is the lack of sleep caused by many factors, from diet and weight to chronic stress. DTC for a product that can keep people awake for nine hours is a message for potential abuse. Did I mention that they are using a flying pig in their DTC? One of the most common complaints people have is “lack of energy” Consumers have turned to energy drinks which was valued at $53.01 billion in 2018, and is expected to grow at a

Doctor 181
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Top 5 Common Misconceptions About Meeting with the FDA

Camargo

Preparing to meet with the FDA can be challenging and stressful for sponsors, especially when they do not know what to expect. Many have misunderstandings about how meetings should be conducted and what constitutes success. Others find themselves needing to dispel incorrect preconceptions about this interactive process for board members or investors.

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Pfizer Accused of Holding Some Countries to “Ransom” Over COVID-19 Negotiations

BioSpace

Pfizer has been accused of bullying governments in Latin America over coronavirus disease 2019 (COVID-19) vaccine negotiations, a recent investigative article revealed.

Vaccine 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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Why this week's FDA meeting on J&J's coronavirus vaccine will be important

Bio Pharma Dive

The FDA is widely expected to authorize the drugmaker's one-dose shot.

Vaccine 334
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Drug side effects should be easier to understand

World of DTC Marketing

SUMMARY: Per the Times, “what if consumers could calculate the benefits and risks of taking a prescription drug as easily as they can gauge the carbohydrates and calories in an Oreo cookie?” Drug facts boxes are needed, but the FDA disagrees. According to the AMA one of the key reasons for non-adherence is that patients may be frightened of potential side effects.

Drugs 173

More Trending

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Israel Real-World Study: Pfizer-BioNTech COVID-19 Vaccine Prevents 98.9% of Deaths

BioSpace

Israel’s Health Ministry announced results of a study in the country that showed that the Pfizer-BioNTech COVID-19 vaccine was 98.9% effective at preventing COVID-19 deaths.

Vaccine 141
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Moderna, Pfizer ready multi-pronged plans for coronavirus variants

Bio Pharma Dive

Moderna has delivered a modified version of its vaccine to NIH scientists, while Pfizer has begun testing of an additional booster shot in a clinical trial, both precautionary steps against emerging strains.

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New Sales Directors at Romaco in Cologne, Bologna and Karlsruhe

Pharma Mirror

Borja Guerra has been appointed new Sales & Service Director of Romaco Kilian in Cologne. The Romaco facilities in Bologna and Karlsruhe likewise have new Sales Directors: Massimiliano Cesarini and Ralph Augenstein. Romaco Kilian GmbH in Cologne has acquired a new Sales & Service Director. As of February 2021, Borja Guerra is responsible not only for the Sales & Service department but also for product and project management at the manufacturer of tablet presses for the pharmaceutical

Sales 130
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Parkinson’s UK creates Vivifi Biotech to research ‘promising’ experimental treatment

Pharma Times

Biotech company will be dedicated to accelerating development of potential treatment

Research 128
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Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model

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Healthcare’s digital transformation began within weeks of pandemic – report

pharmaphorum

Healthcare organisations that have been traditionally slow to adopt new technology produced a response to the pandemic that was almost in line with less regulated industries, according to a new report. Findings of research from the cloud communications platform Twilio based on 2,500 enterprise decision makers, including 117 healthcare organisations, showed it took 36 days on average to accelerate a digital transformation strategy.

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FDA review supports safety, efficacy of J&J coronavirus vaccine

Bio Pharma Dive

Agency scientists noted the shot's strong protection against severe COVID-19, even for the virus variant first detected in South Africa and known to weaken vaccine potency.

Vaccine 326
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Catalent to Acquire Delphi Genetics and Launch US Plasmid Manufacturing Site

Pharma Mirror

SOMERSET, N.J. and GOSSELIES, BELGIUM — Catalent, the leading global provider of advanced delivery technologies, development, and manufacturing solutions for drugs, biologics, cell and gene therapies, and consumer health products, and Delphi Genetics, a plasmid DNA (pDNA) cell and gene therapy contract development and manufacturing organization (CDMO) based in Gosselies, Belgium, today announced that they have entered into a final and definitive agreement whereby Catalent will acquire 100% of th

Genetics 130
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Climate impacts drive east-west divide in forest seed production

Scienmag

Western forests may be less able to regenerate following large-scale diebacks Credit: USGS DURHAM, N.C. — Younger, smaller trees that comprise much of North America’s eastern forests have increased their seed production under climate change, but older, larger trees that dominate forests in much of the West have been less responsive, a new Duke University-led […].

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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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A history of Johnson & Johnson

pharmaphorum

By most measures the single largest pharma company in the world, US-based Johnson & Johnson (J&J) is also arguably one of the most well-known drugmakers among the general public. . Both these factors can be tied in part to J&J’s strong presence in the consumer sector – but behind household name products is a strong pharmaceutical backbone that has emerged over the company’s long and varied history.

Sales 126
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Top Moderna executive to leave company later this year

Bio Pharma Dive

Tal Zaks, the biotech's chief medical officer for the past six years, will depart in September after playing a high-profile role in the company's coronavirus vaccine development.

Vaccine 317
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Wayra, GE Healthcare launch accelerator programme for digital health start-ups

Pharma Times

Edison Accelerator to support start-ups to develop AI applications for healthcare

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'Vaccines are working': UK unveils real-world data from vaccination campaign

BioPharma Reporter

Real-world data from England shows that the Pfizer/BioNTech vaccine offers 'clear protection from first dose' and may help interrupt transmission; while Scottish data shows the first doses of vaccines led to a substantial fall in hospital admissions.

Vaccine 114
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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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Common but not normal: It’s time to talk about maternal mental health

pharmaphorum

As part of our Patients Insights series, the founder and CEO of Motherhood Understood shares her experience of postpartum depression, talks about the power of peer support, and explains what the wider healthcare community could do to play their part. Within days of giving birth to her first child, Jen Schwartz’s fairy tale view of motherhood lay in tatters at the foot of the bed she found it impossible to leave.

Doctor 122
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After FDA feedback, a biotech's ALS therapy faces murky path forward

Bio Pharma Dive

Brainstorm Cell Therapeutics said that, following a review of Phase 3 data, the agency felt the results were not enough to support an approval application.

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NHS to open mental health support hubs dedicated to staff

Pharma Times

Services will be offered to staff who have been affected by the COVID-19 pandemic

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70% Drop in COVID-19 Cases in UK Analyses After Just One Pfizer Shot

BioSpace

Public Health England (PHE) published real-world analyses of people in the UK who had received the first shot of the Pfizer-BioNTech COVID-19 vaccine.

Vaccine 110
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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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Why we need research into the mental health impact of a rare disease diagnosis

pharmaphorum

Rare diseases impact between 3.5%-5.9% of the world’s population. For Rare Disease Day, RBW Consulting’s Emma Thorp discusses why the consultancy is taking revenue earned from its rare disease clients and using it to fund research into the mental health impact of a rare disease diagnosis. Rare diseases are often chronic and life-threatening, and with a large percentage of cases presenting in young children, a diagnosis has a profound and unique impact on everyone affected.

Research 117
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Regeneron wins FDA OK in lung cancer for immunotherapy rival to Merck's Keytruda

Bio Pharma Dive

The approval of Libtayo in first-line lung cancer will pit Regeneron's drug, developed in partnership with Sanofi, against Merck's top-selling immunotherapy Keytruda.

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15 Clinical Research Job Roles & Responsibilities (2021)

Clinical Trial Podcast

Almost everyone I’ve met in clinical research has accidentally discovered this hidden profession. Your interest in science and medicine somehow got you involved in clinical research and clinical trial management. But didn’t you wish you had a crystal clear understanding of “Who’s Who In Clinical Research?”. That’s when this post comes handy. Clinical Research is sometimes also referred to as Medical Affairs or Clinical Affairs.

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NHS England to trial at-home smear testing kits

Pharma Times

Over 31,000 women in London to be offered the at-home tests

Trials 105
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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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AZ COVID jab efficacy debate is hindering EU’s vaccine drive

pharmaphorum

The spat between the EU and AstraZeneca over access to the company’s COVID-19 shot led to scathing remarks about its efficacy that now threaten to undermine the EU’s vaccination targets. . The European Commission approved AZ’s AZD1222 vaccine for use in the EU in all adults aged over 18 at the end of January, more than a month after it was given a green light in the UK, but it seems people in some EU countries are reluctant to receive it and even deliberately missing appointments.

Vaccine 116
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Icon to buy contract researcher PRA Health for $12B

Bio Pharma Dive

The cash-and-stock deal gives PRA shareholders roughly one-third ownership of the new company, which will be one of the larger providers of contract research support.

Research 300
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Need Health Insurance? Marketplaces are Open Now!

Triage Cancer

Health Insurance Marketplaces are now open for a Special Enrollment Period (SEP). In the 36 states with Marketplaces on www.HealthCare.gov, individuals have the opportunity to buy a new health insurance policy or change policies until May 15, 2021. While this SEP was created in response to the pandemic, you do not have to have been impacted by COVID-19 to benefit.

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Ocugen’s inherited retinal disease gene therapy OCU400 wins orphan status

Pharma Times

Orphan designation granted for the treatment of retinitis pigmentosa and Leber Congenital amaurosis

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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.