Mon.Feb 22, 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.

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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

Doctors 181
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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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Pfizer/BioNTech to trial COVID-19 vaccine in pregnant women and children

BioPharma Reporter

Pfizer and BioNTech have dosed the first participants in a Phase 2/3 study for their COVID-19 vaccine in pregnant women; and plan to trial the vaccine in children later this year.

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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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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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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.

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More Trending

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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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Sanofi and GSK start trial of upgraded coronavirus vaccine after first version disappoints

Bio Pharma Dive

The companies think a new formulation will yield better results than their first attempt. But with several vaccines available, testing may be more challenging.

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Clinical Research Jobs: How to Choose the Right Career Path

XTalks

Clinical research is part of a growing industry that provides individuals with rewarding career options and a ladder to climb. Working in the clinical trials industry allows clinical researchers to work with patients and bring new drugs to market. There are many professions under the clinical research umbrella. To become a professional in this field, one must begin by achieving a bachelor’s degree in a science-related field.

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AstraZeneca withdraws immunotherapy in bladder cancer after trial failure

Bio Pharma Dive

The British drugmaker's decision to pull Imfinzi from what was its first approved treatment setting hints at the limitations of immuno-oncology drugs.

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Roles and Responsibilities of Specialized Clinical Supply Experts

When selecting a clinical supply provider, consideration often focuses upon the manufacturing, packaging, storage and distribution capabilities available that will, at face-value, be sufficient to meet the needs of the sponsor and their trial. However, there are human-based and knowledge-driven factors that are often overlooked that go beyond these basic physical capabilities and are integral to the development and delivery of high performing clinical supply chains.

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Slate Chocolate Milk: The Better-for-You, Canned Dairy Beverage Designed for Adults

XTalks

Chocolate milk — the childhood-favorite drink typically packaged in a brown carton — hasn’t changed much in the last few decades. Aside from a few plant-based milk brands venturing over to the “dark” side in recent years, chocolate milk has witnessed little innovation since it was introduced in the late 1600s — that is, until now. Slate, a Boston-based startup, flipped the concept of chocolate milk on its head by creating a line of better-for-you, canned chocolate milk targeted towards adult con

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Accelerating virtual clinical trials

Bio Pharma Dive

Leveraging the guidance and support of trial virtualization professionals with experience in key areas of a trial's lifecycle will undoubtedly impact overall success.

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Amgen Submits Supplemental NDA for Mild-to-Moderate Psoriasis Drug Otezla

BioSpace

Otezla, an oral small-molecule inhibitor of phosphodiesterase 4 (PDE4) directed for cyclic adenosine monophosphate (cAMP), may indirectly modulate inflammatory mediators in certain conditions, but the specific underlying mechanisms are not clearly understood.

Drugs 114
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Analytical quality by design: Development of cell-based bioassays

Bio Pharma Dive

Care needs to be taken during analytical development to ensure methodologies firstly, reflect the MoA, and are also reproducible, accurate, and robust.

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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.

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Rare Disease Day 2021: Data Is the Key to a Rare Disease Diagnosis  

Intouch Solutions

1 in 10 Americans are suffering from a rare disease and for some, it can take years to reach a diagnosis. We're sharing stories that celebrate people who successfully reached a diagnosis through the power of data in honor of #RareDiseaseDay. Learn how to get involved! The post Rare Disease Day 2021: Data Is the Key to a Rare Disease Diagnosis appeared first on Intouch Solutions.

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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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BrainStorm Receives Feedback on Potential BLA Submission for ALS Therapy

BioSpace

The U.S. Food and Drug Administration said that data from BrainStorm Cell Therapeutics’ ALS Phase III trial does not meet the threshold of substantial evidence needed to support a BLA for the company’s ALS NurOwn therapy.

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Could Pfizer and BioNTech’s COVID-19 Vaccine be Stored at Standard Freezer Temperatures?

XTalks

Pfizer Inc. (NASDAQ: PFE ) and BioNTech SE (Nasdaq: BNTX ) revealed they have submitted new data to the US Food and Drug Administration (FDA) that demonstrates the stability of their COVID-19 vaccine when stored at common freezer temperatures of -25°C to -15°C for pharmaceutical products. The submitted data is in support of a proposed update to the US Emergency Use Authorization (EUA) prescribing information, which would make it possible for vaccine vials to be stored at standard freezer tempera

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Accelerating Clinical Supply Through Integrated Drug Development

As the development pipeline for new drugs continues to grow, biopharmaceutical companies are re-evaluating how to best manage and balance resources across an increasing number of development projects and complex clinical trials. There are two approaches that can be used to speed a drug from development to clinic faster: timeline compression and parallel processing, but only one that considers the benefits of integrating clinical supply into the overall drug development process.

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GRAIL and Quest Seek to Advance Multi-Cancer Early Detection Blood Test

BioSpace

Cancer detection company GRAIL has entered into an agreement with Quest Diagnostics that sees Quest providing phlebotomy services to support GRAIL’s multi-cancer early detection blood test Galleri™.

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AZ withdraws Imfinzi indication in the US for advanced bladder cancer

Pharma Times

Decision made in consultation with the FDA following disappointing trial results

Trials 105
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Regeneron and Sanofi Collab Picks Up Third FDA Drug Approval

BioSpace

On Monday, the companies announced their checkpoint inhibitor Libtayo (cemiplimab-rwlc) won Food and Drug Administration approval for lung cancer.

Drugs 98
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NHS Digital tweaks e-referral system to hospitals

pharmaphorum

NHS Digital has tweaked its electronic referral system, to smoothen the process of making a hospital appointment. The e-Referral Service (e-RS) is used by primary care doctors to talk to and seek advice from secondary colleagues ahead of making a formal referral. e-RS is an important part of the NHS’ response to the COVID-19 crisis as the system struggles to manage patient workload at a time when there is intense pressure on the system.

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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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LightDeck Diagnostics Gets $5.65 Million for Rapid, Portable SARS-CoV-2 Antigen Test

BioSpace

The funding, provided by the Biomedical Advanced Research and Development Authority at the Department of Health and Human Services, is enough to advance the test to commercialization.

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‘No COVID-19 is good COVID-19’: Variants spur WVU scientists to study, mitigate strain outbreaks

Scienmag

Credit: Brian Persinger/West Virginia University West Virginia University scientists knew it was coming. When health officials confirmed the first three cases of a COVID-19 variant in West Virginia late Friday (Feb. 19), they were not surprised. In fact, WVU researchers had, in recent weeks, already formed a partnership with colleagues at Marshall University and the […].

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UK to launch new US$1.1bn DARPA-like research agency to support high risk, high reward science

BioPharma Reporter

The UK government has announced the launch of the Advanced Research and Invention Agency (ARIA), an initiative to fund âhigh-risk, high-rewardâ scientific research in the hope of achieving âgroundbreakingâ discoveries.

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Steady now: Unfortunate timing and rate of change may be enough to tip a climate system

Scienmag

Unpredictable, abrupt changes to Earth’s system of ocean currents could commence from rate-induced tipping, model study shows; ‘The findings point to fundamental limitations in climate predictability,’ authors warn Credit: TiPES/HP Imagine abrupt shifts of the tropical monsoons, reductions in Northern Hemisphere rainfall, and strengthening of North Atlantic storm tracks within decades.

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The New Clinical Trial Supply Chain: Resilient, Flexible, and Patient-Centric

The global landscape of clinical trials is rapidly changing as studies become more complex. An increasing number of sponsors are seeking enhanced flexibility in their supply chains to address a variety of clinical supply challenges, including patient demand and reducing delays. Demand-led supply and direct-to-patient distribution are next-generation solutions that are helping to meet these growing needs, allowing for more streamlined processes and patient-centric studies.

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Pfizer/BioNTech COVID-19 vaccine can be stored at standard freezer temperature for 2 weeks, say companies

BioPharma Reporter

Pfizer and BioNTech have submitted new stability data to the US Food and Drug Administration (FDA), showing that their vaccine can be stored at standard freezer temperatures for two weeks.

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Study: Effects of past ice ages more widespread than previously thought

Scienmag

Cold temperatures during North America’s last ice age may have shaped landscapes well beyond the reach of glaciers, according to a new study led by a U of A geologist Credit: Jill A. Marshall FAYETTEVILLE, Ark. – Cold temperatures, prevalent during glacial periods, had a significant impact on past and modern unglaciated landscapes across much […].

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Otonomy Shifts Focus to Hearing Loss and Tinnitus After Meniere's Phase III Failure

BioSpace

Otonomy shares plunged 50.1% at news that its drug to treat Meniere’s disease failed to hit the primary endpoint in its Phase III trial.

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Three longtime antibiotics could offer alternative to addictive opioid pain relievers

Scienmag

Credit: UT Southwestern Medical Center DALLAS – Feb. 22, 2021 – Three decades-old antibiotics administered together can block a type of pain triggered by nerve damage in an animal model, UT Southwestern researchers report. The finding, published online today in PNAS, could offer an alternative to opioid-based painkillers, addictive prescription medications that are responsible for […].

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Deliver Fast, Flexible Clinical Trial Insights with Spotfire

Clinical research has entered a new era, one that requires real-time analytics and visualization to allow trial leaders to work collaboratively and to develop, at the click of a mouse, deep insights that enable proactive study management. Learn how Revvity Signals helps drug developers deliver clinical trial data insights in real-time using a fast and flexible data and analytics platform to empower data-driven decision-making.