Sat.Dec 26, 2020 - Fri.Jan 01, 2021

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UK authorizes AstraZeneca, Oxford coronavirus vaccine, but questions linger

Bio Pharma Dive

The first public vaccinations with AstraZeneca and Oxford’s shot will begin early in the New Year. But it’s still unclear how effective the vaccine is, or the best way to use it.

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The immediate future of DTC

World of DTC Marketing

As we look forward to 2021 DTC marketers should be noting the changes in consumer attitudes and the way they request new treatments. Much has changed but a lot is also the same. Business magazines are writing about the “digital future” of healthcare but are consumers ready? Some are, but most aren’t. First, let’s dispel a recent topic: telehealth.

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New and Emerging Drug Classes That Will Outlast the Pandemic

BioSpace

From synthetic polymer-based anti-infectives to antiviral conjugates and DNA vaccines, the past year has given new and emerging drug classes an opportunity to shine.

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Vulnerable should all get COVID-19 shot before summer, says NHS chief

pharmaphorum

NHS England’s chief executive Sir Simon Stevens has said that all vulnerable people over the age of 50 will be offered a COVID-19 vaccine by “late spring” in a message to healthcare workers. The prediction comes after the NHS announced on Christmas Eve that more than half a million people had received the Pfizer/BioNTech shot approved in early December, but will depend on additional vaccine supplies coming “on stream”, according to Stevens.

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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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Peer-reviewed report on Moderna COVID-19 vaccine publishes

Scienmag

Data from Phase 3 clinical trial confirm vaccine is effective Credit: NIH WHAT: The investigational vaccine known as mRNA-1273 was 94.1% efficacious in preventing symptomatic coronavirus disease 2019 (COVID-19), according to preliminary results from a Phase 3 clinical trial reported in the New England Journal of Medicine. The vaccine also demonstrated efficacy in preventing severe […].

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And just like that, the goodwill is gone

World of DTC Marketing

THOUGHT: The reports of “pharma goodwill” were premature. At least three major pharmaceutical companies are ringing in the new year by raising drug prices on a range of products, according to Reuters , in the midst of a pandemic that has taken a serious toll on healthcare systems and limited regular interactions with patients. Business as usual.

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[WEBINAR] Video, Voice, and Virtual: Applying New Digital Technology to Enhance Customer Experience

Pharma Marketing Network

2020 was a year defined by unexpected challenges – and related opportunity – for pharmaceutical marketers. The COVID-19 pandemic pushed the industry to experiment with new media, emerging technologies and innovative platforms to keep physicians, providers and patients informed, engaged and empowered. As telehealth appointments replaced office visits, webinars replaced in-person conferences and digital communication replaced reps in the field, what have we learned about how to create connec

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NEW FEXOFENADINE over the counter – Allevia tablets

Druggist

Fexofenadine recently received a green light and soon will be available over the counter without a prescription. Until now, fexofenadine was a prescription-only medication. The Government recently announced the reclassification of fexofenadine 120mg, which will be available as General sale Medication (GSL), sold as branded products – Allevia 120mg tablets.

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Good Judgement; Bad Judgment on Personal Drug Imports

Pharmacy Checkers

Here’s a kind of funny story to end the year with. I make a big deal on these pages about the decriminalized reality of personal drug importation. Federal law prohibits under most circumstances importing prescription drugs for your own use, but people are never busted for it. I’ve been around this a long time and I mean never. But that’s for personal use only.

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Iowa State University Approaches COVID-19 Using Nanotechnology

BioSpace

The vaccine will be able to be administered without needles and in one dose. It also won’t require refrigeration.

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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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Largest study of Asia’s rivers unearths 800 years of paleoclimate patterns

Scienmag

The SUTD study will be crucial for assessing future climatic changes and making more informed water management decisions. Credit: SUTD 813 years of annual river discharge at 62 stations, 41 rivers in 16 countries, from 1200 to 2012. That is what researchers at the Singapore University of Technology and Design (SUTD) produced after two years […].

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New patent for Kala Pharms drug INVELTYS

Drug Patent Watch

Annual Drug Patent Expirations for INVELTYS Inveltys is a drug marketed by Kala Pharms Inc and is included in one NDA. There are eight patents protecting this drug. INVELTYS drug…. The post New patent for Kala Pharms drug INVELTYS appeared first on DrugPatentWatch - Make Better Decisions.

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For Covid-19 Vaccines, Some Are Too Rich — and Too Poor

NY Times

Global inequality is shaping which countries get vaccines first. In South Africa, people’s best chance for vaccines anytime soon is to join an experimental trial.

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Operation Warp Speed Slow to Ramp Up COVID-19 Vaccine Distribution

BioSpace

Operation Warp Speed succeeded on the development component, but is failing in the early stages of distribution.

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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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Sustained cellular immune dysregulation in individuals recovering from COVID-19

Scienmag

Observational clinical research of COVID-19 patients can help clinicians better understand how the previously unknown SARS-CoV-2 virus acts, and findings from this research can better inform treatment and vaccine design. Credit: UAB BIRMINGHAM, Ala. – COVID-19, which has killed 1.7 million people worldwide, does not follow a uniform path. Many infected patients remain asymptomatic or […].

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Treatment and Outcomes of Inpatient Hypertension Among Adults With Noncardiac Admissions

JAMA Internal Medicine

This cohort study uses data from the electronic health record of patients admitted to Cleveland Clinic Hospitals to assess the outcomes of adults with noncardiac inpatient admissions who were treated for hypertension.

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Don’t Worry Too Much About Covid Vaccine Allergic Reactions

NY Times

We should expect some people to experience side effects. The shot is still safer than the disease.

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10 Biopharma Stories to Look Forward to in 2021

BioSpace

If 2020 taught us anything, it was that unexpected things happen. That said, there are some stories we’ll be watching for. Here’s a look.

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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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Published data from Moderna COVID-19 vaccine trial show 94.1 percent efficacy

Scienmag

Results from the primary analysis of the ongoing phase 3 clinical trial demonstrate efficacy in preventing symptomatic COVID-19 infections and severe illness BOSTON — A peer-reviewed paper published in The New England Journal of Medicine provides data from the much-anticipated COVE study, which evaluated mRNA-1273, a vaccine candidate against COVID-19 manufactured by Moderna, Inc.

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Health of the Highest-Income White US Citizens vs Average Residents of Other Developed Countries

JAMA Internal Medicine

This comparative effectiveness study assesses whether the health outcomes of White US citizens living in the 1% and 5% richest counties are better than the health outcomes of average residents in other developed countries.

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These Famous Foods Were Invented For (and By) the US Military

XTalks

In today’s modern world, a plethora of new technologies have been instrumental in creating new foods, especially plant-based foods. But even with today’s available food tech, some of America’s most popular foods were born out of necessity for, and by, the US military — the necessity being to develop compact and nutritional ways to feed soldiers. The food processing techniques pioneered by the military didn’t just stay within the military.

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AstraZeneca Vaccine Not Likely to Receive U.S. EUA Until April, Warp Speed Chief Says

BioSpace

The U.K authorized AstraZeneca’s COVID-19 vaccine on Wednesday, but it could be April at the earliest before the drug will likely be administered in the United States, Operation Warp Speed’s chief said.

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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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Moving due to unaffordable housing may jeopardize healthcare

Scienmag

Study links cost-related relocations to reduced access to prescribed drugs and medical services Credit: Photo by Cedars-Sinai LOS ANGELES (Dec. 30, 2020) — People who move due to unaffordable housing are at increased risk of failing to receive the medical care they need, according to a new study from Cedars-Sinai and the University of California, […].

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Vibegron (Gemtesa) – a new drug for overactive bladder

Druggist

Vibegron (brand name: Gemtesa) is the latest drug used to treat overactive bladder that has been approved by the FDA in the USA. Gemtesa will be available in the US as prescription-only medication from April 2021. In this post, I will summarise: . Licensed use and legal status of vibegron (US). It’s a mechanism of action . The effectiveness of vibegron: summary of clinical trial . vibegron vs mirabegron: what is the difference?

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AstraZeneca's COVID-19 vaccine gets the green light in the UK

BioPharma Reporter

The UK has authorized emergency supply of AstraZeneca's COVID-19 vaccine: with the first vaccinations set to begin early in the new year.

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rBIO Launches with Technology to Hyper-Produce Insulin Cost-Effectively, at Scale

BioSpace

rBIO launched last week with technology that can reduce the cost of insulin by 30 percent, making U.S. manufacturing cost-effective for insulin and several other drugs.

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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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New research may explain severe virus attacks on the lungs

Scienmag

Credit: The research team. In some cases, immune cells in the lungs can contribute to worsening a virus attack. In a new study, researchers at Karolinska Institutet in Sweden describe how different kinds of immune cells, called macrophages, develop in the lungs and which of them may be behind severe lung diseases. The study, which […].

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Watch Out For Top Pipeline Therapies Making An Impact In The Bipolar Depression Market

Delveinsight

Characterized by debilitating episodes of depression and mood elevation (mania or hypomania), Bipolar depression is an under-recognized and unappreciated phase of bipolar disorder. Since most patients exhibit depression, Bipolar depression gets misdiagnosed with other mental disorders easily. Thus, it is associated with a heavier burden of illness, morbidity, and cost.

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Aravive Announces Board Member Transition to Advisory Role

The Pharma Data

HOUSTON, Dec. 31, 2020 (GLOBE NEWSWIRE) — Aravive, Inc. (Nasdaq: ARAV), a clinical-stage oncology company developing transformative therapeutics, today announced that Dr. Ray Tabibiazar will be stepping down from the Aravive Board of Directors but will remain an advisor to the company, effective December 31, 2020. This transition will allow Dr.

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Top 2020 Biopharma Scandals and Outrages

BioSpace

Over the course of 2020, the biopharmaceutical industry came together to rapidly address the global COVID-19 crisis. Despite that spirit of comradery and partnership, there were still a few incidents that caused some arched eyebrows, gasps of astonishment and even fits of anger.

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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.