Wed.Aug 26, 2020

article thumbnail

Moderna says its coronavirus vaccine sparks immune response in older people

Bio Pharma Dive

An initial look at the vaccine's effects on the elderly shows those in their 70s had similar responses to those under 55, Moderna told a government panel.

article thumbnail

No digitization with HCP’s is not permanent

World of DTC Marketing

IN SUMMARY : When patients return to doctor’s offices will HCP’s have time to go online with every drug company that requests an online detail? Will patients be happy with telehealth once they feel it’s safe to return to physicians’ offices? After I read the Medscape report on the move to digitization I decided to reach out to some industry contacts to hear what they had to say.

Doctors 237
Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

Moderna's vaccine may have an edge when immunization programs roll out

Bio Pharma Dive

A rival shot from Pfizer and BioNTech needs to be stored at colder temperatures and doesn't last as long in a refrigerator, which may limit its use.

article thumbnail

The first mobile processing machine for pilot scale applications – VENTILUS® Pilot by Romaco Innojet

Pharma Mirror

Romaco Innojet has just developed the first mobile processing machine for pilot scale applications. The VENTILUS® Pilot represents an all-in-one solution both for laboratories and for manufacturers of small batch sizes. The system design with only one spray nozzle simplifies scale-up processes. Romaco Innojet has just launched the first mobile processing machine in the market.

article thumbnail

Unlocking Excellence: How Catalent Is Transforming Japan’s Clinical Research

Planning on running clinical trials in Japan? How can you reliably supply these studies? Discover Catalent’s clinical supply packaging facility in Shiga, Japan. Strategically located between Tokyo and Osaka, and one of largest in Japan, this 6,000 square meter facility offers comprehensive services including primary and secondary clinical packaging and labelling, comparator sourcing, cold chain storage, local and global distribution, local language support and white glove service to support stud

article thumbnail

A new biotech forms to revive Amgen's old heart drug

Bio Pharma Dive

Founders of Dutch biotech Dezima have created NewAmsterdam Pharma and bought back the cholesterol drug they sold to Amgen in 2015.

Drugs 327
article thumbnail

AbbVie submits Rinvoq for ankylosing spondylitis

Pharma Times

In a pivotal Phase II/III study, twice as many patients receiving the drug achieved the primary endpoint of ASAS 40 response at week 14 versus placebo

Drugs 129

More Trending

article thumbnail

Humana lawsuit exposes fraud risk in high-growth telehealth market

pharmaphorum

Health insurer Humana has filed a lawsuit against telemedicine company QuivvyTech that it says resulted in fraudulent prescriptions worth millions of dollars being written for duped customers. According to the complaint, QuivvyTech hired telemarketers to cold-call Humana members, whose details were obtained using “illegal means,” and encouraged them to talk about common ailments, claiming to be calling from Humana.

Marketing 122
article thumbnail

Freenome raises $270M to run pivotal trial of colorectal cancer blood test

Bio Pharma Dive

The 14,000-person study could set the company up to compete with Exact Sciences and Guardant Health for the colorectal cancer screening market.

Trials 148
article thumbnail

BARDA and JLABS Pick 7 Startups to Battle COVID-19 and Future Pandemics

BioSpace

The idea is to support companies that anticipate “potential health security threats, activating the global innovation community, and amplifying scientific and technological advances with the aim to prepare for and respond to our rapidly evolving global health environment.

119
119
article thumbnail

What Do We Really Know About Macrophage Programming?

XTalks

Macrophages are white blood cells that specialize in the detection, phagocytosis and destruction of bacteria and other harmful organisms. They can also present antigens to T cells and initiate inflammation by releasing cytokines, which activate other cells. In other words, when fighting bacteria, the macrophages are programmed to be pro-inflammatory.

Bacteria 105
article thumbnail

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

article thumbnail

Foundation Medicine Wins Approval of Comprehensive Pan-Tumor Liquid Biopsy Test

BioSpace

With a new regulatory approval in hand for its comprehensive pan-tumor liquid biopsy test, Foundation Medicine said it plans for the product to be available for commercial use by Friday, Aug. 28.

Medicine 117
article thumbnail

How the Pandemic Has Reduced Household Food Waste

XTalks

The UN Food and Agriculture Organization estimates that a third of the world’s food is wasted every year. Forests are cleared, fuel is burnt and packaging is produced just to provide food which is thrown away. Meanwhile, rotting food in landfills releases more greenhouse gases into the atmosphere. When the pandemic hit, food security became a concern for many people and they began wasting less food.

article thumbnail

Equipping the Immune System to Fight Against COVID-19

BioSpace

When someone gets sick with COVID-19, there is a lag in an efficient immune response, giving the virus time to do significant damage before the immune system can reign in the infection.

article thumbnail

Adapting Customer Engagement Strategies to the COVID Landscape

Pharma Marketing Network

The pharmaceutical industry has been under pressure for the past decade to change its go-to-market models. While the industry has attempted change, any change to its approach has been guarded. But the industry’s new challenge—marketing and selling in a COVID-19 environment—abruptly changes the customer interaction landscape, perhaps permanently. In office/in person sales promotion, the staple of pharmaceutical company activities, is simply not possible today with interactions reduced to the spor

Sales 98
article thumbnail

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.

article thumbnail

Abbott Wins Approval for $5, 15-Minute Coronavirus Test

BioSpace

The U.S. Food and Drug Administration granted Emergency Use Authorization to Abbott’s rapid COVID-19 test that will retail for $5 and provide results within 15 minutes, the company announced this morning.

Drugs 98
article thumbnail

Breaking FDA COVID-19 news

Outsourcing Pharma

The agency continues to take actions and issue advice related to COVID-19 treatments, tests, consumer products and other pressing industry concerns.

article thumbnail

FDA Approves First Acne Treatment with New Mechanism of Action in 40 Years

BioSpace

The U.S. Food and Drug Administration (FDA) approved Italy-based Cassiopea SpA’s acne treatment Winlevi (clascoterone cream 1%).

article thumbnail

Collaborative VLP tech bolsters COVID-19 vaccine development

BioPharma Reporter

VLP platform using structural elements of coronavirus and modified surface spike molecules could be an âidealâ for COVID-19 vaccine development.

article thumbnail

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.

article thumbnail

Dermavant Announces Two Successful Phase III Plaque Psoriasis Trials

BioSpace

The trials were identical, multi-center, randomized, vehicle-controlled, double-blind, parallel studies that evaluated tapinarof cream, 1% in adults with plaque psoriasis.

Trials 89
article thumbnail

No increased risk from COVID-19 for healthy pregnant women

Pharma Times

Pregnant women were no more likely to suffer severe symptoms of COVID-19 or be ill for longer than those who weren’t pregnant, if otherwise healthy

84
article thumbnail

Kinnate Biopharma Raises $98M in Series C Financing Round

BioSpace

New investors who joined the funding round include Viking Global Investors, Venrock Healthcare Capital Partners and Janus Henderson Investors.

81
article thumbnail

Takeda signs deal with UK biotech Engitix

Pharma Times

The firms will use Engitix' extracellular matrix (ECM) discovery platform to develop new therapies for fibrotic liver diseases

article thumbnail

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.

article thumbnail

BioSpace Global Roundup, Aug. 27

BioSpace

Biopharma and life sciences companies from around the globe share updates on their business practices and pipelines.

article thumbnail

Novartis' CML drug hits PhIII targets

Pharma Times

Asciminib was superior to bosutinib in inducing a major molecular response

Drugs 93
article thumbnail

Coronavirus: Payment for people on low incomes who must self-isolate

The Pharma Data

Image copyright. Reuters. Image caption. The payment will only be available for people who claim benefits. Workers on low incomes in parts of England where there are high rates of coronavirus will be able to claim up to £182 if they have to self-isolate. From Tuesday, those who claim Universal Credit or Working Tax Credit and cannot work from home will be able to get the money – equal to £13 a day.

Trials 52
article thumbnail

CRA Academy Interns Discuss Breast Cancer Study and Clinical Research Action Items During an IMV

Clinical Trial Gurus

Several CRA Academy students review oncology study charts and look for any potential errors. These students are able to successfully identify items requiring attention and are able to work with the study coordinator to resolve minor issues. The CRA Academy may be one of the few institutions that is able to offer both CRA lessons and an internships with demonstrable success.

article thumbnail

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.

article thumbnail

SAM vaccine technology rapidly effective against Zika

BioPharma Reporter

Preclinical proof of concept study concludes SAM vaccine candidate delivered through CNE can rapidly elicit protective immunity against ZIKV, with potential use for additional antigens.

article thumbnail

Social Detriments of Health Goes Beyond Just Healthcare

Delveinsight

Health care or medical care is very important for health, but it can’t be the only criteria for determining health. In 1948, the WHO defined Health as a state of complete physical, mental and social well-being and not merely the absence of disease or infirmity. The definition is relevant however it didn’t address various factors that affect the health outcomes.

article thumbnail

Research Shows How Gut Bacteria Can Help Fight Cancer

XTalks

Increasing research into the gut microbiome has revealed new and emerging roles for the ‘good bacteria’ in our bodies, with the latest being a new study that shows how they can help the immune system attack cancer cells. Scientists at the Snyder Institute for Chronic Diseases, Cumming School of Medicine (CSM) at the University of Calgary have learned that certain bacterial species in the gut can enhance immune system responses against cancerous tumours.

article thumbnail

Strategic and Tactical Considerations for 2021 Planning During COVID-19

Intouch Solutions

Many brand teams follow the same planning process year after year, but during the pandemic, the parameters have shifted dramatically. How can marketers plan for the future when there are so many unknowns? Read on to find out. The post Strategic and Tactical Considerations for 2021 Planning During COVID-19 appeared first on Intouch Solutions.

article thumbnail

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.