Mon.Oct 19, 2020

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Intellia cleared to start key CRISPR drug study in UK

Bio Pharma Dive

The trial would be the first test of a systemically administered gene editing treatment that uses the Nobel Prize-winning technology to alter DNA.

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Projections on pharma digital ad spending wrong

World of DTC Marketing

GOOD MORNING: eMarketer is promoting a report on pharma’s projected digital ad spending in the coming year, and from my conversations with pharma insiders, it’s wrong. There will be an investment in new digital platforms but display and search spending, I believe, are going to decline. There is no doubt that more people are turning to the Internet to help sort through the conflicting health information but that does not translate into more online ads.

Insiders

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Doctors are consumers too! How DTC media impacts HCPs

Bio Pharma Dive

The findings have implications for how pharma teams should think about their DTC and HCP efforts — they are no longer two separate marketing channels.

Doctors 294
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UK trials digital ‘health passport’ to help borders reopen

pharmaphorum

Regular fliers are used to long queues to clear security – but a rigorous COVID-19 testing regime could be added to pre-flight checks backed by a digital “health passport” to prove passengers are free from the coronavirus. The UK is the latest country to test the scheme that allows passengers to demonstrate their coronavirus status as part of a global framework for COVID-safe air travel.

Trials 140
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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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Vifor Pharma and Cara Expand Licensing Deal for Late-Stage Kidney Disease Drug

BioSpace

Under terms of the deal, Connecticut-based Cara Therapeutics will receive $100 million in an upfront payment, as well as an equity investment of $50 million. Additional milestone payments could bring the total of the deal to about $290 million.

Licensing 108
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How real human experiences can power a healthier future

pharmaphorum

As part of our series of opinion pieces from leaders at Janssen, the company’s Maria Raad looks at how we can embrace tech and data science to overcome increasing pressures on healthcare systems. For the next generation born in the western world, living to be 100 will be the norm. While this seems like a desirable aspiration for our grandchildren, it adds new pressures on our healthcare systems.

Big Data 128

More Trending

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Kite cues up first EMA okay for mantle cell lymphoma CAR-T

pharmaphorum

Gilead Sciences’ Kite Pharma unit is closing on approval of its second European approval for a CAR-T for cancer, after the CHMP backed its Tecartus therapy for mantle cell lymphoma. The EMA’s human drugs advisory committee recommended approval of Tecartus (brexucabtagene autoleucel; formerly KTE-X19 ) for relapsed or refractory MCL setting up a formal approval by the regulator in the coming weeks.

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How COVID-19 Popularized Contactless Food Delivery

XTalks

COVID-19 has given rise to a slew of new terms, namely “social distancing,” and drastically changed the context of wearing a mask and standing six feet away from others. But in the food and beverage industry, the rise of the term “contactless delivery” cannot be understated. To stay in business during the pandemic, foodservice enterprises — including fast-food chains, dine-in restaurants and grocery stores — have turned to take out and delivery to generate income.

Engineer 111
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WHO: remdesivir shows little effect on COVID-19

Outsourcing Pharma

The agencyâs Solidarity Therapeutics Trial examined a range of drugs repurposed for COVID-19 treatment, finding nearly no effect on patient mortality.

Trials 121
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INCOG BioPharma Paves the Way for New Jobs with Expansion in Indiana

BioSpace

INCOG BioPharma Services, a biopharmaceutical manufacturing services startup, announced on Oct. 15 that it will be establishing its first manufacturing facility and global headquarters in Fishers, Indiana.

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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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Time to Reassess Tocilizumab’s Role in COVID-19 Pneumonia

JAMA Internal Medicine

In this issue of JAMA Internal Medicine, 3 important articles explore the use of tocilizumab in coronavirus disease 2019 (COVID-19) pneumonia. Tocilizumab is a humanized monoclonal antibody that binds human interleukin 6 (IL-6) receptors. It is used routinely in inflammatory arthritis, giant cell arteritis, and cytokine release syndrome after chimeric antigen receptor T-cell therapy.

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Edesa Biotech gets green light for COVID-19 monoclonal antibody study in the US

BioPharma Reporter

Edesa Biotech, Inc. has received clearance from the U.S. Food and Drug Administration (FDA) to begin the Phase 2 portion of its Phase 2/3 clinical study of its investigational drug, EB05, for the treatment of hospitalized COVID-19 patients.

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What Do Doritos, Mountain Dew and Call of Duty Have in Common? A Customer Base of 75 Million Gamers

XTalks

PepsiCo snack and beverages, Mtn Dew, Mtn Dew Game Fuel and Doritos are joining forces with Activision’s blockbuster Call of Duty game franchise for the launch of Call of Duty: Black Ops Cold War. The program gives players access to bonus in-game rewards and prizes. With every purchase comes a chance to win special gaming swag and scoring double XP.

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Novartis’ big bet on inclisiran nears fruition, as CHMP backs drug

pharmaphorum

Novartis’ near-$10 billion takeover of The Medicines Company last year was focused mainly on one asset – cholesterol-lowering drug inclisiran – and the Swiss pharma is now a step closer to getting a return on its investment. Inclisiran – now given the trade name Leqvio – has been recommended for approval by the CHMP as a treatment for hypercholesterolaemia or mixed dyslipidaemia, two common forms of elevated cholesterol linked to increased risk of cardiovascular disease.

Drugs 98
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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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UCI-led study reveals restoration of retinal and visual function following gene therapy

Scienmag

New generation CRISPR technology lays foundation for therapeutics to treat a wide range of inherited ocular diseases Credit: Nature Biomedical Engineering Irvine, CA – October 19, 2020 – A breakthrough study, led by researchers from the University of California, Irvine, results in the restoration of retinal and visual functions of mice models suffering from inherited […].

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Aptinyx Jumps Following Positive Phase II PTSD Study Results

BioSpace

Shares of Aptinyx skyrocketed more than 75% after the company reported its mid-stage experimental treatment for post-traumatic stress disorder demonstrated clinically meaningful and statistically significant results that will set up a pivotal study next year.

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HCP > MD: How Brands Can Help NPs and PAs Improve Healthcare

Intouch Solutions

Brands can help patients and physicians by building and strengthening their relationships with NPs and PAs. Engaging them helps the entire care team perform at a higher level. Learn how here! The post HCP > MD: How Brands Can Help NPs and PAs Improve Healthcare appeared first on Intouch Solutions.

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UK Government Plans Human COVID-19 Challenge Trials with CRO

BioSpace

In a challenge trial, people are given a vaccine then intentionally dosed with the virus or bacteria that causes the disease.

Trials 97
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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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UCB acquires new campus to support UK operations

Pharma Times

Following completion of acquisition, site will undergo refurbishment

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Palau’s coral reefs: a jewel of the ocean

Scienmag

The latest report from the Khaled bin Sultan Living Oceans Foundation finds Palau’s reefs had the highest coral cover observed on the Global Reef Expedition–the largest coral reef survey and mapping expedition in history. Credit: ©Keith Ellenbogen/iLCP Scientists at the Khaled bin Sultan Living Oceans Foundation (KSLOF) have released their findings on the state of […].

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Biopharma Update on the Novel Coronavirus: October 20

BioSpace

Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for October 20, 2020.

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ABPI chief exec says no-deal Brexit is ‘not in the interest of patients’

Pharma Times

Chief executive of trade body warns no-deal could affect medicines supply

Medicine 124
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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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Moffitt Cancer Center Sees Breakthrough in Latest Pan-Cancer Analysis

BioSpace

Through their work, they were able to determine that the protein, TAp63, appears to impact the level of RNA molecules within the body. This subsequently connects the activities of p53 and AKT, the altered genes in cancer.

RNA 58
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Moderna COVID-19 vaccine under rolling review process in Canada, EU

BioPharma Reporter

Moderna is engaging with international regulators to accelerate approval of its COVID-19 vaccine candidate.

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Intellia Aims Big with CRISPR Therapy to Cure ATTR

BioSpace

Intellia has received approval to launch their Phase I trial of NTLA-2001 in hereditary ATTR.

Trials 115
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Roche deal latest in AAV gene therapy partnership plan for Dyno

BioPharma Reporter

US company, Dyno Therapeutics, has inked a deal with Roche to develop next-generation AAV gene therapy vectors for central nervous system (CNS) diseases and liver-directed therapies.

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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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Ten new medicines backed for EU approval

Pharma Times

Dupixent, Forxiga and Opdivo were also recommended for therapeutic extensions

Medicine 111
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FHI Clinical, Oracle partner on cloud-based trial tech

Outsourcing Pharma

The CRO and life-sciences tech firm collaborated on a solution capable of meeting challenges tied to starting and conducting global clinical trials.

Trials 84
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Tapping secrets of Aussie spider’s unique silk

Scienmag

Silk so robust potential new genetic material touted Credit: Professor Mark Elgar, the University of Melbourne An international collaboration has provided the first insights into a new type of silk produced by the very unusual Australian basket-web spider, which uses it to build a lobster pot web that protects its eggs and trap prey. The […].

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Effect of Tocilizumab on Clinical Worsening in Patients Hospitalized With COVID-19 Pneumonia

JAMA Internal Medicine

This randomized clinical trial evaluates the effect of early tocilizumab administration vs standard therapy in preventing clinical worsening in patients hospitalized with COVID-19.

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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.