Bio Pharma Dive
NOVEMBER 11, 2020
The biotech won a grant from the foundation two days after dosing the first patient in a study of an in vivo CRISPR medicine, a milestone for the company and the technology.
World of DTC Marketing
NOVEMBER 10, 2020
SUMMARY : Pfizer’s 90 percent effectiveness is very impressive, but the rate is based on a relatively small number of people and the data has not been peer-reviewed but today headlines rule the news, not content. You need to ask yourself why in the hell Pfizer’s CEO would say that their vaccine is 90% effective when there is a lot more testing and review of data needed.
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Camargo
NOVEMBER 11, 2020
Each month, Camargo’s “In the News” series highlights important changes and advancements in the regulatory and development space and explores how those changes could impact your program. Unpacking the (Black) Box: Antares Licenses Urology Product with Boxed Warning. When the FDA requires a product’s labeling to include a boxed warning (also called a “black box warning” because the text is surrounded by black border), the potential market value of the drug often drops severely.
BioSpace
NOVEMBER 12, 2020
Researchers at Washington University School of Medicine in St. Louis published the results of a clinical trial evaluating an antidepressant, fluvoxamine, for early treatment for COVID-19.
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Bio Pharma Dive
NOVEMBER 10, 2020
An early analysis found the companies' shot more than 90% effective in preventing COVID-19. Beyond that highly encouraging number, however, there were few other details.
World of DTC Marketing
NOVEMBER 11, 2020
SUMMARY: Social media continues to be used by online health seekers, but there is also a high level of health misinformation. Using social media for DTC can be effective if you have a story to tell in short messages. Still, DTC marketers should be aware of what’s being said around certain health conditions via social media. BMS has been running an ad for Optivio on Twitter that makes no sense because of FDA guidelines.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
BioSpace
NOVEMBER 11, 2020
Vaxart announced new data from its Hamster Challenge Study today, showing that its oral COVID-19 vaccine candidate can potentially reduce viral load and induce a significant immune response.
Bio Pharma Dive
NOVEMBER 10, 2020
Along with an equity investment, Pfizer will get first dibs on any potential transaction involving Homology's lead programs, which the biotech is developing for a rare metabolic disorder.
World of DTC Marketing
NOVEMBER 9, 2020
SUMMARY: Patient influencers trust social media groups more than pharma websites for health information, according to a survey from Wego Health. Imagine a survey like this from a company that specializes in patient influencers. Over the years, I am very proud to say that I’ve been involved in a LOT of qual and quant research. I’ve seen that, while people will turn to social media for health information, they seldom make treatment decisions based on what they find.
Drug Patent Watch
NOVEMBER 10, 2020
We prefer simple flat-rate unrestricted subscriptions — we’ll work on your terms, and with your favorite subscription contract template, to find a solution that fits. If your colleagues would like to…. The post Thinking of signing your company up for DrugPatentWatch? appeared first on DrugPatentWatch - Make Better Decisions.
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White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations
NY Times
NOVEMBER 10, 2020
The German company BioNTech, founded by two scientists, has teamed up with Pfizer on a vaccine that was found to be more than 90 percent effective.
Bio Pharma Dive
NOVEMBER 9, 2020
The Food and Drug Administration cleared the company's synthetic antibody treatment, but short supplies and logistical challenges could limit its initial impact.
World of DTC Marketing
NOVEMBER 13, 2020
SUMMARY: Big pharma is still using outdated bureaucratic processes for everything from hiring to implementing marketing tactics to the point the industry is becoming more bloated. Unless employees challenge the status quo, DTC marketing will continue down a path to irrelevance. How long does it take to hire a new pharma employee? Would you believe the answer is between 4.5 and 6 weeks?
BioSpace
NOVEMBER 12, 2020
Despite the large number of people dealing with the stinging, burning and blurring of the eye caused by the illness, there remains a significant unmet need for effective and lasting therapies.
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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.
BioPharma Reporter
NOVEMBER 9, 2020
Agenus Inc, an immuno-oncology company with a pipeline of agents designed to activate immune response to cancers and infectious diseases, has reported the dosing of the first COVID-19 patient with agenT-797, an allogeneic cell therapy, through its subsidiary, AgenTus Therapeutics.
Bio Pharma Dive
NOVEMBER 9, 2020
An interim analysis conducted after 94 cases of COVID-19 in Pfizer and BioNTech's large study found their vaccine to be more than 90% effective.
Outsourcing Pharma
NOVEMBER 12, 2020
A leader from the AI technology firm discusses how life-sciences pros are harnessing AI to help continue their work in the face of the pandemic.
BioSpace
NOVEMBER 12, 2020
Sanofi was formally charged over Depakine, its epilepsy drug, for not taking action when they first discovered the fetal risks when taken by pregnant women.
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.
pharmaphorum
NOVEMBER 11, 2020
Abid Rahman from Intouch Group tells pharmaphorum how AI-based technology is solving challenges across healthcare systems, pharmaceutical companies, and patient treatment. With AI already the key engine for a growing list of consumer devices, the trend has created exciting opportunities for pharma and healthcare. “We have now entered a new phase of AI implementation where AI-based technology is expected to be foundational and not just a novel technology,” Abid Rahman, vice president, innovation,
Bio Pharma Dive
NOVEMBER 11, 2020
The companies' early success helps validate an industry-wide bet to target the coronavirus' spike protein. But differences between each vaccine could still prove crucial.
BioPharma Reporter
NOVEMBER 10, 2020
The U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for Novavaxâs COVID-19 vaccine. Novavax plans to start Phase 3 trials for the candidate in the US and Mexico by the end of the month.
BioSpace
NOVEMBER 8, 2020
With the opinions that were expressed by the advisory committee, along with the data presented, the FDA will continue onward with its review process. It is expected to determine whether to approve the aducanumab Biologics License Application by March 7, 2021.
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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.
pharmaphorum
NOVEMBER 11, 2020
In the second positive piece of COVID-19 vaccine news in a week, Russia’s Sputnik V candidate has been shown to be 92% effective at the interim point of a 40,000-patient study. The preliminary assessment is based on 20 coronavirus cases split between the vaccinated and placebo arms of the study at 21 days, according to a press statement issued this morning by the Gamaleya Institute which developed the shot and the Russian Direct Investment Fund (RDIF).
Bio Pharma Dive
NOVEMBER 12, 2020
Coronavirus' fast accelerating spread in the U.S. has sped up Moderna's timeline for its late-stage vaccine study, which now has sufficient COVID-19 cases for a first look at results.
BioPharma Reporter
NOVEMBER 9, 2020
Pfizer says its COVID-19 vaccine candidate is more than 90% effective in preventing COVID-19, releasing interim analysis from its Phase 3 study this morning. âToday is a great day for science and humanity,â says the companyâs CEO.
BioSpace
NOVEMBER 11, 2020
Researchers from Penn Medicine have developed a new targeted approach that modifies viral vectors and inhibits toxicities in the sensory neurons of dorsal root ganglia that commonly occur following the use of gene therapy for neurological diseases.
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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.
pharmaphorum
NOVEMBER 11, 2020
In the first episode of our Health Innovators series, Paul Tunnah speaks to David Van Sickle, CEO of Propeller Health about how digital technologies are revolutionising the field of respiratory medicine. The post Health Innovators: David Van Sickle on digital innovation in respiratory medicine appeared first on.
Bio Pharma Dive
NOVEMBER 9, 2020
The decidedly negative vote at Friday's meeting on aducanumab raises questions about the drug's future, as well as the credibility of the FDA.
Intouch Solutions
NOVEMBER 12, 2020
For years, third-party tracking cookies were the backbone of the internet. Now, marketers must develop strategies to address targeting and measurement in a world without them. Read on to get creative solutions that keep messaging personalized in a cookieless world. The post A Cookieless Future: Why All the Fuss Around Cookies? appeared first on Intouch Solutions.
BioSpace
NOVEMBER 9, 2020
It isn’t often that a contestant pulls ahead in a major contest and their competitor wins too, but Moderna – along with other COVID-19 vaccine contenders – will take it.
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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.
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