Seres finds the microbiome data it's been waiting for
Bio Pharma Dive
AUGUST 10, 2020
The biotech's value more than quadrupled after reporting pivotal data that, according to executives, "substantially exceeded" what's needed for approval.
Bio Pharma Dive
AUGUST 10, 2020
The biotech's value more than quadrupled after reporting pivotal data that, according to executives, "substantially exceeded" what's needed for approval.
World of DTC Marketing
AUGUST 9, 2020
Pharma digital marketing has been lagging behind key trends for a long while. Let’s face it, pharma organizations are not made for speed while digital marketing is all about “now” Digital marketing is also about experimentation and learning from successes as well as failures. An internal team of consultants, dedicated to digital, can add a lot of value to a company.
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Camargo
AUGUST 13, 2020
Each month, Camargo’s “In the News” series will highlight important changes and advancements in the. The post In the News: July Regulatory and Development Updates appeared first on Camargo.
BioSpace
AUGUST 12, 2020
American Gene Technologies (AGT), based in Rockville, Maryland, received the go-ahead from the U.S. Food and Drug Administration (FDA) to begin a Phase I clinical trial of AGT103-T, a gene therapy, to eliminate HIV from infected individuals.
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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
Bio Pharma Dive
AUGUST 10, 2020
Lawmakers questioned the timing of stock options granted to Kodak executives a day before the planned $765 million loan was announced. An SEC investigation is reportedly underway.
World of DTC Marketing
AUGUST 13, 2020
IN BRIEF: Pharma companies have been posting jobs on LinkedIn almost every day. While most offices remain closed pharma is preparing for the launch of new products and has to have the infrastructure to ensure a successful launch. I keep in touch with all my clients via email newsletters and ask them to “stay in touch” It seems that this year, I’ve been seeing more people leave for other jobs within the industry or clients asking me to suggest people for open positions.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
BioSpace
AUGUST 12, 2020
Researchers at the University of California, Riverside leveraged machine learning to screen more than 10 million commercially available small molecules for interactions with SARS-CoV-2 viral proteins, and found hundreds of drugs that might offer treatments against COVID-19.
Bio Pharma Dive
AUGUST 12, 2020
Viltepso, from Japanese drugmaker NS Pharma, is approved to treat the same subset of Duchenne patients as Sarepta's Vyondys 53.
Outsourcing Pharma
AUGUST 11, 2020
American Gene Technologies has received the agencyâs approval to launch the first human trial for its lead HIV program, starting in Baltimore and DC.
pharmaphorum
AUGUST 12, 2020
Author and journalist John-Manuel Andriote has spent much of his career writing about the impact of HIV/AIDS – a job that became much more personal when he himself was diagnosed in 2005. He tells pharmaphorum about the importance of resilience in coping with a serious illness. John first began writing about HIV/AIDS as a journalist in 1986. “I had two friends of mine in their 20s die from AIDS while I was in journalism school in 1985 – a time when AIDS was always in the news and there was a lot
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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
BioSpace
AUGUST 11, 2020
Although the world is eagerly awaiting news of an effective and safe vaccine against COVID-19, several companies are moving ahead testing therapeutic antibodies against the disease.
Bio Pharma Dive
AUGUST 11, 2020
The U.S. has already invested heavily in Moderna's vaccine, having previously committed $1 billion to fund clinical trials and manufacturing scale-up.
BioPharma Reporter
AUGUST 10, 2020
Moderna Therapeutics reveals it is selling its COVID-19 vaccine for up to $37 a dose, well above the amount charged by some of its rivals.
pharmaphorum
AUGUST 10, 2020
Why did I do that? A common question I often ask myself after opening the biscuit packet for the third time in an hour. Only ten minutes before I had a mental argument with myself, which I thought I had won, promising not to eat another one until tomorrow. The process that goes on inside our heads, affecting the good and bad choices we make regarding our health every day, is the focus of health psychology and the growing interest around behavioural change.
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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.
BioSpace
AUGUST 13, 2020
Phase III clinical trials for Russia’s Sputnik V vaccine for COVID-19 began Wednesday, one day after the Russia Direct Investment Fund (RDIF) launched a new website to share the details of the vaccine with the public and scientists around the world.
Bio Pharma Dive
AUGUST 11, 2020
The shot, developed by the state-backed Gamaleya Research Institute, hasn't yet been tested in the large, placebo-controlled tests scientists emphasize are needed to prove a vaccine is protective.
Pharma Times
AUGUST 10, 2020
Pfizer becomes one of multiple external manufacturing organisations supporting scale-up of treatment
pharmaphorum
AUGUST 12, 2020
A new digital therapy is aiming to tackle depression during the COVID-19 pandemic, using a brain stimulation headset and therapy app that claims to have similar beneficial effects to drugs but with fewer side-effects. Flow is the first drug-free at-home treatment of its type to be approved in the EU and UK. While using the Flow headset, patients engaged with a therapy app program, which offers personalised behavioural therapy in areas proven to reduce symptoms of depression, including nutrition,
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.
BioSpace
AUGUST 11, 2020
Moderna signed a contract worth up to $1.525 billion with the U.S. government to supply 100 million doses of mRNA-1273, the company’s experimental COVID-19 vaccine.
Bio Pharma Dive
AUGUST 13, 2020
The manufacturing deal could help supply Latin America with Oxford's shot, which is one of the most advanced in clinical testing.
XTalks
AUGUST 14, 2020
While the COVID-19 pandemic has disrupted the way consumers shop and food manufacturers operate, food safety remains a top priority for all stakeholders. The entire food supply chain is committed to meeting this expectation despite the fact that our new normal is changing from day-to-day. Many companies have successfully transitioned their meetings, events and even happy hours to virtual platforms to meet social distancing recommendations.
pharmaphorum
AUGUST 14, 2020
After ditching its home-grown attempt at a coronavirus contact-tracing app for smartphones, the UK is ready to start pilot trials of a second version based on a platform developed by Apple and Google. The new NHS Test and Trace app is intended to be used as an add-on to the controversial national and local contact-tracing service, and was due to start initial trials yesterday on the Isle of Wight and among a group of NHS volunteers.
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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.
BioSpace
AUGUST 13, 2020
Novavax entered into an agreement to provide the United Kingdom with 60 million doses of the vaccine should it be approved, as well as a late-stage efficacy study in that country.
Bio Pharma Dive
AUGUST 12, 2020
The drugmaker aims to double Black and Latinx representation in its executive ranks, among other commitments.
Pharma Marketing Network
AUGUST 14, 2020
2022 will usher in the demise of third-party cookies—that means pharma brands must change their approach to targeting and measurement. For decades, the third-party cookie has been a core component of any digital marketing strategy, allowing advertisers to deliver targeted ads and measure their effectiveness. However, with increased consumer privacy concerns and regulations, third-party cookies are set to expire by 2022.
pharmaphorum
AUGUST 13, 2020
How the COVID-19 pandemic is forging pharmaceutical brands into better shape. Day by day it becomes clearer that some brands are coming through the pandemic in better shape than ever. These are the brands that have clearly demonstrated emotional intelligence, that have shown emotional empathy to their target audience. They understand the current, heightened emotional state of their customers and respond to it in ways that show they give a damn.
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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.
BioSpace
AUGUST 13, 2020
Niclosamide is an oral anthelminthic drug. It was first approved by the U.S. Food and Drug Administration (FDA) in 1982 and is included in the World Health Organization (WHO)’s list of essential medicines.
Bio Pharma Dive
AUGUST 11, 2020
The unusual startup already has partial rights to multiple drugs developed by MyoKardia and affiliates of BridgeBio, and plans to acquire many more.
Scienmag
AUGUST 11, 2020
Demonstrate the production of 3D structure in 620nm pixels with over 50 times higher resolution than that of 8K QLED TV for the first time in the world. Application available on wearable devices and the result published in ACS Nano, the world’s most prest Credit: Korea Electrotechnology Research Institute (KERI) Companies across the world are […].
pharmaphorum
AUGUST 14, 2020
Verona Pharma is to develop its lung drug ensifentrine for patients with COVID-19, joining the legions of drug companies repurposing their medicines to fight the pandemic. Based in the UK and US, Verona is due to start a phase 3 trial of ensifentrine in chronic obstructive pulmonary disease (COPD) later this year after encouraging results in phase 2.
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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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