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.
Sat.Aug 08, 2020 - Fri.Aug 14, 2020
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How pharma digital marketing can excel
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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In the News: July Regulatory and Development Updates
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.
American Gene Technologies Gets Go-Ahead to Test Possible HIV Cure
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.
US puts Kodak loan on hold after stock scrutiny
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.
Pharma is hiring
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.
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Using Machine Learning to ID Potential COVID-19 Treatments
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.
FDA gives speedy approval to another Duchenne drug
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.
Potential HIV cure Phase I trial gets FDA green light
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.
Finding resilience after an HIV diagnosis
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
The New Age of Decentralized Clinical Trials
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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
Companies Press Ahead with COVID-19 Antibody Therapies
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.
Moderna gets $1.5B from US for coronavirus vaccine supply
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.
Moderna makes commercial case for COVID-19 vaccine amid price pressure
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.
Bad behaviour: why understanding human behaviour can improve outcomes
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.
How Machine Learning Drives Clinical Trial Efficiency
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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.
Moderna Signs COVID-19 Vaccine Supply Deal with U.S. for $1.525 Billion
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.
Russia, with scant study data, approves coronavirus vaccine
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.
Pfizer inks manufacturing deal with Gilead for COVID-19 med remdesivir
Pharma Times
AUGUST 10, 2020
Pfizer becomes one of multiple external manufacturing organisations supporting scale-up of treatment
UK’s second go at a contact tracing app heads for pilot study
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.
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.
New RDIF Website Details Russia’s COVID-19 Vaccine as Global Phase III Trials Begin
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.
Argentina, Mexico line up to produce AstraZeneca, Oxford coronavirus 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.
How to Stay Food Safety Compliant and Be Inspection Ready, Even During a Pandemic
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.
Novo Nordisk: Prevention, digital tools and collaboration to define the future of diabetes
pharmaphorum
AUGUST 11, 2020
In our latest UK Leaders article Pinder Sahota, UK general manager at Novo Nordisk, tells us how he hopes to bring the NHS and pharma together to improve outcomes in diabetes and other long-term conditions. Though Novo Nordisk is perhaps not as much of a household name as other pharma companies in the UK, it has a huge presence in diabetes, with a bigger market cap than the likes of GSK and AstraZeneca – and UK GM Pinder Sahota is keen to shout about the organisation that he describes as a “slee
Sinopharm Publishes Positive Data from Phase I/II COVID-19 Vaccine Study
BioSpace
AUGUST 13, 2020
A COVID-19 vaccine candidate developed by Chinese pharmaceutical company Sinopharm triggered antibody-based immune responses in early and mid-stage trials.
Bristol Myers pledges to spend $300M on addressing racial, health disparities
Bio Pharma Dive
AUGUST 12, 2020
The drugmaker aims to double Black and Latinx representation in its executive ranks, among other commitments.
What Happens When 3rd-Party Cookies Expire?
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.
BMS’ Opdivo aces trial in asbestos-linked lung cancer
pharmaphorum
AUGUST 10, 2020
Bristol-Myers Squibb’s Opdivo has improved survival in a trial involving patients with mesothelioma, a form of lung cancer, getting one up over rival checkpoint inhibitor Keytruda from Merck & Co. The results of the CheckMate-743 trial showed that a combination of Opdivo (nivolumab) with low-dose Yervoy (ipilimumab) reduced the risk of death by 26% compared to platinum-based chemotherapy after 22 months of follow-up.
The New Age of Decentralized Clinical Trials
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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.
U.K. Government Secures 60 Million Doses of Novavax’s COVID-19 Vaccine Candidate
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.
A hedge fund bets on a biotech startup to bring new drugs to China
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.
KERI creates a super-high-resolution nano display based on the 3D printing close to virtual reality
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 […].
Verona Pharma to trial lung drug ensifentrine for COVID-19
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.
Deliver Fast, Flexible Clinical Trial Insights with Spotfire
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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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