Bio Pharma Dive
OCTOBER 16, 2020
Newly published data show that, after joining a clinical trial, patients who were given a drug from Amylyx Pharmaceutcials lived a median 6.5 months longer than those who didn't.
Camargo
OCTOBER 15, 2020
As a sponsor designs clinical studies, the respective comparison control groups become a critical factor to consider. Often, to gain clinical trial design insights, a sponsor reviews the physician package inserts from approved New Drug Applications (NDAs) and Biologics License Applications (BLAs) with similar indications or in the same therapeutic area.
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BioSpace
OCTOBER 15, 2020
Immuno-oncology and CAR T cells energized the field of regenerative medicine, but for cell and gene to deliver on their promises, new, disruptive technologies and new modes of operation are needed.
BioPharma Reporter
OCTOBER 16, 2020
Pfizerâs CEO says the company will apply for Emergency Use Authorisation (EUA) for its COVID-19 vaccine candidate âsoon afterâ a safety milestone is reached in the third week of November.
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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
OCTOBER 16, 2020
Normally staid affairs, next Thursday's advisory committee meeting could be historic and set expectations for how the FDA will approach any future vaccine approval.
pharmaphorum
OCTOBER 16, 2020
Patients with heart failure often have a dismal prognosis as the condition usually worsens over time, but a new study aims to see if digital health technologies can improve their prospects. The trial – run by Boehringer Ingelheim and Yale University – will test a smart bathroom scale device that has cardiac monitoring built in, as well as an app to help patients improve their diet and lose weight and a digital assistant designed to motivate them to actively manage their health.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
NY Times
OCTOBER 12, 2020
The months ahead will be difficult. But the medical cavalry is coming, and the rest of us know what we need to do.
Bio Pharma Dive
OCTOBER 14, 2020
The Swiss pharma is the third large drugmaker to partner with Harvard spinout Dyno Therapeutics, a small biotech aiming to improve gene therapy technology.
pharmaphorum
OCTOBER 13, 2020
Ayming Group’s second annual International Innovation Barometer (IIB) has said that the international outlook for R&D is “remarkably promising” despite strong headwinds caused by COVID-19. The report reveals that R&D departments are being empowered by the creation of ‘innovation ecosystems’, new funding methods, and the deployment of technology.
BioSpace
OCTOBER 11, 2020
AstraZeneca signed a deal with Operation Warp Speed, the U.S. government program to advance COVID-19 vaccines and therapeutics, for a monoclonal antibody cocktail.
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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
OCTOBER 15, 2020
An antiviral widely used to treat hospitalized patients did not lower the mortality rate in a multinational trial.
Bio Pharma Dive
OCTOBER 14, 2020
Safety signals in a mid-stage study led Vertex to stop work on one of its experimental drugs for the inherited disorder alpha-1 antitrypsin deficiency.
Outsourcing Pharma
OCTOBER 12, 2020
Technology impacting generic drugs include artificial intelligence, telemedicine, fraud-preventing digital solutions and more, according to a report.
BioSpace
OCTOBER 15, 2020
By using naturally-derived scaffolds, human cells and other biocompatible materials, 3D bioprinting has ushered in opportunities for researchers to design, print and optimize patient personalized tissues for purposes ranging from transplantation to drug testing.
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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.
XTalks
OCTOBER 16, 2020
Each year, World Food Day falls on October 16, serving as a reminder that 821 million people worldwide — or one in nine — experience hunger. The pandemic has not only highlighted the ongoing need for nutritious food but also shed light on the fragility of food supply chains internationally. Some people experienced long lines at grocery stores, while others couldn’t buy food at all.
Bio Pharma Dive
OCTOBER 13, 2020
The company did not disclose details, nor could it confirm whether the participant had received its shot. But J&J is now the second vaccine developer, along with AstraZeneca, to suspend testing for a safety review.
BioPharma Reporter
OCTOBER 15, 2020
Potential vaccines for COVID-19 should not be affected by changes in SARS-CoV-2 seen to date, nor are they likely to need to be redeveloped seasonally, according to Australian scientists.
BioSpace
OCTOBER 12, 2020
Gossamer Bio announced today that its two studies examining GB001 – the Phase IIb LEDA trial in eosinophilic asthma and Phase II TITAN trial in chronic rhinosinusitis – failed to meet their primary endpoints.
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.
Pharma Marketing Network
OCTOBER 13, 2020
Below is a Q&A with Mark Bard, Co-Founder of The DHC Group, who offers his insights on the challenges COVID-19 has brought to pharma, as well as what innovation is taking place due to this full shift to digital and what lies ahead in the future. What is the most challenging aspect of COVID-19 for the industry? Mark Bard: I think the most challenging aspect of the current situation is the inability of anyone – patient, physician, payor, or pharma – to truly predict how long it will take for v
Bio Pharma Dive
OCTOBER 16, 2020
An unusual letter from Pfizer chief Albert Bourla confirms that the drugmaker won't file for an approval of its experimental shot, assuming positive results, before the U.S. presidential election.
BioPharma Reporter
OCTOBER 15, 2020
The U.S. Food and Drug Administration (FDA) has approved Regeneronâs Inmazeb for treatment of Ebola. The antibody cocktail was developed using the same ârapid responseâ technologies as Regeneronâs investigational COVID-19 antibody combination.
BioSpace
OCTOBER 15, 2020
This morning, the company, which was formerly known as EpiPM Therapeutics, will begin trading on the Nasdaq Global Select Market under the ticker symbol PRAX.
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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
OCTOBER 16, 2020
In the age of artificial intelligence, no trial data should be going to waste. Findacure’s Rick Thompson looks at how these technologies could bring us closer to treatments for underserved rare diseases. The repurposing of drugs is becoming more common, especially in the field of rare diseases. In the past, repurposing has mostly been driven by academics looking for new possibilities in generics.
Bio Pharma Dive
OCTOBER 16, 2020
The results could weaken the case for widely using Veklury, also known as remdesivir, just as the company is asking for full approval from the FDA.
BioPharma Reporter
OCTOBER 13, 2020
Roche plans to launch its high-volume Elecsys SARS-CoV-2 Antigen test at the end of 2020 in markets accepting the CE mark; while the company will file for Emergency Use Authorisation (EUA) from the U.S. Food and Drug Administration (FDA).
BioSpace
OCTOBER 13, 2020
With multiple COVID-19 vaccines in development, the CDC is confident that any vaccines the FDA authorizes or approves will be safe because they are based on the FDA’s usual stringent protocols. The greater question, after a vaccine is approved, is how it will be distributed.
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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.
Scienmag
OCTOBER 16, 2020
International research team including University of Göttingen explains advantages of molecular breeding methods Credit: M Qaim More than two billion people worldwide suffer from micronutrient malnutrition due to deficiencies in minerals and vitamins. Poor people in developing countries are most affected, as their diets are typically dominated by starchy staple foods, which are inexpensive sources […].
Bio Pharma Dive
OCTOBER 13, 2020
We observe that the COVID-19 crisis shines a light on the benefits to patients and industry stakeholders of bringing clinical trials closer to patients' homes.
BioPharma Reporter
OCTOBER 12, 2020
The progress in the race for a COVID-19 vaccine to date has been nothing short of phenomenal. But what can the industry learn from these achievements to inform vaccine development in the future?
BioSpace
OCTOBER 11, 2020
Although the Phase III trial for the intravenous formulation demonstrated statistically significant outcomes for all of the primary and many secondary endpoints, the FDA rejected the application.
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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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