Bio Pharma Dive
OCTOBER 8, 2020
The biotech, a frontrunner in the coronavirus vaccine race, said it won't tie up resources defending the intellectual property covering its experimental shot as long as the pandemic continues.
World of DTC Marketing
OCTOBER 6, 2020
WHAT’S THIS ABOUT THEN : Researchers are rushing to launch clinical trials of experimental vaccines against the coronavirus, and treatments for COVID-19. But as hospitals brace for an onslaught of critically ill patients and laboratories worldwide are disrupted, researchers have had to shelve clinical trials of therapies for other illnesses. Eli Lilly recently announced that it would halt enrolment in ongoing studies and delay the launch of new trials.
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Pharma Mirror
OCTOBER 6, 2020
One of the biggest medical advancements of recent times is the invention of the cell isolation method. Also known as cell sorting or cell separation, the cell isolation method has rapidly become an integral component of modern biological and medical research. In this method, a one-cell population or multiple cell types are isolated from a. The post How is Cell Isolation Revolutionizing Medical Industry?
BioSpace
OCTOBER 4, 2020
Philadelphia-based software company eResearchTechnology (ERT), which offers software used in hundreds of clinical trials, has suffered a ransomware attack.
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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 8, 2020
Recent deals for MyoKardia and The Medicines Co. may be hard to follow, since venture investors and big pharma acquirers have largely ignored cardiovascular drugs.
pharmaphorum
OCTOBER 6, 2020
An Excel spreadsheet was behind IT glitch that caused thousands of positive COVID-19 tests to be omitted from the UK’s official records, according to press reports. The issue that left almost 16,000 positive results going unreported has been blamed on the way Public Health England tracks results from mainly private labs that have been hired to add extra testing capacity.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
BioSpace
OCTOBER 6, 2020
There is little doubt that CRISPR gene editing is and will continue to revolutionize biology and medicine. The Nobel Committee confirmed their belief in that by awarding the Nobel Prize in Chemistry to Emmanuelle Charpentier and Jennifer A. Doudna for their discovery and development of CRISPR.
Bio Pharma Dive
OCTOBER 6, 2020
The review criteria outlined in the document, which the White House had held up for weeks, make the early approval of a coronavirus shot before the Nov. 3 election less likely.
pharmaphorum
OCTOBER 5, 2020
Digital health firm Your.MD has secured $30 million in a Series A round investment led by the consumer health giant Reckitt Benckiser (RB). Your.MD is the company behind the medical-grade, augmented intelligence self-care app Healthily, and will use the funding to accelerate the platform through a series of clinically-validated “health hubs”. Following a seed funding round led by RB and existing shareholders, the now completed Series A funding round will allow the app to reach other markets incl
BioPharma Reporter
OCTOBER 6, 2020
The UKâs Vaccines Manufacturing & Innovation Centre (VMIC) announces that the UK Medicines & Healthcare products Regulatory Agency (MHRA) has approved the second of two GMP COVID-19 vaccine manufacturing suites located at Oxford Biomedica's Oxbox centre.
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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
OCTOBER 4, 2020
Grace Wei, Ph.D., who founded Encellin in 2016 with co-founder Crystal Nyitray, Ph.D., shared some of her lessons during a recent Innovation Centre Denmark, Silicon Valley presentation for would-be biotech entrepreneurs.
Bio Pharma Dive
OCTOBER 7, 2020
The pharma is the first to seek emergency approval for this kind of treatment, and may quickly follow up with a second request after reporting promising data for a two-drug combination.
Outsourcing Pharma
OCTOBER 8, 2020
A veteran with more than 20 years of experience talks about the vitality of recruiting an inclusive patient population, and the perils of falling short.
pharmaphorum
OCTOBER 8, 2020
A few months into the pandemic, the world is now moving beyond managing the crisis, with more focus on addressing the collateral damages and shaping the future. As part of a new series looking at how pharma has responded to the pandemic, Neale Belson, SVP UK & Ireland and general manager for the UK at GSK, tells us that it is “absolutely critical” to do this with the pace and out-of-the box thinking of the past months.
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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
OCTOBER 6, 2020
The new guidelines posted Tuesday by the FDA, call for vaccine developers to follow patients dosed with the experimental medication for at least two months before seeking Emergency Use Authorization.
Bio Pharma Dive
OCTOBER 6, 2020
Blocked by the White House from issuing new vaccine guidelines, the FDA made its criteria for an emergency authorization clear anyway, publishing requirements it had previously communicated to drugmakers.
NY Times
OCTOBER 8, 2020
The “cell lines” used to develop monoclonal antibodies, as well as remdesivir and vaccines, began with fetal tissue decades ago.
pharmaphorum
OCTOBER 9, 2020
Eli Lilly’s Olumiant (baricitinib) has a significant effect on recovery from COVID-19 when combined with Gilead Veklury (remdesivir), according to a large trial backed by funding from the US government. The findings came from additional safety and efficacy data harvested from the US National Institute of Allergy and Infectious Diseases’ (NIAID) ACCT-2 trial.
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
OCTOBER 7, 2020
Regeneron stated that under its agreement with the U.S. government for initial doses of the cocktail, if an EUA is granted the government “has committed to making these doses available to the American people at no cost and would be responsible for their distribution.
Bio Pharma Dive
OCTOBER 8, 2020
The two antibody treatments are now being reviewed by the FDA, although limited supply could mean their impact won't be felt for months, even if they are cleared for use.
BioPharma Reporter
OCTOBER 6, 2020
Vaxxas has received a $22m US Government award to conduct a Phase 1 clinical study for its novel skin-patch vaccination platform. While the trial will use a pandemic influenza vaccine, Vaxxas is also investigating opportunities to use the technology against COVID-19.
pharmaphorum
OCTOBER 5, 2020
As European regulators begin a rolling review of AstraZeneca’s COVID-19 vaccine, the focus in the UK has shifted to the government’s plans to distribute any vaccine that is deemed to be a safe and effective way of preventing the disease. According to weekend press reports a rollout of a vaccine could be just three months away – but the feedback from the government is that not everyone will get it, with the target group being around 30 million older people and health workers, less than half the p
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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
OCTOBER 8, 2020
Supplies of remdesivir are running out across Europe, leading to rationing and reliance on the generic drug, dexamethasone. The UK rationed its supplies of remdesivir Tuesday in the face of rising demands.
Bio Pharma Dive
OCTOBER 5, 2020
The availability of three vastly different, cutting-edge medicines for the rare disease has put patients, families and doctors in an unfamiliar position.
Scienmag
OCTOBER 4, 2020
Credit: Yen Strandqvist/Johan Bodell/Chalmers University of Technology Over the last few years, a specially designed molecule and an energy system with unique abilities for capturing and storing solar power have been developed by a group of researchers from Chalmers University of Technology in Sweden. Now, an EU project led by Chalmers will develop prototypes of […].
pharmaphorum
OCTOBER 9, 2020
Delayed diagnosis, lack of awareness, and a limited evidence base – Aarskog syndrome faces all the challenges of rare diseases everywhere. But a new study hopes to kick start a revolution in understanding. For five years, Michelle Erskine faced a succession of closed doors and disbelief as she struggled to convince someone that all was not well with her son.
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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
OCTOBER 6, 2020
This morning, the Swiss pharma giant acquired a portfolio of experimental cystic fibrosis therapies, including a candidate that has the potential to treat all patients with this disease.
Bio Pharma Dive
OCTOBER 6, 2020
The decision by European regulators to start speedy, "rolling" reviews of two vaccine candidates comes as the FDA and White House have reportedly been unable to agree on early approval standards.
Scienmag
OCTOBER 9, 2020
A major study from Aarhus University in Denmark has now identified that there are actually two types of Parkinson’s disease. Credit: Per Borghammer/Jonathan Bjerg Møller (video), Aarhus University Although the name may suggest otherwise, Parkinson’s disease is not one but two diseases, starting either in the brain or in the intestines. Which explains why patients […].
pharmaphorum
OCTOBER 9, 2020
The European Commission has taken its advance orders for potential COVID-19 vaccines to more than 1.1 billion, after signing a supply deal for up to 400 million doses of Johnson & Johnson’s experimental candidate. The agreement is the third for coronavirus vaccine supply for the EU, coming after earlier deals with AstraZeneca and Sanofi/GlaxoSmithKline, and comes as wealthy nations are scrambling to secure access to the initial supplies of the shots furthest ahead in development.
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