Bio Pharma Dive
AUGUST 26, 2020
An initial look at the vaccine's effects on the elderly shows those in their 70s had similar responses to those under 55, Moderna told a government panel.
World of DTC Marketing
AUGUST 26, 2020
IN SUMMARY : When patients return to doctor’s offices will HCP’s have time to go online with every drug company that requests an online detail? Will patients be happy with telehealth once they feel it’s safe to return to physicians’ offices? After I read the Medscape report on the move to digitization I decided to reach out to some industry contacts to hear what they had to say.
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Pharma Mirror
AUGUST 28, 2020
A CPAP machine is a device that can replace or improve human breathing, increase lung ventilation, and improve respiratory function. It is generally used for lung failure or airway obstruction to breathing normally to help the patient complete the breathing process of inhalation and exhalation. It has a variety of breathing modes (various ways in. The post What Is the Difference Between Oxygen Generators and CPAP?
BioSpace
AUGUST 27, 2020
EcoHealth had already developed a partnership with a WIV laboratory in Wuhan, China, under a five-year NIH grant. It was expected to run through 2024 but was canceled in April.
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Bio Pharma Dive
AUGUST 27, 2020
Canada was set to help CanSino produce its experimental shot as part of a deal to run what would've been the country's first coronavirus vaccine study.
World of DTC Marketing
AUGUST 23, 2020
COVID-19 has disrupted traditional healthcare person-to-person communication and accelerated digital options, such as telehealth and remote patient-clinician contacts, digital therapeutics that deliver remote patient monitoring, and interventions through the use of software. But is this really the future? Medscape conducted some research in May to find out.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
BioSpace
AUGUST 24, 2020
“I have been criticized for remarks I made Sunday night about the benefits of convalescent plasma,” Hahn tweeted. “The criticism is entirely justified. What I should have said better is that the data show a relative risk reduction not an absolute risk reduction.
Bio Pharma Dive
AUGUST 26, 2020
A rival shot from Pfizer and BioNTech needs to be stored at colder temperatures and doesn't last as long in a refrigerator, which may limit its use.
pharmaphorum
AUGUST 24, 2020
Could collecting, understanding, and disseminating patient-reported outcomes during trials be the key to advancing oncology treatments and improving cancer outcomes? . With our understanding of cancer accelerating at an unprecedented rate, and personalised medicines on the cusp of becoming mainstream, regulatory bodies need new ways to assess products. .
Pharma Times
AUGUST 26, 2020
In a pivotal Phase II/III study, twice as many patients receiving the drug achieved the primary endpoint of ASAS 40 response at week 14 versus placebo
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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 27, 2020
According to data from Phase I clinical trials, a new breast cancer drug developed by researchers at the University of Illinois Chicago can potentially stop disease progression without toxicity.
Bio Pharma Dive
AUGUST 26, 2020
Founders of Dutch biotech Dezima have created NewAmsterdam Pharma and bought back the cholesterol drug they sold to Amgen in 2015.
pharmaphorum
AUGUST 23, 2020
Normal. 0. false. false. false. EN-GB. X-NONE. X-NONE. A smartphone-based app that uses facial analysis technology to spot chronic pain in people with dementia, called PainChek, is being rolled out in the UK by its Australian developer. The artificial intelligence-powered tool can help care workers and clinicians to identify and manage pain in patients with conditions like Alzheimer’s disease that can make it difficult for them to communicate.
NY Times
AUGUST 28, 2020
The agency’s chief spokeswoman, Emily Miller, was removed from her position just 11 days into the job. And the contract was terminated of a consultant who had advised the F.D.A. chief to correct misleading claims about plasma’s benefits.
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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 27, 2020
One day after Abbott secured Emergency Use Authorization for its $5 coronavirus test, the White House awarded the company a $750 million contract to deliver 150 million Abbott BinaxNOW COVID-19 Ag Card Point of Care (POC) SARS-CoV-2 diagnostic tests.
Bio Pharma Dive
AUGUST 28, 2020
A draft report from the drug pricing watchdog concluded that, under the right conditions, Roctavian may be cost-effective at a price of $2.5 million.
pharmaphorum
AUGUST 27, 2020
Despite the UK’s world class research output and the many start-ups successfully spinning out from its academic institutions, in recent years UK biotech companies have struggled to access the capital they need to scale up and make their mark on the industry. The COVID-19 pandemic has brought about a radical transformation, with investors now eager to fund companies involved in the fight against the virus.
NY Times
AUGUST 24, 2020
Many experts — including a scientist who worked on the Mayo Clinic study — were bewildered about where a key statistic came from.
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 24, 2020
According to a study published in Nature Medicine on August 17, researchers from the Stanford University School of Medicine have discovered a way to regenerate the cushion of cartilage found in joints.
Bio Pharma Dive
AUGUST 27, 2020
The approval for the FoundationOne Liquid CDx follows the agency's nod earlier this month for Guardant Health's next-generation sequencing diagnostic.
pharmaphorum
AUGUST 26, 2020
Health insurer Humana has filed a lawsuit against telemedicine company QuivvyTech that it says resulted in fraudulent prescriptions worth millions of dollars being written for duped customers. According to the complaint, QuivvyTech hired telemarketers to cold-call Humana members, whose details were obtained using “illegal means,” and encouraged them to talk about common ailments, claiming to be calling from Humana.
XTalks
AUGUST 28, 2020
To help address the continued need for personal protective equipment (PPE) in the current COVID-19 pandemic, a group of entrepreneurs and PPE specialists have developed a modular full-face mask called Blanc; it is being marketed by their new company that goes by the same name. Xtalks spoke to one of the co-founders of Blanc, Philipp Egorov, to learn more about the mask.
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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 26, 2020
The idea is to support companies that anticipate “potential health security threats, activating the global innovation community, and amplifying scientific and technological advances with the aim to prepare for and respond to our rapidly evolving global health environment.
Bio Pharma Dive
AUGUST 28, 2020
The reported talks between CanSino and several countries highlight the urgency with which governments are operating to secure supply of experimental coronavirus vaccines.
pharmaphorum
AUGUST 27, 2020
Moderna has said that its coronavirus vaccine stimulated an immune response in older people in phase 1 trials, suggesting that the jab is effective in the age groups most susceptible to COVID-19. An analysis of the latest data from a phase 1 trial showed that in 20 older adults given the vaccine – ten between the ages of 56 and 70 and ten aged 71 and older – the vaccine produced neutralising antibodies and T-cells in comparable levels to those aged 18 to 55-years-old.
Pharma Times
AUGUST 27, 2020
It is hoped that the vaccine will generate protection not only against SARS-CoV-2, but also against new strains of coronavirus that may arise in the future
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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 26, 2020
With a new regulatory approval in hand for its comprehensive pan-tumor liquid biopsy test, Foundation Medicine said it plans for the product to be available for commercial use by Friday, Aug. 28.
Bio Pharma Dive
AUGUST 27, 2020
The results keep Bluebird Bio on track to seek approval of the experimental treatment, known as eli-cel, in Europe later this year and in the U.S. in 2021.
pharmaphorum
AUGUST 27, 2020
Already under fire for what some view as a premature authorisation of convalescent plasma for COVID-19, the FDA is now being accused of a blunder that could render current supplies unusable. Bioindustry association MichBio says the FDA’s labelling requirements for COVID-19 convalescent plasma (CCP) – which were published alongside the emergency use authorisation – could lead to “hundreds, if not thousands, of in-date, ready to transfuse CCP units across the country being rendered unusable.”.
XTalks
AUGUST 26, 2020
Macrophages are white blood cells that specialize in the detection, phagocytosis and destruction of bacteria and other harmful organisms. They can also present antigens to T cells and initiate inflammation by releasing cytokines, which activate other cells. In other words, when fighting bacteria, the macrophages are programmed to be pro-inflammatory.
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