Bio Pharma Dive
SEPTEMBER 15, 2020
Importantly, the study committee hasn't had reason to pause vaccinations in the trial, something AstraZeneca and the University of Oxford recently reported in tests of their vaccine.
Pharma Mirror
SEPTEMBER 15, 2020
The Royal Society of Chemistry has launched its new Text and Data Mining (TDM) solution, making its full collection of research journals available to companies for AI and machine learning applications. With the volume of published research available growing hourly, access to the RSC’s collection in machine-readable format offers companies the opportunity to extract, pinpoint.
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Bio Pharma Dive
SEPTEMBER 15, 2020
The Japanese drugmaker has made cell therapy a focus, advancing three experimental cancer treatments into clinical testing with plans for two more.
World of DTC Marketing
SEPTEMBER 15, 2020
TO THE POINT: When it comes to online advertising the creative is more important than the money you’re spending on media. DTC marketers need to create a “hook point” to lead to action. Consumers today are bombarded with so much information you have to grab their attention quick. In fact, you realistically only have 3-seconds or less.
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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
SEPTEMBER 15, 2020
The Serum Institute of India, a go-to partner for coronavirus vaccine makers, will help Novavax boost capacity to levels matching its larger rivals.
Camargo
SEPTEMBER 15, 2020
Each month, Camargo’s “In the News” series highlights important changes and advancements in the regulatory and development space and explore how those changes could impact your program. Fitbit developing algorithm COVID-19 early detection. Fitbit recently posted a study that may indicate the company’s ability to create an algorithm that can flag cases of COVID-19 early.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
BioSpace
SEPTEMBER 15, 2020
One company working towards an ARDS treatment is Athersys, a biotech company focusing on regenerative medicine therapies for diseases with significant unmet need.
BioPharma Reporter
SEPTEMBER 15, 2020
Vaxart will start a Phase 1 clinical trial for its oral COVID-19 vaccine candidate, having received Investigational New Drug (IND) clearance.
BioSpace
SEPTEMBER 15, 2020
Although it is increasingly likely that one of the COVID-19 vaccines currently being tested will be approved or receive Emergency Use Authorization before the end of the year, experts are increasingly warning that widespread distribution may take a much longer time.
pharmaphorum
SEPTEMBER 15, 2020
As pharmaceutical marketers prepare their brands for the future, there are a number of important ways they can learn from digitally-native brands. Companies like prescription glasses firm Warby Parker, shoe brand Rothy’s and tele-dentistry’s SmileDirectClub have grown up in today’s digitally native environment and can offer some key pointers for pharma.
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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
SEPTEMBER 15, 2020
Only days after saying it expects to have key data from its Phase III clinical trial of its COVID-19 vaccine in October, Germany’s BioNTech received a grant of up to €375 million from the German Federal Ministry of Education and Research.
XTalks
SEPTEMBER 15, 2020
A vaccine developed by Swedish company Diamyd Medical has demonstrated significant treatment efficacy in a predefined genetic subgroup of individuals with type 1 diabetes in a Phase IIb clinical trial. The predefined genetic subgroup consists of patients positive for the human leukocyte antigen (HLA) DR3-DQ2 haplotype, which is found in approximately 50 percent of all type 1 diabetics worldwide.
BioSpace
SEPTEMBER 15, 2020
The company is genetically programming RNA not just to deliver a gene of interest, but to control the location, timing and intensity of therapeutic protein expression using mRNA-encoded logic circuits.
Druggist
SEPTEMBER 15, 2020
Cold sores are a common viral infection caused by herpes simplex virus. Cold sores usually affect the area around the mouth (usually caused by the herpes simplex virus 1) or the genital area (usually caused by the herpes simplex virus 2). Cold sore can affect children and adults. Zovirax cream for cold sores can be purchased over the counter from pharmacies and supermarkets.
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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
SEPTEMBER 15, 2020
The United Arab Emirates has granted Emergency Use Authorization to an investigational vaccine for the novel coronavirus six weeks after late-stage studies began.
pharmaphorum
SEPTEMBER 15, 2020
Humanigen is hoping for emergency use authorisation in the US for an antibody to treat severe COVID-19 before the end of 2020, and has teamed up with Swiss contract manufacturer Lonza to make sure it can meet demand. The antibody – called lenzilumab – targets colony stimulating factor 2 (CSF2) and granulocyte-macrophage colony stimulating factor (GM-CSF), two cytokines that are linked to the runaway immune response that can result in serious lung damage in COVID-19.
BioSpace
SEPTEMBER 15, 2020
Novavax and Serum Institute of India Private Limited (SIIPL) amended an agreement struck last month that will allow the company to double the number of doses of its experimental COVID-19 vaccine for potential use in 2021.
pharmaphorum
SEPTEMBER 15, 2020
Boehringer Ingelheim has signed a $500 million contract with Click Therapeutics to co-develop and market a digital treatment for patients with schizophrenia. The deal is based around a digital therapeutic (DTx) app, called CT-155, which will be prescribed either as a standalone treatment or in combination with pharmaceuticals. With this deal BI becomes the latest big pharma player to invest in DTx products, which have already become established in mental health conditions such as depression.
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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
SEPTEMBER 15, 2020
Shares of Marinus Pharmaceuticals soared more than 60% in after-hours trading Monday following the company’s announcement that its experimental epilepsy treatment ganaxolone hit the mark in a Phase III study.
pharmaphorum
SEPTEMBER 15, 2020
Gilead has made another big oncology acquisition, paying $21 billion for US biotech Immunomedics and its potential cancer blockbuster Trodelvy, days before survival data is due to be revealed in tough-to-treat triple negative breast cancer. California-based Gilead announced its strong intentions in oncology in 2017 with its $11.9 billion buy of Kite Pharma and followed that earlier this year by acquiring immuno-oncology firm Forty Seven for $4.9 billion.
BioSpace
SEPTEMBER 15, 2020
Clinical-stage biopharmaceutical firm ESCAPE Bio has snagged a $73 million crossover financing deal, led by Wellington Management Company, which will help advance the company’s two clinical development programs of precision neurology medicines for patients with genetic neurodegeneration.
pharmaphorum
SEPTEMBER 15, 2020
A team of US health analysts has cast doubt on whether the increased use in telehealth will continue after the pandemic. The Peterson Center on Healthcare and Kaiser Family Foundation has analysed the increased use of telehealth as part of its Health System Tracker project, which monitors how well the US healthcare system is performing in terms of quality and cost.
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As the development pipeline for new drugs continues to grow, biopharmaceutical companies are re-evaluating how to best manage and balance resources across an increasing number of development projects and complex clinical trials. There are two approaches that can be used to speed a drug from development to clinic faster: timeline compression and parallel processing, but only one that considers the benefits of integrating clinical supply into the overall drug development process.
BioSpace
SEPTEMBER 15, 2020
Takeda Pharmaceutical opened a new 24,000-square-foot R&D cell therapy manufacturing facility in Boston, Massachusetts. It is at the site of the company’s R&D headquarters.
Pharma Times
SEPTEMBER 15, 2020
Agreement grants MSD access to investigational ADC and a small molecule tyrosine kinase inhibitor
BioPharma Reporter
SEPTEMBER 15, 2020
In a Phase III trial, Farxiga reportedly showed reduction in the risk of kidney failure, and cardiovascular (CV) or renal death, in CKD patients.
Scienmag
SEPTEMBER 15, 2020
Credit: University of Ottawa Jennifer Keir, a uOttawa PhD student and Research Associate whose research investigates firefighters’ health and their occupational exposure to hazardous substances, has been named the 2020 Fire Researcher of the Year by the Canadian Fire Chiefs Association. In October 2017, Jennifer Keir and her research team published a groundbreaking study in […].
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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.
pharmaphorum
SEPTEMBER 15, 2020
The UK government has signed a €1.4 billion ($1.66 billion) order for up to 190 million doses of a coronavirus vaccine in development at French company Valneva. The new deal firms up an earlier agreement in principle with the UK in July that covered up to 100 million doses of VLA2001 , a purified inactivated SARS-CoV-2 vaccine that is expected to require a two-dose vaccination regimen.
Scienmag
SEPTEMBER 15, 2020
An extremely social robotic fish helps unravel the collective patterns of animal groups Credit: David Bierbach The spectacular and complex visual patterns created by animal groups moving together have fascinated humans since the beginning of time. Think of the highly synchronized movements of a flock of starlings, or the circular motion of a school of […].
Outsourcing Pharma
SEPTEMBER 15, 2020
The technology from Opyl uses artificial intelligence to anticipate a COVID-19 treatment, vaccine, diagnostic or deviceâs chances of success in a study.
Scienmag
SEPTEMBER 15, 2020
Credit: Joshua Yospyn Michael E. Mann, distinguished professor of atmospheric sciences and director of the Earth System Science Center at Penn State, will share the 2020 World Sustainability Award with Antonella Santuccione Chadha, co-founder and the CEO of the Women’s Brain Project and global medical manager for Alzheimer’s disease at Roche Diagnostics.
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The global landscape of clinical trials is rapidly changing as studies become more complex. An increasing number of sponsors are seeking enhanced flexibility in their supply chains to address a variety of clinical supply challenges, including patient demand and reducing delays. Demand-led supply and direct-to-patient distribution are next-generation solutions that are helping to meet these growing needs, allowing for more streamlined processes and patient-centric studies.
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