Bio Pharma Dive
JULY 1, 2021
A five-year alliance with high-profile biotech ElevateBio is designed to get around a bottleneck that has held back the institution’s gene therapy work.
World of DTC Marketing
JULY 1, 2021
SUMMARY: Online health seeker numbers are still very high, indicating that people are doing their research first before asking for a prescription drug. Online health seekers trust pharma products but find product websites hard to read and inconsistent with their needs. Telehealth numbers are dropping rapidly, but people still want to use telehealth to ask for Rx renewals and ask general questions.
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Bio Pharma Dive
JULY 1, 2021
Final results from CureVac's large Phase 3 study showed an overall efficacy of just 48%, although the German biotech emphasized stronger protection against more severe disease and in younger adults.
XTalks
JULY 1, 2021
The safety of titanium dioxide in food, an additive found in thousands of ultra-processed foods, is now being questioned by the European Food Safety Authority (EFSA) after an in-house study conducted in March. In a surprising twist, the study concluded that the agency no longer considers titanium dioxide a safe food additive. So what does this mean?
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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
JULY 1, 2021
The health science unit at Nestlé may pay more than $500 million to secure rights in the U.S. and Canada for SER-109, a spore-filled capsule meant for patients with recurrent C. diff infections.
BioSpace
JULY 1, 2021
Every week there are numerous scientific studies published. This week there was an unusual number of research stories revolving around Alzheimer’s disease. Here’s a look at some of the more interesting ones.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
BioSpace
JULY 1, 2021
Positive results from Sellas Life Sciences Group’s Phase I/II trial using galinpepimut-S (GPS) as a combination therapy with pembrolizumab (Keytruda®) were announced Wednesday, shortly after similarly positive news was issued from a combination study in which GPS was evaluated as a treatment for.
Pharma Times
JULY 1, 2021
Checkpoint inhibitor approved in combination with chemotherapy in the first-line setting for these patients
NY Times
JULY 1, 2021
The Pfizer and Moderna vaccines are safe and effective. Full approval from the F.D.A. will help stop the spread of Covid-19.
Scienmag
JULY 1, 2021
CPAP also plays a vital role in suppressing tumorigenesis in OSCC by facilitating EGFR homeostasis Credit: Correspondence to – Radhika Gudi – gudi@musc.edu and Chenthamarakshan Vasu – vasu@musc.edu Oncotarget published “Loss of CPAP causes sustained EGFR signaling and epithelial-mesenchymal transition in oral cancer” which reported that not only do the abnormal functions of microtubule and […].
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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
pharmaphorum
JULY 1, 2021
Merck KGaA has joined forces with a unit of medtech firm B Braun – neuroloop – on a way to treat inflammatory diseases using neurostimulator devices. The German drugmaker will work with startup neuroloop on bioelectronics , put simply the harnessing of electrical stimulation to treat human disease, with a focus on chronic conditions like arthritis and inflammatory bowel disease. neuroloop – a spinout of Freiburg University in Germany formed in 2016 – has been working to date on using its device
Scienmag
JULY 1, 2021
Revised date of the Laacher See eruption 13,077 years ago provides crucial information about historical climate fluctuations at the end of the last Ice Age Credit: photo/©: Olaf Jöris The eruption of the Laacher See volcano in the Eifel, a low mountain range in western Germany, is one of Central Europe’s largest eruptions over the […].
BioPharma Reporter
JULY 1, 2021
After the success of COVID-19 mRNA vaccines, the company takes the decision as part of a âlong-term playâ to target diseases beyond the pandemic.
Scienmag
JULY 1, 2021
Credit: Schweiger et al./Communications Earth & Environment In a rapidly changing Arctic, one area might serve as a refuge – a place that could continue to harbor ice-dependent species when conditions in nearby areas become inhospitable. This region north of Greenland and the islands of the Canadian Arctic Archipelago has been termed the Last Ice […].
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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.
Pharma Times
JULY 1, 2021
Data also shows pharma companies worked with fewer HCPS and HCOs in 2020 compared to 2019
Scienmag
JULY 1, 2021
First global assessment of the extent of snow and ice cover on Earth’s surface–a critical factor cooling the planet through reflected sunlight–and its response to warming temperatures Credit: Peng et al. (2021) Earth’s Future [link] WASHINGTON–The global cryosphere–all of the areas with frozen water on Earth–shrank by about 87,000 square kilometers (about 33,000 square miles), […].
pharmaphorum
JULY 1, 2021
Synthetic biology holds much promise for the life sciences sector as it continues to look for new ways of treating disease and accelerating drug development, says Debiopharm’s Tanja Dowe. Synthetic biology has grown exponentially in less than a decade, with CRISPR gene-editing as the key technology driving this through its use in areas like cancer, infectious diseases, and rare, undertreated indications.
Scienmag
JULY 1, 2021
Researchers explore telehealth as a treatment option following $7.5 million award Credit: Cincinnati Children’s CINCINNATI – The COVID-19 pandemic has prompted scientists at Cincinnati Children’s Hospital Medical Center to pivot their suicide prevention research efforts with a focus on telehealth. They received a five-year research award totaling almost $8 million from Patient-Centered Outcomes Research Institute […].
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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.
Pharma Times
JULY 1, 2021
Interim advice says boosters could be offered to priority groups from September
Scienmag
JULY 1, 2021
LJI researchers highlight the importance of T cell cross reactivity in stopping severe COVID-19 cases Credit: La Jolla Institute for Immunology LA JOLLA, CA–Researchers at La Jolla Institute for Immunology (LJI) have found that T cells from people who have recovered from COVID-19 or received the Moderna or Pfizer-BioNTech vaccines are still able to recognize […].
Pharma Times
JULY 1, 2021
JAK inhibitor hit primary endpoint of improved clinical remission at 52 weeks in maintenance study
Scienmag
JULY 1, 2021
New non-invasive method to track the progress of one highly sought-after anti-cancer immunotherapy can change research in the field Several cancer tumors grow through immunosuppression; that is, they manipulate biological systems in their microenvironments and signal to a specific set of immune cells–those that clear out aberrant cells–to stop acting.
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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.
BioPharma Reporter
JULY 1, 2021
Biotech, Mogrify, recently closed a Series A financing of US$17m, bringing the total raised to US$33m in the round, with the investment set to support the advancement of the companyâs immuno-oncology and ophthalmology programs.
Scienmag
JULY 1, 2021
Despite a large heterogeneity in Spike-specific antibody levels, most individuals remain seropositive for at least one year after infection One year after infection by SARS-CoV-2, most people maintain anti-Spike antibodies regardless of the severity of their symptoms, according to a study with healthcare workers co-led by the Barcelona Institute for Global Health (ISGlobal), the Catalan […].
pharmaphorum
JULY 1, 2021
The Institute for Clinical and Economic Review (ICER) was very damning of Biogen’s new Alzheimer’s disease therapy Aduhelm when it issued its first report on the drug last month, and a swift update to its deliberations won’t be much comfort to the company. The cost-effectiveness watchdog has revised its calculation of a fair price range for Aduhelm (aducanumab) upwards, but only by a small amount.
Scienmag
JULY 1, 2021
ESMO World Congress on Gastrointestinal Cancer 2021 Lugano, Switzerland, 2 July 2021 – Doctors and patients are being advised to reduce unnecessary antibiotic use following new data suggesting that these medicines may increase the risk of cancer of the large intestine (colon), especially in people under 50 years. (1) The results, presented at the ESMO […].
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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
JULY 1, 2021
Introduction. The clinical trial process is a long, expensive, complicated one that often ends in failure. This means that to have a successful outcome, careful decision making and planning are absolutely essential. And so are data standards! The FDA requires clinical study data to be submitted in a standardized format. This allows the FDA to receive, process, review and archive submissions efficiently.
Scienmag
JULY 1, 2021
Cash in on the kids’ inheritance and spend up big on the retirement plans – that’s the message coming from the University of South Australia as new research reveals that older people are keen to spend their well-earned savings, rather than passing them on to their kids. And while it may seem like bad news […].
BioSpace
JULY 1, 2021
Biopharma and life sciences companies strengthen their leadership teams and boards with these Movers & Shakers.
Scienmag
JULY 1, 2021
Researchers devise a new technique to identify specific neural pathways involved in executive functions of the brain Credit: National Institutes for Quantum and Radiological Science and Technology The human brain is a wonderfully enigmatic organ, helping to juggle multiple tasks efficiently to help us get through a long day! This feature, called executive function, seats […].
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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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