Bio Pharma Dive
SEPTEMBER 21, 2020
The maker of Keytruda unveiled data for three experimental cancer drugs, including results for an anti-TIGIT therapy that compare favorably to those for a similar medicine being developed by Roche.
BioPharma Reporter
SEPTEMBER 21, 2020
Sanofi and GSK will provide the EU with up to 300 million doses of their COVID-19 vaccine candidate, with the agreement suppporting scale-up of manufacturing capabilities in several European countries.
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Bio Pharma Dive
SEPTEMBER 21, 2020
The wide-ranging role of an inflammatory protein known as NLRP3 has made it a hot drug target — particularly for Roche, which has now bought two startups developing drugs to block it.
pharmaphorum
SEPTEMBER 21, 2020
Compass Pathways and its potential magic mushroom depression drug went public last week – and now psychedelic therapy firm Mind Medicine is aiming to follow suit by up-listing its shares on the Nasdaq. UK-based Compass has a patented synthetic version of psilocybin, the active ingredient in magic mushrooms, and raised around $127.5 million with its IPO on Friday and shares are still significantly above their launch price of $17.
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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 21, 2020
The acquisition, announced shortly before a planned IPO by Grail, establishes sequencing giant Illumina as a major player in the chase to use blood tests to catch cancers early. Wall Street, however, isn't sold on the deal.
pharmaphorum
SEPTEMBER 21, 2020
Amazon’s Alexa device can already field health and medical questions, but the library of responses has now been bulked up thanks to a partnership with digital health company Sharecare. The new deal adds more than 80,000 questions and answers to the repertoire of the Alexa virtual assistant, which provides information, entertainment and advice to users on voice command via devices such as Amazon’s Echo smart speakers.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Scienmag
SEPTEMBER 21, 2020
New study finds presence of regulatory T cells enables partial recovery from paralysis Credit: UCI School of Medicine Irvine, CA – September 21, 2020 – In a new University of California, Irvine-led study, researchers have discovered how regulatory T cells (Treg) are instrumental in limiting the damage caused to the spinal cord in diseases like […].
BioSpace
SEPTEMBER 21, 2020
More than 150 countries have signed on to a World Health Organization program to ensure global access to a COVID-19 vaccine, however, the United States, Russia and China refrained from signing the agreement.
NY Times
SEPTEMBER 21, 2020
While scientists are rushing to develop an immunization for adults, no one has started the process yet for children.
Scienmag
SEPTEMBER 21, 2020
University of Colorado Boulder co-led study completes first global detection of nitrous acid in wildfire plumes Credit: NASA worldview In lab studies of wildfire, nitrous acid seems like a minor actor, often underrepresented in atmospheric models. But in the real-world atmosphere, during wildfires, the chemical plays a leading role–spiking to levels significantly higher than scientists […].
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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 21, 2020
Tagrisso demonstrated an 82% reduction in the risk of central nervous system recurrence or death. The safety and tolerability of the product in the Phase III trial was consistent with previous trials in the metastatic EGFRm NSCLC setting.
Scienmag
SEPTEMBER 21, 2020
A Plasmodium species-specific, ultrasensitive, nucleic acid detection assay to enable fast and inexpensive testing of symptomatic and asymptomatic carriers in low-resource settings Credit: Peter Nguyen / Wyss Institute at Harvard University (BOSTON) — To achieve the goal of eradicating malaria set by the World Health Organization (WHO)’s Global Malaria Control Programme, it is critical that […].
BioSpace
SEPTEMBER 21, 2020
The U.S. National Institutes of Health (NIH) awarded seven companies and academic institutions grants to develop digital health technology to help with the COVID-19 pandemic.
Scienmag
SEPTEMBER 21, 2020
ESA’s Rosetta mission discovers unique aurora at Comet 67P/Churyumov-Gerasimenko Credit: ESA/Rosetta/NAVCAM SAN ANTONIO — Sept. 21, 2020 — Data from Southwest Research Institute-led instruments aboard ESA’s Rosetta spacecraft have helped reveal auroral emissions in the far ultraviolet around a comet for the first time. At Earth, auroras are formed when charged particles from the Sun […].
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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 21, 2020
Bristol Myers Squibb and bluebird bio are eying a potential quick approval for a CAR-T treatment for multiple myeloma after the U.S. Food and Drug Administration accepted the Biologics License Application under priority review.
Scienmag
SEPTEMBER 21, 2020
Credit: Tumisu from Pixabay New research suggests that the impact of natural and vaccine-induced immunity will be key factors in shaping the future trajectory of the global coronavirus pandemic, known as COVID-19. In particular, a vaccine capable of eliciting a strong immune response could substantially reduce the future burden of infection, according to a study […].
Pharma Times
SEPTEMBER 21, 2020
Positive opinions include Pacira's Exparel and two new vaccines from Sanofi
Scienmag
SEPTEMBER 21, 2020
Credit: Graphic by Shireen Dooling Often considered the workhorses of the body, proteins are among the most important biomolecules critical to life processes. They provide structural foundation for cells and tissues and perform a dizzying array of tasks, from metabolizing energy and helping cells communicate with one another to defending the body from pathogens and […].
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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 21, 2020
Competition for resources is growing, and the usual supply chain partners may not have available capacity in the preferred timeframe.
Scienmag
SEPTEMBER 21, 2020
Credit: Kammie Tavares The reactive and piecemeal approach historically used to manage beaches in Hawai’i has failed to protect them. If policies are not changed, as much as 40% of all beaches on O’ahu, Hawai’i could be lost before mid-century, according to a new study by researchers in the Coastal Geology Group at the University […].
Pharma Times
SEPTEMBER 21, 2020
Detailed results presented at ESMO also show benefit in prostate cancer
Scienmag
SEPTEMBER 21, 2020
Fralin Biomedical Research Institute scientists’ finding has implications for brain diseases Credit: Ben Heithoff et al/Virginia Tech Hard skulls help protect our brains from physical injuries. In addition to a tough outer shell, brains have internal defenses, including a powerful shield called the blood-brain barrier that defends brain cells from substances in the bloodstream that […].
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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 21, 2020
Legend’s CEO and Board Chairman, Fangliang “Frank” Zhange, was placed on “residential surveillance” by PRC law enforcement.
Scienmag
SEPTEMBER 21, 2020
Credit: Cornell University ITHACA, N.Y. – Cornell University scientists have engineered a key plant enzyme and introduced it in Escherichia coli bacteria in order to create an optimal experimental environment for studying how to speed up photosynthesis, a holy grail for improving crop yields. The method is described in a paper, “Small subunits can determine […].
pharmaphorum
SEPTEMBER 21, 2020
Immunomedics has revealed the trial data that convinced Gilead to stage a $21 billion takeover , after the biotech’s Trodelvy significantly extended survival in patients with tough-to-treat triple negative breast cancer. In April, Trodelvy was conditionally approved in the US in triple-negative breast cancer (TNBC) on the basis of a phase 1/2 study, which showed a response rate of 33%.
Scienmag
SEPTEMBER 21, 2020
Credit: The University of Texas at Austin. An international team of researchers have found a way to refine and reliably produce an unpredictable and hard-to-control material that could impact environmental conservation, energy and consumer electronics. The material, Molybdenum Disulfide (MoS2), holds tremendous potential for numerous applications in energy storage, water treatment, gas, chemical and light […].
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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.
Pharma Times
SEPTEMBER 21, 2020
Investors include SV Health Investors and Cancer Research UK
Scienmag
SEPTEMBER 21, 2020
Credit: Lancaster University Physicists from Lancaster University have established why objects moving through superfluid helium-3 lack a speed limit in a continuation of earlier Lancaster research. Helium-3 is a rare isotope of helium, in which one neutron is missing. It becomes superfluid at extremely low temperatures, enabling unusual properties such as a lack of friction […].
BioSpace
SEPTEMBER 21, 2020
Vaccinex announced topline data from the early manifest treatment arm of its Phase II SIGNAL trial of pepinemab in patients with early manifest and prodromal Huntington’s disease.
pharmaphorum
SEPTEMBER 21, 2020
Just a month after taking up the CEO role at Legend Biotech, Frank Zhang has been forced to step aside by the board following an investigation into suspected illegal activity by Chinese customs. The nature of the probe isn’t being disclosed at the moment, but according to Legend involves “suspected violations of import and export regulations” at the company’s parent company GenScript Biotech, as well as subsidiaries including Legend.
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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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