Bio Pharma Dive
JULY 19, 2021
The German biotech purchased Kite Pharma's Gaithersburg, Maryland-based site, along with related research on T cell receptor-based cancer treatments.
BioSpace
JULY 19, 2021
Preclinical data for its drug candidate, LP-184, reportedly showed over 90 percent efficacy in shrinking pancreatic cancer tumors in mouse models in vitro, in-vivo, and ex-vivo.
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Bio Pharma Dive
JULY 19, 2021
The offering is the latest step in the rapid emergence of Adagio, which raised nearly $400 million and brought a drug to pivotal testing in less than a year.
BioPharma Reporter
JULY 19, 2021
Celltrion Group has reported that data from an in vivo efficacy study shows that its monoclonal antibody treatment for COVID-19, regdanvimab (CT-P59), has a strong neutralizing effect against the rapidly spreading Delta variant.
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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 19, 2021
Approval of Merck's shot sets the stage for the two large pharmas to compete for market share with new pneumococcal vaccines that are meant to improve on older versions.
XTalks
JULY 19, 2021
Social media has been abuzz with posts about Kraft’s new vibrant orange macaroni-and-cheese-flavored ice cream —and for good reason. The maker of the famous boxed mac n’ cheese recently released a limited-edition ice cream in partnership with Brooklyn-based Van Leeuwen Ice Cream to merge together two iconic foods, whether consumers wanted it or not.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
pharmaphorum
JULY 19, 2021
America’s biopharmaceutical industry says it is “ready to do its part” in building a stronger, more resilient, affordable, and equitable health care system for all. COVID-19 highlighted both the challenges of the US healthcare system and the huge change potential of the country’s pharmaceutical industry. Now, as vaccination continues at pace, the sector has pledged to help “build back better”, by lowering barriers between medical innovations and the patients who need them.
Bio Pharma Dive
JULY 19, 2021
One COVID-19 study, 1,000 seniors — ahead of schedule. Find out how eSource made it happen.
Outsourcing Pharma
JULY 19, 2021
A recent study indicates patients taking the cholesterol-lowering drugs prior to COVID hospitalization are far less likely to die as a result of the virus.
Bio Pharma Dive
JULY 19, 2021
Treatment with one of the biotech's drugs improved heart function in a small trial, an outcome that could help the company rebound and potentially challenge a rival medicine from Bristol Myers Squibb.
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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
JULY 19, 2021
The Boston-based company merged with Capstar Special Purpose Acquisition Corp. and will begin trading on the New York Stock Exchange under the ticker symbol “GLS.
Scienmag
JULY 19, 2021
Credit: Andrea Crisanti Testing of an entire Italian town shows antibody levels remain high nine months after SARS-CoV-2 infection, whether symptomatic or asymptomatic. Researchers from the University of Padua and Imperial College London tested more than 85 percent of the 3,000 residents of Vo’, Italy, in February/March 2020 for infection with SARS-CoV-2, the virus that […].
BioSpace
JULY 19, 2021
Shares of Arcus Biosciences dipped sharply in post-market trading Monday after it was learned that the company’s chief medical officer was departing for a role at Gilead Sciences.
XTalks
JULY 19, 2021
Phosphorus, a leading preventative genomics company, has developed the first comprehensive preventative genetic test for consumers. The test is called GeneCompass and features medical-grade technology to provide a holistic assessment of genetic health and wellness. Unlike other consumer genetic tests that are largely based on DNA microarray technology, Phosphorus’ GeneCompass test uses next-generation sequencing (NGS) to sequence over 400 genes, providing high sensitivity and specificity i
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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
JULY 19, 2021
A new study has found that statins, a popular class of cholesterol-lowering drugs, may decrease the odds of dying from coronavirus disease 2019 (COVID-19) by 41% and reduce the risk of severe disease.
pharmaphorum
JULY 19, 2021
Shares in Cytokinetics surged after it reported positive mid-stage results for CK-274, a drug for hypertrophic cardiomyopathy (HCM) that could tread on the toes of Bristol-Myers Squibb’s mavacamten – acquired as part of its $13.1 billion takeover of MyoKardia last October. In HCM, the heart muscle become thickened and in some patients can obstruct blood flow, causing symptoms like chest pain and palpitations.
BioSpace
JULY 19, 2021
The Boston-based company announced an infusion of $135 million in Series C funds to support the late-stage development of its lead candidate, AMX0035, for amyotrophic lateral sclerosis.
Scienmag
JULY 19, 2021
Credit: Michael Holahan, Augusta University An internal transporter that enables us to use the copper we consume in foods like shellfish and nuts to enable a host of vital body functions also has the essential role of protecting the receptor that enables us to grow new blood vessels when ours become diseased, Medical College of […].
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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
JULY 19, 2021
American health authorities have a dilemma. On one hand, COVID-19 booster shots for immunocompromised patients dramatically increase their immune response. On the other, in many parts of the world only a tiny fraction of the population have received even one dose of any COVID-19 vaccine. So, who.
pharmaphorum
JULY 19, 2021
Digital therapeutics (DTx) startup Dopavision has raised funding to develop its lead product, an app designed to slow the progression of myopia – or short-sightedness – in children or adolescents. The €12 million series round, led by Seventure Partners and backed by investors including Novartis, Boehringer Ingelheim and Abbax Health, will be used to fund clinical development of the DTx.
Scienmag
JULY 19, 2021
Credit: NASA, ESA, K. Kuntz (JHU), F. Bresolin (University of Hawaii), J. Trauger (Jet Propulsion Lab), J. Mould (NOAO), Y.-H. Chu (University of Illinois, Urbana), and STScI Black holes with masses equivalent to millions of suns do put a brake on the birth of new stars, say astronomers. Using machine learning and three state of […].
Pharma Times
JULY 19, 2021
The latest funding round was led by Praetura Ventures with follow-on equity from the Development Bank of Wales
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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.
Scienmag
JULY 19, 2021
$1.26 million enables inclusive curriculum and textbook project Credit: (Yat Sun Poon/UCR) UC Riverside is leading a new, $1.26 million project to bring calculus classes to life for students who are underrepresented in science, technology, engineering, and math subjects. “Calculus has been taught in the same linear fashion for over a century,” said curriculum developer […].
BioSpace
JULY 19, 2021
?The FDA said it found an issue with the "size of the treatment effect and clinical relevance" of Ardelyx's new drug tenapanor without providing additional details.
Scienmag
JULY 19, 2021
Credit: Victor O. Leshyk, Center for Ecosystem Science and Society, Northern Arizona University Scientists at Northern Arizona University, Arizona State University, the Arizona Geological Survey at the University of Arizona, and the National Snow and Ice Data Center at the University of Colorado Boulder have been awarded almost $2 million from the National Science Foundation […].
BioPharma Reporter
JULY 19, 2021
The US Food and Drug Administration (FDA) has granted priority review designation for Pfizer and BioNTechâs COVID-19 vaccine Biologics License Application (BLA).
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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.
Scienmag
JULY 19, 2021
Credit: Kotani et al A new mathematical model helps predict the tiny changes in carbon-based materials that could yield interesting properties. Scientists at Tohoku University and colleagues in Japan have developed a mathematical model that abstracts the key effects of changes to the geometries of carbon material and predicts its unique properties. The details were […].
Eye on FDA
JULY 19, 2021
It has been a regular feature of the blog to give a read on what FDA has been talking about, at least through the form of press releases. It is not always an easy task because the nature of FDA’s practice in this respect has evolved over time. But here is what we see looking at the first 6 months 2021, and comparing it to mid-years past. You may recall from the last posting on this topic at the beginning of the year, during 2020, FDA had a lot to say – a real lot, and that isn’
Scienmag
JULY 19, 2021
Credit: J. Tennyson The Royal Astronomical Society (RAS) is pleased to announce the launch of its first new journal in almost 100 years. Tentatively titled RAS Techniques and Instruments, it will cover topics in astronomy and geophysics ranging from instrumentation, data science, machine learning, software, and numerical and statistical methods. The RAS plans to release […].
BioPharma Reporter
JULY 19, 2021
Boston headquartered biotherapeutics company, GentiBio, Inc, and CGT focused CDMO, Forge Biologics, have set up a development and manufacturing partnership.
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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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