Bio Pharma Dive
DECEMBER 14, 2021
Fitusiran, which Sanofi licensed from Alnylam, could finally get to market after trial delays and safety concerns slowed its progress. But gene therapies and other new medicines might provide competition.
BioPharma Reporter
DECEMBER 14, 2021
Moderna and the Australian Government have announced an agreement in principle to build a mRNA vaccine manufacturing facility in Victoria, Australia: providing up to 100 million doses a year.
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Bio Pharma Dive
DECEMBER 14, 2021
Novartis' CAR-T drug Kymriah didn't appear better than standard of care in earlier lymphoma treatment. Its two similar rivals, Gilead's Yescarta and Bristol Myers' Breyanzi, did, raising questions about potential differences.
NY Times
DECEMBER 14, 2021
Two drugmakers have been mired for years in the pre-application phase of getting F.D.A. approval for over-the-counter use.
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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
DECEMBER 14, 2021
The pharma has expanded an alliance with a German biotech by paying $150 million for a drug candidate that executives hope can have "cell therapy-like efficacy" for solid tumors.
Pharma Times
DECEMBER 14, 2021
Nivolumab plus ipilmumab has been accepted as a treatment option for adult patients by NHS Scotland for patients who have previously failed fluoropyrimidine-based chemotherapy.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
NY Times
DECEMBER 14, 2021
Vuity, a once-a-day treatment that can help users see up close without affecting their long-range vision, went on the market Thursday after being approved by the F.D.A. in October.
Bio Pharma Dive
DECEMBER 14, 2021
The insurers filed suit against Gilead, J&J, Bristol Myers Squibb and Teva, claiming the drugmakers conspired to protect lucrative HIV drugs from competition.
Scienmag
DECEMBER 14, 2021
For the first time ever, scientists have been able to measure the speed of a bacterium that causes the incurable citrus greening disease. Citrus greening disease (also known as Huanglongbing) is the most devastating citrus disease in the world. Afflicted trees grow yellow leaves and low-quality fruit and eventually stop producing altogether, resulting in enormous […].
BioPharma Reporter
DECEMBER 14, 2021
Samsung Biologics will manufacture AstraZenecaâs COVID-19 long-lasting antibody combination (AZD7442) and cancer immunotherapy product from next year under an expanded partnership.
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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
DECEMBER 14, 2021
Gilead Sciences has taken a big step towards positioning its CAR-T therapy Yescarta as an option for previously-untreated large B cell lymphoma (LBCL) with updated results from the ZUMA-12 trial at the ASH congress this week. The phase 2 trial showed that 78% of high-risk LBCL patients treated first-line with Yescarta (axicabtagene ciloleucel) had a complete response to the treatment after a follow-up period of just under 16 months, with an overall response rate of 89%.
BioPharma Reporter
DECEMBER 14, 2021
Novartis has introduced its T-Charge platform at ASH 2021, which it says will serve as the foundation for various new investigational CAR-T cell therapies in its pipeline.
pharmaphorum
DECEMBER 14, 2021
Pfizer has found another use for the windfall profits it is making from it BioNTech-partnered COVID-19 vaccine, agreeing to buy Arena Pharma and its late-stage ulcerative colitis drug etrasimod. The $100-per-share deal values Arena at around $6.7 billion, and gives Pfizer an entry into the oral S1P receptor modulator category that puts it in contention with Bristol-Myers Squibb and its already approved rival Zeposia (ozanimod).
Pharma Times
DECEMBER 14, 2021
The public have been assured more sites, mobile units and pop-ups would be set up across the country to fulfill the vaccination pledge ahead of the original deadline of 31 January 2022.
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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.
Scienmag
DECEMBER 14, 2021
In November 2019, visitors to Joshua Tree National Park in California encountered a strange sight. Joshua trees and closely related Mojave yuccas, which normally remain reproductively dormant until late spring, were in full bloom at the tail end of autumn. Credit: Aubrey Diehl In November 2019, visitors to Joshua Tree National Park in California encountered […].
NY Times
DECEMBER 14, 2021
The company said the pill, Paxlovid, reduced the risk of hospitalization and death by 89 percent if given within three days of the onset of symptoms.
Scienmag
DECEMBER 14, 2021
Astronomers have made the most precise measurements yet of the motions of stars around the supermassive black hole at the center of the Milky Way. These results, obtained with the help of the Gemini North telescope, show that 99.9% of the mass contained at the very center of the galaxy is due to the black […].
BioPharma Reporter
DECEMBER 14, 2021
SGS, the Swiss-based testing, inspection and certification company, has acquired Quay Pharma, a UK based pharmaceutical industry targeted contract development and manufacturing organization (CDMO).
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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.
Scienmag
DECEMBER 14, 2021
Women’s Brain Health Initiative (WBHI), Canadian Institutes of Health Research (CIHR), and Brain Canada are pleased to announce that Dr. Mario Masellis has been selected to receive funding as part of the European Union Joint Programme on Neurodegenerative Disease Research (JPND)’s initiative on linking pre-diagnosis disturbances of physiological systems to neurodegenerative diseases.
Outsourcing Pharma
DECEMBER 14, 2021
The US agency continues to work with industry professionals on vaccines and treatments for the virus, and to wrestle with current and emerging variants.
Scienmag
DECEMBER 14, 2021
Ten thousand years ago, just after the last Ice Age, a group of hunter-gatherers buried an infant girl in an Italian cave. They entombed her with a rich selection of their treasured beads and pendants, and an eagle-owl talon, signaling their grief, and showing that even the youngest females were recognized as full persons in […].
pharmaphorum
DECEMBER 14, 2021
Novartis as opted out of a collaboration with Mesoblast to develop its stem cell-based therapy remestemcel-L as a treatment for COVID-19, prompting a slump in the biotech’s share price. Novartis agreed to pay $25 million upfront for opt-in rights to remestemcel-L just over a year ago and to make a $25 million equity stake in Mesoblast, with up to $1.25 billion in additional payments tied to regulatory and commercial objectives.
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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
DECEMBER 14, 2021
The number of microbial enzymes with the ability to degrade plastic is growing, in correlation with local levels of plastic pollution. That is the finding of a new study from Chalmers University of Technology, Sweden, that measured samples of environmental DNA from around the globe. The results illustrate the impact plastic pollution is having on […].
NY Times
DECEMBER 14, 2021
The treatment, called Paxlovid, is likely to work against Omicron and could be available in the United States before the end of the year.
Scienmag
DECEMBER 14, 2021
Many types of cancer exhibit changes in their cellular metabolism. These contribute to the development and progression of cancer. Metabolic reprogramming has, thus, been recognized as a hallmark of cancer and may thus represent a vulnerability to be exploited by targeted cancer therapy. Scientists from the research group of Giulio Superti-Furga, Scientific Director at the […].
pharmaphorum
DECEMBER 14, 2021
Embracing a “once-in-a-generation opportunity” to improve access to oncology treatments could save thousands of years of life across the European Union. Without “decisive action” cancer deaths across the European Union (EU) will increase by almost a quarter by 2035, making it the bloc’s leading cause of death. Expediating access to new treatments is key to avoiding this devastating outcome, according to a new publication from the European Federation of Pharmaceutical Industries and Associations
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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
DECEMBER 14, 2021
Cambridge, MASS. – A spacecraft launched by NASA has done what was once thought impossible. On April 28, the Parker Solar Probe successfully entered the corona of the Sun — an extreme environment that’s roughly 2 million degrees Fahrenheit. Credit: NASA/Johns Hopkins APL/Steve Gribben Cambridge, MASS. – A spacecraft launched by NASA has done what […].
pharmaphorum
DECEMBER 14, 2021
Data from a real-world study South Africa has indicated that the Omicron variant of COVID-19 is 29% less likely to cause hospitalisation among infected adults than other strains – although the researchers behind the work stress the findings are preliminary. The results – released by healthcare insurance group Discovery SA and the South African Medical Research Council – back up speculation among experts that Omicron may be less virulent than other variants even though it seems to have a frighten
Scienmag
DECEMBER 14, 2021
PITTSBURGH, Dec. 14, 2021 – Artificial intelligence (AI) models that evaluate medical images have potential to speed up and improve accuracy of cancer diagnoses, but they may also be vulnerable to cyberattacks. In a new study, University of Pittsburgh researchers simulated an attack that falsified mammogram images, fooling both an AI breast cancer diagnosis model […].
Outsourcing Pharma
DECEMBER 14, 2021
According to the company, the latest Phase II/III study results show its novel oral treatment candidate is effective in reducing hospitalizations and deaths.
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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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