Bio Pharma Dive
NOVEMBER 29, 2022
At a medical conference, the companies detailed clinical trial results that could help support approval of their drug, lecanemab. However, some doctors aren’t yet convinced the medicine’s risks are worth its potential benefits.
Pharmaceutical Technology
NOVEMBER 29, 2022
The National Health Service (NHS) in England, UK, has expedited the rollout of Bayer ’s new life-extending drug, darolutamide, to treat the most advanced kinds of prostate cancer that have spread to other body parts. With the latest development, NHS will become the first healthcare system in Europe to offer this drug to prostate cancer patients. Nearly 9,000 men with prostate cancer will be eligible to receive this treatment.
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Bio Pharma Dive
NOVEMBER 29, 2022
The British drugmaker will pay as much as $320 million to acquire Neogene Therapeutics, a developer of cell-based treatments for solid tumors — its first significant investment in the field.
Pharmaceutical Technology
NOVEMBER 29, 2022
AstraZeneca has signed an agreement for the acquisition of all outstanding equity of clinical-stage biotechnology firm Neogene Therapeutics in a deal totalling up to $320m. Neogene focuses on discovering, developing and producing next-generation T-cell receptor therapies (TCR-Ts) that provide a new cell therapy approach for fighting cancer. TCR-Ts can detect intracellular targets such as cancer-specific mutations to unlock targets which were not accessible earlier using cell therapies.
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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
NOVEMBER 29, 2022
Research into the cellular droplets has spawned at least five companies in recent years. But the closure of one of them, Faze Medicines, shows the significant obstacles they still face.
Pharmaceutical Technology
NOVEMBER 29, 2022
For several decades, researchers have been investigating the role of ketamine in treating depression. Now, efforts are underway to study ketamine’s effects in Parkinson’s disease, fibromyalgia, and Rett syndrome. On November 14, the Canadian developer PharmaTher announced positive data from a Phase I/II study where ketamine was used to treat levodopa-induced dyskinesia in Parkinson’s disease.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Pharmaceutical Technology
NOVEMBER 29, 2022
Full-Life Technologies has signed an agreement for the acquisition of US-based Focus-X Therapeutics to expand its peptide-focused radiopharmaceutical pipeline. Focus-X works on developing targeted radiopharmaceuticals based on peptide engineering technology for treating cancer. This takeover will bolster the pipeline of Full-Life, offer a second peptide-based discovery platform and utilise the Radio Technology manufacturing and logistics platforms of Focus-X to progress compounds into clinics.
Bio Pharma Dive
NOVEMBER 29, 2022
The pharma will no longer market the immunotherapy in the U.S. for urothelial carcinoma, the indication for which the drug was first approved six years ago.
Pharmaceutical Technology
NOVEMBER 29, 2022
Researchers at City of Hope in the US have developed a new potential therapy to treat glioblastoma multiforme (GBM), a kind of brain cancer. For this approach, the team leveraged an oncolytic herpes simplex virus for releasing chemokines, which are signalling proteins that aid in attracting immune cells to tumours. These viruses are engineered genetically for killing cancer.
Pharma Mirror
NOVEMBER 29, 2022
As AI technology advances, it is quickly finding its way into the world of healthcare. The rise of machine learning and chatbots in healthcare is moving away from the traditionally doctor-centric model and towards a more patient-centric and automated process built on trust and data. Healthcare is one of the few industries that’s heavily regulated.
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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
Rethinking Clinical Trials
NOVEMBER 29, 2022
Dr. Shruti Gohil. The NIH Pragmatic Trials Collaboratory is excited to welcome the INSPIRE Demonstration Project to its portfolio of innovative, large-scale pragmatic clinical trials embedded in healthcare systems. INSPIRE (or Intelligent Stewardship Prompts to Improve Real-Time Empiric Antibiotic Selection for Patients) will implement the INSPIRE-ASP Trials for Abdominal and Skin and Soft Tissue Infections.
NPR Health - Shots
NOVEMBER 29, 2022
Public health experts and social media researchers are concerned that the change could have serious consequences if it discourages vaccination and other efforts to combat the still-spreading virus.
STAT News
NOVEMBER 29, 2022
He Jiankui, the Chinese biophysicist who created the first gene-edited children , had been quiet since completing a three-year prison sentence in April, leaving many to wonder whether he had plans to return to scientific research. Earlier this month, we got his answer. On Nov. 9, He posted photos to Twitter of himself sitting at a computer in a white office.
NPR Health - Shots
NOVEMBER 29, 2022
The advent of vaping revived nicotine addiction among young people after a dramatic decline. The FDA seems poised to at last yank some products aimed at teens from the market. Will it work? (Image credit: Helen H.
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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.
STAT News
NOVEMBER 29, 2022
SAN FRANCISCO — A closely watched new treatment for Alzheimer’s disease held up to scrutiny in a detailed scientific presentation Tuesday, as its developers, partners Eisai and Biogen, begin the lengthy process of turning this medicine into what they hope could be a groundbreaking therapy. The drug, lecanemab, slowed the cognitive and functional decline of patients with early-stage Alzheimer’s by 27% relative to placebo in a roughly 2,000-volunteer clinical trial.
Medical Xpress
NOVEMBER 29, 2022
Two studies comparing injections commonly used to relieve the pain of knee osteoarthritis found that corticosteroid injections were associated with the progression of the disease. Results of both studies were presented today at the annual meeting of the Radiological Society of North America (RSNA).
STAT News
NOVEMBER 29, 2022
At its surface, it seems like a simple problem with a simple solution. Across the country, medicine cabinets are littered with unused, potentially addictive opioids. So the federal government wants to distribute prepaid envelopes alongside new painkiller prescriptions, allowing Americans to mail back their leftovers. But the seemingly innocuous proposal has generated opposition from a surprising source: the Community Anti-Drug Coalitions of America, a powerful nonprofit organization that has dom
BioPharma Reporter
NOVEMBER 29, 2022
BigHat Biosciences, a US biotech with a machine learning-guided antibody discovery and development platform, has announced a collaboration with Merck to apply its technology to design candidates for up to three drug discovery programs.
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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.
STAT News
NOVEMBER 29, 2022
Amgen, Janssen, and Sanofi are in talks to acquire Horizon Therapeutics, the Irish drugmaker confirmed Monday. Horizon confirmed the discussions following a report in the Wall Street Journal, adding that the conversations were “highly preliminary.
NPR Health - Shots
NOVEMBER 29, 2022
La información falsa dirigida a la comunidad latina está creciendo. Gran parte de ella está diseñada para impulsar a los votantes o desalentar a las mujeres embarazadas a buscar atención medica.
Medical Xpress
NOVEMBER 29, 2022
At the end of a bad day, how do you feel about yourself? The answer could indicate not only how your self-perception formed, but also how it renews, according to experimental results from a research group in Japan.
Pharma Times
NOVEMBER 29, 2022
Bill & Melinda Gates Foundation grant will boost potential of nanoparticle-formulated doggybone DNA
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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.
Medical Xpress
NOVEMBER 29, 2022
A new, single-dose, oral treatment for sleeping sickness is as effective as current treatments and could be a key factor in eliminating disease transmission by 2030, suggests a new study published in The Lancet Infectious Diseases.
STAT News
NOVEMBER 29, 2022
WASHINGTON — PhRMA has a reputation in Washington for might, for money, for scorched-earth tactics, and for fighting even the tiniest of policy changes. The pharmaceutical industry’s lobbying arm raised hell, for example, when lawmakers asked it to cover a slightly larger share of seniors’ drug costs. It spent years refusing to concede even minimal tweaks to an obscure bill related to generic competition.
Medical Xpress
NOVEMBER 29, 2022
COPD, or chronic obstructive pulmonary disease, is a leading cause of disability and death in the U.S., according to the American Lung Association. More than 12.5 million people have been diagnosed with COPD, but millions more may have the disease without knowing it.
STAT News
NOVEMBER 29, 2022
Hello, everyone, and how are you today? Gray skies are hovering over the Pharmalot campus this morning, but our spirits remain sunny. And why not? Once again, we are reminded of a favorite bit of wisdom from the Morning Mayor: “Every new day should be unwrapped like a precious gift.” So go ahead — tug on the ribbon, and join us for a delicious cup of stimulation.
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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.
Medical Xpress
NOVEMBER 29, 2022
Bowel ischemia is a potentially fatal medical condition caused by a decrease or obstruction of blood flow to the intestine. It is linked to many serious gastrointestinal disorders that can have long-term and deadly effects. Left untreated, it quickly progresses to irreversible intestinal necrosis that in turn leads to fatal metabolic disorders and end-organ dysfunction.
Drug Discovery World
NOVEMBER 29, 2022
England will become the first country in Europe to roll out darolutamide (Nubeqa) to patients whose prostate cancer has spread to other parts of the body. . The drug works by blocking androgen receptors in cancer cells, which in turn blocks the effect of testosterone that allows the cancer cells to survive and multiply. Studies show the chances of living longer are increased by one third in men who were previously left untreated. .
Medical Xpress
NOVEMBER 29, 2022
Alzheimer's disease can remain undetected until it is too late to treat. Large-scale screening programs could help to detect early-stage disease, but current diagnostic methods are too cumbersome and expensive. Now, a new study is the first to identify formic acid as a sensitive urinary biomarker that can reveal early-stage Alzheimer's disease, potentially paving the way for inexpensive and convenient disease screening.
XTalks
NOVEMBER 29, 2022
The American Cancer Society Cancer Action Network ( ACS CAN ) makes cancer a major priority for public officials and candidates at the local, state and federal levels. The goal of the ACS CAN is to “empower advocates across the country to make their voices heard and influence evidence-based public policy change as well as legislative and regulatory solutions that will reduce the cancer burden.”.
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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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