Bio Pharma Dive
NOVEMBER 17, 2022
While the biotech will not develop the gene editing therapy further on its own, CEO Gilmore O’Neill claimed the data are still a meaningful demonstration of what CRISPR can accomplish.
Pharmaceutical Technology
NOVEMBER 17, 2022
The National Institute of Health and Care Excellence (NICE) has agreed to update its guidelines on endometriosis diagnosis, surgical management, and surgical management when fertility is a priority. The decision came following a surveillance review led by NICE, which identified sufficient new evidence to support this update. This marks the first update to NICE’s endometriosis guidelines since 2017, representing a huge milestone for patients and practitioners alike.
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Bio Pharma Dive
NOVEMBER 17, 2022
The new candidate is meant to provide broader immunity over a longer period of time and is part of the companies’ strategy to stay ahead of a shifting coronavirus threat.
AuroBlog - Aurous Healthcare Clinical Trials blog
NOVEMBER 17, 2022
One of the most consumed drugs in the US – and the most commonly taken analgesic worldwide – could do a lot more than simply take the edge off your headache. Acetaminophen, also known as paracetamol and sold widely under the brand names Tylenol and Panadol, also increases risk-taking, according to a study from 2020 […].
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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 17, 2022
Pablo Cagnoni was appointed CEO at the RNA drug startup Laronde days after departing Rubius, a once high flying biotech that’s now laid off nearly all its employees and is seeking a sale.
Pharmaceutical Technology
NOVEMBER 17, 2022
Horizon Therapeutics and Johns Hopkins University School of Medicine have entered a multi-year scientific partnership for advancing autoimmunity and inflammation research. The collaboration will work on identifying new disease targets and developing therapies to treat serious autoimmune and inflammatory conditions. Initially, it will focus on the emerging immunometabolism field, and additional projects are set to follow.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Pharmaceutical Technology
NOVEMBER 17, 2022
The UK National Institute for Health and Care Excellence (NICE) has issued final guidance recommending using Takeda ’s mobocertinib (Exkivity) to treat advanced lung cancer. Mobocertinib has been recommended to treat epidermal growth factor receptor (EGFR) exon 20 insertion gene mutation-positive advanced non-small-cell lung cancer (NSCLC) patients who have previously received platinum-based chemotherapy.
AuroBlog - Aurous Healthcare Clinical Trials blog
NOVEMBER 17, 2022
The Department of Pharmaceuticals (DoP) has issued a notification amending the Drugs (Prices Control) Order, 2013, in order to replace the previous version of National List of Essential Medicines (NLEM) with NLEM, 2022, which was launched in September, this year by the Union health minister Dr Mansukh Mandaviya. The Drugs (Prices Control) Amendment Order, 2022, […].
Bio Pharma Dive
NOVEMBER 17, 2022
Regeneron will pay CytomX $30 million to try to create bispecific antibody drugs that are safer and have a wider reach than existing treatments.
NPR Health - Shots
NOVEMBER 17, 2022
Some credit cards advertised by hospitals lure in patients with rosy promises of convenient, low-interest payments on big bills. But interest rates soar if you can't quickly pay off the loan.
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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
STAT News
NOVEMBER 17, 2022
Editas Medicine, one of the small handful of original CRISPR companies, announced Thursday it is halting development on its first clinical program after data showed only a small subset of patients were responding. Edit-101, an experimental CRISPR-based treatment for a rare eye disease called CEP290-meditated LCA10, led to “clinically meaningful” improvements in sight in only three out of 14 patients treated in the company’s Phase I study.
NPR Health - Shots
NOVEMBER 17, 2022
Nationally, infant mortality declined to a record low in 2020. But a 58% rise in Black infant mortality in Kansas sent birth experts searching for answers and solutions.
STAT News
NOVEMBER 17, 2022
The mystery started with some skin samples. Anura Rambukkana was a Ph.D. student in Amsterdam, analyzing biopsies from migrants with Hansen’s disease, or leprosy. The illness could be painful and disfiguring, but in the lab, the infected cells didn’t look sickly. To Rambukkana’s eye, they seemed to be doing great. He noticed the same thing with nerve cells from mice.
Medical Xpress
NOVEMBER 17, 2022
BRCA1 (BReast CAncer Gene 1), a key gene that becomes faulty in some instances, leading to breast and ovarian cancer, plays an important role in the body's DNA repair mechanisms. BRCA1, once mutated, can cause cancer to develop. According to the Center for Familial Breast and Ovarian Cancer at the Vienna General Hospital, it is believed that if the BRCA1 or BRCA2 gene is mutated, the likelihood of developing breast and ovarian cancer increases to 85% and 53% respectively.
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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 17, 2022
Polio, a dangerous and even deadly infectious disease, is a distant memory for many global citizens. We have never known life without it. Despite growing up in two countries — Pakistan (Z.B.) and Cameroon (R.L.) — separated by 7,000 kilometers, we both know what it is like to live and work in communities plagued by polio. As a physician, one of us (Z.B.) has sat beside countless parents as they come to terms with the life-long disability, and sometimes even death, of their child.
BioSpace
NOVEMBER 17, 2022
Therapeutics to halt the progression of chronic kidney disease are in Phase III trials, and others will enter that stage soon. NDAs could follow as early as 2024 with regulatory determinations in 2025.
pharmaphorum
NOVEMBER 17, 2022
As medical treatments become more complex, the role of the Medical Science Liaison (MSL) has never been more important. Healthcare professionals trust MSLs to keep them informed and up-to-date about the latest treatments, especially in fast-moving areas like oncology. But who keeps the MSLs up-to-date, and who makes sure they have the hard and soft skills necessary to be an effective partner for healthcare professionals?
Medical Xpress
NOVEMBER 17, 2022
Patients with a type of breast cancer called HER2-positive are less likely to survive if their initial treatment fails to eradicate the tumor completely and they have high levels of immune cells called tumor infiltrating lymphocytes in the residual disease.
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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.
NPR Health - Shots
NOVEMBER 17, 2022
The tournament will make an exception to its strict all-white clothing rules, after female players described altering their menstrual cycles to not stress about leaking onto their tennis whites.
Medical Xpress
NOVEMBER 17, 2022
Autism spectrum disorder (ASD) refers to a group of disabilities due to atypical brain development. Individuals with ASD have difficulties in social communication and interaction. Diverse causes of ASD are hypothesized, but most of them remain to be understood. A vast research effort has thus been invested to develop appropriate animal models to study the causes.
NPR Health - Shots
NOVEMBER 17, 2022
In Chad, one of the continent's poorest countries, rising food and fuel prices — and drought — have left many hungry and unable to afford the limited food that is for sale.
Medical Xpress
NOVEMBER 17, 2022
Radiotherapy after breast-conserving surgery in conjunction with chemotherapy or tamoxifen to treat early breast cancer reduces the risk of the disease returning in the same breast in the next ten years, but makes little difference to that risk thereafter, nor does it improve overall survival after 30 years.
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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.
Fierce Pharma
NOVEMBER 17, 2022
Nothing to sneeze at: AstraZeneca donates thousands of nasal spray flu vaccines after Swiss pricing row. fkansteiner. Thu, 11/17/2022 - 13:27.
BioSpace
NOVEMBER 17, 2022
???????The FDA has approved Provention’s BLA for intravenous antibody TZIELD to delay stage 3 type 1 diabetes, making it the first disease-modifying drug indicated to slow disease progression.
STAT News
NOVEMBER 17, 2022
NUTLEY, N.J. — A once-in-a-generation medicine was built on more than two decades of regret. In 1997, Eisai launched Aricept, a revolutionary treatment for the symptoms of Alzheimer’s disease, invented and developed by the company’s scientists in Japan. The arrival of the drug was a galvanizing moment for Eisai — a blockbuster product for a company on the rise and the first of what was expected to be a string of medicines to slow or even reverse the effects of the dis
pharmaphorum
NOVEMBER 17, 2022
In this mini episode of the pharmaphorum podcast, web editor Nicole Raleigh spoke with Sylvana Sinha, founder, chair, and CEO of Praava Health, Bangladesh’s fastest growing healthcare brand. Praava Health is a patient-driven company disrupting the standard of healthcare for Bangladesh’s 170 million citizens. No mean feat. Having heard Sylvana speak with other panellists at Frontiers Health 2022 in Milan, during the Tony Estrella-moderated discussion ‘Beyond video visits: How advanced telehealth
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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.
Antidote
NOVEMBER 17, 2022
While the holiday season can be a time filled with joy and cheer, for many, these are not the only emotions associated with this time of year. In fact, a 2021 survey found that 3 in 5 Americans feel that their mental health is negatively impacted by the holidays.
pharmaphorum
NOVEMBER 17, 2022
Rising payment percentages under the Voluntary Scheme for Branded Medicines Pricing and Access (VPAS) have been criticised despite (some in) the industry knowing that payment percentages in the range of 30% were not only possible, but predicted. Leela Barham argues that more transparency at a minimum is required next time around, should a VPAS style of agreement be agreed upon for 2024 onwards, and perhaps even a more radical re-think about how a deal is struck in the future.
Medical Xpress
NOVEMBER 17, 2022
Researchers in the Brain Bridge Lab at UChicago have found that personal moments captured via social media allowed them to map out a multidimensional topography of memory—and it could open up new venues for exploring memory.
pharmaphorum
NOVEMBER 17, 2022
At Frontiers Health 2022, pharmaphorum Editor in Chief Jonah Comstock speaks with Sai Shankar and Pierre Leurent, co-presidents of Aptar Digital Health. They discuss their new partnership with Chiesi around disease management for asthma and COPD that was announced at Frontiers Health. Jonah also checks in with Pierre about how the Aptar Pharma – Voluntis acquisition is going one year in and discusses the emergence of the Aptar Digital Health unit that came out of that deal.
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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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