Bio Pharma Dive
JANUARY 23, 2023
This year could stay turbulent for the biotech sector as investors look for what the Roivant CEO described in an interview with BioPharma Dive as “safe harbors in a storm.
Pharmaceutical Technology
JANUARY 23, 2023
Systemic lupus erythematosus (SLE) is a systemic, inflammatory, chronic autoimmune disease that can affect multiple organs simultaneously or sequentially, with a relapsing and remitting nature. While SLE can affect multiple major organ systems in the body, one of its most severe manifestations is renal (kidney) involvement, known as lupus nephritis (LN).
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Bio Pharma Dive
JANUARY 23, 2023
A high dose of the company’s experimental medicine appeared potent in patients with idiopathic pulmonary fibrosis, an elusive target for drugmakers. The results are from a small and short clinical trial, however.
AuroBlog - Aurous Healthcare Clinical Trials blog
JANUARY 23, 2023
Six minutes of high-intensity exercise is enough to produce a key protein in the brain, one that’s important in brain formation, function, and memory, and which has been implicated in the progress of neurodegenerative disorders such as Alzheimer’s disease.
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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
JANUARY 23, 2023
Agency scientists are proposing to update COVID shots once a year to match circulating coronavirus strains, as well as simplifying current vaccination regimens.
Pharma Mirror
JANUARY 23, 2023
The White House Office of Science & Technology Policy (OSTP) convened a listening session January 11. This webinar focused on the need for a coordinated clinical trials enterprise, one that can quickly characterize emerging viral threats and evaluate the effectiveness of vaccines, therapeutics, and other countermeasures across a diversity of trial participants.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Pharmaceutical Technology
JANUARY 23, 2023
In recent years, with the advent of biologics and novel therapeutic targets such as anti-TNF, anti-interleukin, and anti-integrin, there has been a steady increase in the number of agents approved to treat inflammatory bowel diseases (IBD), which has provided physicians with an increasing number of options to treat Crohn’s disease (CD). However, this progress is not reflected with respect to approved treatments for paediatric IBD patients.
Bio Pharma Dive
JANUARY 23, 2023
The deal is the second big licensing deal Takeda has signed in as many months and gives the company rights to a drug Hutchmed began submitting to U.S. regulators in December.
AuroBlog - Aurous Healthcare Clinical Trials blog
JANUARY 23, 2023
Indian medical experts stress on the need for USFDA advice to reduce the risk of transfusion-transmitted malaria. This is because the life-threatening infectious disease is a major health challenge not just in the country but many developing countries. Malaria is a life-threatening disease primarily found in tropical countries.
Bio Pharma Dive
JANUARY 23, 2023
A conversation with Teresa Nunes, chief medical officer of Allucent.
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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
Pharmaceutical Technology
JANUARY 23, 2023
Takeda has signed an exclusive licence agreement with HUTCHMED (China) and its subsidiary HUTCHMED to develop and market the latter’s fruquintinib. Under the deal terms, the company will have an exclusive global licence for the development and commercialisation of fruquintinib for all indications and territories outside of mainland China, Macau, and Hong Kong.
Medical Xpress
JANUARY 23, 2023
An anti-aging gene discovered in a population of centenarians has been shown to rewind the heart's biological age by 10 years. The breakthrough, published in Cardiovascular Research and led by scientists at the University of Bristol and the MultiMedica Group in Italy, offers a potential target for patients with heart failure.
Pharmaceutical Technology
JANUARY 23, 2023
Disc Medicine has entered an exclusive licence agreement with Mabwell Therapeutics for the latter’s new Anti-TMPRSS6 (Transmembrane Serine Protease 6, also known as Matriptase-2) monoclonal antibodies to modulate iron homeostasis. Under the deal terms, Disc Medicine will have exclusive rights to develop and market MWTX-003, as well as other new anti-TMPRSS6 monoclonal antibodies, discovered by Mabwell, in Europe, the US and other territories excluding China and some other territories in Southeas
STAT News
JANUARY 23, 2023
Scientists at the Food and Drug Administration propose making Covid vaccination a regular, once-a-year shot that is updated to match current strains of the SARS-CoV-2 virus, according to documents posted by the FDA on Monday. For people who are older or immunocompromised, the FDA would recommend two annual doses of the revised shot.
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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.
NPR Health - Shots
JANUARY 23, 2023
The new approach would simplify vaccination guidance so that, every fall, people would get a new shot, updated to try to match whatever variant is dominant.
STAT News
JANUARY 23, 2023
Hospitals have bemoaned rising employee expenses throughout the pandemic, as they’ve paid workers more to prevent them from jumping to competitors, pursuing traveling gigs, or leaving the profession completely. But some, like those in Texas, have been able to bring in traveling nurses and other temporary staff on the taxpayers’ dime.
BioPharma Reporter
JANUARY 23, 2023
Charles River Laboratories International, Inc and Rznomics Inc, a South Korea-based biopharmaceutical company specialized in the development of RNA-based gene therapeutics, have established a viral vector contract development and manufacturing organization (CDMO) partnership.
STAT News
JANUARY 23, 2023
SAN FRANCISCO — The team behind Rezo Therapeutics, a new biotech co-founded by a group of University of California, San Francisco, scientists and industry veterans George Scangos and Norbert Bischofberger, was weighing if, and how, to finally come out of stealth mode after nearly five years of work. It was September, and Rezo’s board was meeting for the first time after closing the company’s Series A round.
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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.
Medical Xpress
JANUARY 23, 2023
The amount of time spent in moderate and vigorous physical activity every day is linked to midlife brain power, indicates research published online in the Journal of Epidemiology & Community Health.
STAT News
JANUARY 23, 2023
In an unexpected move, the Food and Drug Administration will continue to apply exclusive marketing rights for so-called orphan drugs under its existing regulations, rather than take a broader approach suggested by a federal court in a highly controversial case involving one such medicine. Going forward, the agency will continue to grant seven years of marketing exclusivity for specific uses or indications for orphan drugs — the regulatory term for rare disease medicines — instead o
Medical Xpress
JANUARY 23, 2023
Researchers have developed a new tool and technique that uses "vortex ultrasound"—a sort of ultrasonic tornado—to break down blood clots in the brain. The new approach worked more quickly than existing techniques to eliminate clots formed in an in vitro model of cerebral venous sinus thrombosis (CVST).
STAT News
JANUARY 23, 2023
The mental health field is increasingly looking to chatbots to relieve escalating pressure on a limited pool of licensed therapists. But they’re entering uncharted ethical territory as they confront questions about how closely AI should be involved in such deeply sensitive support. Researchers and developers are in the very early stages of figuring out how to safely blend artificial intelligence-driven tools like ChatGPT, or even homegrown systems, with the natural empathy offered by huma
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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.
Drug Discovery World
JANUARY 23, 2023
Over the three days of Advanced Therapies Week (ATW) 2023 in Miami, Florida, US, from 18 to 20 January, DDW’s Megan Thomas heard from attendees about what they were most looking forward to learning from the event, as well as why they think the potential of cell and gene therapies outweighs the obstacles that must be overcome to achieve it. Matt Lakelin, co-founder of TrakCel, shared that although ATW took place last year, 2023 sees the first fully subscribed ATW since the coronavirus pandemic.
STAT News
JANUARY 23, 2023
Pliant Therapeutics said Sunday that an experimental pill significantly improved lung function in patients with idiopathic pulmonary fibrosis, or IPF, a deadly lung disease with few approved treatments. Sunday’s data add to positive results Pliant released in July from patients who received smaller doses of its drug, bexotegrast. Although the new data come from just a couple dozen patients, they suggest that the higher dose had a greater effect on patients’ lung function, while als
Medical Xpress
JANUARY 23, 2023
Taste cells are heavily exposed to the microbes in the mouth, but their role in helping the body respond to those microbes has not yet been studied in detail. A recent study from a team of researchers from the University of Nebraska–Lincoln and other institutions, however, has found that a subset of taste cells called type II taste cells may play a key role in the body's immune response to harmful oral microbes.
STAT News
JANUARY 23, 2023
At least on paper, businesses and institutions have achieved equality through thoughtful diversity, equity, and inclusion (DEI) policies that examine bias and end discrimination against women and people from underrepresented groups. In reality, though, little has changed to truly integrate women and people from underrepresented groups into the workplace.
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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
JANUARY 23, 2023
Insufficient and disturbed sleep during the teenage years may heighten the subsequent risk of multiple sclerosis (MS), suggests a case-control study published online in the Journal of Neurology Neurosurgery & Psychiatry.
STAT News
JANUARY 23, 2023
Grail spent more than $1 million last quarter lobbying Congress, underscoring the urgency of the company’s bid to secure Medicare coverage for its pricey blood-based cancer screening test that has been on the market for over a year but is not widely used. A recently posted lobbying report indicates that, during the fourth quarter of last year, the biotech spent $1.07 million on “issues related to oncology and multi-cancer early detection,” including House and Senate bills th
Medical Xpress
JANUARY 23, 2023
A Michigan Medicine study suggests that hospitals without the highest stroke care designation may be missing strokes that occur after a common heart valve replacement procedure.
Pharma Times
JANUARY 23, 2023
Treatment is a maintenance therapy for certain patients with acute myeloid leukaemia
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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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