Bio Pharma Dive
NOVEMBER 1, 2022
To some analysts, the recent acquisitions of Akouos and AGTC, as well as Astellas’ equity investment in Taysha, are a positive signal for an area of drug research that’s been “in investors' penalty box for much of 2022.
Pharmaceutical Technology
NOVEMBER 1, 2022
FEATURED COMPANIES COMMENDED : • Innovation • Product Launch • Safety VIEW PROFILE COMMENDED : • Business Expansion • Innovation • Investments VIEW PROFILE COMMENDED: • Social VIEW PROFILE. The Excellence Rankings celebrate the greatest achievements and innovations in the industry. The programme provides a platform to recognise the people and companies that are driving change.
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Bio Pharma Dive
NOVEMBER 1, 2022
Company executives highlighted the “viral nature” of demand for Mounjaro, which was approved in May for diabetes and has also shown a strong weight-loss benefit in clinical testing.
AuroBlog - Aurous Healthcare Clinical Trials blog
NOVEMBER 1, 2022
As drug companies have embarked on an initiative to launch affordable medicines for rare diseases in India, experts have called for using pharmacogenetics to develop treatments and whole genome sequencing to identify etiologies. “Although rare diseases have a huge impact when taken together, there is a significant gap between clinical interventions and basic research.
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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 1, 2022
The deal is the biggest by J&J since its $30 billion buyout of Actelion in 2017, and comes as the company works to split its consumer health business from its pharma and medtech units.
Pharmaceutical Technology
NOVEMBER 1, 2022
Intrinsic Medicine has signed a definitive business combination agreement with special purpose acquisition (SPAC) firm Phoenix Biotech Acquisition to create a public company. The merged business will use human milk biology for the treatment of Gut-Brain Axis (GBA) disorders. The merger reflects a $136m pre-money equity price and is anticipated to offer up to $178.8m in cash held in trust to Intrinsic. .
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Pharmaceutical Technology
NOVEMBER 1, 2022
The number one mechanism of action (MoA) for the Alzheimer’s disease (AD) pipeline is the inhibition of amyloid plaque formation. However, according to new research by the University of Cincinnati, amyloid plaques may not be the major cause of AD as previously thought—so are they the best target? AD is the leading cause of dementia, which is an umbrella term for a series of syndromes that can lead to memory loss, cognitive decay and behavioural change.
Bio Pharma Dive
NOVEMBER 1, 2022
The shot kept newborns from getting severe respiratory infections in a Phase 3 trial, paving the way for the drugmaker to seek approval before its top rivals.
Pharmaceutical Technology
NOVEMBER 1, 2022
FEATURED COMPANIES COMMENDED : • Innovation • Product Launch • Safety VIEW PROFILE COMMENDED : • Business Expansion • Innovation • Investments VIEW PROFILE COMMENDED: • Social VIEW PROFILE. The Excellence Rankings celebrate the greatest achievements and innovations in the industry. The programme provides a platform to recognise the people and companies that are driving change.
Rethinking Clinical Trials
NOVEMBER 1, 2022
The NIH Pragmatic Trials Collaboratory will offer a full-day preconference workshop at the 2023 Health Care Systems Research Network (HSCRN) Annual Conference in Denver, Colorado. This year’s conference theme is “Leveraging the Power of the Network in Rapidly Changing Times.”. The NIH Collaboratory workshop, “Changing Trials for Changing Times: Essentials of Embedded Pragmatic Clinical Trials,” will introduce concepts in the design, conduct, and implementation of pragmatic clinical t
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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
NOVEMBER 1, 2022
FEATURED COMPANIES COMMENDED : • Innovation • Product Launch • Safety VIEW PROFILE COMMENDED : • Business Expansion • Innovation • Investments VIEW PROFILE COMMENDED: • Social VIEW PROFILE. The Excellence Rankings celebrate the greatest achievements and innovations in the industry. The programme provides a platform to recognise the people and companies that are driving change.
AuroBlog - Aurous Healthcare Clinical Trials blog
NOVEMBER 1, 2022
“Zombie cells” that contribute to age-related diseases also help heal damaged tissues, so wiping them out could come with major downsides, a new study suggests. The zombies, scientifically known as “senescent” cells, are cells that stop multiplying due to damage or stress but don’t die, according to the National Institute on Aging.
Pharmaceutical Technology
NOVEMBER 1, 2022
The US Food and Drug Administration (FDA) has granted Fast Track designation for Dyne Therapeutics’ DYNE-251 to treat Duchenne muscular dystrophy (DMD) mutations amenable to exon 51 skipping. DYNE-251 comprises a phosphorodiamidate morpholino oligomer (PMO) conjugated to a fragment antibody (Fab) that attaches to the transferrin receptor 1 (TfR1) expressed highly on muscle.
Rethinking Clinical Trials
NOVEMBER 1, 2022
? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ?. Speakers. Emily O’Brien, PhD, FAHA. Associate Professor. Duke Clinical Research Institute. Duke University School of Medicine. Department of Population Health Sciences. Russell Rothman, MD, MPP. Senior Vice President, Population and Public Health. Director, Vanderbilt Institute for Medicine and Public Health.
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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.
Pharmaceutical Technology
NOVEMBER 1, 2022
FEATURED COMPANIES COMMENDED : • Innovation • Product Launch • Safety VIEW PROFILE COMMENDED : • Business Expansion • Innovation • Investments VIEW PROFILE COMMENDED: • Social VIEW PROFILE. The Excellence Rankings celebrate the greatest achievements and innovations in the industry. The programme provides a platform to recognise the people and companies that are driving change.
STAT News
NOVEMBER 1, 2022
A Food and Drug Administration advisory panel suggested Tuesday that the agency improve how it regulates pulse oximeters, calling for clearer labeling and more rigorous testing of the devices. The widely used instruments monitor blood oxygen levels and have been shown to work less well on patients with darker skin, possibly exacerbating health disparities in many racial and ethnic groups.
Pharmaceutical Technology
NOVEMBER 1, 2022
FEATURED COMPANIES COMMENDED : • Innovation • Product Launch • Safety VIEW PROFILE COMMENDED : • Business Expansion • Innovation • Investments VIEW PROFILE COMMENDED: • Social VIEW PROFILE. The Excellence Rankings celebrate the greatest achievements and innovations in the industry. The programme provides a platform to recognise the people and companies that are driving change.
STAT News
NOVEMBER 1, 2022
The pandemic is a prime case study of what can be accomplished when science delivers. The pharmaceutical and biotech industry harnessed new technologies, collaborated in new ways, and worked at an accelerated pace to help prevent infections with SARS-CoV-2, the virus that causes Covid-19, and treat those who got the disease. Applying these new ways of working will revolutionize the understanding and treatment of diseases with no available therapies.
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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 1, 2022
Researchers are launching a make-or-break study to test the conventional wisdom about what causes Alzheimer's disease.
BioSpace
NOVEMBER 1, 2022
The future of Editas Medicine’s EDIT-101 will be determined later in November after a data readout is available. The data could inform the company whether there is a potential commercial path forward.
NPR Health - Shots
NOVEMBER 1, 2022
NPR's Mary Louise Kelly talks with professor of medicine at Harvard Lisa Iezzoni about a new study that finds some doctors don't want patients with disabilities.
STAT News
NOVEMBER 1, 2022
The U.S. Supreme Court heard oral arguments on Monday in two cases that could eliminate race as a factor in university’s admissions processes. The precedent established in 2003, when the court ruled that race, along with other factors, could be given limited consideration in higher education admissions when necessary to achieve student body diversity, is now in jeopardy.
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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.
NPR Health - Shots
NOVEMBER 1, 2022
The Anopheles stephensi is a well-known malaria mosquito, but still sort of new in Ethiopia, where it has caused dramatic, out-of-season outbreaks in ill-equipped cities, new research shows.
STAT News
NOVEMBER 1, 2022
In the years since the onset of the Covid-19 pandemic, many health care professionals have turned to Twitter as a way to share news and advice about public health. But Elon Musk’s takeover of Twitter, which closed last week, is raising concerns that the self-described “ free speech absolutist ” could change the social-media platform in ways that promote, rather than curb, the spread of mis- and disinformation.
NPR Health - Shots
NOVEMBER 1, 2022
Activists are campaigning against clinics that offer care for transgender teenagers. Some families worry that will only fuel efforts to ban gender-affirming care in their state.
STAT News
NOVEMBER 1, 2022
Pulse oximeters, which measure oxygen levels in blood, are one of the most widely used medical tools. They are affordable, portable, and easy to use, but they have a major drawback: Numerous studies show they are less accurate for people with darker skin. Watch this video to understand the technology behind these devices and why they are less accurate in some patients.
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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.
BioSpace
NOVEMBER 1, 2022
J.P. Morgan launched its new life science-focused private equity team, Life Sciences Private Capital, to support early- and growth stage biotech companies.
STAT News
NOVEMBER 1, 2022
Pfizer’s maternal vaccine against the respiratory syncytial virus reduced the rate of severe illness in newborns by 81.8%, the company said Tuesday, meeting the goal of a pivotal study. The company said that it plans to file the data on the vaccine with regulators by the end of the year and that it expects an eight-month review.
BioSpace
NOVEMBER 1, 2022
Q1 is the time when many employers are actively recruiting new talent. Because it takes an average of 60 days to fill a job opening, Q4 might be the best time to apply for jobs in the life sciences.
STAT News
NOVEMBER 1, 2022
A Food and Drug Administration advisory committee Tuesday will take up the issue of whether pulse oximeters , the ubiquitous medical devices that became a mainstay for assessing patient oxygen levels during the Covid-19 pandemic, need to be regulated differently — or even completely reconceived — based on research showing the devices are less accurate in people with darker skin.
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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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