Bio Pharma Dive
FEBRUARY 10, 2022
The agency criticized Eli Lilly for using a trial run in China to seek approval of an immunotherapy it licensed from Innovent Biologics. Outside advisers agreed in a decisive vote that could have repercussions for several other drugmakers.
World of DTC Marketing
FEBRUARY 10, 2022
( Washington Post ) Obesity turned out to be a major risk factor for covid hospitalization and death, especially non-elderly. According to the CDC, it is linked to impaired immune function and decreased lung capacity; it can make ventilation more difficult. Once again, obesity indicates that it’s killing us. The United States might well have gotten through the pandemic at far lower cost, economic and human, without the decades-long obesity epidemic that preceded it.
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Bio Pharma Dive
FEBRUARY 10, 2022
Safety concerns, including the recent death of a patient in an early study, led the FDA to place a hold on the therapy and Pfizer to redesign its Phase 3 trial.
BioPharma Reporter
FEBRUARY 10, 2022
Having built up its mRNA expertise with its COVID-19 vaccine, Pfizer now sets out its strategy for the future. âGoing forward, we plan to continue to capitalize on the leadership we have built in both mRNA R&D and manufacturing.".
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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
FEBRUARY 10, 2022
The biotech is predicting sales of Tukysa, its new breast cancer drug, will remain flat or fall in 2022 as competition increases from AstraZeneca's rival medicine Enhertu.
pharmaphorum
FEBRUARY 10, 2022
With staff shortages and digital skill gaps being experienced across the spectrum of healthcare, from CROs and pharma to providers, the people-led sector is facing a personnel challenge that could threaten the potential of digital transformation. The healthcare ecosystem may be the natural beneficiary of recent advances in data collection and analysis, but that’s no use without the staff to develop and implement solutions.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
pharmaphorum
FEBRUARY 10, 2022
Amazon has passed another milestone in the rollout of its healthcare business, makings it telehealth service available nationwide in the US and adding another 20 cities to its in-person services. The online retail giant first started offering the Amazon Care service to some of its own employees in 2019, expanding it to all its US workforce in 2021 and offering it to other organisations, including recently the Hilton hotel chain.
Scienmag
FEBRUARY 10, 2022
BLOOMINGTON, Ind. — A research survey of more than 1,100 people in the United States found that when COVID-19 testing wasn’t available in their community, participants showed significantly greater intentions to engage in risky behavior, possibly leading to increased transmission of the virus. Credit: Indiana University Kelley School of Business BLOOMINGTON, Ind. — A research […].
pharmaphorum
FEBRUARY 10, 2022
The FDA has granted fast-track status to Bayer’s oral Factor Xia inhibitor asundexian, which is in phase 2 testing as an anticoagulant that could offer safety advantages over current drugs. Asundexian (also known as BAY2433334) will be given a speedy review by the US regulator as a secondary preventative treatment for people with ischaemic stroke, specifically those with non- cardioembolic risk factors like narrowed arteries.
Pharma Marketing Network
FEBRUARY 10, 2022
Experts from top life sciences companies discussed strategies for more effectively engaging oncologists at the Pharma Marketing Network’s 2022 Future Forecast on January 25 th. Here are the top three things to know about engaging oncologists in 2022: 1. Lead with clinical education. It’s no longer enough to build brand awareness, according to the panelists.
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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
XTalks
FEBRUARY 10, 2022
How do cryptocurrency and the Metaverse fit into the food industry? In this episode of the Xtalks Food Podcast, Sydney talks about the impact these digital realms have already had on the food industry and the potential heights they can reach. With a slew of cryptocurrencies named after foods and several food and beverage brands allowing customers to pay with crypto, other technologies like blockchain are allowing brands to push for transparency and safety.
pharmaphorum
FEBRUARY 10, 2022
In the latest episode of the pharmaphorum podcast, editor in chief Jonah Comstock speaks with Jennifer Goldsack, CEO of the Digital Medicine Society (DiMe). Tune in to hear about the year ahead in digital health and life sciences, as well as the need for partnership and collaboration more broadly between the pharma and tech worlds. Goldsack reports on what she heard in the virtual events surrounding JP Morgan this year, and then puts some of those insights into context out of her own experience.
Scienmag
FEBRUARY 10, 2022
BATON ROUGE, LOUISIANA – Calorie restriction improves metabolic and immune responses that help determine both how long a person lives and how many years of good health they enjoy, a new study shows. Credit: Pennington Biomedical Research Center BATON ROUGE, LOUISIANA – Calorie restriction improves metabolic and immune responses that help determine both how long […].
Pharma Times
FEBRUARY 10, 2022
Research demonstrates that people who live with peanut allergies face isolation and discrimination
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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
FEBRUARY 10, 2022
Sometimes, a gut feeling is literal. Nerves in the intestines help regulate the gut’s acidity, new research from the University of Oregon shows. That helps keep their bacterial communities in balance. “We found an unexpected connection between the nervous system of the intestine and the community of gut microbes,” says UO microbiologist Karen Guillemin.
NY Times
FEBRUARY 10, 2022
Pharmacists and technicians, who have played a critical role in administering Covid-19 tests and vaccines, say they are burned out nearly two years into the pandemic.
Scienmag
FEBRUARY 10, 2022
The strongest part of a tree lies not in its trunk or its sprawling roots, but in the walls of its microscopic cells. Credit: Image courtesy of A. John Hart, Abhinav Rao; edited by MIT News. The strongest part of a tree lies not in its trunk or its sprawling roots, but in the walls […].
Outsourcing Pharma
FEBRUARY 10, 2022
In the first of a two-part series, leaders from the CRO discuss how study data has progressed in recent years and how trial teams can keep up effectively.
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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
FEBRUARY 10, 2022
Planetary bodies observed for first time in habitable zone of dead star Credit: Credit: Mark A. Garlick / markgarlick.com. Planetary bodies observed for first time in habitable zone of dead star A ring of planetary debris studded with moon-sized structures has been observed orbiting close to a white dwarf star, hinting at a nearby planet […].
NY Times
FEBRUARY 10, 2022
The agency threw out previous recommended limits on doses but encouraged “nonopioid therapies” wherever possible.
Scienmag
FEBRUARY 10, 2022
Biochemists in Japan were surprised to discover that the molecule hemoglobin in the blood works not only as an oxygen carrier, but when the blood is spilled as a result of aggression, accident or predator attack, the molecule also acts as a chemosensory signal — a chemical stimulus picked up by the senses, namely smell […].
Pharma Times
FEBRUARY 10, 2022
Diurnal’s pioneering phase 2 study evaluates modified-release hydrocortisone for adrenal insufficiency
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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
FEBRUARY 10, 2022
A new study led by University of Liverpool reserchers has shown that the effects of pollutants can be transmitted over many generations in water fleas and may persist long enough to influence the evolutionary process. Credit: Dr Stewart Plaistow, University of Liverpool A new study led by University of Liverpool reserchers has shown that the effects of […].
Outsourcing Pharma
FEBRUARY 10, 2022
The pharmaceutical company, which uses thin-film freezing to develop inhalable therapies, has completed enrollment in the first phase for its drug candidate.
Scienmag
FEBRUARY 10, 2022
Niigata, Japan – Currently, the world’s energy demand mainly depends on fossil fuels being a limited resource. The consumption of fossil fuels leads to emission of carbon dioxide (CO2) that is one of the major greenhouse gases contributing to global warming and climate changes. We need to urgently establish sustainable energy societies based on renewable […].
BioPharma Reporter
FEBRUARY 10, 2022
CDMO Piramal Pharma Solutions will expand capabilities of its Antibody-Drug Conjugate (ADC) facility in Grangemouth, Scotland; and invest in new Active Pharmaceutical Ingredient (API) infrastructure at its Morpeth, England facility.
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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
FEBRUARY 10, 2022
A team of astronomers using the European Southern Observatory’s Very Large Telescope (ESO’s VLT) in Chile have found evidence of another planet orbiting Proxima Centauri, the closest star to our Solar System. This candidate planet is the third detected in the system and the lightest yet discovered orbiting this star. At just a quarter of […].
pharmaphorum
FEBRUARY 10, 2022
Japanese drugmaker Eisai has published comments filed with the US Centers for Medicare & Medicaid Services over its restrictive coverage proposal for beleaguered Alzheimer’s drug Aduhelm, saying it undermines well-established FDA processes. The letter to CMS’ director of coverage and analysis Tamara Syrek Jensen said the decision to impose a coverage with evidence development (CED) on Biogen-partnered Aduhelm (aducanumab) – effectively limiting use of the drug to approved clinica
Scienmag
FEBRUARY 10, 2022
New research published today in the Journal of Archaeological Science Reports reveals how archaeologists can determine when a pot was used by Romans as a portable toilet, known as a chamber pot. Credit: Roger Wilson New research published today in the Journal of Archaeological Science Reports reveals how archaeologists can determine when a pot was […].
NY Times
FEBRUARY 10, 2022
The panel debated whether overseas trials could be applied to a more diverse U.S. population. The decision may affect other Chinese drug trials, and spotlights the high cost of immunotherapy.
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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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