Bio Pharma Dive
FEBRUARY 16, 2023
The company’s platform technology is built on research from Zhang’s lab at the Broad Institute, which focuses on a proteins that could be used to package and deliver nucleic acids.
Pharmaceutical Technology
FEBRUARY 16, 2023
The University of Texas MD Anderson Cancer Center has entered a strategic collaboration with biotech company Xilis for advancing new technology and expediting new cancer therapy development. The preclinical research deal will combine the MicroOrganoSphere (MOS) platform of Xilis with the expertise of MD Anderson for advancing new therapies development and cancer research.
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Bio Pharma Dive
FEBRUARY 16, 2023
Following a patient death and difficulty enrolling study participants, the company is laying off a third of its staff and ending a pair of studies for a two-decade-old program once owned by Novartis.
AuroBlog - Aurous Healthcare Clinical Trials blog
FEBRUARY 16, 2023
When was the last time you walked into a public space and didn’t hear someone coughing? After three years of flinching at the sound, it can be disarming to hear so many people coughing – and embarrassing if it’s you. But take heart in knowing that you’re not alone.
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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 16, 2023
Stéphane Bancel will testify before the Senate’s HELP committee to defend the company’s pricing plans for its COVID-19 vaccine, which Sen. Sanders has described as “unacceptable corporate greed.
Pharmaceutical Technology
FEBRUARY 16, 2023
Aqilion and Merck have entered an exclusive licence and strategic research partnership for the discovery, development and commercialisation of the transforming growth factor-β-activated kinase 1 (TAK1) protein-small molecule inhibitors. Under the deal, Aqilion will receive $10.6m (€10m) in upfront cash payment from Merck and also eligible for up to $1,015m (€950m) in potential development and commercialisation milestone payments, along with tiered royalties on global net sales.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Pharmaceutical Technology
FEBRUARY 16, 2023
Ophthalmic technology firm Eyenovia and Formosa Pharmaceuticals have entered a collaboration agreement to develop new ophthalmic therapeutics. The collaboration will combine the Optejet dispensing technology of Eyenovia with the APNT nanoparticle formulation platform of Formosa to develop topical therapeutics. The Optejet microdose formulation and delivery platform use Microdose Array Print (MAP) technology for delivering 6ml-8ml of the drug.
NPR Health - Shots
FEBRUARY 16, 2023
Among the enacted changes, 16- and 17-year-olds will be allowed to undergo an abortion without parental consent. And workers suffering debilitating period pain can take paid time off.
Pharmaceutical Technology
FEBRUARY 16, 2023
On February 13, it was revealed that Novo Nordisk’s Wegovy (semaglutide) would be available in high-street pharmacies in the UK this spring. Wegovy is of great interest as it is the first therapy to be approved in the obesity space that is administered on a weekly basis, and shows superior efficacy to other currently marketed therapies in this space.
Medical Xpress
FEBRUARY 16, 2023
Whether we're night owls or morning larks, our body clocks are set by the sun. Theoretically, changing day length and light exposure over the course of the year could affect the duration and quality of our sleep. But figuring out how this applies in practice is difficult. Although studies where people assess their own sleep have suggested an increase in sleep duration during winter, objective measures are needed to determine how exactly the seasons affect sleep.
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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
FEBRUARY 16, 2023
We are born, we live, we age, we die. For millennia, this has been the natural order of human life. However, in the last 25 years, humanity has made massive strides in understanding, and importantly manipulating, the ageing process. The idea of ageing is now being challenged. Rather than viewing ageing as an inevitability, scientists are beginning to perceive it as a disease, one that could be treated, halted, or even reversed.
STAT News
FEBRUARY 16, 2023
Matt Fitzgerald used to bike up and down 3,500 feet through the Santa Ana Mountains on three-hour rides just for fun. Now, nine months after being infected with SARS-CoV-2, the virus that causes Covid-19, he can’t muster walking on flat surfaces for 20 minutes without days of exhaustion. “My long Covid life remains terrifying,” he told me.
Pharmaceutical Technology
FEBRUARY 16, 2023
The US Food and Drug Administration (FDA) has accepted the biologics licence application (BLA) for Shanghai Henlius Biotech ’s proposed biosimilar HLX02 (trastuzumab for injection). Accord BioPharma (Accord US), the business partner of Shanghai Henlius Biotech, has submitted the BLA. The application is seeking approval for the biosimilar to treat HER2-overexpressing metastatic breast cancer, and metastatic gastric or gastroesophageal junction adenocarcinoma.
STAT News
FEBRUARY 16, 2023
Akin Akinc was scouring his email spam box last summer, looking for a missing message, when he stumbled across an unexpected email from a quite recognizable name: Feng Zhang. Zhang, one of the leading scientists in the groundbreaking field of genetic editing, had reached out two days prior to discuss a new company he was working on. Since helping to discover CRISPR-Cas9 — often referred to as molecular scissors that can cut into the genome and edit DNA — Zhang has founded at least
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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
FEBRUARY 16, 2023
Eye-opening testimony from a top scientist offers a useful primer on the role social media may play in the teen mental health crisis. (Image credit: Tracy J.
Rethinking Clinical Trials
FEBRUARY 16, 2023
A workshop focused on responding to signals of mental and behavioral health risk in pragmatic trials; the ethics of data sharing; ethical and regulatory considerations in the design and conduct of pragmatic trials; pragmatic research involving patients with dementia; and the use of waivers and alterations of consent. In 2022-2023, NIH Collaboratory Grand Rounds held a special workshop series to examine ethical and regulatory challenges in pragmatic clinical trials.
Medical Xpress
FEBRUARY 16, 2023
US biotech company Moderna said Thursday it had mixed results from a large-scale trial of its mRNA flu shot, based on the same technology used in its successful Covid-19 vaccine.
Rethinking Clinical Trials
FEBRUARY 16, 2023
Speakers Pearl O’Rourke, MD (retired) Harvard Medical School David S. Wendler, PhD, MA Senior Researcher Head, Section on Research Ethics Department of Bioethics NIH Clinical Center Miguel Vazquez, MD Professor of Internal Medicine UT Southwestern Medical Center Michael Ho, MD, PhD Professor of Medicine University of Colorado School of Medicine Slides Keywords Ethics and Regulatory, Consent, Waiver of Consent,
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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
FEBRUARY 16, 2023
A University of Texas at Arlington bioengineer and his doctoral student have discovered how to identify which brain cells lead to epileptic episodes in children.
XTalks
FEBRUARY 16, 2023
It’s been a year since Indorsia Pharmaceuticals’ “Seize the Night and Day” insomnia awareness ad campaign featuring Jennifer Aniston first aired on TV, and the numbers are in. In 2022, Indorsia’s insomnia drug Quviviq (daridorexant) brought in a total of ₣6.5 million CHF (about $7 million USD). Though the drug — which was launched in the US in May 2022 and in parts of Europe in November — wasn’t the focus of the disease-awareness campaign, Indorsia was using the campaign to establish its reputat
Medical Xpress
FEBRUARY 16, 2023
Some 10% to 15% of people will have a substance abuse problem at some point in their life, making it one of the most common psychiatric disorders. Risks associated with substance abuse include dangerous driving, missed work, problems with depression, anxiety, health and money problems. Yet people with addictions seem to experience a sort of myopia, getting in deeper and deeper to cope with unpleasant emotions and to feel good, regardless of the cost.
NPR Health - Shots
FEBRUARY 16, 2023
Politicians are again pointing fingers over cutting Medicare. Any party accused of threatening the program tends to lose elections, but without a bipartisan agreement, seniors stand to lose the most.
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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
FEBRUARY 16, 2023
For someone previously infected with COVID-19, their risk of hospitalization or death is 88% lower for at least 10 months compared to those who had not been previously infected, according to a systematic review and meta-analysis published in The Lancet.
NPR Health - Shots
FEBRUARY 16, 2023
The state Supreme Court kept two state bans in place after Kentucky voters signaled support for abortion rights at the ballot box last November. (Image credit: Timothy D.
Medical Xpress
FEBRUARY 16, 2023
Many fears develop during childhood. And the scientific literature is quite clear: learning to fear through observation is common especially in children who take their parents as models and learn to fear a stimulus without being directly exposed to an aversive situation. For example, a child may be afraid of cats because he or she has seen his or her mother being bitten by a cat.
BioPharma Reporter
FEBRUARY 16, 2023
Bavarian Nordic will acquire two travel vaccines â typhoid fever vaccine Vivotif and cholera vaccine Vaxchora - alongside a Phase 3 Chikungunya vaccine candidate: as well as facilities in the US and Switzerland.
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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
FEBRUARY 16, 2023
Shawn Blymiller spent 10 years of feeling mostly numbed while prescribed traditional anti-depressants, trudging through his day-to-day life as a suburban Salt Lake City father of two kids balancing the obligations of family and work selling technology software.
STAT News
FEBRUARY 16, 2023
With hundreds of genes thought to be linked to obesity, the challenge is sifting through them all to determine which ones increase the risk of downstream complications like heart disease and diabetes. In a study published Thursday in Nature Genetics, researchers took the first steps in finding a potential candidate specifically in women.
Medical Xpress
FEBRUARY 16, 2023
Virginia Tech researchers studying brain development have identified a molecule that is critical in developing the stress response, a finding that sheds new light on the potential cause of mental health conditions such as stress, anxiety and related disorders.
STAT News
FEBRUARY 16, 2023
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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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