Bio Pharma Dive
MARCH 22, 2023
Armed with a $50 million Series A round, the startup is building off of research from a lab run by protein engineering pioneer Jim Wells.
Pharmaceutical Technology
MARCH 22, 2023
Healthcare providers are under pressure to address the growing issue of substance use disorders. Spurred on by factors such as the Covid-19 pandemic, geopolitical tensions, and a fluctuating macroeconomic environment, GlobalData forecasts that by 2028, total prevalent cases in the 16 major pharmaceutical markets (16MM*) for opioid addiction will surpass eight million; cases of alcohol addiction will reach 770 million; and cases of smoking cessation will surpass 360 million.
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Bio Pharma Dive
MARCH 22, 2023
The companies will collaborate to identify compounds that could treat insulin resistance by targeting shape-shifting cellular droplets known as biomolecular condensates.
Rethinking Clinical Trials
MARCH 22, 2023
In this Friday’s PCT Grand Rounds, Erin Holve, Russell Rothman, Schuyler Jones, and Neha Pagidipati will present “From Observational Studies to Pragmatic Clinical Trials: (Almost) A Decade of Research in PCORnet®.” The Grand Rounds session will be held on Friday, March 24, 2023, at 1:00 pm eastern. Holve is the chief research infrastructure officer for PCORI.
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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
MARCH 22, 2023
Stéphane Bancel said his company's planned price hike covers the higher costs of commercial sales. Sen. Bernie Sanders called it part of industry’s “unprecedented level of corporate greed.
AuroBlog - Aurous Healthcare Clinical Trials blog
MARCH 22, 2023
Drug regulatory experts have advocated for decriminalizing the existing drugs act without compromising on the drug quality and patient safety.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
STAT News
MARCH 22, 2023
The ongoing Marburg fever outbreak in Equatorial Guinea is significantly larger than has previously been acknowledged, according to new information released Wednesday by the World Health Organization, which warned there may be undetected chains of transmission of the deadly virus in the West African country. The update, the first in nearly a month, shows that the number of confirmed and probable cases has grown from nine to 29, with cases having been reported in three different provinces over a
Bio Pharma Dive
MARCH 22, 2023
The rebooted biotech plans to test whether blocking TYK2 in the brain could help treat neurological diseases, licensing a compound from China-based Hangzhou Highlightll Pharmaceutical.
NPR Health - Shots
MARCH 22, 2023
Infections from drug-resistant bacteria have caused death and illness in 68 patients across the U.S., the CDC says. The strain has been linked to recalled eyedrops like EzriCare Artificial Tears.
Bio Pharma Dive
MARCH 22, 2023
The agency, which is taking a closer look at the pharma industry, submitted a brief to federal court in a case it says could have “significant implications” for Parkinson’s patients.
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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
NPR Health - Shots
MARCH 22, 2023
Little is known about the mosquito species known as Culex lactator. But it belongs to a group of mosquitoes known to carry diseases and researchers are worried about what will happen.
Medical Xpress
MARCH 22, 2023
For mosquito-borne diseases such as dengue fever, the abundance of the insects in places where people gather has long served as the main barometer for infection risk. A new study, however, suggests that the number of "hidden" infections tied to a place, or cases of infected people who show no symptoms, is the key indicator for dengue risk.
NPR Health - Shots
MARCH 22, 2023
Mora Leeb was 9 months old when surgeons removed half her brain. Now 15, she plays soccer and tells jokes. Scientists say Mora is an extreme example of a process known as brain plasticity.
STAT News
MARCH 22, 2023
Five years ago, I donated my “spare” kidney at the Mayo Clinic to a woman I read about in the newspaper. Though living with only one kidney has risks, I was not particularly concerned about my own health. The clinic’s medical evaluation was extremely thorough, and I knew their highly conscientious selection committee would not approve me to be a living donor if they were even the slightest bit concerned the procedure would cause me long-term health problems.
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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.
Fierce Pharma
MARCH 22, 2023
AbbVie's blockbuster-to-be Parkinson's combo hits a wall as FDA questions delivery pump aliu Wed, 03/22/2023 - 11:17
STAT News
MARCH 22, 2023
An independent panel of advisors to the Food and Drug Administration on Wednesday concluded that a treatment developed by Biogen for a rare, genetic form of ALS should be approved, despite unanswered questions about its benefit to patients. By a 9-0 vote, the FDA advisory panel said the “totality of the evidence” was sufficient to support conditional approval of the Biogen drug, called tofersen.
Medical Xpress
MARCH 22, 2023
Despite nearly 60 years of research, there is still a lack of high-certainty evidence on the effectiveness and safety of commonly used painkillers (analgesics) for short bouts of low back pain, finds an analysis of the evidence published by The BMJ.
STAT News
MARCH 22, 2023
WASHINGTON — Moderna CEO Stéphane Bancel and Senate health committee Chair Bernie Sanders shook hands amicably before Wednesday’s hearing examining the company’s vaccine pricing strategy began. That’s about where the goodwill ended between the two.
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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
MARCH 22, 2023
A promising cancer drug that targets only cancer cells has been developed by researchers from the Norwegian University of Science and Technology (NTNU) and a university spin-off company, APIM Therapeutics.
STAT News
MARCH 22, 2023
CHICAGO — Abdullah Hassan Pratt is giving a tour of a sheep heart that sits, heavy and sodden, in his hand. Dressed all in black, with his Jordans and easy manner, Pratt doesn’t look all that different from his audience: dozens of teenagers from this city’s roughest and poorest neighborhoods. One student raises a tentative hand, utterly confused by how blood travels through the heart.
Medical Xpress
MARCH 22, 2023
Researchers from the Neuroscience Center at Children's Hospital of Philadelphia (CHOP) have developed a prediction model that determines which newborn babies are likely to experience seizures in the Neonatal Intensive Care Unit (NICU). This model could be incorporated into routine care to help the clinical team decide which babies will need electroencephalograms (EEGs) and which babies can be safely managed in the Neonatal Care Unit without monitoring through EEGs.
STAT News
MARCH 22, 2023
Biotech company 89bio said Wednesday that its experimental treatment improved liver scarring at more than three times the rate of placebo without worsening other symptoms of patients with the fatty liver disease known as NASH. The results met the main goal of a mid-stage clinical trial, with the potential for less frequent injections than a similar experimental treatment being developed by a competing drugmaker.
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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
MARCH 22, 2023
A new study, appearing today in the New England Journal of Medicine, shows that nursing homes that conducted staff surveillance testing more regularly during the COVID-19 pandemic experienced significantly lower rates of COVID infections and deaths among residents.
STAT News
MARCH 22, 2023
WASHINGTON — The Biden administration said Wednesday it will attempt to break up the network that runs the nation’s organ transplant system as part of a broader modernization effort. More people than ever are getting new organs, with a record 42,888 transplants last year — but that’s not nearly enough to meet the demand. More than 100,000 patients are on the national transplant list, thousands die waiting, and critics have long urged an overhaul to save more liv
Medical Xpress
MARCH 22, 2023
Statistically, people with low educational attainment and income who have epilepsy suffer more than others from the condition. Not only are they hospitalized with epilepsy more often than others, but they also have less access to specialized neurological care, a University of Gothenburg thesis shows.
STAT News
MARCH 22, 2023
Health policy circles have erupted in debate over a wonky administrative tool: the quality-adjusted life year ( QALY ) and similar metrics to value and price drugs and other health interventions. Rep. Cathy McMorris Rodgers (R-Wash.) has warned of the potential for these approaches to discriminate, arguing that “All lives are worth living. It’s unconscionable that a health care bureaucracy would so callously determine that someone’s life is worth less,” suggesting tha
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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
MARCH 22, 2023
Ending performance-related payments for NHS GPs in Scotland was associated with a decline in the quality of some aspects of care, compared with England where financial incentives have continued, finds a study published by The BMJ today.
STAT News
MARCH 22, 2023
A potential class-action lawsuit against troubled digital prescribing startup Cerebral raises crucial questions about whether online marketing methods violate legal and ethical standards — an issue with important implications for dozens of other telehealth companies doing largely the same thing , experts tell STAT. For years, Cerebral and other telehealth companies have used free tracking technologies known as “pixels” — provided by big technology companies like
Medical Xpress
MARCH 22, 2023
Low-income neighborhoods that were subject to federally sanctioned redlining beginning in the 1930s tend to host high concentrations of businesses that sell alcohol for either on- or off-premise consumption.
STAT News
MARCH 22, 2023
DALLAS — It took just three years, after the tool’s invention, for researchers to devise ways of using CRISPR-Cas9 gene editing to treat mice with Duchenne muscular dystrophy. Since those first 2015 papers, dozens more have been published and multiple startups have launched, spurred by the hope that CRISPR could outperform the gene therapy approaches now nearing approval.
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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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