Bio Pharma Dive
FEBRUARY 1, 2023
The agency is currently assessing applications filed by the two companies for what they hope will become the first vaccines against the virus in older adults.
Pharmaceutical Technology
FEBRUARY 1, 2023
Pfizer has reported a 30% operational growth in revenues to $100.3bn in full-year 2022 compared with $81.2bn reported last year. The revenues grew 2% operationally excluding Paxlovid and Comirnaty’s contributions. In the fourth quarter (Q4) of 2022, they increased 13% operationally to $24.3bn compared to $23.8bn in the same quarter last year. On an operational basis, the revenues rose by 5%, omitting contributions from Paxlovid and Comirnaty.
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Bio Pharma Dive
FEBRUARY 1, 2023
Termination of the branaplam program, according to Novartis, was due to an “overall assessment of the risk-benefit profile” observed in a mid-stage clinical trial that raised safety concerns last year.
AuroBlog - Aurous Healthcare Clinical Trials blog
FEBRUARY 1, 2023
A study of around 500,000 medical records has suggested that severe viral infections like encephalitis and pneumonia increase the risk of neurodegenerative diseases like Parkinson’s and Alzheimer’s. Researchers found 22 connections between viral infections and neurodegenerative conditions in the study of around 450,000 people.
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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 1, 2023
Evelo Biosciences, Quince Therapeutics and Inovio are the latest to pare down workforces in the face of clinical setbacks and depressed stock prices.
AuroBlog - Aurous Healthcare Clinical Trials blog
FEBRUARY 1, 2023
Indian pharma and clinical research organisations are working to explore the potential usage of ChatGPT in pharmacovigilance, the science of monitoring the safety of medications. ChatGPT is a chatbot launched by the US-based OpenAI in November 2022. This tool can be used across the pharmaceutical industry and its related service providers.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Rethinking Clinical Trials
FEBRUARY 1, 2023
In this Friday’s PCT Grand Rounds, Professor Luregn Schlapbach of the University Children’s Hospital Zurich will present “Pragmatic Trials for Children With Congenital Heart Disease: Insights From the NITRIC Trial.” The Grand Rounds session will be held on Friday, February 3, 2023, at 1:00 pm eastern. Schlapbach is head of intensive care and neonatology at the University Children’s Hospital Zurich and a researcher at the University of Queensland.
STAT News
FEBRUARY 1, 2023
A recent study and accompanying news story in the preeminent journal Nature provocatively concludes that disruptive innovation in science has dramatically and mysteriously declined 90% since 1945. The study has prompted a wave of news coverage and tweets decrying the apparent languishing of modern science. We feel that the authors make interesting observations on publishing trends, but their conclusions seem to be quite disconnected from the valuable and transformative innovations that benefit h
NPR Health - Shots
FEBRUARY 1, 2023
As the marketing of soda and fast food ramps up around the world, the companies involved forge partnerships to help the poor. The new book 'Junk Food Politics ' casts a critical eye at their efforts.
STAT News
FEBRUARY 1, 2023
Medicare Advantage insurers could face an average 2.3% cut to baseline payments in 2024, the Biden administration said Wednesday. If the proposal stands, it would be a net cut of more than $3 billion to the industry. The major reason behind the proposed pay cut: Medicare officials want to update data and coding systems that are used to explain the health conditions of an insurance company’s enrollees.
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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
FEBRUARY 1, 2023
Since the Supreme Court ended the constitutional right to an abortion, many Muslims Americans have been turning to their faith to try to figure out: What does Islam say about the issue?
STAT News
FEBRUARY 1, 2023
Not long after the artificial intelligence company OpenAI released its ChatGPT chatbot, the application went viral. Five days after its release, it had garnered 1 million users. Since then, it has been called world-changing , a tipping point for artificial intelligence, and the beginning of a new technological revolution. Like others, we began exploring potential medical applications for ChatGPT, which was trained on more than 570 gigabytes of online textual data, extracted from sources like boo
NPR Health - Shots
FEBRUARY 1, 2023
During the time that deaths from addiction and suicide among white Americans rose by about 9%, deaths among Native Americans shot up by about 30%, a new study shows.
STAT News
FEBRUARY 1, 2023
Medicare officials made a clear statement four years ago about how best to audit the country’s Medicare Advantage insurers: Failing to take back all overpayments “would be contrary to the public interest.” But based on a final regulation published Monday, Medicare is going against that public interest by giving a free pass to Medicare Advantage plans for any erroneous codes they submitted between 2011 and 2017.
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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.
Medical Xpress
FEBRUARY 1, 2023
For people of middle age or older with a tear in the meniscus, but without a history of acute knee trauma, surgery is rarely useful. Many studies have already shown that an arthroscopic surgery, in which a doctor treats a tear, is no better than physiotherapy or even a sham surgery, in which a doctor only makes incisions in the knee. Tears in the meniscus also often occur in people who have no complaints and are often not the cause of pain.
STAT News
FEBRUARY 1, 2023
The Federal Trade Commission on Wednesday accused GoodRx, the prescription drug discount platform, of sharing sensitive personal information about its users’ prescriptions and health conditions with big tech companies. GoodRx, which also runs a marketplace for telehealth services, agreed to pay a $1.5 million civil penalty for sharing users’ health data — like medication use or health conditions — with third parties including Facebook, Google, and Twilio for advertisi
Medical Xpress
FEBRUARY 1, 2023
Scientists from CSIRO, Australia's national science agency, in partnership with Queensland University of Technology, have used artificial intelligence to develop a world-first benchmark for measuring brain atrophy—or thinning—in neurodegenerative diseases, including Alzheimer's disease.
STAT News
FEBRUARY 1, 2023
Locked behind the firewalls of proprietary systems sits a treasure trove of data that could help diagnose heart disease, diabetes, cancer, and other conditions faster and more accurately and better treat people with them. But there it sits, largely untapped, because the electronic health record infrastructure was never designed to let organizations easily share data.
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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 1, 2023
Young blood has a rejuvenating effect when infused into older bodies, according to recent research: Aging hearts beat stronger, muscles become stronger, and thinking becomes sharper.
STAT News
FEBRUARY 1, 2023
The Food and Drug Administration is nearing a decision on the first treatment for geographic atrophy, a progressive eye disease and a leading cause of blindness in older people. Apellis Pharmaceuticals, the drug’s maker, has expressed public confidence in the data supporting approval. Investors are more divided. The agency has until Feb. 26 to issue a ruling on the Apellis drug, three months longer than originally anticipated.
Medical Xpress
FEBRUARY 1, 2023
Understanding one's susceptibility to developing post-traumatic stress disorder (PTSD) is important. If you knew you were at risk, for example, you might steer clear of jobs that carry more likelihood of high stress and potential trauma or seek treatment as soon as you experienced a potentially triggering event.
STAT News
FEBRUARY 1, 2023
On Wednesday, the Federal Trade Commission made history by enforcing, for the first time, its power to go after companies that don’t notify consumers about health data breaches. The agency said it will fine GoodRx $1.5 million for sharing its users’ private health information with data brokers and advertising platforms such as Facebook and Google.
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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 1, 2023
Racial discrimination was found to be a significant force behind higher levels of depression among college-educated Black Americans, finds a new study from the Brown School at Washington University in St. Louis.
STAT News
FEBRUARY 1, 2023
The former head of health care investing at private equity giant KKR has set records with the first fundraising for his new firm. The firm, Patient Square Capital, closed on $3.9 billion for its fund Wednesday. That makes it the largest inaugural fund for a new U.S.-based private equity firm. The previous record was set by Centerbridge Partners’ $3.2 billion fundraising in 2006, according to data from PitchBook.
Pfizer
FEBRUARY 1, 2023
Closing the Cancer Care Gap: World Cancer Day and Beyond kimkevin Wed, 02/01/2023 - 10:44 Closing the Cancer Care Gap: World Cancer Day and Beyond Friday, February 03, 2023 - 10:00am Share Every two seconds, someone in the world is diagnosed with cancer. 1 It’s a disease that knows no borders, doesn’t distinguish between race or religion, and pays no mind to whether a person is rich or poor.
XTalks
FEBRUARY 1, 2023
Researchers at the Institute of Psychiatry, Psychology & Neuroscience (IoPPN) at King’s College London have found that a blood test could aid in the early detection of Alzheimer’s disease up to three and a half years before diagnosis. The researchers found that factors in the blood can potentially predict the risk of developing the disease years before a clinical diagnosis is made.
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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 1, 2023
Potentially lifesaving steroids commonly given to preterm babies also increase the risk of long-term cardiovascular problems, but a new study in rats has found that if given in conjunction with statins, their positive effects remain while the potential negative side effects are "weeded out.
STAT News
FEBRUARY 1, 2023
A small Phase 2 trial of a new antidepressant may hold clues to the direction of Verily, the high-profile Alphabet health tech spinout that announced a new, more focused direction for its business after laying off employees last month. Part of the goal of the research will be to recruit patients more remotely, and also to gather more data in ways that don’t require patients to come into a doctor’s office unnecessarily.
Drug Discovery World
FEBRUARY 1, 2023
Investment in UK biotech has fallen from £4.5 billion in 2021 to just £1.8 billion in 2022, mirroring the global economic downturn impacting all sectors. However, venture capital investment in the sector was the third-best year recorded for the UK, with £1.2 billion raised, new analysis from the UK BioIndustry Association (BIA) and Clarivate shows.
STAT News
FEBRUARY 1, 2023
Top of the morning to you. The middle of the week is upon us and, since you made it this far, why not forge ahead? After all, there is always light at the end of the proverbial tunnel. You never know what you may accomplish. So please join us as we celebrate this notion with a cup or three of delicious stimulation. Our choice today is chocolate cappuccino.
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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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