Bio Pharma Dive
JANUARY 25, 2023
The veteran investors see the marriage of tech and life sciences as the “largest opportunity in venture today,” said co-founder and former Lux Capital general partner Adam Goulburn.
Pharmaceutical Technology
JANUARY 23, 2023
Systemic lupus erythematosus (SLE) is a systemic, inflammatory, chronic autoimmune disease that can affect multiple organs simultaneously or sequentially, with a relapsing and remitting nature. While SLE can affect multiple major organ systems in the body, one of its most severe manifestations is renal (kidney) involvement, known as lupus nephritis (LN).
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STAT News
JANUARY 27, 2023
After weeks of deliberation, Pfizer was scolded by a U.K. pharmaceutical industry trade group after its chief executive officer made misleading statements in a media interview about the need to vaccinate young children against Covid-19. The fracas began when the Pfizer chief, Albert Bourla, gave an interview to the BBC and discussed the idea of vaccinating children between five and 11 years old, a course of action that had not yet been approved by regulators in the U.K.
Medical Xpress
JANUARY 23, 2023
An anti-aging gene discovered in a population of centenarians has been shown to rewind the heart's biological age by 10 years. The breakthrough, published in Cardiovascular Research and led by scientists at the University of Bristol and the MultiMedica Group in Italy, offers a potential target for patients with heart failure.
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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
JANUARY 23, 2023
This year could stay turbulent for the biotech sector as investors look for what the Roivant CEO described in an interview with BioPharma Dive as “safe harbors in a storm.
Pharmaceutical Technology
JANUARY 22, 2023
Eli Lilly and Company and Boehringer Ingelheim have announced that the US Food and Drug Administration (FDA) accepted a supplemental New Drug Application (sNDA) for Jardiance (empagliflozin) tablets for chronic kidney disease (CKD) in adult patients. Jardiance is currently being evaluated as a potential therapy for reducing kidney disease progression and cardiovascular death risk in CKD adult patients.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
NPR Health - Shots
JANUARY 22, 2023
An NPR/Ipsos poll finds that most Americans say Supreme Court justices are guided more by their politics than the law, and that lawmakers aren't deciding abortion policy based on public sentiment.
Bio Pharma Dive
JANUARY 23, 2023
A high dose of the company’s experimental medicine appeared potent in patients with idiopathic pulmonary fibrosis, an elusive target for drugmakers. The results are from a small and short clinical trial, however.
Pharmaceutical Technology
JANUARY 26, 2023
Health Canada has accepted for review Valeo Pharma partner Veru’s new drug submission (NDS-CV) for Covid-19 therapy sabizabulin. The new dual antiviral and anti-inflammatory agent Sabizabulin is being developed to treat hospitalised adult patients with moderate to severe Covid-19 who are at high acute respiratory distress syndrome (ARDS) and mortality risk.
STAT News
JANUARY 23, 2023
Scientists at the Food and Drug Administration propose making Covid vaccination a regular, once-a-year shot that is updated to match current strains of the SARS-CoV-2 virus, according to documents posted by the FDA on Monday. For people who are older or immunocompromised, the FDA would recommend two annual doses of the revised shot.
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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
Medical Xpress
JANUARY 22, 2023
Scientists have worked out why common anti-depressants cause around half of users to feel emotionally "blunted." In a study published today in Neuropsychopharmacology, they show that the drugs affect reinforcement learning, an important behavioral process that allows people to learn from their environment.
Bio Pharma Dive
JANUARY 24, 2023
The agency plans to convene a panel of experts on March 22 to discuss the approval application for tofersen, a closely watched medicine Biogen submitted to the FDA despite its failure in a key clinical trial.
NPR Health - Shots
JANUARY 23, 2023
The new approach would simplify vaccination guidance so that, every fall, people would get a new shot, updated to try to match whatever variant is dominant.
pharmaphorum
JANUARY 27, 2023
AstraZeneca’s revenue boost from COVID-19 therapy Evusheld looks set to be curbed early, as the FDA withdraws authorisation for the antibody on the grounds that it is ineffective against most subvariants now circulating in the US. Evusheld (tixagevimab and cilgavimab) was cleared by the FDA towards the end of 2021, becoming the first antibody to be authorised for prevention of COVID-19 infection, and it rapidly found use among people with compromised immune systems, such as cancer chemothe
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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.
STAT News
JANUARY 27, 2023
When institutions in the United States and other high-income countries embark on collaborations to improve health or the delivery of health care in low-income countries, they do it with the best of intentions. But intentions aren’t good enough. Projects conducted by trainees at schools of medicine, public health, and other health disciplines in high-income countries can often make the problems they set out to address worse.
Bio Pharma Dive
JANUARY 23, 2023
Agency scientists are proposing to update COVID shots once a year to match circulating coronavirus strains, as well as simplifying current vaccination regimens.
NPR Health - Shots
JANUARY 22, 2023
The overturning of the Roe v. Wade decision just months ahead of its 50th anniversary has prompted many abortion providers to shift how they serve patients. (Image credit: Rogelio V.
pharmaphorum
JANUARY 26, 2023
2022 was a banner year for genomics. In March, the collaborative T2T consortium published the first complete telomere-to-telomere sequence of the human genome, filling in the last 8% of the 3 billion base pairs that make up our DNA. And in the UK specifically, genomics remained high on the national agenda, with several significant government programmes and investments announced – including the Newborn Genomes Programme in healthcare and the Precision Breeding Bill in the agricultural sector.
Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist
What will the future hold for clinical research? A recent draft from the FDA provides valuable insight. In "Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases," the FDA notes that "targeted therapies demonstrate different dose-response relationships compared to cytotoxic chemotherapy, such that doses below the Maximum Tolerated Dose (MTD) may have similar efficacy to the MTD but with fewer toxicities.
Medical Xpress
JANUARY 26, 2023
New research from the Institute of Psychiatry, Psychology & Neuroscience (IoPPN) at King's College London has established a blood-based test that could be used to predict the risk of Alzheimer's disease up to 3.5 years before clinical diagnosis.
Bio Pharma Dive
JANUARY 27, 2023
The FDA gave the top-selling immunotherapy a broad label in adjuvant lung cancer despite mixed results in the main study supporting its application, taking one Wall Street analyst by surprise.
NPR Health - Shots
JANUARY 27, 2023
The defendants allegedly took part in a scam that sold more than 7,600 fraudulent nursing degree diplomas from three Florida-based nursing schools, according to recently unsealed federal indictments. (Image credit: D.A.
STAT News
JANUARY 26, 2023
WASHINGTON — The FDA is giving up on trying to figure out a way to regulate CBD on its own. The agency announced Thursday that it is formally calling on Congress for help — and, according to one official, looking for guidance on other hemp products like Delta 8 THC, too. For nearly four years, the Food and Drug Administration has been laboring to craft a solution that would allow CBD to be legally sold in capsules, gummy vitamins, and various foods, even though the agency also cons
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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
JANUARY 27, 2023
Researchers at the Francis Crick Institute and King's College London have created a tool to predict the effects of different diets on both cancerous cells and healthy cells.
Bio Pharma Dive
JANUARY 24, 2023
The drugmaker reported fourth quarter revenue that fell short of forecasts, but reiterated confidence in reaching a $60 billion pharmaceutical sales goal.
NPR Health - Shots
JANUARY 26, 2023
A new study finds that UV dryers for gel nail polish can damage DNA and mutate cells, confirming dermatologists' safety concerns. There are precautions you can take and alternatives to consider.
STAT News
JANUARY 23, 2023
Hospitals have bemoaned rising employee expenses throughout the pandemic, as they’ve paid workers more to prevent them from jumping to competitors, pursuing traveling gigs, or leaving the profession completely. But some, like those in Texas, have been able to bring in traveling nurses and other temporary staff on the taxpayers’ dime.
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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
JANUARY 26, 2023
Diet trends come and go, but intermittent fasting, a form of dieting based around periods of non-eating followed by periods of concentrated eating, has somehow endured.
Bio Pharma Dive
JANUARY 25, 2023
The former Biogen head is retiring after taking Vir from a small startup to a publicly traded developer of infectious disease drugs. Bayer executive Marianne De Backer will succeed him.
NPR Health - Shots
JANUARY 25, 2023
The days might seem long, but the years go by quickly, friends warned when my son was born. I wanted to savor each precious memory, but how? Living on "toddler time," showed me the way.
STAT News
JANUARY 26, 2023
A loophole in prescription drug regulation exposes American consumers to false and misleading claims of drug ads via on-line businesses promoting potent drugs without accurate information about their risks and benefits. Many countries prohibit direct-to-consumer advertising of prescription drugs. The United States allows it, but only if pharmaceutical companies comply with standards for accuracy and balance established and enforced by the Food and Drug Administration.
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Clinical research has entered a new era, one that requires real-time analytics and visualization to allow trial leaders to work collaboratively and to develop, at the click of a mouse, deep insights that enable proactive study management. Learn how Revvity Signals helps drug developers deliver clinical trial data insights in real-time using a fast and flexible data and analytics platform to empower data-driven decision-making.
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