Bio Pharma Dive
JANUARY 3, 2023
By the end of June, highly anticipated study results are expected in Alzheimer’s, obesity and Huntington’s disease, while a pair of high-priced acquisitions could be put to the test.
Pharmaceutical Technology
JANUARY 6, 2023
While the treatment options for multiple sclerosis (MS) patients are growing each year with the approval of new agents, all of the currently marketed treatments only slow the disease’s progression and sometimes carry risks of severe side effects, such as liver failure or the development of viral infections. However, new mechanisms of action (MoAs) are in constant development, with some of the more innovative ones utilizing cell-based therapies.
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NPR Health - Shots
JANUARY 6, 2023
An Alzheimer's drug that removes the substance amyloid from the brain has received a conditional approval from the FDA. A large study found the drug decreased the loss of thinking and memory by 27%.
STAT News
JANUARY 4, 2023
Continuing economic uncertainty and the threat of a recession are casting a pall over health tech in 2023 — a dramatic shift for an industry that enjoyed abundant funding in the pandemic’s early stages. Last quarter’s string of layoffs at companies like Ro, Noom and ThirtyMadison portend tight budgets and conservative contracts this year, with employers unsure about which digital offerings actually drive down health care costs for workers.
Speaker: Simran Kaur, Founder & CEO at Tattva Health Inc.
The healthcare landscape is being revolutionized by AI and cutting-edge digital technologies, reshaping how patients receive care and interact with providers. In this webinar led by Simran Kaur, we will explore how AI-driven solutions are enhancing patient communication, improving care quality, and empowering preventive and predictive medicine. You'll also learn how AI is streamlining healthcare processes, helping providers offer more efficient, personalized care and enabling faster, data-driven
Bio Pharma Dive
JANUARY 6, 2023
The agency’s approval comes months after a large clinical trial showed the drug, called Leqembi, could slow the disease’s progression. Yet experts have raised concerns about its safety.
Pharmaceutical Technology
JANUARY 4, 2023
The China National Medical Products Administration’s (NMPA) Center for Drug Evaluation (CDE) has granted clearance for Transcenta’s investigational new drug (IND) application for its TST003 to treat solid tumours. TST003 is a first-in-class Gremlin1 targeting humanised monoclonal antibody. It has demonstrated better single-agent activities in patient-derived xenograft tumour models of many difficult-to-treat solid tumours, including microsatellite stable colorectal cancer and castration-resistan
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Medical Xpress
JANUARY 2, 2023
Adults who stay well-hydrated appear to be healthier, develop fewer chronic conditions, such as heart and lung disease, and live longer than those who may not get sufficient fluids, according to a National Institutes of Health study published in eBioMedicine.     Using health data gathered from 11,255 adults over a 30-year period, researchers analyzed links between serum sodium levels—which go up when fluid intake goes down—and various indicators of health.
Bio Pharma Dive
JANUARY 4, 2023
The Lilly-owned subsidiary will pay $55 million to gain access to Capsida’s AAV gene therapy technology in a deal aimed at central nervous system disorders.
Pharmaceutical Technology
JANUARY 5, 2023
Capsida Biotherapeutics and Eli Lilly and Company ’s wholly owned subsidiary Prevail Therapeutics have announced a partnership for the development of non-invasive gene therapies for central nervous system (CNS) diseases. Under the multi-year strategic partnership, Prevail will detect and advance capsids, which are clinically translatable, along with its cargo to develop the transformative genetic medicines by using Capsida’s novel adeno-associated virus (AAV) engineering platform.
NPR Health - Shots
JANUARY 6, 2023
RSV and the flu appear to be receding in the U.S., but COVID is on the rise, new data suggests, driven by holiday gatherings and an even more transmissible omicron subvariant that has become dominant.
Medical Xpress
JANUARY 2, 2023
People with a condition known as dry eye disease are more likely than those with healthy eyes to suffer injuries to their corneas. Studying mice, researchers at Washington University School of Medicine in St. Louis have found that proteins made by stem cells that regenerate the cornea may be new targets for treating and preventing such injuries.
Bio Pharma Dive
JANUARY 6, 2023
The pharma set the average annual cost of it and Biogen’s newly approved medicine Leqembi to $26,500, below the cost of the companies’ earlier drug Aduhelm but above one estimate of cost effectiveness.
Pharmaceutical Technology
JANUARY 6, 2023
The US Food and Drug Administration (FDA) has accepted AstraZeneca ’s nirsevimab biologics licence application (BLA) for review to prevent respiratory syncytial virus (RSV) lower respiratory tract disease in children aged up to 24 months. Being jointly developed and commercialised by Sanofi and AstraZeneca, nirsevimab is a single-dose, long-acting antibody designed to provide RSV protection for newborns and infants.
STAT News
JANUARY 3, 2023
A diverse and inclusive workforce benefits science and research. But unless it includes people living with a disability — the largest minority group in the U.S. and around the world — research will never be fully representative and science will not reach its full potential. Although 27% of U.S. adults live with a disability, only 10% of science, engineering, and health doctorate holders, and less than 2% of researchers funded by the National Institutes of Health, report having a di
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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
JANUARY 4, 2023
Climate goals can feel distant. But climate change is a happening right now. Speed up the benefits for taking action, psychologists say, if you want leaders and others to pay attention and act.
Bio Pharma Dive
JANUARY 6, 2023
The Takeda-backed biotech revealed it’s raised $85 million in new funding alongside announcing the acquisition of gene editing startup Twelve Bio.
Pharma Times
JANUARY 4, 2023
AstraZeneca trial will study activity of AZD5156 which includes monoclonal antibody discovered by RQ Bio
pharmaphorum
JANUARY 6, 2023
Google and DeepMind have developed an artificial intelligence-powered chatbot tool called Med-PaLM designed to generate “safe and helpful answers” to questions posed by healthcare professionals and patients. The tool is an example of a large language model or LLM, which are designed to understand queries and generate text responses in plain language, drawing from large and complex datasets – in this case, medical research.
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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
JANUARY 5, 2023
More than a dozen countries have slapped fresh travel regulations on travellers from China, as the world's most populous nation faces a surge in COVID cases following its decision to relax strict virus restrictions.
Bio Pharma Dive
JANUARY 6, 2023
The cuts at Fate, Century Therapeutics and TCR2 Therapeutics signal a longer road in the companies’ plans to develop next-generation cell therapies for cancer.
STAT News
JANUARY 5, 2023
SAN DIEGO — Fate Therapeutics, a biotech upstart with big ambitions to use cell-based therapies to treat autoimmune diseases and cancer, is now planning to cut back on both jobs and experimental drugs after an early end to a deal with Janssen. The setback, announced Thursday, will cut the company’s size to 220 workers by the end of the first quarter of this year.
NPR Health - Shots
JANUARY 3, 2023
It involves the impact of a specific force to the chest at a specific moment in the cardiac cycle. One cardiologist told NPR that what happened to Hamlin was likely "a perfect storm of events.
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 6, 2023
Scientists from The University of Texas Health Science Center at San Antonio (UT Health San Antonio) today reported that an inflammatory trigger like one present during viral infections is elevated in Alzheimer's disease and progressive supranuclear palsy, a rare brain disorder.
Bio Pharma Dive
JANUARY 3, 2023
Analysts noted hundreds of wholesale price increases, including dozens by Pfizer. Many checked in around 5%, roughly in line with hikes taken in recent years.
Pharma Times
JANUARY 3, 2023
Company has reported booster details from a study of its inactivated COVID-19 candidate
NPR Health - Shots
JANUARY 3, 2023
There are many more drinking options this Dry January if you like the taste of alcoholic drinks but don't like the effects of alcohol.
Medical Xpress
JANUARY 2, 2023
Researchers at UCSF have developed a novel, potentially life-saving approach that may prevent antibodies from triggering immune rejection of engineered therapeutic and transplant cells.
Bio Pharma Dive
JANUARY 6, 2023
The gene therapy developer will receive $95 million from Bristol Myers Squibb, slightly less than it got in the recent sale of another priority review voucher.
Pharmaceutical Technology
JANUARY 6, 2023
Danish biotech company Adcendo has entered into a licence agreement with Duality Biologics on the next-generation antibody-drug conjugates (ADC) platform. Under the deal, the company will be granted a licence to Duality’s Duality Immune Toxin Antibody Conjugates (DITAC) linker/payload platform for its lead uPARAP-ADC mesenchymal cancers programme. The platform has been designed for producing ADCs with better safety profiles, payload delivery sustainably and release in tumours, and destroying ant
Rethinking Clinical Trials
JANUARY 4, 2023
In this Friday’s COVID-19 Grand Rounds, Dr. Carolyn Bramante and Dr. Thomas Murray of the University of Minnesota will present “Outpatient Treatment of COVID-19 With Metformin, Ivermectin, or Fluvoxamine: 10-Month Follow-up and Effects on Developing Long COVID.” The Grand Rounds session will be held on Friday, July 29, at 1:00 pm eastern. Join the online meeting.
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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.
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