Pharmaceutical Technology
JANUARY 25, 2023
Clinical trials require precision and faultless execution for hypotheses to become therapies. For most of pharmaceutical history, this has made the potential benefits from outsourcing elements of these trials elusive. But that is changing; technological and cultural shifts mean decentralised research – where part or all of a clinical trial is conducted remotely – is on the rise.
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.
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AuroBlog - Aurous Healthcare Clinical Trials blog
JANUARY 25, 2023
Losing focus for a brief moment might actually help boost learning by giving our brains a quick reprieve from the task at hand. According to a new study, this could allow us to absorb information that might not be directly related to the task at hand, but could still be handy to know.
Pharma Mirror
JANUARY 23, 2023
The White House Office of Science & Technology Policy (OSTP) convened a listening session January 11. This webinar focused on the need for a coordinated clinical trials enterprise, one that can quickly characterize emerging viral threats and evaluate the effectiveness of vaccines, therapeutics, and other countermeasures across a diversity of trial participants.
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
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).
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.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
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.
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.
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.
AuroBlog - Aurous Healthcare Clinical Trials blog
JANUARY 23, 2023
Six minutes of high-intensity exercise is enough to produce a key protein in the brain, one that’s important in brain formation, function, and memory, and which has been implicated in the progress of neurodegenerative disorders such as Alzheimer’s disease.
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.
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.
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.
AuroBlog - Aurous Healthcare Clinical Trials blog
JANUARY 24, 2023
People asking for exercise advice are usually looking for a simple answer. Do this over that. Do this many of that thing, for this long. Get these gains. In reality, things are never that simple. That’s certainly true for the age-old question of how often one should change up one’s exercise routine.
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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 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.
Pharmaceutical Technology
JANUARY 27, 2023
The European Union (EU) has granted approval for Daiichi Sankyo and AstraZeneca ’s Enhertu (trastuzumab deruxtecan) as monotherapy to treat unresectable or metastatic HER2 low (IHC 1+ or IHC 2+/ISH-) breast cancer adult patients. Enhertu has been approved for patients who have previously received chemotherapy in the metastatic setting or who have seen disease recurrence during or in six months after adjuvant chemotherapy.
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.
AuroBlog - Aurous Healthcare Clinical Trials blog
JANUARY 26, 2023
The Indian Council of Medical Research (ICMR) has issued Guidelines for Umbilical Cord Blood Banking: Collection, Processing, Testing, Storage, Banking and Release for Clinical Application (2023).
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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.
Fierce Pharma
JANUARY 26, 2023
BMS settles lawsuit with two fired employees who refused COVID vaccines kdunleavy Thu, 01/26/2023 - 14:30
Pharmaceutical Technology
JANUARY 24, 2023
The US Food and Drug Administration (FDA) has granted clearance for Neurogene’s investigational new drug (IND) application for NGN-401 to treat Rett syndrome. The investigational adeno-associated virus (AAV) gene therapy candidate NGN-401 is claimed to be the first to deliver the full-length human MECP2 gene using the company’s Expression Attenuation via Construct Tuning (EXACT) gene regulation technology.
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.
AuroBlog - Aurous Healthcare Clinical Trials blog
JANUARY 22, 2023
The vacancies of teaching faculties in the two government ayurveda medical colleges in the state of Telangana still remain vacant despite pressures from association of ayurveda doctors and educational experts on the government wanting appointment of regular faculties.
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.
Fierce Pharma
JANUARY 25, 2023
Merck's Keytruda dealt another blow in prostate cancer but readies new challenge to AZ's Imfinzi aliu Wed, 01/25/2023 - 10:17
Pharmaceutical Technology
JANUARY 27, 2023
The UK National Institute for Health and Care Excellence (NICE) has issued final draft guidance recommending the use of Kite’s axicabtagene ciloleucel (yescarta) to treat aggressive forms of lymphoma. The chimeric antigen receptor T-cell (CAR-T) therapy axicabtagene ciloleucel has been recommended for relapsed or refractory diffuse large B-cell lymphoma (DLBCL) and primary mediastinal large B-cell lymphoma (PMBCL) in adult patients who have previously received two or more lines of systemic thera
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.
AuroBlog - Aurous Healthcare Clinical Trials blog
JANUARY 24, 2023
Exports of Ayush related products from the country have gone up around 53 per cent in five years from the financial year 2016-17 to 2020-21, according to the Ministry of Ayush.
STAT News
JANUARY 26, 2023
Fasten your seat belts, folks. We’re about to hit some turbulence. If you’re reading this, you’re interested in the discussion on the future of Covid-19 vaccination that’s going to take place today in a meeting of the Food and Drug Administration’s Vaccines and Related Biological Products Advisory Committee. We at STAT can’t predict the outcome, but we know enough to expect that this meeting will feature some heated debate.
Pharmaceutical Technology
JANUARY 23, 2023
In recent years, with the advent of biologics and novel therapeutic targets such as anti-TNF, anti-interleukin, and anti-integrin, there has been a steady increase in the number of agents approved to treat inflammatory bowel diseases (IBD), which has provided physicians with an increasing number of options to treat Crohn’s disease (CD). However, this progress is not reflected with respect to approved treatments for paediatric IBD patients.
Bio Pharma Dive
JANUARY 24, 2023
The company blamed a range of factors in its decision, including limited funding, slower-than-anticipated trial enrollment and “broader sector trends.
AuroBlog - Aurous Healthcare Clinical Trials blog
JANUARY 23, 2023
Indian medical experts stress on the need for USFDA advice to reduce the risk of transfusion-transmitted malaria. This is because the life-threatening infectious disease is a major health challenge not just in the country but many developing countries. Malaria is a life-threatening disease primarily found in tropical countries.
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