Bio Pharma Dive
AUGUST 25, 2023
Neumora’s filing late Friday, along with that of radiopharmaceutical startup RayzeBio earlier this week, could be an important test of the biotech IPO market.
Pharmaceutical Technology
AUGUST 25, 2023
Soliris is already approved to treat refractory generalised myasthenia gravis in adults in different regions.
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AuroBlog - Aurous Healthcare Clinical Trials blog
AUGUST 22, 2023
The saying goes that money can’t buy you love. But can it buy you time? This is what US billionaire Bryan Johnson is hoping to find out. The 45-year-old reportedly spends millions each year in an attempt to reverse ageing and regain his 18-year-old body (presumably sans acne).
Rethinking Clinical Trials
AUGUST 22, 2023
In an article published this month in Clinical Trials , researchers from the NIH Pragmatic Trials Collaboratory’s Distributed Research Network share opportunities for conducting pragmatic trials embedded in health insurance plans. “There are unique opportunities related to the design and conduct of pragmatic trials embedded in health insurance plans, which have longitudinal data on member/patient demographics, dates of coverage, and reimbursed medical care, including prescription drug dispensing
Speaker: Simran Kaur, Co-founder & CEO at Tattva Health Inc.
AI is transforming clinical trials—accelerating drug discovery, optimizing patient recruitment, and improving data analysis. But its impact goes far beyond research. As AI-driven innovation reshapes the clinical trial process, it’s also influencing broader healthcare trends, from personalized medicine to patient outcomes. Join this new webinar featuring Simran Kaur for an insightful discussion on what all of this means for the future of healthcare!
Bio Pharma Dive
AUGUST 23, 2023
The company doesn’t know if the needles have caused retinal vasculitis in some people receiving its geographic atrophy drug Syfovre, but is no longer recommending their use.
Pharmaceutical Technology
AUGUST 25, 2023
The US Food and Drug Administration's recent accelerated approval of Pfizer's Elrexfio for the treatment of adult patients with relapsed or refractory multiple myeloma (RRMM) has made a significant impact in the oncology community.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Worldwide Clinical Trials
AUGUST 23, 2023
Patients are the backbone of clinical trials, playing an essential role in the drug development process. However, patients also play a vital role in engaging directly with the FDA. This engagement is often less understood and is underutilized by sponsors, meaning a significant element of the trial and drug experience is missed during sponsor engagement with the FDA.
Bio Pharma Dive
AUGUST 23, 2023
The job cuts are meant to preserve enough cash so the nearly three-decade-old company can potentially pursue its first drug approval next year.
Pharmaceutical Technology
AUGUST 24, 2023
Dizal has received approval from China’s NMPA for sunvozertinib to treat adult patients with locally advanced or metastatic NSCLC
AuroBlog - Aurous Healthcare Clinical Trials blog
AUGUST 20, 2023
Scientists have used advanced imaging techniques to identify brain activity and regions linked to cognitive motor dissociation (CMD), or ‘hidden consciousness‘ CMD is a state in which a person appears comatose and unresponsive while inwardly showing signs of conscious brain activity.
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
Rethinking Clinical Trials
AUGUST 23, 2023
In this Friday’s PCT Grand Rounds, Gabriela Schmajuk of the University of California, San Francisco, will present “Pragmatic Trial of an EHR Application to Display Real-Time PRO Data: Successes and Challenges.” The Grand Rounds session will be held on Friday, August 25, 2023, at 1:00 pm eastern. Schmajuk is a professor of medicine at UCSF and the chief of rheumatology at the San Francisco VA Health Care System.
Bio Pharma Dive
AUGUST 23, 2023
Data inadvertently published from a closely watched lung cancer study suggest a drug blocking the protein TIGIT may help extend survival, a finding that boosted shares of other developers.
Pharmaceutical Technology
AUGUST 23, 2023
Revive has begun the development of a next-generation formulation of Bucillamine to treat public health emergencies.
AuroBlog - Aurous Healthcare Clinical Trials blog
AUGUST 24, 2023
Mounting evidence suggests microplastics in our blood are likely capable of crossing our mammalian brain-blood barrier. Now preliminary experiments reveal the potential impact they can have once in there, finding weathered microplastics are far more toxic to human brain cells than fresh ones.
Pharma Times
AUGUST 24, 2023
The drug is the first to be approved in Japan to treat children and adolescents with& generalised myasthenia gravis - News - PharmaTimes
Bio Pharma Dive
AUGUST 24, 2023
Bristol Myers Squibb is among those backing the startup, which claims the manufacturing capacity at its New Jersey plant can surpass that of conventional CDMO facilities.
Pharmaceutical Technology
AUGUST 24, 2023
The newly-launched business, called Corvardis, is already targeting the Humira biosimilar landscape with Hyrimoz via a planned Sandoz-partnered launch in Q1 2024.
AuroBlog - Aurous Healthcare Clinical Trials blog
AUGUST 23, 2023
Our immune system is made up of multiple smart defenses built into our bodies – but if those defenses go haywire, it can lead to diseases such as multiple sclerosis (MS). Scientists may have found a new way to control potentially dangerous autoimmune responses.
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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
Pharma Times
AUGUST 25, 2023
The decision follows a recent recommendation from the European Medicines Agency’s human medicines committee - News - PharmaTimes
Bio Pharma Dive
AUGUST 25, 2023
According to one analyst, the approval was the last hurdle keeping Sandoz’s Tyruko from directly competing in the U.S. market against Biogen’s inflammation-regulating medicine Tysabri.
Pharmaceutical Technology
AUGUST 21, 2023
The US Food and Drug Administration (FDA) has granted approval to Regeneron Pharmaceuticals’ EYLEA HD injection 8 mg.
AuroBlog - Aurous Healthcare Clinical Trials blog
AUGUST 23, 2023
The Central drug regulator has issued alert on suspected falsified versions of Glucagon-like peptide 1 receptor agonist (GLP-1-RA) products, an anti-diabetes management drug, in the market. The alert follows the World Health Organisation (WHO)’s communication about a safety threat which has been identified with falsified versions of these products being available in the market.
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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.
Pharma Times
AUGUST 24, 2023
The drug is currently being assessed in a phase 1b/2a clinical trial - News - PharmaTimes
Bio Pharma Dive
AUGUST 21, 2023
The expanded approval follows the FDA’s May clearance of the shot, called Abrysvo, in older adults.
Pharmaceutical Technology
AUGUST 21, 2023
The EC approved Janssen's Type II variation application for reduced dosing frequency of bispecific antibody TECVAYLI for multiple myeloma.
AuroBlog - Aurous Healthcare Clinical Trials blog
AUGUST 21, 2023
In a move to strengthen the research and development (R&D) and innovation efforts of Indian pharma industry and academia, the Cabinet has approved the National Policy on Research & Development and Innovation in the Pharma-MedTech Sector and the Scheme for Promotion of Research and Innovation in Pharma-MedTech (PRIP).
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.
Pharma Times
AUGUST 22, 2023
Around 670 people in England with epidermolysis bullosa will benefit from the treatment - News - PharmaTimes
Bio Pharma Dive
AUGUST 21, 2023
By partnering with an accomplished CTDMO, gene therapy innovators can benefit from guidance and support.
Pharmaceutical Technology
AUGUST 24, 2023
Japan has granted a new drug substance patent for BioArctic’s monoclonal antibody (mAb), BAN0805, to treat Parkinson’s disease.
AuroBlog - Aurous Healthcare Clinical Trials blog
AUGUST 22, 2023
In order to ease out application experience, security and faster turnaround time, the National Accreditation Board for Hospitals and Healthcare Providers (NABH) has launched new online application portal for its Small Healthcare Organizations (SHCO) (maximum sanctioned bed strength of 50) Accreditation Programme.
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