7 best practices for assessing eCOA technology solutions
pharmaphorum
JULY 17, 2023
7 best practices for assessing eCOA technology solutions Mike.
Sat.Jul 15, 2023 - Fri.Jul 21, 2023
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Opinion: Who Really Pays for Drug Development? Both Government and Industry
BioSpace
JULY 16, 2023
Bringing new drugs to the market costs billions of dollars. It could not be done without investments by both the NIH and biopharma companies.
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Pfizer, Flagship join forces to hunt for 10 new drugs
Bio Pharma Dive
JULY 18, 2023
The unusual research alliance involves the startup creator’s Pioneering Medicines initiative, which previously struck pacts with Novo Nordisk and the Cystic Fibrosis Foundation.
Scribe and Sanofi expand genetic therapy development deal
Pharmaceutical Technology
JULY 18, 2023
Scribe Therapeutics and Sanofi have expanded partnership to progress the development of in vivo genetic therapies to treat genomic diseases.
From Diagnosis to Delivery: How AI is Revolutionizing the Patient Experience
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
Lilly Alzheimer’s drug slowed disease by roughly half a year, new results show
Bio Pharma Dive
JULY 17, 2023
New data presented Monday at a research conference support the case for Lilly’s donanemab, which works in a similar way as the two Alzheimer’s medicines recently approved in the U.S.
Novartis buys a preclinical biotech and its RNA drug technology
Bio Pharma Dive
JULY 17, 2023
For $500 million, Novartis will acquire DTx Pharma and its preclinical neurological disease drugs, marking the Swiss company’s latest investment in gene-silencing medicines.
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Apellis shares sink on reports of rare side effects with new vision loss drug
Bio Pharma Dive
JULY 17, 2023
An organization of retinal specialists flagged six cases of severe eye inflammation from commercial use of Syfovre. Apellis says the drug’s safety profile is consistent with testing.
SNIPR celebrates US court’s favourable ruling on CRISPR patent
Pharmaceutical Technology
JULY 17, 2023
The US Federal Court overturned a previous ruling in the patent infringement case against Rockefeller University.
Advent receives US NIH grant for bronchopulmonary dysplasia therapy
Pharmaceutical Technology
JULY 19, 2023
Advent Therapeutics has received a grant worth $3m from the US NIH for expediting the development of bronchopulmonary dysplasia therapy.
This Drug Might Offer Hope For Those With Difficult-to-Treat Depression
AuroBlog - Aurous Healthcare Clinical Trials blog
JULY 20, 2023
Ketamine might be better known as a recreational drug or anesthetic. But there’s growing evidence for its use for people with hard-to-treat depression. An Australasian study out today [July 14] showed some positive results for people with treatment-resistant depression when they had ketamine injections.
Cell therapy startup Turnstone adds to biotech IPO flurry with $80M raise
Bio Pharma Dive
JULY 21, 2023
The offering is a financial lifeline for Turnstone and the fourth for the sector this month, the first time that’s happened in nearly a year and a half, according to BioPharma Dive data.
July 19, 2023: IMPACt-LBP Study Team Will Share Early Lessons in This Friday’s PCT Grand Rounds
Rethinking Clinical Trials
JULY 19, 2023
From left: Dr. Christine Goertz and Dr. Adam Goode of the IMPACt-LBP Demonstration Project In this Friday’s PCT Grand Rounds, Dr. Christine Goertz and Dr. Adam Goode of Duke University will present “Implementing New Care Pathways for Low Back Pain in Academic Healthcare Systems: Early Lessons From IMPACt-LBP.” The Grand Rounds session will be held on Friday, July 21, 2023, at 1:00 pm eastern.
US DoD enlists VitriVax to develop one-shot vaccine for melioidosis
Pharmaceutical Technology
JULY 19, 2023
B. pseudomallei is resistant to many antibiotics and, without treatment, can be lethal to those infected.
WHO Declares Aspartame Possibly Carcinogenic. Here’s What It Means For Your Diet Soda
AuroBlog - Aurous Healthcare Clinical Trials blog
JULY 18, 2023
The International Agency for Research on Cancer (IARC), which is the specialized cancer agency of the World Health Organization, has declared aspartame may be a possible carcinogenic hazard to humans.
The New Age of Decentralized Clinical Trials
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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
Idorsia warns of up to 500 layoffs as part of cost-cutting initiative
Bio Pharma Dive
JULY 21, 2023
The Swiss drugmaker now joins a lengthy list of biotechs that, amid a drawn-out market downturn, have turned to job cuts and research re-evaluations to save money.
July 18, 2023: NIH Collaboratory Researchers Highlight Ethical Obligation, Value of Sharing Trial Results With Participants
Rethinking Clinical Trials
JULY 18, 2023
Dr. Lynn DeBar and Dr. Natalia Morone In an interview at the annual NIH Pragmatic Trials Collaboratory Steering Committee meeting, Dr. Lynn DeBar and Dr. Natalia Morone had a conversation about sharing trial results with participant partners. Both also participated in a discussion session about the challenges and value of results dissemination. DeBar is a principal investigator of the BackInAction and PPACT Demonstration Projects, and Morone is the principal investigator of the OPTIMUM Demonstra
Twist and Cancer Research Horizons sign antibody library platform deal
Pharmaceutical Technology
JULY 19, 2023
Twist Bioscience and CRUK innovation arm Cancer Research Horizons have signed an agreement for licensing a library of libraries.
The US Just Approved The First Over-The-Counter Daily Birth Control Pill
AuroBlog - Aurous Healthcare Clinical Trials blog
JULY 17, 2023
On July 13, 2023, the U.S. Food and Drug Administration approved a drugmaker’s application for the first daily over-the-counter birth control pill for people seeking to prevent pregnancy.
How Machine Learning Drives Clinical Trial Efficiency
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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.
Wilson Bryan, former FDA gene therapy leader, joins consulting firm
Bio Pharma Dive
JULY 19, 2023
The agency veteran, who led the Office of Tissues and Advanced Therapies during a boom in gene and cell therapy research, retired in March.
July 17, 2023: NIH Pragmatic Trials Collaboratory Welcomes First Class of Fellows
Rethinking Clinical Trials
JULY 17, 2023
From left: Dr. Stephanie Ibemere and Dr. Kaitlyn McLeod The NIH Pragmatic Trials Collaboratory is welcoming its first class of fellows in a new program for early-career investigators from underrepresented or minoritized groups with a scholarly interest in pragmatic clinical trials. “We are very excited to welcome the 2 inaugural fellows to the NIH Pragmatic Trials Collaboratory Fellowship Program and give them the education and tools that they need to launch their careers as pragmatic clin
China grants ruquintinib and sintilimab breakthrough therapy status
Pharmaceutical Technology
JULY 21, 2023
Hutchmed has secured breakthrough therapy designation from China’s NMPA for fruquintinib and sintilimab combination to treat EMC.
Alzheimer’s Can Strike as Young as 30. These Are The Signs to Watch For.
AuroBlog - Aurous Healthcare Clinical Trials blog
JULY 16, 2023
Alzheimer’s disease is often thought of as a condition that only affects the elderly. But around 3.9 million people worldwide aged 30-64 live with young-onset Alzheimer’s disease – a form of dementia in which symptoms appear before the age of 65.
What the FDA's New Dosage Guidance Means for the Future of Clinical Research
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.
The rise of the new pharma marketer in an evolving commercial model
Bio Pharma Dive
JULY 17, 2023
Meet the pharma marketer of the future, primed for personalization and powered by technology.
Cannabinoid company expands into oncology
Pharma Times
JULY 17, 2023
OCTP develops cannabinoid medicines and is looking at potential treatment of cancer malignancies - News - PharmaTimes
FDA expands Veklury’s use to Covid-19 patients with severe kidney disease
Pharmaceutical Technology
JULY 17, 2023
The move follows a positive decision made by the EMA earlier this year, broadening the use of Veklury to the high-risk patient group.
AI set to make tectonic shift in healthcare with accuracy in diagnostics and predictability of disease
AuroBlog - Aurous Healthcare Clinical Trials blog
JULY 18, 2023
Artificial intelligence (AI) is set to make tectonic shift in healthcare with accuracy in diagnostics and predictability of disease. On the occasion of the Artificial Intelligence Appreciation Day observed annually on July 16, 2023, with the theme as ‘trust, ethics, innovation and public good’, industry experts see a paradigm shift on the healthcare landscape.
A cancer biotech’s collapse gives Neurogene a path to Wall Street
Bio Pharma Dive
JULY 18, 2023
The startup, a developer of gene therapies for brain diseases like Rett Syndrome, will bypass an IPO by merging with struggling cancer drugmaker Neoleukin.
ADDF reflects on Eli Lilly’s donanemab
Pharma Times
JULY 18, 2023
Company’s phase 3 research showed the importance of running biomarker-powered clinical trials - News - PharmaTimes
EU prepares for the winter with plans to avoid an antibiotic shortage
Pharmaceutical Technology
JULY 18, 2023
The EC, the Heads of Medicines Agencies (HMA), and the EMA have issued recommendations to prevent shortages of antibiotics.
DGFT notifies curriculum for industry-led skilling to enhance available skilling opportunities
AuroBlog - Aurous Healthcare Clinical Trials blog
JULY 20, 2023
The Directorate General of Foreign Trade (DGFT) has notified a curriculum for the industry-led skilling and mentorship initiative towards equipping Status Holders as per Para 1.30 of Foreign Trade Policy (FTP) – 2023. This will further improve the pharma trade ecosystem by enhancing the available skilling opportunities.
The New Age of Decentralized Clinical Trials
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