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.
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.
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.
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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.
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
Fighting AMR with a value and subscription model
Pharmaceutical Technology
JULY 17, 2023
The recent reintroduction of the Pasteur Act seeks to address the global threat that antimicrobial-resistant (AMR) infections pose, one subscription contract at a time.
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.
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.
Partnership could enhance antibody discovery for cancer research
Drug Discovery World
JULY 21, 2023
Cancer Research Horizons has signed a collaboration agreement to license the entire Twist Biopharma Solutions Library of Libraries. Under the terms of the agreement, Cancer Research Horizons will license Twist’s ‘Library of Libraries’, an collection of synthesised antibody libraries designed based on naturally occurring sequences that harness innovative structural and developability features to cover a wide range of antibody drug targets, for a period of five years.
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.
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.
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.
Westlake raises $450M in latest biotech venture fund
Bio Pharma Dive
JULY 17, 2023
Leaders from the firm said that, despite a turbulent biotech market, most of their existing limited partners returned to participate in the new fund, which will support approximately a dozen startups.
OncoHealth Expands Its Iris Platform for Digital Cancer Care
XTalks
JULY 21, 2023
OncoHealth, an Atlanta-based digital health firm, is on a mission to address the multifaceted challenges of cancer care that include physical, mental and financial factors. The company recently announced the expansion of its Iris platform, extending its comprehensive digital cancer care services to 240,000 fully insured commercial members of HealthPartners.
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.
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.
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.
Engaging Communities through High-Impact Healthcare Sponsorships in the Pharmaceutical Industry
Pharma Marketing Network
JULY 19, 2023
Sponsorships can be a powerful tool for pharmaceutical companies to engage with communities and make a positive impact on health and wellness. When done right, sponsorships can help pharmaceutical companies connect with their target audience, build relationships with key stakeholders, and promote their brand in a meaningful way. Here are some examples of how pharmaceutical companies can use sponsorships to engage communities: Sponsoring community health events: Pharmaceutical companies can s
Unlocking Excellence: How Catalent Is Transforming Japan’s Clinical Research
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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
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.
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.
Sanofi expands research deal with gene editing startup Scribe
Bio Pharma Dive
JULY 17, 2023
Scribe will receive $40 million upfront from Sanofi in a collaboration initially focused on developing an in vivo gene editing treatment for sickle cell disease.
New patent expiration for Genzyme drug MOZOBIL
Drug Patent Watch
JULY 21, 2023
Annual Drug Patent Expirations for MOZOBIL Mozobil is a drug marketed by Genzyme and is included in one NDA. It is available from two suppliers. There are two patents protecting… The post New patent expiration for Genzyme drug MOZOBIL appeared first on DrugPatentWatch - Make Better Decisions.
The New Age of Decentralized Clinical Trials
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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.
Controlling the pharma machine: EMA conveys thoughts on AI use in industry
Pharmaceutical Technology
JULY 21, 2023
While artificial intelligence (AI) in medical devices has regulatory boundaries, its use in a medicine’s life cycle is less clear.
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.
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.
Content Marketing as a Sales Driver: Unlocking Your Business Potential in the Pharmaceutical Industry
Pharma Marketing Network
JULY 19, 2023
Content Marketing as a Sales Driver: Unlocking Your Business Potential in the Pharmaceutical Industry Content marketing is a long-term strategy that can help businesses of all sizes generate leads, increase brand awareness, and drive sales. By creating and distributing valuable content, businesses can attract and engage their target audience, position themselves as experts in their field, and build trust with potential customers.
Deliver Fast, Flexible Clinical Trial Insights with Spotfire
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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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