Bio Pharma Dive
NOVEMBER 13, 2023
Regulatory agencies have set the framework and use cases for RWE. How can these increase the probability of success or efficiency in a pre-clinical and clinical drug development program?
Pharmaceutical Technology
NOVEMBER 13, 2023
As per the company, the candidate THIO, is the only direct telomere-targeting agent currently in clinical development.
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Bio Pharma Dive
NOVEMBER 13, 2023
Forge Biologics operates a contract manufacturing business as well as develops its own gene therapies, which appears to have attracted the Japan-based food and biotechnology company.
Pharmaceutical Technology
NOVEMBER 13, 2023
The UK government has announced £267m ($326.4m) funds for developing treatments for drug and alcohol misuse.
Bio Pharma Dive
NOVEMBER 13, 2023
Trial results add to evidence that so-called Factor XIa inhibitors could have less bleeding risk than currently available oral anticoagulants like Xarelto.
Pharmaceutical Technology
NOVEMBER 13, 2023
At the BIO-Europe conference, experts discussed remaining challenges in AI healthcare interventions.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Bio Pharma Dive
NOVEMBER 13, 2023
With the deal, the Swiss pharma is exploring a tumor target, DLL3, that’s thwarted past drugmaker efforts to attack it.
AuroBlog - Aurous Healthcare Clinical Trials blog
NOVEMBER 13, 2023
The Union Ministry of Ayush has come out with the revised guidelines governing the National Dhanwantari Ayurveda Award to be conferred to renowned ayurvedic practitioners, while celebrating the Ayurveda Day every year on the day of Dhanwantari Jayanti (Dhanteras).
Bio Pharma Dive
NOVEMBER 13, 2023
Shares in several heart device makers, which have been battered over the perceived impact of obesity medicines, rose this week following AHA data on Novo’s therapy.
Pharmaceutical Technology
NOVEMBER 13, 2023
On 8 November, Takeda announced it had received US Food and Drug Administration (FDA) approval for its oral Fruzaqla (fruquintinib) as a third-line treatment for adults with metastatic colorectal cancer (mCRC).
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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
Bio Pharma Dive
NOVEMBER 13, 2023
As biopharmaceutical organizations around the globe adjust to the new guidelines, Baroni shared insights on four things they need to know about Annex 1.
Pharmaceutical Technology
NOVEMBER 13, 2023
The EMA CHMP provided a positive opinion for granting approval to Merck’s Keytruda combination therapy to treat biliary tract cancer.
Bio Pharma Dive
NOVEMBER 13, 2023
Explore how decentralized clinical trials (DCTs) can enhance rare disease research in three key ways.
Pharmaceutical Technology
NOVEMBER 13, 2023
The UK government has seen a cabinet reshuffle as the Prime Minister removed Steve Barclay as UK health secretary and replaced him with Victoria Atkins.
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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
Rethinking Clinical Trials
NOVEMBER 13, 2023
The NIH Pragmatic Trials Collaboratory published a new chapter of its Living Textbook of Pragmatic Clinical Trials this week. The chapter, “ Ethics and Equity for Artificial Intelligence and Machine Learning in Pragmatic Clinical Trials ,” describes key considerations and challenges with leveraging artificial intelligence and machine learning in pragmatic clinical trials.
Pharmaceutical Technology
NOVEMBER 13, 2023
At the FT Global Pharma and Biotech Summit in London, various industry players shared their thoughts on technological and regulatory advancements.
Antidote
NOVEMBER 13, 2023
Each November is designated as Diabetes Awareness Month , an event that highlights the importance of spreading awareness about diabetes and the health issues it can cause.
Pharmaceutical Technology
NOVEMBER 13, 2023
Procaps studies show that by consuming Unigel® products, patients avoided the production and disposal of 27.5 million blister packs in 2022.
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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.
BioPharma Reporter
NOVEMBER 13, 2023
IO Biotech, a clinical-stage biopharma company developing therapeutic cancer vaccines, has completed enrollment in its phase 3 trial for IO102-IO103, in combination with KEYTRUDA (pembrolizumab), Merckâs anti-PD-1 therapy, in patients with advanced melanoma.
Pharmaceutical Technology
NOVEMBER 13, 2023
Mirati Therapeutics has obtained EMA CHMP's positive opinion for Krazati to treat KRASG12C-mutated non-small cell lung cancer.
Drug Discovery World
NOVEMBER 13, 2023
Researchers at the University of São Paulo (USP) in Brazil and Foresee Pharmaceuticals have tested a synthetic molecule which could increase heart function in patients with heart failure. Heart failure is a condition in which the heart cannot pump enough blood to meet the body’s needs for blood and oxygen. A number of drugs can slow its progression but currently no treatment exists that can reverse it.
Pharmaceutical Technology
NOVEMBER 13, 2023
Ajinomoto has signed a definitive agreement for the acquisition of Forge Biologics in an all-cash transaction totalling $620m.
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When selecting a clinical supply provider, consideration often focuses upon the manufacturing, packaging, storage and distribution capabilities available that will, at face-value, be sufficient to meet the needs of the sponsor and their trial. However, there are human-based and knowledge-driven factors that are often overlooked that go beyond these basic physical capabilities and are integral to the development and delivery of high performing clinical supply chains.
BioSpace
NOVEMBER 13, 2023
Under the potential $770.5 million deal announced Tuesday, Autifony Therapeutics is licensing to Jazz Pharmaceuticals two ion channel targets associated with neurological disorders.
Pharmaceutical Technology
NOVEMBER 13, 2023
Novo Nordisk announced this week that its weight loss drug Wegovy reduces the risk of major cardiovascular events by 20%.
Fierce Pharma
NOVEMBER 13, 2023
Novo Nordisk has made a splash with its GLP-1 drugs that have allowed patients to achieve significant weight loss. | Novo Nordisk has made a splash with its GLP-1 drugs that have allowed patients to achieve significant weight loss. Now the Danish company appears on the verge of another breakthrough, showing that the use of its obesity treatment Wegovy can reduce the risk of heart attack.
Pharmaceutical Technology
NOVEMBER 13, 2023
Heqet Therapeutics and Ethris have collaborated to develop RNA-based therapeutics to treat cardiovascular conditions.
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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.
BioPharma Reporter
NOVEMBER 13, 2023
Ever since injections promising to help people lose weight hit the shelves, interest around the world has been phenomenal. So high was demand, companies were finding it difficult to keep up with the demand.
Pharmaceutical Technology
NOVEMBER 13, 2023
An upcoming two-day event will host talks on the impact of new technology on oncology trials and smaller biotechs.
BioSpace
NOVEMBER 13, 2023
In a late-stage trial, treatment with Ipsen and Genfit’s elafibranor led to high rates of biochemical response and the normalization of alkaline phosphatase levels compared with placebo.
Fierce Pharma
NOVEMBER 13, 2023
Six months on, Teva’s new “pivot to growth” strategy appears to be paying off. | In 2023’s third quarter, the Israeli-American generics giant reported global sales of $3.9 billion, up 7% from the same period in 2022. The company credited that growth to the strong momentum behind its branded meds Austedo and Ajovy, plus a “stable and sustainable generics business” in the U.S. that’s also seen “continued growth” in Europe and other international markets.
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As the development pipeline for new drugs continues to grow, biopharmaceutical companies are re-evaluating how to best manage and balance resources across an increasing number of development projects and complex clinical trials. There are two approaches that can be used to speed a drug from development to clinic faster: timeline compression and parallel processing, but only one that considers the benefits of integrating clinical supply into the overall drug development process.
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