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.
Pharmaceutical Technology
JULY 20, 2023
Ahead of APEC’s "Rare disease vision 2025" deadline, Asian countries are working at different speeds towards improving drug market access.
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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.
Pharmaceutical Technology
JULY 20, 2023
The National Cancer Institute funded Enspectra Health to develop deep learning algorithms to predict which skin lesions are cancerous.
Bio Pharma Dive
JULY 20, 2023
The deal with Recludix Pharma carries a $125 million near-term payment and specifically revolves around a “STAT6,” a protein that research suggests plays a role in some respiratory and skin disorders.
Pharmaceutical Technology
JULY 20, 2023
The centre is planned for completion in 2026, along with plans to build a $400m biologics manufacturing plant.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Pharmaceutical Technology
JULY 20, 2023
WHO’s director-general addresses further action to improve childhood immunisations globally upon the release of new data.
Bio Pharma Dive
JULY 20, 2023
The setback cut shares of the once high-flying infectious disease drug developer in half, adding to the challenge facing new CEO Marianne De Backer.
Pharmaceutical Technology
JULY 20, 2023
Astria Therapeutics hopes its candidate will become a first-choice preventative treatment for hereditary angioedema.
Bio Pharma Dive
JULY 20, 2023
The startup will take on development of a shigellosis vaccine GSK inherited when it acquired LimmaTech’s predecessor, GlycoVaxyn, in 2015.
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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
Rethinking Clinical Trials
JULY 20, 2023
In a new episode of our Rethinking Clinical Trials Podcast , Dr. Julie Fritz speaks with host Dr. Adrian Hernandez about partnering with community health centers in the BeatPain Utah study. Fritz and colleague Dr. Guilherme Del Fiol presented on their experiences during the June 16 session of Grand Rounds. Listen to the latest podcast episode on SoundCloud or Apple Podcasts.
Pharmaceutical Technology
JULY 20, 2023
Biotechnology company SCG Cell Therapy has officially opened its new manufacturing facility and R&D centre at its headquarters in Singapore.
Fierce Pharma
JULY 20, 2023
Despite the widespread hype surrounding new and powerful obesity medicines, the drugs are still out of reach for many Americans who could benefit. | Despite the widespread hype surrounding new and powerful obesity medicines, the drugs are still out of reach for many Americans who could benefit. A group of lawmakers is working to change that.
Pharmaceutical Technology
JULY 20, 2023
The US FDA has awarded fast track designation for Ambrx Biopharma’s ARX517 to treat metastatic castration-resistant prostate cancer (mCRPC).
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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
Fierce Pharma
JULY 20, 2023
Sandoz is doubling down on its commitment to Slovenia in its globe-trotting biosimilar growth quest. | Sandoz is doubling down on its commitment to Slovenia in its globe-trotting biosimilar growth quest. Its latest move follows a separate $400 million pledge to build a plant in the country.
Pharmaceutical Technology
JULY 20, 2023
The EC has refused to grant marketing authorisation for Ipsen’s palovarotene intended to treat fibrodysplasia ossificans progressiva (FOP).
Fierce Pharma
JULY 20, 2023
After a recent study of Eisai's subcutaneous Leqembi formulation, the company is touting its "promising" results. | Eisai showed off "promising" results from a modeling and bioavailability study of its subcutaneous Leqembi formulation. Astellas joined the growing list of drugmakers taking on the Inflation Reduction Act with legal action.
Pharmaceutical Technology
JULY 20, 2023
GeneDx and Prognos Health have entered a strategic collaboration to help patients with rare diseases gain access to treatments quickly.
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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.
BioSpace
JULY 20, 2023
After being rejected by an FDA advisory panel four years ago, Vanflyta is now approved across three phases of treatment for acute myeloid leukemia patients with the FLT3 gene mutation.
Pharmaceutical Technology
JULY 20, 2023
By 2029, RSV drugs are forecast to surpass $9bn in sales, This surge can be attributed to recent developments in preventative measures.
BioSpace
JULY 20, 2023
Amid high rates of U.S. obesity, a bipartisan bill has been reintroduced in the Senate and House of Representatives with backing from Eli Lilly, Novo Nordisk and Boehringer Ingelheim.
Pharmaceutical Technology
JULY 20, 2023
Despite a 7% decrease in job postings, there has been a 407% increase in ads related to generative AI over the last three months.
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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
JULY 20, 2023
Even at its highest dose, Vir Biotechnology’s investigational flu shot failed to significantly outperform placebo at preventing influenza A illness in a mid-stage study.
Pharmaceutical Technology
JULY 20, 2023
Based on the encouraging comments from the FDA, Iovance revealed preliminary analysis from the patients who received LN-145.
BioSpace
JULY 20, 2023
Following seven patient deaths in a Phase II study, ADC Therapeutics is discontinuing the development of its Zynlonta antibody-drug conjugate—combined with Rituxan—for diffuse large B-cell lymphoma.
Pharmaceutical Technology
JULY 20, 2023
Additional clinical data showed improved clinical and anatomical outcomes in DME and wet AMD.
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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
JULY 20, 2023
One of the world’s largest sterile injectables plants has landed in the path of a devastating act of nature. | One of the world’s largest sterile injectables plants has landed in the path of a devastating act of nature. Wednesday, Pfizer said its manufacturing facility in Rocky Mount, North Carolina, suffered damage from a tornado. All of the company's employees are safe and accounted for.
Antidote
JULY 20, 2023
IgA nephropathy, also known as IgAN or Berger disease, is a common kidney disease that can impact any individual at any age. It is one of the most prevalent kidney diseases other than those caused by diabetes or high blood pressure, but the cause and the cure for this condition remain unknown.
Outsourcing Pharma
JULY 20, 2023
The Swiss company Idorsia has sold its operating businesses Idorsia Pharmaceuticals Japan Ltd and Idorsia Pharmaceuticals Korea Co., Ltd to the Japanese firm Sosei Heptares for CHF 400 million ($466 million).
BioPharma Reporter
JULY 20, 2023
PrecisionLife, a computational biology company driving precision medicine in complex chronic diseases, has announced the results of its long COVID study, providing the first detailed genetic insights into the condition and its commonalities with other diseases, including myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS).
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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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