Bio Pharma Dive
SEPTEMBER 20, 2023
Targeted protein degradation has emerged as one of the more competitive areas of pharmaceutical research in recent years as scientists develop new ways to reach difficult-to-drug targets.
Pharmaceutical Technology
SEPTEMBER 20, 2023
The neurotech will receive the investment in Series B equity financing round to invest in Alzheimer’s disease research.
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Worldwide Clinical Trials
SEPTEMBER 20, 2023
Our team has been working diligently to find a way to revitalize how we use automation, and during WRIB this year, we presented a poster on “Revolutionizing Bioanalysis through Automation: Overcoming Challenges and Unlocking Potential.” In case you missed it, we’ve highlighted the top four takeaways: 1. Instrument Integration: At both hardware and software levels, our integration of multiple bioanalytical instruments created a total laboratory automation (TLA) system for ligand bindi
Pharmaceutical Technology
SEPTEMBER 20, 2023
Merck KGaA announced plans to join forces with BenevolentAI and Exscientia to leverage their AI-driven drug discovery platforms.
Bio Pharma Dive
SEPTEMBER 20, 2023
Additional studies proposed by the FDA would be too challenging, according to Taysha, which simultaneously announced that its partner Astellas has declined to pick up an option for the therapy, called TSHA-120.
Rethinking Clinical Trials
SEPTEMBER 20, 2023
In this Friday’s PCT Grand Rounds, Tumaini Rucker Coker of the University of Washington and Seattle Children’s Hospital will present “Community Health Workers in Early Childhood Well-Child Care.” The Grand Rounds session will be held on Friday, September 22, 2023, at 1:00 pm eastern. Coker is the chief of general pediatrics and a professor of pediatrics at the University of Washington School of Medicine and Seattle Children’s Hospital.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Pharmaceutical Technology
SEPTEMBER 20, 2023
Pfizer has received marketing authorisation from the European Commission (EC) for LITFULO for the treatment of severe alopecia areata.
Bio Pharma Dive
SEPTEMBER 20, 2023
The drug regulator has twice rejected Alvotech’s biosimilar due to manufacturing issues with a plant in Europe.
Pharmaceutical Technology
SEPTEMBER 20, 2023
The FDA wanted changes to the Phase I/II study designs investigating TSHA-120 in the rare neurological disorder, giant axonal neuropathy.
XTalks
SEPTEMBER 20, 2023
This episode features an interview with Dr. Tania Kamphaus and Tony Villiotti about new research on the utility and promise of blood-based biomarker tests for the diagnosis of liver diseases like non-alcoholic steatohepatitis (NASH). The research is particularly timely because the American Diabetes Association (ADA) recently called for liver disease screening for all adults with type 2 diabetes.
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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
Pharmaceutical Technology
SEPTEMBER 20, 2023
BeiGene has signed an agreement with Novartis for regaining global rights related to the humanised IgG4 anti-PD-1 antibody, TEVIMBRA
Drug Discovery World
SEPTEMBER 20, 2023
A new cooperative network designed to foster collaboration and boost the sharing of knowledge and expertise for the UK’s advanced therapies sector has been launched. The ‘ Scottish Advanced Therapy Medicinal Products (ATMP) and Vaccines Network ’ specifically targets researchers in the north of the UK and will coordinate events, talks from industry leaders and networking opportunities for the advanced therapies industry.
Pharmaceutical Technology
SEPTEMBER 20, 2023
The US Food and Drug Administration (FDA) has sNDA of Merck’s Welireg for advanced renal cell carcinoma and granted priority review.
Pharma Times
SEPTEMBER 20, 2023
Around 340,000 to 444,000 people in the UK carry one of nine pathogenic gene variants - News - PharmaTimes
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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
Pharmaceutical Technology
SEPTEMBER 20, 2023
The US FDA requested an additional repeat-dose study to be completed before granting approval for the epinephrine nasal spray.
Fierce Pharma
SEPTEMBER 20, 2023
With the surge in demand for GLP-1 diabetes and weight loss drugs—and companies struggling to supply them—it was only a matter of time before knockoffs reached the market. | Early this summer, Novo Nordisk filed multiple lawsuits accusing companies of producing and selling compounded versions of Ozempic and Wegovy. Now, Eli Lilly has done the same, filing eight separate complaints in five states.
Pharmaceutical Technology
SEPTEMBER 20, 2023
UK public sector doctor's pay is below that in Germany or the US, and ongoing strike action may lead to more emigration.
BioPharma Reporter
SEPTEMBER 20, 2023
This week's woman in science, is Maria Pereira, who leads the Innovation Hub at TISSIUM, a Paris-based medtech startup that develops solutions for tissue reconstruction.
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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.
Pharmaceutical Technology
SEPTEMBER 20, 2023
The biologics manufacturing company’s CEO said robotics and AI adoption in biopharma needs to catch up to other industries.
BioSpace
SEPTEMBER 20, 2023
Following a Type A meeting with the regulator, the biotech says it has clarity about the next steps in demonstrating remestemcel-L’s effectiveness in acute graft-versus-host disease.
Pharmaceutical Technology
SEPTEMBER 20, 2023
PeptiDream has entered a deal with Genentech to discover and develop new macrocyclic peptide-RI drug conjugates.
BioSpace
SEPTEMBER 20, 2023
Mock facilities can shorten the time it takes to bring new employees up to speed on processes and logistics, as well as allow companies to recruit individuals with limited experience.
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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.
Fierce Pharma
SEPTEMBER 20, 2023
After a manufacturing-related complete response letter held up the U.S. | UCB had previously expected an FDA decision during the first half of the year after suffering a prior rejection on its medicine. But now the company warned a decision will likely be delayed past the third quarter.
XTalks
SEPTEMBER 20, 2023
This episode features an interview with Dr. Tania Kamphaus and Tony Villiotti about new research on the utility and promise of blood-based biomarker tests for the diagnosis of liver diseases like non-alcoholic steatohepatitis (NASH). The research is particularly timely because the American Diabetes Association (ADA) recently called for liver disease screening for all adults with type 2 diabetes.
Pharma Times
SEPTEMBER 20, 2023
The universal vaccine could protect people against more strains of flu - News - PharmaTimes
Fierce Pharma
SEPTEMBER 20, 2023
Positive FDA advisory committee votes aren’t always a blueprint for approval. | Positive FDA advisory committee votes aren’t always a blueprint for approval. ARS Pharmaceuticals learned that lesson the hard way, as the FDA issued a surprise rejection of its anaphylaxis nasal spray Neffy.
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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.
BioSpace
SEPTEMBER 20, 2023
Bouncing back from two Complete Response Letters, Alvotech’s BLA for its Humira biosimilar AVT02 has been accepted by the regulator with a target action date of Feb. 24, 2024.
pharmaphorum
SEPTEMBER 20, 2023
Merck puts $1.3bn into AI via Exscientia, BenevolentAI deals Phil.
BioSpace
SEPTEMBER 20, 2023
With 88% of life sciences organizations using or planning to use AI in recruitment and/or hiring, AI regulation is a priority for the industry.
XTalks
SEPTEMBER 20, 2023
Neuro health technology company Beacon Biosignals has received FDA 510(k) Clearance for the Dreem 3S, an electroencephalogram (EEG)-based sleep monitoring device to measure sleep patterns. The device is an advanced wearable headband with integrated machine learning algorithms to capture brain activity data to monitor sleep architecture and help diagnose disturbed sleep.
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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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