UniQure sells royalty rights to hemophilia gene therapy
Bio Pharma Dive
MAY 15, 2023
The Dutch biotech sold a portion of royalties owed by CSL Behring on sales of Hemgenix, adding to a cash pile it has built since out-licensing the treatment.
Mon.May 15, 2023
294 
Astellas’ nonhormonal hot flashes treatment Veozah wins FDA nod
Pharmaceutical Technology
MAY 15, 2023
The US Food and Drug Administration (FDA) has approved Astellas Pharma’s Veozah (fezolinetant) for use against moderate to severe vasomotor symptoms caused by menopause on May 12 after some delays due to an extended review. This marks the first-ever FDA approval of a nonhormonal neurokinin 3 (NK3) receptor antagonist for use against vasomotor symptoms caused by menopause.
Join 32,000+
Insiders
Sign Up for our Newsletter
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.
Gilead expands Arcus partnership, with eye to inflammatory disease
Bio Pharma Dive
MAY 15, 2023
The new deal is worth up to $1 billion, and will see the two collaborators work together on up to four inflammatory disease drug targets.
Innovation in small molecules: Leading companies in quinoline derivatives as anticancer agents
Pharmaceutical Technology
MAY 15, 2023
The pharmaceutical industry continues to be a hotbed of innovation, with activity driven by the evolution of new treatment paradigms, and the gravity of unmet needs, as well as the growing importance of technologies such as pharmacogenomics, digital therapeutics, and artificial intelligence. In the last three years alone, there have been over 633,000 patents filed and granted in the pharmaceutical industry, according to GlobalData’s report on Small molecules in Pharmaceuticals: Quinoline derivat
Nido debuts with $109M for its precision approach to brain drugs
Bio Pharma Dive
MAY 15, 2023
Backed by 5AM Ventures and Eli Lilly, the startup has advanced a drug for spinal and bulbar muscular atrophy into clinical testing.
Eating Late Can Alter How You Burn Calories And Store Fat, Depressing Study Finds
AuroBlog - Aurous Healthcare Clinical Trials blog
MAY 15, 2023
A recent study suggests eating later in the day can directly impact our biological weight regulation in three key ways: through the number of calories that we burn; our hunger levels; and the way our bodies store fat.
Sign up to get articles personalized to your interests!
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
More Trending
Leading innovators in nucleoside chemical synthesis for the pharmaceutical industry
Pharmaceutical Technology
MAY 15, 2023
The pharmaceutical industry continues to be a hotbed of innovation, with activity driven by the evolution of new treatment paradigms, and the gravity of unmet needs, as well as the growing importance of technologies such as pharmacogenomics, digital therapeutics, and artificial intelligence. In the last three years alone, there have been over 633,000 patents filed and granted in the pharmaceutical industry, according to GlobalData’s report on Innovation in Pharmaceuticals: Nucleoside chemical sy
NABL issues clarification on CAB combined ILAC MRA mark for effective compliance
AuroBlog - Aurous Healthcare Clinical Trials blog
MAY 15, 2023
The National Accreditation Board for Testing and Calibration Laboratories (NABL) has issued clarification on NABL accredited Conformity Assessment Body (CAB) combined International Laboratory Accreditation Co-operation (ILAC) Mutual Recognition Arrangement (MRA) mark for effective compliance.
Dualyx raises funds to develop therapies for autoimmune diseases
Pharmaceutical Technology
MAY 15, 2023
Biotech company Dualyx, based in Ghent, Belgium, has raised $43.39m (€40m) in a Series A financing round to progress Treg therapies [therapies using regulatory T cells] to treat autoimmune diseases into clinical trials. The financing round has been co-led by Andera Partners, Fountain Healthcare Partners and Forbion and has seen participation from existing investors HTGF, GFF, PMV, V-Bio Ventures, VIB and BGV.
How real-world data helps manufacturers see the complete market access story
Bio Pharma Dive
MAY 15, 2023
Using labs and claims data, pharma companies can uncover new opportunities to improve market access for patients.
The New Age of Decentralized Clinical Trials
Advertisement
White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations
NUCLIDIUM and PharmaLogic partner to develop copper-based theranostics in US
Pharmaceutical Technology
MAY 15, 2023
NUCLIDIUM has signed a strategic collaboration deal with PharmaLogic for the manufacturing and clinical supply of copper-based theranostics ⁶¹Cu in the US. ⁶¹Cu is a new diagnostic radioisotope that provides distinct properties for safe, cost-effective and enhanced diagnostics to improve cancer-staging and ensuing treatment decisions. The deal is set to speed up the development of NUCLIDIUM’s theranostic pipeline.
Dementia study reveals how toxic proteins spread through brain
Medical Xpress
MAY 15, 2023
Fresh insights into the spread of damaging proteins that build up in the brains of people with Alzheimer's disease could hold the key to stopping the condition from progressing, a study says.
Rona and Keymed partner to develop siRNA therapeutics for glomerulonephritis
Pharmaceutical Technology
MAY 15, 2023
Rona Therapeutics has entered a partnership with Keymed Biosciences to discover and develop first-in-class siRNA [a double-stranded RNA molecule that is non-coding] therapeutics for glomerulonephritis, also known as severe kidney disease. The alliance will benefit from both companies’ scientific and technological know-how. It will be based on Rona’s exclusive platform in RNAi targeting liver and extrahepatic tissues.
New threat to privacy? Scientists sound alarm about DNA tool
Medical Xpress
MAY 15, 2023
The traces of genetic material that humans constantly shed wherever they go could soon be used to track individual people, or even whole ethnic groups, scientists said on Monday, warning of a looming "ethical quagmire".
Unlocking Excellence: How Catalent Is Transforming Japan’s Clinical Research
Advertisement
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
Leading innovators in oxazole derivatives-based cancer drug compositions
Pharmaceutical Technology
MAY 15, 2023
The pharmaceutical industry continues to be a hotbed of innovation, with activity driven by the evolution of new treatment paradigms, and the gravity of unmet needs, as well as the growing importance of technologies such as pharmacogenomics, digital therapeutics, and artificial intelligence. In the last three years alone, there have been over 633,000 patents filed and granted in the pharmaceutical industry, according to GlobalData’s report on Innovation in Pharmaceuticals: Oxazole derivatives-ba
Marijuana users have triple the odds for leg artery disease, study suggests
Medical Xpress
MAY 15, 2023
Smoking cigarettes has long been linked to peripheral artery disease (PAD), a condition where the buildup of plaque narrows arteries and limits blood flow to the legs or arms.
Leading innovators in pancreatic extract-based compositions for the pharmaceutical industry
Pharmaceutical Technology
MAY 15, 2023
The pharmaceutical industry continues to be a hotbed of innovation, with activity driven by the evolution of new treatment paradigms, and the gravity of unmet needs, as well as the growing importance of technologies such as pharmacogenomics, digital therapeutics, and artificial intelligence. In the last three years alone, there have been over 633,000 patents filed and granted in the pharmaceutical industry, according to GlobalData’s report on Innovation in Pharmaceuticals: Pancreatic extract-bas
May 15, 2023: EMBED Offers Lessons for Intervention Adoption, Implementation, and Maintenance
Rethinking Clinical Trials
MAY 15, 2023
Organizational culture, clinician training and support, the ability to link patients to ongoing treatment, and the ability to tailor implementation to each clinical site were key determinants of successful implementation of an intervention to promote buprenorphine initiation in emergency departments, according to a qualitative study conducted as part of the EMBED pragmatic clinical trial.
The New Age of Decentralized Clinical Trials
Advertisement
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.
Innovation in immuno-oncology: Leading companies in oncolytic viral proteins
Pharmaceutical Technology
MAY 15, 2023
The pharmaceutical industry continues to be a hotbed of innovation, with activity driven by the evolution of new treatment paradigms, and the gravity of unmet needs, as well as the growing importance of technologies such as pharmacogenomics, digital therapeutics, and artificial intelligence. In the last three years alone, there have been over 633,000 patents filed and granted in the pharmaceutical industry, according to GlobalData’s report on Immuno-oncology in Pharmaceuticals: Oncolytic viral p
Machine learning model able to detect signs of Alzheimer's across languages
Medical Xpress
MAY 15, 2023
Researchers are striving to make earlier diagnosis of Alzheimer's dementia possible with a machine learning (ML) model that could one day be turned into a simple screening tool anyone with a smartphone could use.
Leading innovators in peptide-based inhibitors for cancer treatment
Pharmaceutical Technology
MAY 15, 2023
The pharmaceutical industry continues to be a hotbed of innovation, with activity driven by the evolution of new treatment paradigms, and the gravity of unmet needs, as well as the growing importance of technologies such as pharmacogenomics, digital therapeutics, and artificial intelligence. In the last three years alone, there have been over 633,000 patents filed and granted in the pharmaceutical industry, according to GlobalData’s report on Innovation in Pharmaceuticals: Peptide-based inhibito
Newly discovered RNA molecules hold promise for detecting and treating esophageal cancer
Medical Xpress
MAY 15, 2023
Irregularities in the body's genetic coding to make proteins are linked to cancerous tumors. But most genetic material contains elements whose function isn't clear.
Roles and Responsibilities of Specialized Clinical Supply Experts
Advertisement
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.
Leading innovators in peptide nano-particle conjugates for the pharmaceutical industry
Pharmaceutical Technology
MAY 15, 2023
The pharmaceutical industry continues to be a hotbed of innovation, with activity driven by the evolution of new treatment paradigms, and the gravity of unmet needs, as well as the growing importance of technologies such as pharmacogenomics, digital therapeutics, and artificial intelligence. In the last three years alone, there have been over 633,000 patents filed and granted in the pharmaceutical industry, according to GlobalData’s report on Innovation in Pharmaceuticals: Peptide nano-particle
An unexpected journey reveals a potent way to attack tumors
Medical Xpress
MAY 15, 2023
Research on the effects of prenatal exposure to the Zika virus has yielded an unexpected dividend: a potentially promising way to trigger natural killer (NK) cells to fight cancer.
Leading innovators in periodontitis drugs for the pharmaceutical industry
Pharmaceutical Technology
MAY 15, 2023
The pharmaceutical industry continues to be a hotbed of innovation, with activity driven by the evolution of new treatment paradigms, and the gravity of unmet needs, as well as the growing importance of technologies such as pharmacogenomics, digital therapeutics, and artificial intelligence. In the last three years alone, there have been over 633,000 patents filed and granted in the pharmaceutical industry, according to GlobalData’s report on Innovation in Pharmaceuticals: Periodontitis drugs.
Occasional cannabis use during pregnancy may be enough to impact fetal growth significantly
Medical Xpress
MAY 15, 2023
As more people use cannabis for recreational purposes, attitudes towards the drug have changed. For example, research has shown that dispensaries often recommend cannabis—also referred to as marijuana—to pregnant women to ease pregnancy symptoms, especially morning sickness.
How Machine Learning Drives Clinical Trial Efficiency
Advertisement
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.
Leading innovators in pyridine derivatives for the pharmaceutical industry
Pharmaceutical Technology
MAY 15, 2023
The pharmaceutical industry continues to be a hotbed of innovation, with activity driven by the evolution of new treatment paradigms, and the gravity of unmet needs, as well as the growing importance of technologies such as pharmacogenomics, digital therapeutics, and artificial intelligence. In the last three years alone, there have been over 633,000 patents filed and granted in the pharmaceutical industry, according to GlobalData’s report on Innovation in Pharmaceuticals: Pyridine d erivatives.
Reddit users concerned by health risks of vaping, according to AI analysis
Medical Xpress
MAY 15, 2023
A new artificial intelligence analysis of thousands of posts from the popular online discussion forum Reddit reveals that vapers are concerned about e-cigarettes' possible impact on everything from their respiratory, gastrointestinal, and cardiovascular systems to their mental and sexual health and sleep patterns. They also worry about the possibility of addiction, cancer, and dental problems.
FDA grants orphan drug designation to SiSaf’s siRNA therapy for ADO2
Pharmaceutical Technology
MAY 15, 2023
The US Food and Drug Administration (FDA) has given orphan drug designation to SiSaf’s siRNA [a double-stranded RNA molecule that is non-coding] therapeutic, SIS-101-ADO, for the treatment of autosomal dominant osteopetrosis type 2 (ADO2), a rare and serious skeletal disorder in children. The status offers SiSaf incentives including tax credits for clinical trials, exemption from user fees and improved marketplace exclusivity.
Cardiologists look to the past to create new heart bypass procedure
Medical Xpress
MAY 15, 2023
Henry Ford Health Interventional cardiologists William O'Neill, M.D., and Khaldoon Alaswad, M.D., took a page out of the medical history books by performing a new coronary bypass procedure replicated from one not used in decades to treat a patient living with crippling angina―a severe symptom of coronary artery disease.
Accelerating Clinical Supply Through Integrated Drug Development
Advertisement
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.
Let's personalize your content