Bio Pharma Dive
SEPTEMBER 26, 2023
Much anticipated clinical trial data for Immunovant’s experimental FcRn inhibitor could catalyze business development decisions for its parent, Roivant Sciences.
Pharmaceutical Technology
SEPTEMBER 25, 2023
Eisai and BioArctic’s Leqembi is the only approved treatment that slows cognitive and functional decline in adults with Alzheimer’s.
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Pharmaceutical Technology
SEPTEMBER 21, 2023
The US FDA has accepted Takeda’s NDA resubmission for TAK-721 for the short-term treatment of eosinophilic esophagitis (EoE), for review.
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
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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.
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.
BioPharma Reporter
SEPTEMBER 26, 2023
Psychedelics have re-emerged in the world of medicine as promising treatments for various mental health conditions, particularly post-traumatic stress disorder (PTSD).
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Pharmaceutical Technology
SEPTEMBER 20, 2023
The neurotech will receive the investment in Series B equity financing round to invest in Alzheimer’s disease research.
Worldwide Clinical Trials
SEPTEMBER 26, 2023
In September, as we observe World Alzheimer’s month and focus attention on how far we have come in raising awareness of the disease and research being done to find more effective treatments, I think back to when my grandmother was first diagnosed and how heart wrenching it was to watch her loose herself over the years. When my mother was diagnosed, it was not a surprise, as I had already been witnessing those early changes and knew what was coming.
Rethinking Clinical Trials
SEPTEMBER 27, 2023
In this Friday’s PCT Grand Rounds, Claire Snyder of Johns Hopkins University and Norah Crossnohere and Anne Schuster, both of Ohio State University, will present “Navigating the Use of Patient-Reported Outcomes in Research and Practice: The PROTEUS Consortium.” The Grand Rounds session will be held on Friday, September 29, 2023, at 1:00 pm eastern.
Antidote
SEPTEMBER 25, 2023
Clinical trials are how researchers advance their knowledge about potential new treatments, including medications, medical devices, and lifestyle interventions. Clinical trials are divided into phases , each with a distinct duration, purpose, and number of volunteers needed. Before any new treatment becomes available on the market, it must go through this process, as required by the FDA.
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There’s been a rapid shift towards decentralization in clinical trials & it’s clear why. The potential for reaching a larger pool of recruits is possible when sponsors can bring more trial activities to the patient. Tele visits, digital consent, new monitoring sensors, & direct-to-patient supply are virtual tools that existed before the pandemic, but now there’s swift adoption of these methods because they’ve been proven to help launch & complete trials more effectively.
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 22, 2023
JURA Bio has entered into a research collaboration with Replay cell therapy product company Syena for the development of TCR based therapies.
BioSpace
SEPTEMBER 25, 2023
The Japanese multinational pharma is pledging up to $580 million in a development and commercialization deal with AcuraStem for the latter’s PIKFYVE program for amyotrophic lateral sclerosis.
Fierce Pharma
SEPTEMBER 21, 2023
Looking to establish a “hub” in the cell therapy ecosystem, the Novo Nordisk Foundation is pumping 950 million Danish kroner (about $136 million) into a new clinical production site at the Technica | Looking to establish a “hub” in the cell therapy ecosystem, the Novo Nordisk Foundation is pumping 950 million Danish kroner (about $136 million) into a new clinical production site at the Technical University of Denmark (DTU) in Lyngby.
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.
Antidote
SEPTEMBER 22, 2023
Connecting patients with clinical research opportunities is our mission here at Antidote, but often, we find that misconceptions can serve as barriers to achieving this goal. It’s important to carefully weigh the pros and cons of participating in a clinical trial but to do this effectively, it’s critical to have accurate information.
Bio Pharma Dive
SEPTEMBER 26, 2023
Once valued at more than $7 billion, the liver drug company couldn’t secure a long-sought FDA approval in NASH and last month said it would abandon that research.
BioSpace
SEPTEMBER 24, 2023
The losing streak continues for Merck and Eisai with their Keytruda-Lenvima combination failing to improve progression-free survival and overall survival in two late-stage lung cancer studies.
Fierce Pharma
SEPTEMBER 26, 2023
On a €1 billion quest to build a global mRNA network, Merck KGaA’s MilliporeSigma has rounded out its service offerings to include all key stages of mRNA development, manufacturing and commercializ | On a €1 billion quest to build a global mRNA network, Merck KGaA’s MilliporeSigma has rounded out its service offerings to include all key stages of mRNA development, manufacturing and commercialization.
Advertiser: FourKites
A research study conducted by The Journal of Commerce and FourKites surveyed hundreds of international shippers, exploring how their usage of global supply chain visibility technology has evolved since the onset of global disruptions caused by COVID-19. For international shippers, ocean freight visibility has evolved from optional to essential and satisfaction with visibility varies greatly depending on how it is obtained and delivered.
Pharma Times
SEPTEMBER 26, 2023
Agreement will provide timely boost to pandemic preparedness against influenza - News - PharmaTimes
Bio Pharma Dive
SEPTEMBER 25, 2023
Eisai and Biogen’s anti-amyloid drug is still undergoing regulatory reviews in the EU, U.K. and elsewhere.
Pharmaceutical Technology
SEPTEMBER 22, 2023
A Phase I trial exploring the gene therapy in patients with alpha-1 antitrypsin deficiency is expected to start in Q1 2024.
BioSpace
SEPTEMBER 25, 2023
The FDA on Monday approved the Canadian biopharma’s liquid antibiotic metronidazole, an alternative for patients who are unable to use pills or injections.
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Fierce Pharma
SEPTEMBER 26, 2023
It’s been an uphill battle for Intercept Pharmaceuticals in the three years since the FDA first nixed its attempt to bring Ocaliva to patients with nonalcoholic steatohepatitis (NASH)-related liver | The company inked the buyout at $19 per share after two FDA rejections for Ocaliva in nonalcoholic steatohepatitis-related liver fibrosis and a recent attempt at cutting costs.
Antidote
SEPTEMBER 26, 2023
Recruiting patients for a clinical trial can be a challenging process. Studies show that many patients report having little or no knowledge of clinical trials , and sponsors and researchers often report having difficulties finding and enrolling patients in studies. However, once patients understand more about the medical research process, many individuals do want to participate in a clinical trial.
Bio Pharma Dive
SEPTEMBER 22, 2023
Results show that the medicine helped patients who progressed on earlier-line treatments live longer than those receiving chemotherapy without their disease getting worse, according to a Friday announcement.
Pharmaceutical Technology
SEPTEMBER 21, 2023
Kezar and Everest Medicines have signed a deal for the development and commercialisation of zetomipzomib for lupus nephritis.
Speaker: Steve Goldstein, Sales Leader
Are you currently in sales, or involved in a business that depends on strong sales results? What about the extremely competitive world of medical device sales? What are some of the top challenges your customers face and how do you approach understanding what’s most important to them? Join Steve Goldstein, Sales Success Coach, Motivational Speaker and Medical Device Sales Leader from Gold Selling LLC., to discover critical strategies and approaches you can take to engage your customers, achieve g
BioSpace
SEPTEMBER 21, 2023
A U.S. federal court upheld a prior ruling in favor of Roche’s Genentech, finding that its blockbuster hemophilia treatment Hemlibra did not infringe on patent protections held by Takeda’s Baxalta.
Fierce Pharma
SEPTEMBER 25, 2023
More than five years after an initial FDA approval, Novartis is touting positive trial results for its radiotherapy Lutathera as a first-line therapy against the rare cancer that killed Apple co-fo | More than five years after an initial FDA approval, Novartis is touting positive trial results for its radiotherapy Lutathera as a first-line therapy against the rare cancer that killed Apple co-founder Steve Jobs.
BioPharma Reporter
SEPTEMBER 26, 2023
BioPharma Reporter and Outsourcing Pharma is keeping you in the know with our most recent round-up of important appointments in the pharma industry - including Veranova, Matica Bio and Aldevron.
Bio Pharma Dive
SEPTEMBER 22, 2023
The drug, which is already cleared as a neoadjuvant lung cancer treatment, could further compete with Merck’s Keytruda if it gains approval in the adjuvant setting for patients with the non-small cell form of the disease.
Advertiser: Aggregage
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