Merck’s Pneumococcal Vaccine V116 Matches Pfizer’s Prevnar 20 in Phase 3 Trial
Merck’s investigational pneumococcal vaccine V116 demonstrated efficacy and safety levels similar to Pfizer’s Prevnar 20 vaccine [...]
Bayer’s Asundexian Fails in Phase 3 Trial, Impacting 5 Billion Euro Annual Revenue Plan
Bayer's plans to make Asundexian into a 5 billion euro per year product have faced a [...]
NIH’s New Director Monica Bertagnolli Concerned about Obesity; Emphasizes the Importance of Clinical Trials and Role of Insurers in Healthcare Research
Newly appointed NIH director Monica Bertagnolli expressed her concern about obesity and highlighted the importance of [...]
FDA Approves Takeda’s Novel, Chemotherapy-Free Pill Fruzaqla for Metastatic Colorectal Cancer
The FDA approved Takeda’s Fruzaqla, a pill treatment for refractory metastatic colorectal cancer (mCRC), making it [...]
Izervay’s Efficacy Increases Over Time, Outpacing Competitor in Treating Geographic Atrophy: 2-Year GATHER2 Study Finds
Astellas' drug Izervay, a treatment for eye condition geographic atrophy, has demonstrated an increase in efficacy [...]
ASN Kidney Week 2023: Studies Highlight Issues in CKD Diagnosis Delays and Management Using Real-World Data
Two posters presented at ASN Kidney Week 2023 analyzed real-world data on Chronic Kidney Disease (CKD) [...]
FDA Approves Novartis’ Cosentyx as First New Biologic HS Treatment in Decade: A Potential Rival for AbbVie’s Humira
The U.S. FDA has approved Novartis' Cosentyx (secukinumab) for treating moderate to severe hidradenitis suppurativa (HS), [...]
Olympus Asks Healthcare Providers to Stop Using Its Insufflator Units Due to Over-Inflation Reports; FDA Issues Class I Recall
Olympus, a healthcare equipment company, has asked healthcare providers to stop using its UHI-4 insufflator unit, [...]
Confirmatory Study for Sarepta and Roche’s Duchenne Gene Therapy Fails to Hit Primary Endpoint
Sarepta and Roche's confirmatory Phase III EMBARK study for Duchenne muscular dystrophy gene therapy, Elevidys, failed [...]
The Future of Diversity in Clinical Trials: Real-World Evidence
This episode of tHEORetically Speaking features real-world evidence experts Alexandrina Balanean, Parisa Asgarisabet, and Danielle Gentile from Cardinal Health discussing the problems caused by lack of diverse representation in clinical trials.
The Future of Diversity in Clinical Trials: Real-World Evidence
This episode of tHEORetically Speaking features real-world evidence experts Alexandrina Balanean, Parisa Asgarisabet, and Danielle Gentile from Cardinal Health discussing the problems caused by lack of diverse representation in clinical trials.
Revolutionizing Antibiotics: Harnessing Molecular De-Extinction and AI in the Hunt for New Treatments from Extinct Animals’ DNA
Cesar de la Fuente and his lab at the University of Pennsylvania are utilizing algorithms in [...]
Prescription Drug Use Expected for Half of Americans’ Lifetimes, Study Finds
A recent study by Jessica Ho, associate professor at Penn State University, found that Americans born [...]
Navigating the Clinical Outcomes Maze: An Overview of Clinical Outcomes Assessments and Why Training Matters
This webinar delves into the dynamic landscape of COAs, examining their historical use and significance, current uses and best practices, and making a case for greater standardization in their implementation.
Gero Secures $6M in Series A Extension Round to Advance AI-Based Age-Related Disease Research
Biotechnology company Gero has secured $6M in a Series A extension round led by Melnichek Investments. [...]
Key Steps to Enhance Success Rate and Validity in Pharmaceutical Clinical Trials
Bringing a new drug to market takes pharmaceutical companies 10 to 15 years and more than [...]
Obesity Underrepresentation in Clinical Trials Leads to Concerns Over Drug Efficacy and Safety
Obesity is often not represented adequately in drug development trials, causing uncertainties about drug efficacy and [...]
Optimizing Clinical Trials for Greater Payer Acceptance and Enhanced Patient Access
Biopharma manufacturers face challenges in conveying the clinical value of their medicines to payers due to [...]
Groundbreaking BRAIN Initiative Reveals 3,300 Types of Brain Cells, Offering New Leads for Disease Research and Therapies
Scientists have produced an extensive catalog detailing the types of cells in the human brain and [...]
Recent Biopharmaceutical Updates: Workplace Cuts at Sana, NASH Treatment Setbacks, ALS Treatment Appeals, and Alnylam’s Future
Recent updates from the biopharmaceutical world: Sana Biotechnology: The company is laying off approximately one-third of [...]
FDA Denies Alnylam Pharmaceuticals’ Expansion Plans for Onpattro Treatment
The FDA has denied Alnylam Pharmaceuticals' request to expand the use of its siRNA injection Onpattro for the treatment of [...]
Johnson & Johnson’s Drug Combination Improves Progression-Free Survival in Lung Cancer Trial Against AstraZeneca’s Therapy
The Mariposa study showed that a combination of two Johnson & Johnson (J&J) drugs, Rybrevant, and lazertinib, was successful in [...]
Cell & Gene Therapies – Beginning with the End in Mind
This webinar discusses how early stage planning taking into account commercial production, logistics, reimbursement, and health inequities can lead to successful approvals and market adoption.
Galecto Laying Off 70% of Staff and Exploring Strategic Alternatives after Failed Lung Disease Drug Trial
Boston-based biotech firm Galecto plans to lay off 29 employees, approximately 70% of its workforce, after [...]
Class-Action Lawsuit Targets Johnson & Johnson and IBM after Data Breach
Johnson & Johnson and IBM face a proposed class-action lawsuit following a data breach at J&J’s [...]
