SPOTLIGHT -
What is the Transformation Playbook for Moving From Digital Pilot to a Truly Scaled Production Solution?
A C-suite Q&A with Cristina Ortega Duran, President of Evinova.
High Dose Spinraza Significantly Improves Motor Function in Infants with Spinal Muscular Atrophy
Data from the Phase II/III DEVOTE study demonstrated that Spinraza showed significant motor function improvements at six months in infants with spinal muscular atrophy.
Kerendia Reduces Cardiovascular Deaths in Patients with Cardio-Kidney-Metabolic Conditions
Results from the FINE-HEART pooled analysis of three Phase III clinical trials highlighted the potential of finerenone in treating high-risk cardiovascular patients.
Lumryz Demonstrates Superiority Over Oxybate Treatments in Narcolepsy
Results of the RESTORE study revealed that 94% of participants preferred Lumryz over twice nightly oxybate treatments for narcolepsy.
Camzyos Demonstrates Efficacy, Safety Treating Symptomatic Obstructive Hypertrophic Cardiomyopathy
Results from the Phase III EXPLORER-LTE study found that Camzyos maintained effectiveness in treating symptomatic obstructive hypertrophic cardiomyopathy after 3.5 years of treatment.
Personify Health Offers Employers GLP-1s Best Practices for Coverage Options
The insurance company is offering the guidance in response to continued popularity of the drugs which are commonly used for weight-loss management.
Johnson & Johnson Submits Biologics License Application for Nipocalimab in Patients with Antibody-Positive Generalized Myasthenia Gravis
Submission is supported by results from the Phase III Vivacity-MG3 study, which demonstrated that nipocalimab, combined with standard care, significantly improved outcomes for patients with antibody-positive generalized myasthenia gravis.
Sanyou Biopharmaceuticals Announces Line of Monkeypox Treatments
The product line includes vaccines, monoclonal antibodies, and antigens.
FDA Grants Priority Review to Mirdametinib for Neurofibromatosis Type 1-Associated Plexiform Neurofibromas
Submission of a New Drug Application for mirdametinib included data from the Phase IIb ReNeu trial, which evaluated patients with NF1-associated plexiform neurofibromas causing significant morbidity.
Roflumilast Cream Demonstrates Efficacy, Safety Treating Mild to Moderate Atopic Dermatitis in Children
Results of the INTEGUMENT-OLE study found that the roflumilast cream not only maintained but improved its efficacy over time treating children from two to five years of age with mild to moderate atopic dermatitis.
Has Machine Learning Finally Provided Practical Value for the Healthcare Ecosystem?
A Harvard Business School Healthcare Alumni Association Q&A with Dr. Hersh Sagreiya at the Hospital of the University of Pennsylvania.
Research Growing into the Use of Psychedelics to Treat Substance Abuse
A new National Institutes of Health grant will advance research into the role of the serotonin 5-HT2A receptor in mitigating methamphetamine use.
Leqvio Demonstrates Significant LDL-C Reduction in Patients at Risk of Atherosclerotic Cardiovascular Disease
Topline results from the Phase III V-MONO study of Leqvio found that twice-yearly Leqvio achieved clinically LDL-C lowering compared to both placebo and ezetimibe.
Aetna to Cover Fertility Services
This makes Aetna the first major insurer to cover these types of services.
Lilly Introduces Single-Dose Vials of Zepbound, Expanding Access for Adults with Obesity
The new vials of Zepbound are available through a new self-pay pharmacy channel, priced over 50% lower than other incretin medications for obesity.
Merck Launches Shorespan-007 Clinical Trial of Bomedemstat for Essential Thrombocythemia
Shorespan-007 is expected to enroll approximately 300 patients with essential thrombocythemia and will compare bomedemstat to hydroxyurea, the current standard of care.
FDA Clears Insulet’s Omnipod Automated Insulin Delivery System for Type 2 Diabetes
Expanded indication makes Omnipod the first automated insulin delivery system to be approved for the management of both type 1 and type 2 diabetes.
Are We Entering the Nuclear Medicine Industrial Revolution?
Achieving better outcomes for patients and advancing the fields of nuclear medicine and oncology are not just about adopting new technologies, but also about embracing a profound change in how care is delivered.
Dupixent Demonstrates Efficacy Treating Chronic Obstructive Pulmonary Disease, Asthma
Results from the Phase III BOREAS and NOTUS trials found that Dupixent reduced moderate-to-severe COPD exacerbations by 31% over 52 weeks.
FDA Approves Arthroscopic Delivery of Vericel’s MACI for Knee Cartilage Defects
The MACI Arthro can be administered through small incisions using custom instruments to repair cartilage defects in the knee.
BioVaxy Announces Findings For Use of DPX in Vaccine Development
The novel lipid-in-oil delivery platform showed positive results across multiple disease states.
HitGen Announces Collaboration with Bridge Biotherapeutics
The two companies will work together to accelerate the drug discovery process for cancer treatments.
FDA Grants Fast Track Designation to Clarity Pharmaceuticals’ Novel Treatment for PSMA-Positive Prostate Cancer Lesions
64Cu-SAR-bisPSMA has demonstrated advantages over current diagnostic tools, such as higher tumor uptake, next-day imaging, and a longer half-life in PET imaging of PSMA-positive prostate cancer lesions, Clarity says.
FDA Approves Updated COVID-19 Vaccines
The updated formulas should provide better protection against the currently circulating strains.
Addressing Challenges to Access, Advancement of Myeloma Therapies
In an interview with Pharm Exec Associate Editor Don Tracy, Joseph Mikhael, MD, chief medical officer, IMF, discusses challenges of access and advancement of myeloma therapies.
Study Suggests Promise of Psilocybin in Treating Depressive Symptoms
Findings from a recent study demonstrated that high-dose psilocybin provided a superior reduction in depressive symptoms compared to both placebo and escitalopram in patients with major depressive disorder.
GLP-1 Therapy Significantly Increases Visceral Adipose Tissue Metabolic Activity in Patients with Obesity, Obstructive Sleep Apnea
Findings from a study published in the Journal of the Obesity Society may significantly advance the understanding of GLP-1 analogues and their role in treating obesity.
Why BioPharma C-Suites Can’t Delegate Accountable AI to Their Chief Legal Officers
A Harvard Business School Healthcare Alumni Association Q&A with Kevin Werbach, Professor of Legal Studies and Business Ethics at the Wharton School.
Quest Diagnostics to Acquire Assets from University Hospital’s Outreach Laboratory Services
This agreement will allow the diagnostic information services company to expand its operations in Ohio.
FDA Accepts Bristol Myers Squibb’s sBLA for Opdivo and Yervoy Combination for Hepatocellular Carcinoma
Acceptance of supplemental Biologics License Application was based on results from the Phase III CheckMate-9DW trial, which demonstrated that the combination of Opdivo and Yervoy significantly improved overall survival in patients with hepatocellular carcinoma.