Balversa Gets Full FDA Approval for Locally Advanced, Metastatic Urothelial Carcinoma
Today's approval amends the accelerated approval granted by the FDA in April 2019 to Balversa (erdafitinib) for patients with metastatic urothelial carcinoma with susceptible FGFR2 or FGFR3 alterations following prior treatment with platinum-containing chemotherapy.
How Financialization Has Impacted the US Healthcare System
Experts explore ways in which the financial sector refined the healthcare landscape, including its evolutions throughout the years.
The Evolving Role of PBMs: An Interview with Bill Roth, General Manager, Managing Partner, Blue Fin Group
In an interview with Pharma Commerce editor Nicholas Saraceno, Bill Roth, General Manager, Managing Partner, Blue Fin Group, discusses the changing role of PBMs and recent price structure overhauls.
Radioligand Therapy Found to Improve Survival, Disease Progression in Advanced GEP-NETs
Data presented at the 2024 American Society of Clinical Oncology Gastrointestinal Cancers Symposium show first-line Lutathera plus long-acting release octreotide lowered the risk of disease progression or death by 72% in patients with advanced gastroenteropancreatic neuroendocrine tumors.
In the Shadows of the Drug Affordability Debate, Patients Pay the Ultimate Price
All healthcare stakeholders must participate to dismantle barriers and ensure access to medicines that save lives.
FDA to Evaluate Premarket Approval Application for TTFields in Non-Small Cell Lung Cancer
Application seeks approval for tumor-treating fields therapy combined with either an immune checkpoint inhibitor or docetaxel in patients with metastatic non-small cell lung cancer following progression on or after the use of platinum-based therapy.
The Impact of Eli Lilly's New DTC Platform on Rx Drug Sales and Patient Access: An Interview with Bill Roth, General Manager, Managing Partner, Blue Fin Group
In an interview with Pharma Commerce editor Nicholas Saraceno, Bill Roth, General Manager, Managing Partner, Blue Fin Group, discusses changes that will come with the pharma giant's new platform.
Antibiotic for Uncomplicated Urinary Tract Infections Granted FDA Priority Review
Pivmecillinam (Pivya) has a clinical cure rate of 95% in uncomplicated urinary tract infections and is recommended as a first-line option for treatment in many countries.
Novel BTK Inhibitor Granted FDA Fast Track Designation for SLL, CLL
Data show daily oral dosing of NX-5948 in patients with relapsed or refractory B-cell malignancies experienced a clinical benefit across dose ranges from 50 mg to 200 mg.
Report: Track-and-Trace Solutions Market Anticipated to Hit $9.8 Billion by 2028
The predicted value is largely driven by manufacturers' prioritization of brand protection.
FDA Approves New Device to Track Fetal, Maternal Health
Bloomlife’s MFM-Pro enables healthcare providers to measure maternal and fetal heart rate in the patient's home or clinic.
P360 Builds Out New Artificial Intelligence-Powered Platform
EdenHelp is expected to provide HCPs and patients with real-time access to Rx drug and medical device information.
HyQvia Gets FDA Approval for Chronic Inflammatory Demyelinating Polyneuropathy Maintenance
Patients with chronic inflammatory demyelinating polyneuropathy administered HyQvia showed a statistically significant difference between relapse rates compared with placebo.
The Importance of Drug Supply Chain Security
JAMA Health Forum details the DSCSA and stresses the value of protecting the pharmaceutical supply chain from adulterated products.
New Machine Learning Model May Accelerate Drug Development
Researchers from the University of Cambridge collaborated with Pfizer to develop a platform combining automated experiments with artificial intelligence to predict chemical reactions.
Study Provides Look Into Surgeons' Opioid Prescribing Patterns
Analysis examines how social and healthcare factors play a role.
Department of Defense Grant to Power Multisite Trial of Rett Syndrome Therapy
Initiative seeks to find new therapies to improve the lives of patients with Rett syndrome.
FDA Approves CRISPR/Cas9 Gene-Edited Cell Therapy Casgevy for Transfusion-Dependent Beta Thalassemia
The list price of Casgevy for transfusion-dependent beta thalassemia has yet to be released, however, the cost for the treatment in sickle cell disease is $2.2 million.
Zoryve Produces Promising Results in Dermatologic Conditions Across Recent Trials
Zoryve (roflumilast) shows efficacy in seborrheic dermatitis and atopic dermatitis in clinical trials.
The Benefits and Privacy Concerns in Utilizing Artificial Intelligence for Early Detection of Breast Cancer
Cureus report discuss the value of AI, but the medical community must remain aware of privacy pitfalls.
Dupixent Gets FDA Label Update in Atopic Dermatitis With Uncontrolled Hand and Foot Involvement
Trial shows 52% of patients with atopic dermatitis with uncontrolled moderate-to-severe hand and/or foot involvement administered Dupixent experienced a clinically meaningful reduction in itch on hands and feet vs. 14% with placebo.
Climbing Health Care Costs Result in Elevated Employer Vigilance
Soaring healthcare costs show little sign of abating in 2024, and concerns about the affordability of medications and medical services continue to grow, despite investments in technology, clinical innovation, and efforts to manage utilization and waste.
Report: Pharmaceutical Contract Manufacturing Market Expected to Hit $140 Billion by 2030
Roots Analysis report suggests increase can be attributed to the growing demand for advanced therapies and biologics.
Air Cargo on the Rise in November
IATA’s latest numbers suggest the strongest year-on-year growth in almost two years.
Keytruda Granted Latest FDA Approval in Cervical Cancer
FDA approves Keytruda (pembrolizumab) combined with chemoradiation for the treatment of patients with FIGO 2014 stage III to IVA cervical cancer, which is the 39th overall approved indication for the drug in the United States.
ixlayer Becomes Member of American Heart Association Center for Health Technology & Innovation Consortium
The group—known as the Innovators' Network—is meant to serve as a link between entrepreneurs, providers, researchers, and payers while they strive to combat cardiovascular disease.
The Future of Employer Coverage for Glucagon-Like Peptide 1 Receptor Agonists in Weight Loss
Morgan Company report makes the case for expanding coverage for GLP-1s beyond diabetes treatment and into the weight loss class, but are employers on board?
Investigational Ovarian Cancer Drug Granted FDA Fast Track Designation
RemeGen Co. Ltd’s antibody-drug conjugate RC88 is being analyzed to treat platinum-resistant recurrent epithelial ovarian, fallopian tube, and primary peritoneal cancer.
Reimbursement-Related Analytics and Reporting
An overview of a structural approach that guides development of the analytics and related reporting that may assist brands in gaining or maintaining reimbursement positions and maximizing sales.
Emergent BioSolutions Awarded Contract to Supply US Military With Anthrax Vaccine
The US Department of Defense awarded Emergent BioSolutions Inc. with a contract worth up to $235.8 million to supply all branches of the US military with BioThrax (Anthrax Vaccine Adsorbed) for use as pre-exposure prophylaxis against anthrax disease.
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