Drug Development

A Single Dose of Psilocybin Can Reduce MADRS Score

by Veronica Salib

BMC Psychiatry states that up to one-third of patients with major depressive disorder become resistant to treatment, otherwise known as treatment-resistant depression. In recent years, psilocybin and...

FDA Approves Investigational Drug Application for Bi-Functional Fusion Protein

by Veronica Salib

In a recent announcement, the Simcere Pharmaceutical Group — a global pharmaceutical company with origins in China — revealed that the FDA approved its investigational new drug application...

Understanding the FDA’s Expedited Approval Pathways

by Veronica Salib

The United States Food and Drug Administration (FDA) is responsible for regulating everything from cosmetic products to medical devices to prescription drugs. In recent years, the FDA has been under enormous pressure to accelerate its...

Understanding the Complexities Associated with IgA Nephropathy

by Veronica Salib

According to the Mayo Clinic, IgA nephropathy — sometimes referred to as Berger’s disease — is an autoimmune disease in which an antibody called immunoglobulin A (IgA) builds up in the kidneys, leading to local...

Etripamil Phase III Clinical Trials Are Successful

by Veronica Salib

Milestone Pharmaceuticals recently announced positive test results from a phase III clinical trial of etripamil, a calcium channel blocker to treat paroxysmal supraventricular tachycardia (PSVT). PSVT...

Orexo Pharmaceuticals Announces Phase I Clinical Study Data

by Veronica Salib

Months after announcing the development of a nasal epinephrine rescue medication, Orexo Pharmaceuticals announced positive phase I clinical trial data on the drug — called OX640. Epinephrine is a...

How Antibiotics and Antibiotic Resistance Transformed Medicine

by Veronica Salib

Although the development of antibiotics was a significant revolution in medicine, antibiotic education has become increasingly important as the rates of antibiotic-resistant bacteria have risen. As a result, providers are encouraged to...

Pharmaceutical Industry Is Developing Almost 800 Chronic Disease Drugs

by Veronica Salib

As the rate of chronic disease in the United States continues to rise, industry members are looking for new and effective methods to manage and treat these disorders. The Pharmaceutical Research and...

FDA Approves Drug for Open-Angle Glaucoma and Ocular Hypertension

by Veronica Salib

In a recent press release, Santen announced that the FDA approved OMLONTI, the company’s newest ophthalmic medication. This ophthalmic solution is composed of 0.002% omidenepag isopropyl. This...

Combining Existing Drugs Introduced New Parkinson’s Disease Treatment

by Veronica Salib

The National Institute of Neurological Disorders and Stroke, a subset of the NIH, estimates that nearly one million people in the United States have Parkinson’s disease. Considering the ever-aging population and the increased risk of...

Drug Costs Are Not Justified by Research and Development Costs

by Veronica Salib

It’s no secret that drug costs in the United States have continued to increase in the past few years. The Kaiser Family Foundation states that between 2019 and 2022, 48% of prescription drugs had...

FDA Approves Relyvrio for ALS Treatment

by Veronica Salib

Yesterday, the FDA approved Relyvrio, an ALS drug developed by Amylyx Pharmaceuticals, after extensive discussions about the safety and efficacy of the drug. The drug was initially rejected by an FDA...

How Antirejection Drugs Can Promote Successful Transplants

by Veronica Salib

The United Network for Organ Sharing (UNOS) states that, as of July 2022, there have been 24,414 organ transplants this year in the United States alone. Considering the limitations on the number of organs available for transplant and the...

US FDA Accelerated Approval for 48 Non-oncology Drugs

by Veronica Salib

The FDA approval process is multi-faceted and involves several aspects. One of these aspects is accelerated approval, which is meant to approve drugs to treat severe or fatal diseases. According to a...

How a New Antiviral Therapy May Prevent COVID-19 Transmission

by Veronica Salib

Throughout the COVID-19 pandemic, researchers and clinicians have worked tirelessly to develop new antiviral therapies to prevent, treat, and minimize the effects of the SARS-CoV-2 viral infection....

How Biomarker Research Has Brought Scientists Closer to an HIV Vaccine

by Veronica Salib

In a recent article published in Nature Medicine, researchers shared information on new biomarkers to develop HIV prevention tools. This publication highlighted research from the Antibody Mediated Prevention (AMP) trials. It is thought...

Medications in the US Are More Widely Available than in Germany

by Veronica Salib

A retrospective cohort study was conducted using data from January 1, 2004, to December 31, 2018. The researchers reviewed information from the FDA and the European Medicines Agency (EMA) to determine...

FDA Announces That 35% of Drug Samples Were Non-Compliant

by Veronica Salib

The FDA’s Report on The State of Pharmaceutical Quality is published annually to analyze quality measures related to drug manufacturers and products. The report looked at manufacturing site...

FDA Approved AUVELITY for Major Depressive Disorder in Adults

by Veronica Salib

On August 19, 2022, the FDA approved AUVELITY — an oral medication manufactured by Axsome Therapeutics — for the treatment of major depressive disorder (MDD) in adults. This medication...

FDA Approves Cell-Based Gene Therapy for Patients with Beta Thalassemia

by Veronica Salib

On August 17, 2022, the FDA approved bluebird bio's Zynteglo (betibeglogene autotemcel), the first cell-based gene therapy to treat patients with beta thalassemia who need regular red blood...