Drug Discovery

How to Effectively Integrate AI into Clinical Trials

November 16, 2023 - Since its inception, artificial intelligence (AI) has continually disrupted practices across all industries. As more and more healthcare researchers and clinicians adopt AI, experts have noted the impact of AI on clinical research and trial management. PharmaNewsIntelligence sat down with Tobias Guennel, PhD, SVP of Product Innovation and Chief Architect, QuartzBio, part of Precision...

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FDA Reviews AstraZeneca’s Self-Administered Flu Vaccine, FluMist

by Alivia Kaylor

In a landmark development in the world of healthcare, AstraZeneca's FluMist Quadrivalent is set to revolutionize flu vaccination by potentially becoming the first and only self-administered flu...

How Can Pharmaceutical Companies Meet Drug Launch Expectations

by Veronica Salib

Earlier this month, Deloitte published a report evaluating why so many drug launches failed to meet their expectations. According to data analyzed by the Deloitte Center for Health Solutions through the Life Sciences and Healthcare...

Expanding Product Portfolios Through Technology Integration

by Alivia Kaylor

The biotechnology and pharmaceutical industries have long been at the forefront of technological innovation, leveraging cutting-edge advancements to improve healthcare outcomes and enhance product portfolios.   In an era where...

HHS Petitions DEA to Reclassify Cannabis as a Schedule III Drug

by Veronica Salib

On August 30, 2023, a leaked document revealed that the United States Department of Health and Human Services (HHS) plans to petition the Drug Enforcement Administration (DEA) to reclassify cannabis...

FDA Approves Second OTC Naloxone for Opioid Overdose Management

by Veronica Salib

Four months after approving the first over-the-counter (OTC) naloxone, the FDA has made another harm reduction tool available by supporting a second OTC Naloxone nasal spray, RiVive. The nasal spray...

FDA Proposes Amendment to Human Prescriptions Drug Labeling Guidelines

by Veronica Salib

On May 30, 2023, the United States Food and Drug Administration (FDA) proposed an additional Patient Medication Information (PMI) section on human prescription drug labels, amending current...

FDA Approves Abbvie’s Medication for Crohn’s Disease in Adults

by Veronica Salib

On May 18, 2023, the United States Food and Drug Administration (FDA) approved RINVOQ, manufactured by Abbvie, as a once-daily treatment for adults with moderate or severely active Crohn’s...

A New Era in Medicine: The Therapeutic Promise of HMO-Based Medications

by Alivia Kaylor

Human breast milk has long been recognized as the optimal source of infant nutrition, providing essential nutrients and antibodies that promote growth and protect against infection. However, research has revealed that breast milk contains...

Merck and Moderna Find Success with Cancer Vaccine Clinical Trial

by Hayden Schmidt

Pharmaceutical companies Merck & Co and Moderna Inc announced positive clinical trial results for their investigational melanoma vaccine candidate last week. The personalized cancer treatment that...

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...

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...

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...

A History of Antivirals: Mechanisms, Classes, and Subtypes

by Veronica Salib

Antivirals have rapidly become a popular topic with their implications in treating COVID-19. Understanding antivirals, their mechanisms, classes, and subtypes is an essential part of being able to treat viral infections such as the...

Researchers Discover Promising Compound That Kills Hard-to-Treat Cancer Cells

by Alivia Kaylor

Scientists from the University of Texas Health Science Center at San Antonio have found a new target for eradicating various hard-to-treat cancer cells in culture and animal models, which could...

Academia Partners with Pharma to Discover New SARS-CoV-2 Drug Treatments

by Alivia Kaylor

The National Institutes of Health (NIH) and the National Institutes of Allergy and Infectious Disease (NIAID)’s Antiviral Drug Discovery (AViDD) Centers for Pathogens of Pandemic Concern program...

Eli Lilly Invest $2.1B in Indiana Pharmaceutical Manufacturing

by Hayden Schmidt

Pharmaceutical giant, Eli Lilly, will extend its operations in Indiana, adding two additional manufacturing facilities with a $2.1 billion investment. Lilly will use the new facilities to produce...

Exploring Antidepressants: Selective Serotonin Reuptake Inhibitors (SSRIs)

by Alivia Kaylor

Selective serotonin reuptake inhibitors (SSRIs) are a class of antidepressant drugs that treat depression and other mental health conditions by inhibiting the reabsorption of serotonin by neurons in the brain. According to the National...

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