Drug Development

Understanding HIV Drug Resistance, Minimizing Disease Transmission

by Veronica Salib

Despite having multiple tools and resources to minimize the transmission of human immunodeficiency virus (HIV), the growing rate of drug resistance has forced scientists and medical professionals to explore viral mutations more...

How Do Nonprofit Pharmaceutical Companies Get Funding?

by Veronica Salib

On July 28, 2023, the United States Food and Drug Administration (FDA) approved ReVive, an opioid reversal medication manufactured by Harm Reduction Therapeutics, a nonprofit pharmaceutical company. The concept of a nonprofit...

Biogen and Eisai Secure Traditional FDA Approval for Lequembi

by Veronica Salib

On July 6, 2023, the FDA granted Biogen Inc and Eisai Co’s Lequembi traditional FDA approval. The approval was based on a supplemental Biologics License Application (sBLA) and prior accelerated...

Guiding Obesity Management by Understanding Weight Loss Drugs

by Veronica Salib

As the popularity of weight management drugs, including Ozempic, continues to rise, clinicians and healthcare professionals need a guide to the obesity drug landscape. The nuanced field of weight management continues to become more and...

GSK Receives Fast Track from FDA for Gonorrhea Vaccine

by Hayden Schmidt

On Thursday, the FDA announced that it would grant GSK a fast track designation for its gonorrhea vaccine. The fast track process expedites the review process for drugs used to treat serious conditions...

Biopharmaceutical Leaders Challenge the IRA’s Innovation Implications

by Veronica Salib

On the first day of the 2023 World Medical Innovation Forum (WMIF), sponsored by Mass General Brigham Hospital and Bank of America, biopharmaceutical leaders convened a panel to challenge the Inflation Reduction Act’s (IRA)...

Retatrutide Helps Patients Achieve 17.5% Weight Reduction at 24 Weeks

by Veronica Salib

A phase 2 clinical trial published in the New England Journal of Medicine revealed that retatrutide, Eli Lilly’s newest weight loss drug, helped patients achieve a 17.5% weight reduction in 24...

FDA Issues Guidance on Psychedelic Drug Use in Clinical Trials

by Veronica Salib

On June 23, 2023, the United States Food and Drug Administration issued its first draft guidance on using psychedelic drugs in clinical trials. Marking a pivot in the clinical trial landscape, these...

Eli Lilly Announces $2.4B Acquisition of Immunology Company Dice Therapeutics

by Hayden Schmidt

Monday, Eli Lilly announced that it would acquire Dice Therapeutics for $2.4 billion in cash, representing a 40% premium on the recent trading value of the smaller firm. Lilly’s purchase...

Understanding the Basics of Pharmaceutical Compounding

by Alivia Kaylor

The healthcare industry relies heavily on pharmaceutical compounding, as it allows for personalized medication solutions to meet the specific requirements of individual patients. By delving into the vital components of pharmaceutical...

Merck and Moderna Skin Cancer Vaccine Significantly Reduces Risk of Death

by Hayden Schmidt

An mRNA vaccine produced by Moderna and Merck reduced the risk of skin cancer metastasis or death by 65%, according to clinical trial results shared at the 2023 session of the American Society of...

Addressing Clinical Trial Challenges and High Drug Development Costs

by Editorial Staff

The drug development process is a notably tricky component of the pharmaceutical industry, accounting for the most time and money required to get a drug to market. Across the United States, the average spending on drug development is...

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...

FDA Advisory Committee Favors Approval of Intranasal Epinephrine

by Veronica Salib

On May 11, 2023, the United States FDA Pulmonary–Allergy Drug Advisory Committee (PADAC) favored the approval of Neffy, the first intranasal epinephrine spray for allergic reactions. The panel...

Exploring FDA-Approved Drugs and Potential Treatment Options for ALS

by Alivia Kaylor

According to 2017 CDC data, over 31,000 people are living with amyotrophic lateral sclerosis (ALS) in the United States. In America, approximately 5,000 individuals are diagnosed with ALS annually. ALS is associated with high costs, as the...

Comparing Small Molecule and Biologics Drug Development Challenges

by Veronica Salib

In recent years, pharmaceutical industry members have identified a boom in the biologic and biosimilar space. Although they only comprise a small part of the pharmaceutical industry, biological drug...

A Melatonin Study Highlights a Lack of Supplement Regulation

by Veronica Salib

JAMA recently published a research letter highlighting the lack of supplement regulation by comparing the amount of melatonin and CBD in varying brands of melatonin gummies. The researchers determined...

Advancing Health Equity with Clinical Trial Diversity: Key Strategies

by Veronica Salib

Clinical trials are currently the gold standard for proving the efficacy and safety of new treatments for regulatory approval. Globally, clinical trial data supports medical decisions and drug development. Each year, hundreds of thousands...

Understanding the Pharmaceutical Drug Development Life Cycle

by Veronica Salib

While the pharmaceutical industry and its stakeholders constantly develop and advance new drugs, products, and treatments, the drug development life cycle always needs new discoveries and additions in...

GSK Acquires Bellus Health for $2 Billion

by Hayden Schmidt

On Tuesday, GSK announced that it had reached an agreement to acquire Bellus Health Inc. for nearly $2 billion. Bellus, a Canada-based biopharmaceutical company, will provide GSK access to camlipixant,...