article thumbnail

Thienopyrimidine: Unveiling the Versatile Potential of a Promising Heterocyclic Scaffold in Drug Discovery

Chemical Biology and Drug Design

The presence of thienopyrimidine derivatives in several FDA-approved drugs and clinical trial candidates underscores their therapeutic potential and safety profile. Thienopyrimidines exhibit multifarious features, mainly, this is due to their structural resemblance with purine bases, such as guanine and adenine.

article thumbnail

FDA Approves Merck’s ENFLONSIA™ to Prevent RSV in Infants

The Pharma Data

This new monoclonal antibody therapy is designed to prevent lower respiratory tract disease caused by respiratory syncytial virus (RSV) in neonates and infants born during or entering their first RSV season. Key results from the CLEVER trial include: A 60.5% Octavio Ramilo, Chair of the Department of Infectious Diseases at St.

Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

Sarepta Strengthens ELEVIDYS Safety Measures for Non-Ambulatory Duchenne Patients

The Pharma Data

ENVISION Study Dosing Currently Paused Sarepta is also voluntarily pausing dosing in its ongoing ENVISION clinical study (Study SRP-9001-303), a trial that includes both non-ambulatory and ambulatory individuals with Duchenne muscular dystrophy. The FDA agrees with this cautious approach.

article thumbnail

Navigating Regulatory Hurdles in Drug Development

DrugBank

The failure rate in clinical trials exceeds 90%, often due to insufficient safety data, efficacy concerns, or regulatory non-compliance. Even drugs that complete clinical trials may face delays or rejections if submission documents are incomplete or do not align with regulatory expectations.

article thumbnail

PRITELIVIR MESYLATE

New Drug Approvals

1428321-10-1 Pritelivir mesylate is an antiviral drug currently under development, specifically targeting herpes simplex virus types 1 and 2 (HSV-1 and HSV-2). Clinical Trials: Pritelivir is currently in phase II clinical trials, with ongoing research into its effectiveness and safety.

Virus 62
article thumbnail

mRNA Tech Transfer Phase 2.0 Discussed at G20 Summit

The Pharma Data

These include misinformation and vaccine hesitancy, policy uncertainty, high clinical trial costs, and a lack of well-understood and adaptable procurement mechanisms for low- and middle-income markets.

Vaccine 40
article thumbnail

Merck’s ENFLONSIA Receives ACIP Recommendation for Protecting Infants from Severe RSV

The Pharma Data

CDC panel backs long-acting monoclonal antibody to protect infants during their first RSV season; drug also included in federal Vaccines for Children program Merck , operating as MSD outside the United States and Canada, has announced a key regulatory milestone for its respiratory syncytial virus (RSV) prevention program.

Vaccine 52