FDAcop, Author at FDA Copilot

July 10, 2023 Artificial Intelligence FDAcop

Toxicity Concerns Cast Uncertainty on Phase 3 Results of AstraZeneca and Daiichi Cancer Drug

A targeted cancer therapy developed by AstraZeneca and Daiichi Sankyo has shown promising results in a Phase 3 study for advanced non-small cell lung cancer (NSCLC). The drug, called datopotamab deruxtecan, demonstrated a statistically significant improvement in progression-free survival compared to chemotherapy. However, the companies also disclosed that an unspecified number of patient deaths occurred […]

July 10, 2023 Artificial Intelligence FDAcop

Johnson & Johnson to Conduct Phase 3 Trial to Stay Competitive in the Pursuit of Oral Psoriasis Medications

Johnson & Johnson (J&J) is making progress in developing a pill formulation to treat plaque psoriasis, a skin disorder that is currently treated with injectable biologic drugs. The company presented mid-stage data for its experimental drug JNJ-2113 at the World Congress of Dermatology meeting in Singapore. The study showed that a higher proportion of patients […]

July 10, 2023 Artificial Intelligence FDAcop

FDA Removes Partial Hold on Curis Drug, Enabling Progression to Phase 2 Leukemia Study

Lexington, Massachusetts-based biotech company Curis has received clearance from the FDA to resume a clinical trial that was placed on hold for over a year. The trial is testing the drug emavusertib, which is designed to block the enzyme IRAK4, involved in certain cancers and inflammatory diseases. The trial was put on hold after a […]

July 9, 2023 Artificial Intelligence FDAcop

Update from the FDA: June 6, 2023

The U.S. Food and Drug Administration (FDA) has released a summary of recent news and updates. First, the FDA issued a letter to health care providers recommending conservation strategies for non-sterile, single-use pneumatic tourniquet cuffs. The agency provided a list of best practices for cleaning and sterilization/disinfection of these devices and recommended the use of […]

July 9, 2023 Artificial Intelligence FDAcop

Gratitude Expressed | Analysis of Life Sciences

The FDA’s Office of Pharmaceutical Quality (OPQ) recently published a report on the current state of pharmaceutical quality. However, there are some concerns and gaps in the report’s information. The creation of OPQ was aimed at addressing the lack of quality-related information available outside of the product review process and post-approval inspections. The office aims […]

July 9, 2023 Artificial Intelligence FDAcop

FDA News Roundup: June 9th, 2023

In a recent announcement, the U.S. Food and Drug Administration (FDA) provided updates on various topics related to healthcare and medical devices. Here are the key highlights: Oxygenator Device Recall: The FDA issued a letter to healthcare providers and facilities regarding a recall notice by Getinge/Maquet for Quadrox Oxygenators. The letter includes recommendations for healthcare […]

July 9, 2023 Artificial Intelligence FDAcop

Regulatory Experts Provide an Exclusive Analysis on Life Sciences

The FDA’s Office of Pharmaceutical Quality (OPQ) has recently released a report titled “State of Pharmaceutical Quality,” which aims to provide insight into the current state of quality in the pharmaceutical industry. However, upon closer analysis by AgencyIQ, it becomes apparent that the report is lacking in certain areas and contains some potentially misleading information. […]

July 8, 2023 Artificial Intelligence FDAcop

FDA Releases Draft Guidelines for Decreasing Microbial Contamination in Tattoo Inks

The U.S. Food and Drug Administration (FDA) has issued a draft guidance to help manufacturers and distributors prevent microbial contamination in tattoo inks. With approximately 30 percent of people in the U.S. having a tattoo, it is important to ensure that tattoo inks are free of contamination to prevent infections and serious injuries. The FDA […]

July 8, 2023 Artificial Intelligence FDAcop

FDA News Roundup: June 13, 2023

The U.S. Food and Drug Administration (FDA) has released a summary of recent news from the agency. One of the highlights is the publication of an article by Kerry Jo Lee, M.D., Associate Director for Rare Diseases at the FDA, on the Accelerating Rare disease Cures (ARC) Program. The ARC Program aims to increase the […]

July 8, 2023 Artificial Intelligence FDAcop

Bausch + Lomb Remains on Acquisition Path: Buys J&J Eye Drops for $106M

Bausch + Lomb, a global eye care company, is expanding its over-the-counter presence by acquiring Johnson & Johnson’s Blink line of eye drops for $106.5 million. The acquisition includes the Blink product line, which consists of six eye drops and contact lens drops for rewetting and lubricating the eye. Bausch + Lomb will finance the […]

Author: FDAcop