PINK Better Mammo Service - World’s First FDA Cleared Artificial Intelligence Solution for 3D Mammography

ImageCare Centers is unveiling their new “PINK Better Mammo” service with the addition of ProFound AI for Digital Breast Tomosynthesis (DBT). ProFound AI was the first artificial intelligence (AI) software for DBT, or 3D mammography, to be FDA cleared; the software is clinically proven to improve accuracy and efficiency for radiologists reading mammography. 

The technology will be rolled out to all of ImageCare’s mammography centers this October.

ProFound AI for DBT was clinically proven in a large reader study to increase radiologists’ sensitivity by 8 percent, minimize the rate of false positives and unnecessary recalls by 7 percent and reduce reading time by 52.7 percent. ProFound AI was also clinically proven to slash reading time by up to 57.4 percent for radiologists reading cases of women with dense breasts.

FDA Ad Comm Votes Unanimously in Favor Of COMIRNATY Booster for Emergency Use in People 65+ and Certain High-risk Populations

 Pfizer (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) have announced that the U.S. Food and Drug Administration’s (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted unanimously to recommend the FDA grant Emergency Use Authorization (EUA) for a booster dose of COMIRNATY (COVID-19 Vaccine, mRNA) in individuals 65 years of age and older and individuals at high risk of severe COVID-19. 

The committee recommended that the additional dose be administered at least six months after the two-dose series. The panel also agreed that healthcare workers and others at high risk for occupational exposure should be included in this EUA.

VRBPAC based its recommendation on the totality of scientific evidence shared by the companies, including data from their clinical program evaluating the safety, tolerability and immunogenicity of a booster dose of COMIRNATY. A booster dose of the vaccine elicited significantly higher neutralizing antibody titers against the initial SARS-CoV-2 virus (wild type), as well as the Beta and Delta variants, when compared with the levels observed after the two-dose primary series. The reactogenicity profile within seven days after the booster dose was typically mild to moderate, and the frequency of reactions was similar to or lower than after dose two. The adverse event profile was generally consistent with other clinical safety data for COMIRNATY.

Real-world surveillance data also were presented to the VRBPAC by the Israel Ministry of Health, providing further support for the public health impact of boosters. The data presented from Israel included an analysis published this week in The New England Journal of Medicine. The analysis comprised approximately 1.1 million individuals ages 60 years and older who were eligible for a booster dose of the vaccine between July 30 through August 31, 2021. No new safety signals were observed, and reported adverse events were lower than those observed after dose two. The analysis showed that a booster dose restored very high levels of protection against COVID-19 infections and severe disease in this period when Delta was the dominant strain. Individuals who received the booster dose were less likely by a factor of 11.3 (95% CI: 10.4, 12.3) to develop a confirmed infection and less likely by a factor of 19.5 (95% CI: 12.9, 29.5) to develop severe illness compared to those who were previously fully vaccinated but did not receive a booster dose.

Dr. Reddy’s Laboratories and Citius Pharmaceuticals enter into agreement for denileukin diftitox

 Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY) have announced that they have entered into a definitive agreement with Citius Pharmaceuticals pursuant to which they sold all of their rights to E7777 (an engineered IL-2-diphtheria toxin fusion protein) and certain related assets.

Under the terms of agreement, Dr. Reddy’s will receive $40 million upfront upon the closing of the transaction, followed by approval milestone payment of up to $40 million related to the CTCL (cutaneous T-cell lymphoma) indication approval and up to $70 million for additional indication approvals. Further, Dr. Reddy’s will receive certain sales-based milestones and tiered earn-out payments.

Recall, in Mar 2016, Dr. Reddy’s had acquired the exclusive global rights (excluding Japan and Asia) to the investigational anti-cancer agent E7777 from Eisai Co. Ltd.

Click here to know more about the clinical trials of denileukin diftitox.