A robust research and innovation ecosystem makes Italy an attractive life sciences hotspot, according to a post from an Italian trade delegation at Bio Digital 2021.
BMS drug Opdivo lands FDA approval for gastro cancers By Jenni Spinner The therapeutic has been approved as an adjuvant treatment for varieties of esophageal cancers in patients who have received neoadjuvant chemoradiotherapy.
Bristol Myers Squibb (BMS) announced the US Food and Drug Administration (FDAP has approved Opdivo (nivolumab, injection for intravenous use) for adjuvant treatment of completely resected esophageal or gastroesophageal junction (GEJ) cancer with residual pathologic disease in patients who have received neoadjuvant chemoradiotherapy (CRT). The approval is based upon results from the recent Phase III CheckMate -577 trial, which evaluated the drug in comparison to placebo in esophageal or GEJ cancer patients with residual pathologic disease following neoadjuvant CRT and complete resection.
Moderna has initiated the rolling submission process with the US Food and Drug Administration (FDA) for a Biologics License Application (BLA) to distribute and market its mRNA COVID-19 vaccine in the US for use in individuals aged 18 and older.
Despite COVID-19, pharma R&D funding at all-time high: IQVIA According to the clinical research solutions firm, disruptions due to the pandemic did not stop the industry from fueling R&D at unprecedented levels.
The IQVIA Institute for Human Data Science has released its latest industry latest report, Global Trends in R&D: Overview Through 2020. According to the findings, research and development funding maintained historically high levels, thanks to new funding sources, strategic transactions, and other activity.
Murray Aitken, executive director of the IQVIA Institute for Human Data Science, spoke with Outsourcing-Pharma about the report. He shared perspective on what the document reveals about the industry’s optimism, ingenuity, and innovation.
The trial services firm has entered an acquisition agreement with Thoma Bravo, a private equity company centered on software and technology services.
Greenphire, a technology firm that provides financial lifecycle management solutions for clinical trials, has entered an agreement with Thoma Bravo, a private equity outfit that focuses on software and technology buys. The deal is expected to wrap in the second quarter of 2021, pending regulatory approvals; financial details were not disclosed.
Greenphire CEO Jim Murphy discussed the deal with Outsourcing-Pharma, the milestones in the company’s 13-year history, and what the acquisition might mean for the future of the firm.