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LATEST PUBLICATIONS



Quality Considerations for Using AI in Bio/Pharma

July 25, 2024

Category: Biotech, Industry, Pharma

The use of artificial intelligence (AI) is seeing a surge in a variety of industries. But does the regulated nature of bio/pharmaceutical development, manufacturing, and commercialization serve up unique challenges for incorporating AI into processes? According to Siegfried Schmitt, vice-president, […]


Boehringer backs Brainomix AI software for lung fibrosis

July 18, 2024

Category: News

The new project will focus on the real-world use of Brainomix’s artificial intelligence-powered Brainomix 360 e-Lung software, which was recently approved by the FDA in May to assist in the diagnosis and assessment of patients with interstitial lung diseases (ILDs) from medical […]


FDA rejects Novo Nordisk’s weekly basal insulin

July 11, 2024

Category: FDA, Regulations

The FDA sent the Danish drugmaker a complete response letter (CRL) declining to approve the drug, insulin icodec, saying that it needs more information on its manufacturing process, as well as more data on how well it performs in people with […]


Clinical Trials, Research and Development

Revolution Medicines firms up Phase 3 trial plans with latest cancer drug data

July 15, 2024

Via: Biopharma Dive

Revolution Medicines is one of a handful of biotechnology and pharmaceutical firms looking to exploit drug research advances that have made RAS mutations easier to target. Mutations in the gene are frequently a trigger for cancers of the lungs, pancreas […]


FDA, Regulations

Novo’s once-weekly insulin rejected by FDA

July 11, 2024

Via: Biopharma Dive

Novo is one of the world’s premier manufacturers, along with Indianapolis-based Eli Lilly. Both have been working for years to offer patients a more convenient option than the once-daily injections of insulin that many diabetics require. Lilly in May announced positive […]