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The article presents an interview with Amy Lavelle, Associate Director at Massachusetts Bioanalytical Lab, PPD Clinical Research, wherein, she discusses about the challenges of performing bioanalytical studies and how contract research organizations (CROs) can help mitigate possible regulatory submission problems. Also, talks about kind of data from bioanalytical studies that are included in regulatory filings; and the benefits of outsourcing bioanalytical studies.

The article informs that Bristol Myers Squibb announced that the U.S. Food & Drug Administration has accepted the New Drug Application (NDA) and the European Medicines Agency (EMA) has validated the Marketing Authorization Application for BMS 986165 for the treatment of psoriasis.

The author highlights the late-stage treatments that are expected to earn one billion dollars in the next five years according to Clarivate in 2022 including adagrasib from Mirati Therapeutics and Zai Lab, faricimab from Roche and Chugai Pharmaceutical, and vutrisiran from Alnylam Pharmaceuticals.

The article reports on an international phase III study of patients with metastatic castration-resistant prostate cancer (mCRPC) conducted by Dr. Robert Dreicer and colleagues which suggested that lyase inhibitor orteronel failed to significantly extend overall survival (OS).

The article discusses efforts to improve antibiotic development through incentives like Food and Drug Administration (FDA) reviews and additional 5 years of market exclusivity. Topics discussed include GBI Research's report product Frontier Pharma whose goal is to identify first-in-class targets from the company's extensive proprietary databases and the limited diversity among the first-in-class drugs with majority being novel protein synthesis inhibitors and bacterial cell wall disruptors.