Posts by Sam

Pfizer/BioNtech’s Emergency Use Authorization (EUA) application for a COVID-19 vaccine for young children has cleared its first regulatory hurdle. Source: Drug Industry Daily

The FDA has rejected a citizen petition seeking to revoke the Emergency Use Authorizations (EUAs) of both the Moderna and Johnson & Johnson (J&J) COVID-19 vaccines. Source: Drug Industry Daily

The FDA is outperformed by the European Medicines Agency (EMA) and Health Canada when it comes to proactively releasing data on drug approvals, says a new study ― prompting concerns about the FDA’s relative transparency. Source: Drug Industry Daily

Moderna released top line data yesterday from a pediatric study of its mRNA COVID-19 vaccine, which showed a half-dose of the vaccine to be safe and effective in kids ages six up to 12 years old. Source: Drug Industry Daily

During its third-quarter earnings report, Eli Lilly announced that it’s pursuing accelerated approval for the investigational Alzheimer’s drug donanemab ― and that it also plans to evaluate the therapy compared to Biogen’s Aduhelm (aducanumab) in a head-to-head study. Source: Drug Industry Daily

For the second time, Novartis’ workhorse anti-inflammatory, Ilaris (canakinumab), has failed to prove its mettle as an anti-cancer agent. Source: Drug Industry Daily

As Congress races to finalize details on President Biden’s signature social spending package by week’s end, a provision allowing Medicare to negotiate prescription drug prices is expected to stay in the bill, but likely in a diluted form. Source: Drug Industry Daily

AstraZeneca has scored another win with Imfinzi (durvalumab), showing that the checkpoint inhibitor in combination with standard chemotherapy improved both overall and progression-free survival for patients with advanced biliary tract cancer (BTC), a rare, aggressive disease with extremely low 5-year survival rates. Source: Drug Industry Daily

Merck’s investigational once-daily combination pill for HIV has shown positive results in two late-stage trials. Source: Drug Industry Daily

The FDA approved 17 original abbreviated new drug applications (ANDAs) in the third quarter of fiscal 2020, 14 in the fourth quarter and 18 in the first quarter of fiscal 2021. It’s seen a downward trend in manufacturing supplements for new drug applications (NDAs), biologics license applications (BLAs) and ANDAs, approving 314 in the third…