All posts by egp dave

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

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

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