The FDA has revised its fiscal 2022 Generic Drug User Fee Act (GDUFA) II research priorities based on feedback gleaned from a June public workshop in which generic drugmakers critiqued…
Several different COVID-19 booster shot combinations appear to improve protection against infection but the messenger RNA (mRNA)-based jabs from Pfizer and Moderna might be the most effective. Source: Drug Industry…
UCB and Novartis have joined forces in what could be a $1.5 billion deal to develop two investigational molecules targeting alpha synuclein, the misfolded protein involved in Parkinson’s disease. Source:…
Bayer’s phase 3 study of Nubeqa (darolutamide) in combination with androgen-deprivation therapy (ADT) and docetaxel for patients with metastatic hormone-sensitive prostate cancer has hit its primary endpoint, showing that the…
The FDA canceled its scheduled Oncologic Drugs Advisory Committee (ODAC) meeting last week during which it had planned to discuss two cancer drugs that hold accelerated approvals (AA). Source: Drug…
Along an almost entirely Democratic party line vote, the House of Representatives voted 221 to 212 yesterday to pass a continuing resolution funding the government through Feb. 18 of next…
A drugmaker in Jiangsu, China failed to properly back-up data, among other IT-related lapses observed during an FDA inspection. Source: Drug Industry Daily
A federal appeals court has struck down Moderna’s coronavirus vaccine-related challenge to patents held by Arbutus Biopharma. Source: Drug Industry Daily
Novavax is throwing two punches at Omicron, the new COVID-19 variant that’s sparking fresh waves of travel restrictions: evaluating how well its lead COVID-19 vaccine candidate NVX-CoV2373 targets the new…
Supreme Court justices heard oral arguments this week in a lawsuit — the American Hospital Association (AHA) vs. HHS Secretary Xavier Becerra — centering on a 2018 HHS decision to…