President Biden delivered a speech yesterday highlighting the drug pricing reform measures in the Build Back Better Act — especially for insulin products — shortly after Sen. Majority Leader Chuck…
Democrats are reportedly set to meet with the Senate parliamentarian today to start discussing healthcare components in the Build Back Better Act — and to gauge whether the chamber’s gatekeeper…
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…
After a delay in 2020, the FDA has launched its new NextGen Portal for drug manufacturers to use for reporting volume data for drugs and biologics. Source: Drug GMP Report
Dercher Enterprises of Upper Darby, Pa., doing business as Gordon Laboratories, was hit with an eight-observation Form 483, and the company’s new quality director told FDAnews that he’s working to…
The FDA has closed out its three-year-old warning letter to Zhejiang Huahai Pharmaceutical’s site in Linhai, Taizhou because of corrective actions the manufacturer has undertaken. Source: Drug GMP Report