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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 will object to any provisions included in the $1.75 trillion package. Read More
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 the agency’s fiscal 2021 initiatives. Read More
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. Read More
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). Read More
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 slash outpatient Medicare drug reimbursements to 340B hospitals by almost 30 percent. Read More
Several states and the Department of Justice have been seeking to stop pay out of the settlement, charging that the Sacklers weren’t held sufficiently accountable. Read More
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 year. Hours later the Senate passed the bill in a 69-28 vote. Read More
The FDA has sent a complete response letter (CRL) to BeyondSpring Pharmaceuticals denying approval of the company’s new drug application (NDA) for plinabulin in combination with granulocyte colony-stimulating factor (G-CSF) for the prevention of chemotherapy-induced neutropenia (CIN), an abnormally low white blood cell count. Read More