FDA Panel Rejects Broad Olaparib Indication in Metastatic CRPC
In a near-unanimous vote on Friday, outside advisors to the FDA recommended a narrow indication should the agency approve olaparib (Lynparza) plus abiraterone (Zytiga) as initial treatment for metastatic castration-resistant prostate cancer (mCRPC). In an 11-1 vote (with one abstention), the Oncologic Drugs Advisory Committee (ODAC) recommended that any approval be restricted to patients with […]
Supreme Court Preserves Access to Mifepristone
The Supreme Court on Friday preserved access to mifepristone (Mifeprex), a drug used in medication abortions by millions of women since its approval more than two decades ago, rejecting restrictions set to be imposed by lower courts while the case can be fully heard. “Although the Supreme Court has kept mifepristone available to patients for […]
Supreme Court Extends Stay on Abortion Pill Ruling
The Supreme Court extended a hold on a lower-court ruling on mifepristone until Friday, meaning the drug will remain broadly available for now. On Wednesday afternoon, hours before the stay on the lower-court ruling was expected to be lifted, Justice Samuel Alito extended the pause through Friday evening. Had the Supreme Court not extended the […]
Federal Judge Halts FDA’s Abortion Pill Approval
A federal judge in Texas on Friday suspended the FDA’s 2000 approval of mifepristone (Mifeprex) — the most commonly used drug for medication abortion nationwide. Importantly, Judge Matthew Kacsmaryk, of the U.S. District Court for the Northern District of Texas, also stayed the effective date of his order for 7 days to allow the federal […]
Plan for More Oversight of Pathogen-Related Research Passes Hurdle
On Friday, federal advisors endorsed new recommendations for improving the biosecurity oversight of scientific research involving potential pandemic-causing pathogens. The board of directors of the National Science Advisory Board for Biosecurity (NSABB) voted to approve a proposed framework requiring federal departments to review any research that could potentially enhance the transmissibility or virulence of a […]
California Bill Barring Docs From Telling COVID Lies Signed Into Law
California Governor Gavin Newsom signed legislation on Friday that gives the state some ammunition against physicians who spread lies about COVID in the context of direct patient care, although it won’t apply to those who spread such misinformation on social media. It is said to be the first such law in the nation. Such misinformation […]
MedPAC Commissioners Mull Proposals to Change Part B Drug Payment
WASHINGTON — Members of the Medicare Payment Advisory Commission (MedPAC) spoke up Friday in favor of considering new approaches to the way Medicare pays for Part B drugs. “I think we’re going in the right direction,” said commissioner Gary Poulsen, MBA, of Intermountain Healthcare in Salt Lake City, Utah. “I think this is an improvement.” […]
Biden Signs Order Protecting Access to Reproductive Health Services
President Biden signed an executive order on Friday aimed at protecting reproductive rights, especially access to abortion, following the Supreme Court’s decision to strike down Roe v. Wade late last month. Biden also issued a call to action, urging those who support reproductive rights to vote this fall. “What we’re witnessing wasn’t a constitutional judgment. […]
Beta-Thalassemia Gene Tx Gets Ringing Endorsement From FDA Advisers
An FDA advisory committee on Friday unanimously recommended betibeglogene autotemcel (beti-cel) for approval in patients with transfusion-dependent beta-thalassemia, a chronic inherited blood disorder. With a 13-0 vote, FDA’s Cellular, Tissue, and Gene Therapies Advisory Committee said the benefits of the one-time, first-in-class lentiviral vector (LVV) gene therapy outweigh any of the risks associated with the […]
Dr. Lorna Breen Law Signals Hope for Healthcare Workers
On Friday, President Joe Biden signed the Dr. Lorna Breen Health Care Provider Protection Act into law. The law will direct $140 million over the next 3 years to training healthcare providers on suicide prevention strategies and behavioral health, promoting self-care and the importance of seeking help, and scaling best practices. For the family of […]