Half of US states are expected to restrict or ban abortion following the Supreme Court’s leaked draft majority opinion; Bayer’s darolutamide (Nubeqa) received FDA priority review as a treatment for metastatic hormone-sensitive prostate cancer; Biogen stops marketing its controversial Alzheimer drug as its CEO plans to step down.
According to a state-by-state breakdown by Kaiser Health News, 15 states and the District of Columbia currently have laws protecting abortion access, while 14 states have “trigger laws” that would restrict abortion if the Supreme Court comes to a final ruling overturning Roe v Wade. Five states—Alabama, Arizona, Michigan, West Virginia, and Wisconsin—have laws in place from pre-Roe banning abortion. Some state governors have already responded to the Supreme Court leak by vowing to protect abortion rights in their respective states, including New Jersey Governor Phil Murphy and Illinois Governor JB Pritzker. While 16 states lack laws protecting or banning the right to an abortion, 7 of them recognize that right under the state constitution.
Bayer announced that the FDA accepted a supplemental new drug application and granted priority review for its oral androgen receptor inhibitor darolutamide (Nubeqa) in combination with docetaxel for treatment of metastatic hormone-sensitive prostate cancer. According to a release, this decision was based on positive results from a phase 3 trial that showed statistically significant improvement in overall survival in men with this type of prostate cancer who received the treatment. Darolutamide is currently used to treat early disease stages and nonmetastatic castration-resistant prostate cancer, but this priority review will focus on its treatment of metastatic cases.
Biogen has announced plans to stop marketing its Alzheimer disease drug, aducanumab (Aduhelm), following its controversial approval, low sales, and Medicare’s extremely limited coverage of the drug. According to the biotechnology company, aducanumab created $2.8 million in revenue so far in 2022, combined with only $3 million in 2021. As reported by The New York Times, this news comes as Biogen CEO Michel Vounatsos has decided to step down after more than 5 years of serving as CEO. Vounatsos will continue to lead the company until a successor is appointed.