BioSpace News Archive

AstraZeneca has decided to drop the hypercholesterolemia candidate AZD8233 through to Phase III, despite meeting its Phase IIb primary efficacy endpoint, its partner Ionis announced Friday.

The U.S. FDA had a busy week with a range of drug approvals, advisory committee meetings and classification announcements.

One-year data indicates Biogen’s tofersen for SOD1-ALS, slows the decline of the disease through the lowering of SOD1 protein and neurofilament levels.

The FDA’s Oncologic Drugs Advisory Committee (ODAC) voted 14-2 against Oncopeptides’ Pepaxto, a drug that has been on the market since 2021 for multiple myeloma under accelerated approval.

Merck announced positive results on its patent infringement case against Viatris, while Amgen faces political headwinds from the White House.

This week, researchers delivered insights and breakthroughs in regenerative medicine, Long COVID, immuno-oncology and inflammatory diseases.

The FDA will meet Friday to discuss the future of Secura Bio’s Copiktra (duvelisib), which has been approved as a third-line treatment for relapsed or refractory CLL/SLL.

NovoCure announced the launching of a U.S.-based arm to focus on and attempt to grow its glioblastoma (GBM) business and increase its patient population.

Recently published research into repairing nerve damage caused by injury may also pay off in treating some of the most vexing neurodegenerative diseases like Alzheimer’s.

Trevi Therapeutics, Inc. announced the pricing of its underwritten public offering of 14,252,670 shares of its common stock at a public offering price of $1.93 per share, and, to certain investors in lieu of common stock, pre-funded warrants to purchase 14,247,330 shares of common stock at a price of $1.929 per pre-funded warrant, for total proceeds of approximately $55 million, before deducting underwriting discounts and commissions and expenses payable by Trevi.