In a step toward what may become the new normal, at least for now, the Pediatric Oncology Subcommittee of the FDA’s Oncologic Drugs Advisory Committee is meeting virtually Wednesday and Thursday to review pediatric development plans for four cancer drugs.
In a deal potentially worth $3 billion, privately held Repare Therapeutics Inc., of Cambridge, Mass., and Montreal, entered a research collaboration with Bristol Myers Squibb Co. (BMS) to identify synthetic lethal precision oncology targets for drug candidates.
The EMA's Committee for Medicinal Products for Human Use said Friday it has started a rolling review of Gilead Sciences Inc.'s antiviral, remdesivir, for the potential treatment of COVID-19. The move put into play one of multiple regulatory tools it has deployed "to speed up the assessment of a promising investigational medicine during a public health emergency."
As the coronavirus pandemic rages on, biopharma companies are being forced to respond to multiple challenges that could derail their existing business plans. Already companies are reporting that, in therapeutic indications not involving COVID-19, their ongoing and planned clinical trials are being interrupted or delayed by the pressures now being imposed on global health care systems.
Barely a day after its PDUFA date, despite the unfolding COVID-19 pandemic, the FDA has approved Bristol Myers Squibb Co.'s immunomodulator, ozanimod, an oral treatment for adults with relapsing-remitting multiple sclerosis (MS) and active secondary progressive disease branded as Zeposia. The win, a much-anticipated milestone precipitated by the company’s multibillion-dollar acquisition of ozanimod developer Celgene Corp. in November 2019, gives patients a new treatment option amid a growing field of therapies for MS.