The news from Quanterix Corp. has come fast and furiously this week. The company reported that Chairman and CEO Kevin Hrusovsky will step down on April 25 and become executive chairman of the board, while current company President Masoud Toloue will assume the CEO position and join the board of directors. Hrusovsky became CEO in 2014 and Toloue joined Quanterix in June 2021 from Perkinelmer Inc. The company also revealed that it has built on its collaboration with Indianapolis-based Eli Lilly and Co. for new tools to diagnose, monitor and treat Alzheimer’s disease (AD) and presented its fiscal 2021 financial results, which showed a 28% increase in total revenue, largely attributable to its neurology segment.
In the wake of recent U.S. FDA pushback on an NDA filing by Innovent Biologics Inc. and Eli Lilly and Co. built around ex-U.S. trial data, few companies are likely to attempt such a feat again soon – at least when the source of the data is China alone.
Drug companies won another round in their battle with the U.S. Department of Health and Human Services (HHS) over how many contract pharmacies must be given the steep discounts dictated under the 340B drug pricing program aimed at helping public clinics and hospitals provide charity care.
Although diversity was front and center, it wasn’t the only reason the U.S. FDA’s Oncologic Drugs Advisory Committee voted 14-1 on Feb. 10 that additional clinical trials demonstrating applicability to the U.S. non-small-cell lung cancer population are needed before sintilimab, a PD-1 inhibitor partnered in the U.S. by Innovent Biologics Co. Ltd. and Eli Lilly and Co., is ready for approval.
Immunogen Inc. and Eli Lilly and Co., having already seen a collaboration collapse in 2018, will try it again. Immunogen granted the exclusive rights to research, develop and commercialize antibody-drug conjugates (ADCs) that are directed toward targets Lilly will select. Waltham, Mass.-based Immunogen will receive $13 million up front from Lilly and is eligible to receive another $32.5 million in exercise fees if Lilly licenses all the targets. Down the road, Immunogen could receive as much as $1.7 billion in exercise fees and milestones payments.
Delivering important but likely unwelcome news to Americans increasingly trying put the COVID-19 pandemic behind them, new research published Feb. 11 by the CDC suggested that "protection conferred by mRNA vaccines waned in the months after receipt of a third vaccine dose reinforces the importance of further consideration of additional doses to sustain or improve protection against COVID-19-associated [emergency department or urgent care (ED/UC)] encounters and COVID-19 hospitalizations."
Although diversity was front and center, it wasn’t the only reason the U.S. FDA’s Oncologic Drugs Advisory Committee voted 14-1 that additional clinical trials demonstrating applicability to the U.S. non-small-cell lung cancer population are needed before sintilimab, a PD-1 inhibitor partnered in the U.S. by Innovent Biologics Co. Ltd. and Eli Lilly and Co., is ready for approval.
The Feb. 10 meeting of the U.S. FDA’s Oncologic Drugs Advisory Committee (ODAC) is about far more than one biologic license application (BLA), as the single question the agency will put to the committee is whether data from a trial in one foreign country are sufficient to support approval in the U.S.
Eli Lilly and Co. has the dubious distinction of receiving the first untitled letter in 2022 from the FDA’s Office of Prescription Drug Promotion. The letter, sent Jan. 19 and posted this week, takes the Indianapolis-based company to task for an Instagram ad promoting Lilly’s diabetes drug Trulicity (dulaglutide).
Once again, the U.S. FDA giveth and it taketh away. Just a few days after expanding its approval for Gilead Sciences Inc.’s Veklury (remdesivir) to provide access to more people infected with COVID-19, the FDA essentially shut down the use of two monoclonal antibody (mAb) treatments Jan. 24 that had been authorized to treat mild-to-moderate COVID-19 infections – Regeneron Inc.’s Regen-Cov (Ronapreve in Europe), an antibody cocktail of casirivimab and imdevimab, and Eli Lilly and Co.’s bamlanivimab and etesevimab that are administered together.
