In Sepsis, Having the Right Drug Still May Not Be Enough
In conjunction with the initial sales numbers for its sepsis drug, Xigris, manufacturer Eli Lilly cautioned that "the selection of patients with severe sepsis as indicated on the label has been complex for physicians initially." To address the knowledge gap, the National Institutes of Health has awarded a $6 million grant for a study of risk factors for sepsis, the first study of its kind and the biggest single R1 grant ever funded through NIH's National Institute of General Medical Sciences. The Xigris pivotal trial was the only one of 31 Phase III trials of sepsis drugs that didn't fail. "It's not just understanding how the drug works, it's believing in it," says the principal investigator for the NIH study, which should help move the process forward.
Eli Lilly & Co. 's update on
early sales of its sepsis drug, Xigris (drotrecogin alfa, or
activated protein C) serves as a reminder that even with a new drug
finally in hand to treat this often rapidly fatal disease, the
inability to diagnose sepsis early remains a significant clinical
challenge.
Since Xigris's launch in late November, sales have reached $35 million—$14 million of it coming in the first two months...
Read the full article – start your free trial today!
Join thousands of industry professionals who rely on In Vivo for daily insights
Editor’s note: This is your final call to participate in the survey to better understand our subscribers’ content and delivery needs. The deadline is 20 September.
Mary Jane Hinrichs, Ipsen’s head of early development, talks to In Vivo about getting ahead of the competition by securing deals for candidates before they enter Phase I trials.
Editor’s note: We are conducting a survey to better understand our subscribers’ content and delivery needs. If there are any changes you’d like to see in the coverage topics, content format or the method in which you receive and access In Vivo, or if you love it how it is, now is the time to have your voice heard.
The cell and gene therapy (CGT) clinical trial landscape in general and CAR-T cell clinical trials in particular are a special focus for the FDA, EMA, and other regulatory agencies. The whole industry is thus aware of the recent FDA safety investigation and requirements for labeling CAR therapy products.
Entrepreneurialism is in the blood of Israel’s medtech innovators, but in a changing medtech world, the local ecosystem must address funding gaps and manufacturing and infrastructure needs. So says Ruti Alon, experienced Israeli medtech leader, investor and co-chair of the Biomed Israel conference.
During Q2, biopharma merger and acquisition deal value reached $24.6bn and drew in $60.7bn in potential deal value from alliances. Device company M&A values reached $223m, while in vitro diagnostics and research tools players’ M&A activity totaled $802m.
Facing rising costs and tighter regulations, PBMs and insurers are accelerating the shift to value-based drug coverage, demanding stronger proof of therapeutic and economic benefit from pharma.
