As companies move into development of drugs against novel targets, including a host of genomically derived drugs, they are assuming a new kind of target risk. The heightened risk exists largely because the targets revealed by genomics techniques for the most part have not been validated by linking them empirically to the initiation or maintenance of a disease state, nor through the use of biomarkers during clinical development. Stumbles in the pursuit of drugs against EGFR are symptomatic of this new pharma industry problem. In this context, the cancer drugs Herceptin and Gleevec, widely touted as the first examples of rapidly developed, rationally designed molecular medicines, will prove to be much more the exception than the rule. And importantly, the emerging pattern of EGFR drug development suggests that pursuit of novel targets will do little to ameliorate the industry's R&D productivity problem.
by Mark L. Ratner
When ImClone Systems Inc. finally acknowledged last December that the US Food and Drug Administration had raised substantial issues...
Join thousands of industry professionals who rely on In Vivo for daily insights
Already a subscriber?
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.
Pharma leaders are shifting from AI pilots to enterprise-scale deployment, favoring external partnerships for efficiency gains while maintaining tight control over sensitive clinical data.
The biotech funding landscape is undergoing a fundamental shift. With traditional VC becoming increasingly cautious and selective, industry executives are exploring new avenues for capital. Conversely, this evolution may ultimately benefit the sector's long-term sustainability.
In Vivo spoke with Edward Ahn, CEO of Medipost, a Korean company that has developed stem cell therapies from cord blood, on how they are working across regulatory markets to provide a novel treatment for degenerative diseases.
Akelos is developing a first-in-class, non-addictive HCN1 inhibitor for peripheral neuropathic pain, based on anesthesiology research from Weill Cornell. The compound is designed to avoid the brain and heart, and has shown strong preclinical efficacy and safety with NIH backed development underway.
As gene therapy advances and regulations tighten, biopharma companies face growing pressure to design diagnostic assays that are both flexible and future ready. Strategic early investment in assay development can prevent costly delays and rework as therapies progress toward approval.
In the latest episode of the In Vivo Podcast, Jeremy Skillington, CEO of Poolbeg Pharma, discussed the company’s ambitious pipeline and strategic direction.
