Cubist, like other companies in the anti-infectives space, was founded on the assumption that anti-infective drugs entering the clinic had a significantly lower risk of failure than other therapeutics. That risk profile may be changing because of the FDA's imposition of stricter standards for the approval of anti-microbials. So far, Cubist has met that challenge with respect to daptomycin, the Phase III antibiotic that would be the company's first marketed product. Yet, a cloud of regulatory uncertainty still lingers. But through aggressive dealmaking, Cubist has built a discovery and development pipeline that helps to balance the risk that daptomycin may run into unexpected roadblocks on the way to approval.
By Jeffrey Dvorin
Like a number of biotech entrepreneurs during the early and mid 1990s, the founders of Cubist Pharmaceuticals Inc. saw...
Join thousands of industry professionals who rely on In Vivo for daily insights
Already a subscriber?
A look at Novo Nordisk, Eli Lilly and other companies' late-stage clinical studies of GLP-1 drugs in indications ranging from neurodegeneration to oncology, and alcoholic liver disease to autoimmune conditions.
Metsera CEO Whit Bernard applies an unconventional leadership philosophy to develop next-generation obesity therapeutics, including monthly GLP-1 injections and oral peptides.
A Q&A with DeAnn Smith, partner and co-chair of the Patent Trial and Appeal Board Proceedings Practice Group at law firm Foley Hoag.
Advanced AI is revolutionizing sales enablement by addressing training gaps and performance challenges. Used correctly, it can help to bridge the sales-marketing divide, accelerate ramp-up times and provide managers with data-driven insights.
While the adoption of most favored nation drug pricing in the US stands to affect Japanese biopharma firms now heavily reliant on this market, it might also present an opportunity for pricing and policy reforms at home.
Ovid Therapeutics' president and COO Meg Alexander is leading the company’s strategic pivot toward innovative neurological treatments, potentially creating a new class of medicines for rare neurological disorders.
Thijs Spoor's bet on lead-212 is paying off as Perspective Therapeutics advances three clinical programs with promising early efficacy signals and a comprehensive manufacturing strategy.
