Device Startups and Alliances: Between a Rock and a Hard Place
Development’s more expensive, markets are smaller, investors are meaner. But alliances aren’t the answer. Or at least not the answer anyone wants to hear. It's time to rethink the anti-alliance logic, which may require a new approach to starting up device companies.
You may also be interested in...
More rolling reviews, a reduction in review rounds, and a rise in applications through two international regulatory collaboration initiatives were among the factors behind a reduction in new drug authorization times in Switzerland last year. However, “submission gaps” versus other regulators remain a problem.
The Paris-headquartered company has thrown in the towel on its oral SERD, leaving Roche, Eli Lilly and AstraZeneca to pursue Menarini in the field.
An ICH guideline describes the “weight of evidence” criteria that in some cases may provide an adequate assessment of human carcinogenicity risk without the need for data from a two-year rat carcinogenicity study.