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Follow-On Biologics' Other Pathway: Mechanisms To Resolve Patent Disputes Vary In Legislation
The debate over follow-on biologics legislation has largely focused on the length of data exclusivity that should be awarded to innovators. But provisions for resolving patent disputes between innovators and follow-on applicants are also a source of contention
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Senior Indegene executive William Lobb talks about complexities of the direct-to-patient distribution model in the US, including potentially introducing new intermediaries into the system. Questions on MFN's feasibility and why it may be “catastrophic” to biopharma were also part of the discussion
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Quick responses to late-breaking changes to US FDA COVID-19 vaccine policy kept Novavax's Nuvaxovid and Moderna's mNexspike close to expected approval timelines despite revised indications and new post-marketing trial commitments.
Last Minute Course Shifts, Focus On Unknowns: What Sponsors Should Learn From Prasad’s Interventions
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The once and current CBER director’s justification for his COVID-19 decision stands as a warning of the uncertainty sponsors, particularly those in the vaccine space, may now face at FDA.