Ista’s ovine hyaluronidase is given five years of exclusivity, but Amphastar’s recently approved bovine version Amphadase is grandfathered in. FDA cites “inadequate” data to determine whether Vitrase is the same as previously approved hyaluronidase.
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The arrangement, which implies a behind the scenes negotiated discount, may signal a trend toward less price transparency in foreign markets as manufacturers parry Trump’s Most Favored Nation price demands.
The pharmaceutical industry is edging closer to EU-wide clarity on how the bloc’s data privacy rules can be applied consistently to clinical trials and pharmacovigilance activities.
A government-backed program is working on improving the ability to run dementia clinical trials in the UK, and access to trials for participants.
