Brenda Sandburg
Are you sure you'd like to remove this alert? You will no longer receive email updates about this topic.
Latest From Brenda Sandburg
Rejecting PhRMA's Request, US FDA Sticks With Size Over Function In Defining Biologic
Agency's final rule defines protein based on size of amino acid sequence, irrespective of method of manufacture, saying this 'bright-line rule' provides regulatory certainty.
Two Companies, Two BARDA Contracts, Two Approaches To Coronavirus
Sanofi follows Janssen in teaming up with HHS' BARDA to develop a COVID-19 vaccine; using technology platform of its Flublok vaccine, Sanofi expects to enter clinical trials in 1 to 1 ½ years.
Sanofi Tries To Stop Lantus Biosimilar By Getting Supreme Court To Review PTAB, Again
Sanofi seeks to delay decision clearing path for Mylan's Lantus biosimilar; says it should be able to get rehearing based on Federal Circuit's ruling that PTAB judges were not constitutionally appointed.
Sanofi Improperly Listed Lantus Patent In FDA's Orange Book, Appeals Court Finds
First Circuit reverses dismissal of direct purchasers' suit alleging improper listing of patent on device drive mechanism delayed competition; district court to decide if this constitutes antitrust violation.
FDA Broke Catalyst's Orphan Exclusivity Due To Pricing, Not Clinical, Concerns, Firm Claims
Suit against agency reveals internal discussions to approve Jacobus' Ruzurgi despite Catalyst's orphan exclusivity for the same drug; Sen. Bernie Sanders urged FDA to address price of Catalyst's Firdapse (amifampridine).
Pharma Enforcement Remains 'Priority Area' In FTC's 2021 Budget Request
US Federal Trade Commission has mainly focused in pay-for-delay cases over the past decade, but pricing strategies are an emerging area of attention; industry is paying close attention to potential enforcement in biosimilar market.