Court denies J&J's motion to dismiss Pfizer's antitrust suit, saying discovery will reveal whether Pfizer has offered more competitive pricing for its Inflectra biosimilar and if there are alternative causes for Pfizer's inability to gain market share.
A district court is allowing Pfizer Inc.'s antitrust suit to go forward to determine if Johnson & Johnson's exclusive contracts with payers for Remicade (infliximab) are legal. It concluded that Pfizer has put forth sufficient information to show it has been injured by J&J's efforts to block market access to its biosimilar Inflectra (infliximab-dyyb).
In an Aug. 10 memorandum denying J&J's motion to dismiss the complaint, Judge C. Curtis Joyner of the US...
We’ve all been told that walking 10,000 steps a day is the magic number for better health. But what if the real secret to walking more isn’t about counting steps at all? In this article, we explore how focusing on motivation, environment, and mindset can help you build a walking habit that lasts.
The bispecific antibody is the latest example of a growing number of biologics receiving complete response letters related to third-party manufacturing facilities.
A US FDA analysis found that facility inspection issues were the fastest growing factor in the recent rise of complete response letters for biologics licensing applications, in part reflecting the limitations of single-product inspections at contract facilities manufacturing multiple products.
A list of EU biosimilar filings, CHMP opinions and EU marketing authorizations, including details of the biosimilar company, the brand name/INN, indication(s), the reference product/company, and the date and type of event.
A US FDA analysis found that facility inspection issues were the fastest growing factor in the recent rise of complete response letters for biologics licensing applications, in part reflecting the limitations of single-product inspections at contract facilities manufacturing multiple products.
Novartis continues to fight tooth and nail to protect its $3bn Entresto brand in the US following the latest FDA approval of a generic version.
A list of EU biosimilar filings, CHMP opinions and EU marketing authorizations, including details of the biosimilar company, the brand name/INN, indication(s), the reference product/company, and the date and type of event.
