Forbes Medi-Tech's ability to sell its Phytrol (Reducol) phytosterol ingredient is "materially affected" by Novartis' noncompliance with terms of 1999 Master License Agreement, firm says March 18. Without detailing alleged noncompliance, Forbes notes it was "surprised" by Novartis' and Quaker's termination of Altus Foods joint venture, says Novartis' actions have led to delayed market introduction of certain Phytrol-containing foods. Forbes will not pay $4 mil. to buy back licensing, distribution rights for Reducol, as previously announced, but has notified Novartis it is terminating the MLA. Consequently, all rights to the ingredient, except for the Reducol name, would revert to Forbes on June 18 unless Novartis corrects noncompliance, Forbes says. Novartis believes it has complied with MLA, seeks amicable resolution...

Attorneys say Sarepta did not have an obligation to report its appeal, particularly since winning a formal dispute filing with the US FDA is a long shot.

Sarepta must perform enhanced pharmacovigilance for serious renal toxicity events and rhabdomyolysis with the Duchenne muscular dystrophy drug, which carries a label warning for renal toxicity. Approval letter includes 2024 target completion date for ESSENCE confirmatory trial.