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...

Notified bodies’ efforts to enhance a harmonized approach to remote audits have failed, raising questions about whether there is any avenue left to get vital devices certified by the 26 May EU MDR deadline.

As Amneal’s generics segment sees significant growth, the company has revealed plans to launch new products and expand in new markets. “We are extremely proud of the progress our company has made since we re-joined as leaders of Amneal,” said Chirag and Chintu Patel, co-CEOs of Amneal.