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# Since Our Last Issue ...
- URL: https://www.fdaweb.com/since-our-last-issue-71/
- Published: 2022-04-18T12:00:00.000Z
- Updated: 2026-09-14T17:41:02.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5137543

**BioDelivery Sciences International** has entered into an agreement with **Endo Pharmaceuticals** to terminate Endo’s licensing rights for pain drug Belbuca (buprenorphine) buccal film. As a result of the agreement, the world-wide rights to Belbuca will be transferred back to BioDelivery Sciences on undisclosed terms. Annual sales for the product are about $27 million.

**Vanda Pharmaceuticals** has entered into a license agreement with **Apotex** to resolve Vanda’s patent litigation against Apotex and its ANDA seeking approval for a generic version of Vanda’s Fanapt (iloperidone). Under the agreement, Vanda granted Apotex a non-exclusive license to manufacture and commercialize its generic Fanapt in the U.S. effective 11/2/2027\. Apotex may enter the market earlier under certain limited circumstances.

**JHL Biotech** has signed a $257 million partnership agreement that gives **Sanofi** rights to market a JHL clinical-stage rituximab biosimilar, initially for China. Rituximab is used to treat autoimmune disorders, cancer and transplant rejection. JHL received approval to start a European Phase I trial for the rituximab biosimilar earlier this year.

A Chinese regulator has fined a local unit of **Medtronic** $17 million for price fixing related to the firm’s cardiovascular and diabetes medical device products. China’s **National Development and Reform Commission** said Medtronic had carried out monopolistic behavior with its distributors and local partners to fix prices and set lower limits on the resale price to hospitals.