Fierce Pharma Asia—Eisai's subQ Leqembi delay; Legend and J&J's supply deal with Novartis; China's Ozempic biosimilar

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来源: FiercePharma

The delay for an injectable version of Leqembi, an expanded CAR-T manufacturing deal for Carvykti and the first Ozempic biosimilar filing in China made our news this week.

Eisai and Biogen's subcutaneous Leqembi faces a regulatory delay. Johnson & Johnson and Legend Biotech have expanded their contract manufacturing deal with Novartis around Carvykti. A Chinese drugmaker is seeking local approval of a biosimilar version of Novo Nordisk's Ozempic. And more.

1. Eisai, Biogen's injectable Leqembi delayed as FDA asks for more data

The FDA is asking for more data on an injectable version of Eisai and Biogen’s Leqembi. The demand has caused the delay in the formulation’s filing, because Eisai can’t start a rolling submission without first gaining a “fast track” designation. Analysts have hoped that a more convenient injection could help accelerated uptake of the currently infused Alzheimer’s disease drug.

2. J&J, Legend expand manufacturing deal with Novartis to include commercial production of Carvykti

Legend Biotech and Johnson & Johnson have expanded a contract manufacturing deal with Novartis to now include both clinical and commercial manufacturing of the pair’s CAR-T therapy Carvykti. The new deal runs through the end of 2029 and will see Novartis produce Carvykti at its Morris Plains plant in New Jersey. The new pact comes as Carvykti looks on track to enter earlier treatment of multiple myeloma.

3. First biosimilar to Novo’s Ozempic seeks approval in China (Reuters)

A Chinese drugmaker, Jiuyuan Gene Engineering of Hangzhou, said it has sought local approval of a biosimilar version of Novo Nordisk’s diabetes drug Ozempic. The company names the drug Jiyoutai and noted that it was the first to file an application for a copycat of semaglutide, the active ingredient of Ozempic. According to Novo’s annual report, its Ozempic patents in China are set to expire in 2026.

4. Otsuka, Click Therapeutics snag FDA clearance for depression therapy app

Otsuka and Click Therapeutics have secured FDA clearance for the first prescription digital therapeutic for major depressive disorder. The six-week digital program, called Rejoyn, is used alongside antidepressant drugs. The treatment provides cognitive emotional training exercises and therapeutic lessons. A 13-week randomized study showed that Rejoyn was better than a sham app at improving depression symptoms.

5. Ascletis pulls FXR agonistFXR agonist from pipeline over phase 2 primary biliary cholangitis data

Chinese biotech Ascletis has reduced its development programs for the FXR agonist ASC42 after phase 2 data indicated the drug “did not show competitiveness” to other candidates in primary biliary cholangitis. As a result, the company has decided not to pursue further development of the drug for hepatitis B virus or as part of a combo treatment for metabolic-associated steatohepatitis.

Other News of Note:

6. Aurobindo's Eugia recalls one lot of muscle relaxant because of possible contamination

7. Hutchmed, Innovent’s drug combo targets China approval in endometrial cancer (release)

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