Fierce Pharma Asia—MEI and Kyowa Kirin's PI3K woes; Takeda's dengue nod, Daiichii Sankyo's Enhertu positivity

After meeting with the FDA last month, MEI and Kyowa Kirin halted development of their B-cell malignancy prospect outside of Japan. Takeda’s dengue fever vaccine nabbed a crucial nod in Europe, possibly setting up other approvals through a special regulatory pathway. Daiichi’s clinical oncology chief Mark Rutstein said he isn’t discouraged after Enhertu’s latest trial results.

1. In fresh blow to floundering PI3K space, FDA feedback drives MEI, Kyowa to halt blood cancer program

MEI Pharma and Kyowa Kirin’s B-cell malignancy prospect, zandelisib, is the latest victim of the FDA’s new tough stance on PI3K inhibitors. The partners decided to stop developing the drug outside of Japan after a late-November FDA meeting, MEI CEO Daniel Gold, Ph.D., said in a statement. MEI will now cut costs by reducing its workforce, starting with a 30% reduction in an initial wave.

2. Takeda's dengue shot scores crucial EU nod, opening the door to wider global use

Takeda has been working on its dengue fever vaccine, Qdenga, for years. Now, thanks to an EU nod, the shot is making strides in its goal to reduce the global burden of dengue. A special regulatory pathway called EU-M4all allows for regulatory officials in other countries to leverage the approval for their own green lights. It’s the vaccine's second nod since Indonesia backed the vaccine in August.   

3. SABCS: After Enhertu's modest showing in neoadjuvant breast cancer, Daiichi Sankyo's clinical oncology chief wants to see more

Enhertu didn’t wow in a recent phase 2 study as a presurgery neoadjuvant therapy in HER-2-low early breast cancer, but Daiichi Sankyo's clinical oncology chief Mark Rutstein, M.D., isn’t fazed. In an interview ahead of the 2022 San Antonio Breast Cancer Symposium (SABCS), Runstein said he wants to see more data with larger sample sizes. Out of the 33 patients enrolled in the study, only one achieved the primary endpoint of pathologic complete response.

4. Daiichi Sankyo walks back Yescarta marketing deal with Gilead, Kite

Daiichii Sankyo is handing marketing authorization of Kite Pharma’s CAR-T cell therapy Yescarta to its original owner’s new parent, Gilead Sciences. Daiichii previously bought the rights to develop, manufacture and commercialize the drug in Japan back in 2017. The ownership change will benefit patients through increased capacity and broader access, Shoji Hirashima, head of Daiichi Sankyo’s Japan business unit, said in a statement.

5. GSK, Sanofi, Takeda sign with Singapore partnership to advance biologic manufacturing

The Biologics Pharma Innovation Programme Singapore (BioPIPS) has three new partners. GSK, Sanofi and Takeda will boost biologics manufacturing in Singapore, including in the recombinant protein and vaccines markets.

6. Glenmark suffers recall, warning letter after subpar investigation into tablet manufacturing glitch

Glenmark Pharmaceuticals’ manufacturing plant in Goa, India, was hit with an FDA warning letter detailing batch failures, lab control and record-keeping issues, plus more. One of the violations surrounded Glenmark’s lack of corrective actions after rejecting batches of desmopressin acetate. The company now has 15 days to respond to the letter and the four manufacturing violations.

Other News of Note

8. SABCS: AZ writes the 'next chapter' in Enhertu's saga with head-to-head win versus Roche's Kadcyla

9. Chasing Gilead, AstraZeneca-Daiichi lay down phase 2 breast cancer data for antibody-drug conjugate