Meanwhile, the closely watched EV-302 trial has yielded a win for the combination of Seagen and Astellas’ Padcev and Merck’s Keytruda. The combo topped chemotherapy on both overall survival and progression-free survival in previously untreated metastatic bladder cancer. The positive trial could serve to convert the combo’s accelerated approval in platinum-ineligible patients and expand it into the platinum-eligible group.
3. AbbVie axes I-Mab pact to exit fast-thinning race for CD47 space
Merck and Eisai’s Lenvima-Keytruda combo has failed two more trials. Adding Lenvima to Keytruda and chemo didn’t move the needle for patients with first-line nonsquamous non-small cell lung cancer (NSCLC) in the LEAP-006 trial. In the LEAP-008 trial, the Lenvima-Keytruda regimen couldn’t beat chemo in NSCLC patients who progressed on chemo and anti-PD-1/L1 treatment.
6. Coherus hits FDA hurdles for PD-1 drugPD-1 drug, Neulasta biosimilar on-body injector
Junshi Biosciences’ China-made PD-1 inhibitor toripalimab has hit another FDA hurdle. After a preapproval inspection, the FDA flagged a problem at a clinical trial site in China for toripalimab’s application in nasopharyngeal carcinoma. Junshi’s U.S. partner Coherus BioSciences said the single observation is “readily addressable” and that the pair still expects an approval by year-end.
8. Glenmark solves its 'decade-long' debt problem with $681M sale of API unit to Nirma
Glenmark is selling 75% of its active pharmaceutical ingredient business to Nirma limited for RS 5,651 crore ($681 million). The deal will cover Glenmark’s debt of about RS 4,600 crore, which was described by a local news outlet as a “decade-long troubled affair.” The API unit represents a relatively high profit margin driver within Glenmark.
Other News of Note
9. J&J inks 'first of its kind' pact with Singapore government to boost regional life sciences innovation
10. Strides to spin off its CDMO and softgel businesses into single group with 1,200 employees
11. WuXi debuts first vaccine CDMO site in China, where it plans to employ more than 500
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