Shots:
BioMarin has entered into a definitive agreement to acquire Inozyme, strengthening its enzyme therapies portfolio with the addition of INZ-701, an enzyme replacement therapy
As per the deal, Inozyme’s shareholders will receive $4.00 per share in an all-cash transaction for a total consideration of ~$270M; closing is expected in Q3’25
INZ-701 (SC) is being evaluated…
Shots:
MHLW has approved Blenrep + BorDex & PomDex in MM pts with ≥1 prior therapy; review ongoing in the US (PDUFA: Jul 23, 2025), EU, Canada, China (PR for DREAMM-7), & Switzerland (with PR for DREAMM-8)
Approval was based on P-III (DREAMM-7 & DREAMM-8) trials assessing Blenrep (2.5mg/kg, IV, Q3W) + BorDex vs Darzalex + BorDex in 494…
Shots:
The EC has approved Opdivo + CT as neoadj. therapy followed by surgery & adj. Opdivo alone to treat adults with resectable NSCLC at high risk of recurrence & PD-L1 expression ≥1% in all 30 EEA states
Approval was based on P-III (CheckMate-77T) study assessing neoadj. Opdivo + CT vs neoadj. PBO & CT…
PharmaShots Weekly Snapshots (May 12, 2025 – May 16, 2025)
This week PharmaShots’ news was all about the updates on Clinical Trials, Regulatory, Pharma, MedTech, M&A & Animal Health. Check out our full report below:
Johnson & Johnson Reveals P-III (ICONIC-TOTAL) Trial Data of Icotrokinra for Plaque Psoriasis
Read More: J&J
AstraZeneca Reports…
Shots:
The US FDA has accepted NDA & granted priority review to Orladeyo (berotralstat) for the treatment of HAE pts (2-11yrs.), with PDUFA action date of Sep 12, 2025. Line extension application has been filed with the EMA; further filings are planned globally incl. Japan & Canada
NDA was supported by P-III (APeX-P) trial assessing Orladeyo…
Shots:
The US FDA has accepted sNDA of Filspari for the treatment of FSGS, plus FDA has planned to hold advisory committee meeting to discuss the application (PDUFA: Jan 13, 2026)
sNDA was supported by P-III (DUPLEX) trial & P-II (DUET) trial assessing Filspari vs irbesartan in FSGS pts; Pts completing the DUPLEX & DUET double-blind…
Shots:
FDA has approved Zynyz (retifanlimab-dlwr) + Pt-based CT as 1L treatment of inoperable locally recurrent or metastatic SCAC, & as monotx. for locally recurrent or metastatic SCAC progressing on or intolerant to Pt-based CT; EMA & PMDA’s application are under review
Approval was based on P-III (POD1UM-303/InterAACT2) trial assessing Zynyz + Pt-based CT vs…
Shots:
The US FDA has granted accelerated approval to Emrelis (telisotuzumab vedotin-tllv) for treatment-experienced pts with locally advanced or metastatic, c-Met overexpressing, non-squamous NSCLC
Approval was backed by an ongoing P-II (LUMINOSITY) study assessing Emrelis as 2L/3L treatment of c-Met overexpressing NSCLC; showing an ORR of 35% & mDoR of 7.2mos. in pts (n=84) with…
Shots:
Merck has reported ongoing P-III (KEYNOTE-B96/ENGOT-ov65) trial findings on Keytruda for the treatment of Pt-resistant recurrent ovarian cancer
Trial assessed Keytruda (400mg, IV, Q6W for ~2yrs.) with CT ± Avastin vs PBO + CT ± Avastin in pts (n=643)
Trial met its 1EP of improved PFS in overall population & 2EP of OS in pts…
Shots:
TelmyVet & PetPace have launched the Quality-of-Life Consultation, a virtual care service to support pets & their families during end-of-life stages
Service combines TelmyVet’s telemedicine platform with PetPace’s AI-powered smart collar, which tracks HRV, vital signs, mobility, & behavior to assess pain & stress. It offers a supportive space for pet parent guidance &…

