Shots:
The US FDA approved Tevimbra (tislelizumab-jsgr) + Pt containing CT as 1L treatment in unresectable or metastatic esophageal squamous cell carcinoma (ESCC) adults whose tumors express PD-L1 (≥1)
The approval was based on the P-III (RATIONALE-306) study (n=649) evaluating Tevimbra + CT vs. PBO + CT in unresectable, locally advanced recurrent, or metastatic…
NEWS
Shots:
The US FDA has approved Stoboclo & Osenvelt (CT-P41, denosumab), a biosimilar to Prolia & Xgeva for all indications of the reference products
Approval is based on P-III trial results in postmenopausal women with osteoporosis, which showed equivalent efficacy & PD of CT-P41 to reference denosumab, with similar PK and comparable safety, and…
Shots:
KYORIN and Novartis entered into a global license agreement for KRP-M223 and its back-up compounds discovered by KYORIN
As per the agreement, Novartis gets an exclusive global license to develop, manufacture, and commercialize KRP-M223, where KYORIN retains an option to commercialize and manufacture product for the Japanese market, with Novartis retaining an option to co-promote…
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The FDA has accepted review application for BLA of depemokimab as an add-on maintenance therapy for inadequately controlled asthma pts (≥12yrs.) with type 2 inflammation marked by blood eosinophil count as well as CRSwNP (PDUFA: Dec 16, 2025), based on P-III (SWIFT & ANCHOR) trials, respectively
SWIFT-1 (n=382) & SWIFT-2 (n=380) studies assessed…
Shots:
Boston Scientific entered into a definitive agreement to acquire SoniVie Ltd. to expand its interventional cardiology therapies offerings
Currently, the company holds an equity stake of approx. 10%, and for the remaining 90% stake, the company will pay approx. $360M upfront and up to $180M regulatory milestones; for 100% stake, the amount sums…
Johnson & Johnson’s Darzalex (daratumumab) Receives the CHMP’s Positive Opinion for Multiple Myeloma
Shots:
The CHMP has recommended Darzalex (SC) + bortezomib, lenalidomide & dexamethasone (D-VRd) to treat newly diagnosed multiple myeloma pts.
Opinion was based on P-III (CEPHEUS) trial, which assessed efficacy & safety in transplant-ineligible or deferred NDMM pts (n=395) not planned for ASCT as initial therapy, in 13 countries across North America, South America and…
Shots:
The data from P-III (DESTINY-Gastric04) study showed statistically significant and clinically meaningful improvement in OS vs ramucirumab & paclitaxel in 2L HER2+ (IHC 3+ or IHC 2+/ISH+) unresectable and/or metastatic gastric or GEJ adenocarcinoma pts.
The safety profile observed in DESTINY-Gastric04 aligns with Enhertu's established safety record. The company expects to present data…
Shots:
AbbVie and Gubra entered into a global license agreement to develop & commercialize GUB014295, a potential long-acting amylin analog for obesity treatment
As per the deal, AbbVie will lead GUB014295's global development & commercialization, whereas Gubra will get $350M upfront, up to $1.875B development, commercial, sales milestones, with tiered royalties; transaction closure is…
Shots:
The EC has approved Vimkunya (pre-filled syringe) against CHIKV disease in individuals (≥12yrs.) in 30 EEA states; launch expected in H1’25. MAA under the UK’s MHRA review with decision anticipated in H1’25
Approval was based on 2 P-III studies that met their 1EP of rapid immune response in 1wk. with ~97.8% of participants…
Shots:
BBOT will reverse merge with Helix in a SPAC transaction, where combined entity - "BBOT” will be listed on Nasdaq; closing expected in Q3’25
Upon closing, BBOT will have ~$550M cash (pre-transaction) incl. $100M in existing cash, $196M from Helix’s trust & $260M from PIPE financing. At $10.36/share, the combined entity's implied pro…

