This week, PharmaShots’ news was all about the updates on Clinical Trials, Regulatory, Pharma, MedTech, M&A, DigiHealth, Animal Health, and Biosimilars. Check out our full report below:
AstraZeneca and Daiichi Sankyo Report P-III (TROPION-Breast02) Trial Results of Datroway for Triple-Negative Breast Cancer
Read More: AstraZeneca and Daiichi Sankyo
AstraZeneca Reports P-III (Bax24) Trial Data on…
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The US FDA has granted FTD to ADCE-D01 for the treatment of soft tissue sarcoma (STS)
ADCE-D01 is being evaluated in P-I/II (ADCElerate1/EUCT) dose escalation & expansion study as a monotx. for metastatic &/or unresectable STS, with enrolment ongoing in the US & EU
ADCE-D01 is an ADC targeting uPARAP & conjugated to the…
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Ono Pharmaceutical has reported the P-II (ONO-4578-08) trial findings of ONO-4578 (EP4 antagonist) regimen for previously untreated, HER2-negative unresectable advanced or recurrent G/GEJ cancer
ONO-4578-08 assessed ONO-4578 (40mg, QD, PO) + Opdivo (360mg, Q3W) & CT (S-1 + Oxa or CapOx) vs PBO + Opdivo & CT in G/GEJ cancer pts across Japan, South Korea…
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Bio-Thera Solutions has entered into an exclusive commercialization & license agreement with Intas Pharmaceuticals for BAT2506, a biosimilar version of Simponi (golimumab), for Canada
The agreement expands their Feb 2025 deal, under which Intas holds US commercialization rights for BAT2506, while Bio-Thera handles its development & manufacturing
BAT2506 is an IgG1 monoclonal antibody that targets…
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Phibro Animal Health has entered into a licensing agreement with Lighthouse Pharmaceuticals to develop & commercialize a therapeutic asset targeting periodontal health in companion animals
As per the agreement, Phibro will obtain exclusive rights to develop, manufacture, and commercialize Lighthouse Pharma’s proprietary compound for canine periodontal care, though financial terms were not disclosed
The…
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The US FDA has approved Eydenzelt, a biosimilar version of Eylea (aflibercept), to treat neovascular age-related macular degeneration, macular edema following retinal vein occlusion, diabetic macular edema (DME), & diabetic retinopathy
Approval was supported by extensive analytical, non-clinical, & clinical data, incl. a P-III trial in DME pts (n=348) comparing Eydenzelt vs Eylea over…
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Novo Nordisk will acquire Akero Therapeutics, incl. its lead asset efruxifermin (EFX), to expand its metabolic dysfunction-associated steatohepatitis (MASH) portfolio
As per the deal, Novo Nordisk will acquire Akero for $54/share in an all-cash transaction totaling ~$4.7B, along with one non-tradeable CVR of $6/share (~$0.5B) tied to EFX’s US FDA approval for compensated cirrhosis due…
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The US FDA has approved Jascayd (nerandomilast) for the treatment of adults with idiopathic pulmonary fibrosis (IPF); regulatory review is ongoing in China, Japan, & the EU, with further filings planned
Approval was based on P-III (FIBRONEER-IPF) & P-II (Trial 2) trials, where FIBRONEER-IPF assessed Jascayd (18 or 9mg, PO, BID) vs PBO in…
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J&J has reported P-III (ASTRO) trial data assessing Tremfya SC induction (400mg at Wks. 0, 4 & 8) followed by maintenance dose of either Tremfya 100mg (SC, Q8W) or 200mg (SC, Q4W) vs PBO in adults (n=418) with mod. to sev. active UC
At Wk. 48, trial showed improved clinical remission rates of 36.7%…
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AviadoBio has entered into an exclusive option & license agreement with UgeneX Therapeutics to develop & commercialize UGX-202
As per the deal, AviadoBio will receive an option to develop & commercialize UGX-202 for retinitis pigmentosa & other indications globally (excl. Greater China), while UgeneX will receive upfront payments, r&d milestones, & sales milestone payments…

