Shots:
FDA has granted IND clearance to initiate its P-II trial of ASC30 (40, 60 & 80mg) vs PBO in ~100 pts with type 2 diabetes mellitus, with enrolment expected to begin in Q1’26
Trial will assess mean change in HbA1c up to 13wks. as 1EP & 2EPs will incl. mean change in fasting blood…
NEWS
Shots:
Insilico Medicine has entered into a multi-year R&D collaboration with Servier to identify & develop novel oncology therapeutics for challenging targets using Insilico's Pharma.AI
As per the deal, Servier will share R&D costs &, upon successful identification of potential candidates, assume responsibility for clinical validation, regulatory engagement, & global commercialization of the resulting oncology drug candidates…
Shots:
HUTCHMED has initiated P-III portion of P-II/III trial of the combination of surufatinib, camrelizumab, nab-paclitaxel & gemcitabine (S+C+AG) as the 1L treatment of metastatic PDAC in China, with the first patient receiving the dose on Dec 30, 2025
Trial will evaluate the combination against nab-paclitaxel + gemcitabine in ~400 PDAC adults who have not…
Shots:
The NEJM published results from the P-I/II study of Denali Therapeutics’ tividenofusp alfa (DNL310) for the treatment of Hunter syndrome (MPS II)
The study evaluated treatment in 47 ERT-naïve (n=15) and previously treated (n=32) study participants (aged 0.3–13 [median, 5] years) demonstrating reduced levels of mean CSF levels of HS, mean urine HS levels,…
Shots:
BioAtla and GATC Health announce into a $40M special purpose vehicle (SPV) transaction to advance ozuriftamab vedotin (Oz-V), a CAB-ROR2-ADC, into a registrational P-III study for 2L+ oropharyngeal squamous cell carcinoma (OPSCC)
Under the agreement, BioAtla will receive $5M upfront to support operations and P-III study execution, with the remaining $35M expected to close…
Shots:
The US FDA has issued a Complete Response Letter (CRL) to Corcept for the NDA of relacorilant for the treatment of hypertension secondary to hypercortisolism
While the US FDA acknowledged that the pivotal P-III (GRACE) study met its 1EP and that data from the GRADIENT study provided supportive evidence, the Agency concluded that additional…
Shots:
Samsung Bioepis has reported the direct commercialization of Byooviz, a biosimilar version of Lucentis (ranibizumab) across Europe, with market availability expected in Q2’26
Byooviz (0.5 mg/0.05 ml) is indicated for the treatment of neovascular (wet) age-related macular degeneration (AMD), visual impairment due to diabetic macular oedema (DME), proliferative diabetic retinopathy (PDR), visual impairment due…
Shost:
Delcath Systems has reported the publication of subgroup analyses from the Phase 3 (FOCUS) study in the Journal of Cancer Research and Clinical Oncology, evaluating the efficacy and safety of the HEPZATO KIT on melphalan/hepatic delivery in pts with unresectable metastatic uveal melanoma
In the subgroup analyses (n=91) of the P-III (FOCUS) Study pts,…
Shots:
Intelligent Bio Solutions has entered into a strategic manufacturing partnership with Syrma Johari MedTech to scale production of its Intelligent Fingerprinting Drug Screening Reader and support long-term margin improvement
Under the agreement, the partnership advances INBS’ global manufacturing strategy by diversifying suppliers, strengthening supply chain resilience, expanding capacity, and increasing flexibility ahead of anticipated multi-region…
Shots:
The FDA issued a complete response letter for the ONS-5010/LYTENAVA™ BLA resubmission, declining approval for wet AMD in its current form
The ONS-5010 BLA resubmission was based on full NORSE trial data, including the pivotal NORSE TWO and confirmatory studies like NORSE EIGHT, a study evaluating ONS-5010 vs ranibizumab in a 12-wk trial of…

