Shots:Nanjing Leads Biolabs has enrolled the first patient in P-Ib/II trial assessing opatisumab as monotx. & in combination with toripalimab, for the treatment of 1L advanced melanoma in ChinaAdditionally, Opatisumab is being evaluated as monotx. in a registrational study for EP-NEC that completed enrolment in Aug 2025, & is also under investigation in multiple P-II trials…
Shots:AI Medical Technology has reported the CE mark approval of Dermalyser for melanoma detection; commercialization to begin in 2025Dermalyser was validated in AI-DSMM study across 36 Swedish centers, where it analyzed 253 suspicious lesions in 228 pts, identifying 21 melanomas (11 as thin invasive & 10 as in situ). It also achieved AUROC…
Shots:Hikma has acquired the Novugen's US FDA ANDA approved trametinibtablets and also entered into a commercial agreement with NovugenUnder the agreement, Hikma will be responsible for all the US sales and marketing of trametinib while Novugen will manufacture and supply them to Hikma. Furthermore, when product is launched Hikma will have 180 days…
With breakthrough discoveries addressing patients' unmet needs, caregivers, decision-makers, and advocacy groups have made great strides towards bringing patient experience to the mainstream. Today's guest is TJ Sharpe, a Patient Insights Expert and Stage-IV Melanoma survivor. In his topic "Complicating is easy, Simplifying is Difficult, the personalized patient experience", T.J. will shed light on patient…
Shots:Gina gave her views on the acceptance of the sBLA by the US FDA and the validation of the Type II Variation Marketing Authorization Application by the EMA for Opdivo as monotherapy for the treatment of patients with completely resected stage IIB or IIC melanomaShe also spoke on the epidemiology of melanoma and…
Active Ingredient: Nivolumab Strength: 40 mg/4 mL, 100 mg/10 mL, & 240 mg/24 mL solution in a single-dose vial Dosage Form: Injection Mechanism of Action: Programmed cell death-1 receptor antagonists (PD-1) First Approval: US (22 Dec 2014), EU (19 Jun 2015) Revenue Analysis of OpdivoBMS’ Opdivo gives tough competition to other drugs in the…
Active Ingredients: PembrolizumabStrength: 100 mg/4 mL (25 mg/mL)Dosage Form: Syringe, VialMechanism of Action: PD-1 ligands antagonistsFirst Approval: US (Sep 4, 2014), EU (Jul 17, 2015)RevenueKeytruda (pembrolizumab) has been a key player in Merck & Co. immuno-oncology drugs for the past years – reaching nearly $17B in annual sales in 2021. Despite the dampening impact…

