Shots: The P-III CheckMate-816 study involves assessing of Opdivo (360mg) + CT (q3w for 3 doses) vs CT (q3w for 3 doses), followed by surgery as a neoadjuvant treatment in 358 patients with resectable NSCLC The study met its 1EPs of improved pathologic complete response. The positive results mark the first time an immune checkpoint […]Read More
Shots: The P-III CheckMate -274 study involves assessing of Opdivo vs PBO in 709 patients in a ratio (1:1) with muscle-invasive urothelial cancer at a high risk of recurrence after radical surgery for up to 1yr. The study met its 1EPs of DFS in both all randomized patients and in patients whose tumor cells express […]Read More
Shots: The company discloses two additional biosimilars in active development referencing Opdivo (nivolumab) and Keytruda (pembrolizumab). The biosimilars are in the advanced stages of pre-clinical development and are being co-developed by NeuClone and Serum Institute of India The disclosure demonstrates NeuClone’s ability to develop multiple biosimilars simultaneously through its NeuMAX platform Additionally, NeuClone and Serum […]Read More
Shots: The approval is based on P-III CheckMate -9LA study assessing Opdivo + Yervoy combined with two cycles of platinum-doublet CT vs CT (four cycles followed by optional pemetrexed maintenance therapy if eligible) as a 1L treatment in patients with metastatic/ recurrent NSCLC regardless of PD-L1 expression and histology The study met its 1EPs & […]Read More
The average life expectancy span of Human Beings are increased due to better medical facilities and drugs developed by Biopharma companies. Pharmaceutical products or drugs or medicines are being produced for a wide range of medical sectors. It includes the lifesaving drugs or the major therapy area including immunology, cardiology, and neurology but are they […]Read More
Shots: The US FDA’s approval is based on P-III ATTRACTION-3 study assessing Opdivo (240mg by IV infusion over 30min, q2w) vs taxane CT (docetaxel/paclitaxel) in patients with unresectable advanced, recurrent or ESCC, refractory/ intolerant to at least one prior fluoropyrimidine & platinum-based CT Opdivo is the first approved immunotherapy in this setting regardless of tumor […]Read More
Shots: NeoImmuneTech to sponsor the trial and BMS will supply Opdivo (nivolumab) for the use in the trial. Additionally, under Master Clinical Trial Collaboration Agreement, the first study will be focusing on gastric/GEJ/EAC cancers and the companies can evaluate additional combination trials in the future The goal of the collaboration is to evaluate preliminary anti-tumor […]Read More
Shots: The approval is based on P-I/II CheckMate -040 study assessing Opdivo (1 mg/kg, IV) + Yervoy (3 mg/kg, IV) q3w for four doses, followed by Opdivo (240mg, q2w) in 49 patients with HCC prior treated with sorafenib The P-I/II CheckMate -040 study results: @28mos. follow-up, 33% of patients respond to combination therapy; CR (8%); […]Read More
Shots: The US FDA has accepted sBLA for the dual regimen as 1L treatment for metastatic or recurrent NSCLC with no EGFR or ALK genomic tumor aberrations and has granted the PR status to the therapy The application is based on part 1 of P-III CheckMate -227 study results assessing Opdivo + Yervoy vs platinum-doublet […]Read More
Shots: The companies have submitted the sBLA for the combination therapy to expand its use as 1L treatment of unresectable, advanced/ recurrent NSCLC in Japan, for a partial change in approved items of the manufacturing and marketing approval The application is based on Part 1 of P-III CheckMate -227 study assessing the combination therapy vs […]Read More
Copyright ©2020 PharmaShots | Powered by Octavus Consulting
