Shots:
VarmX has collaborated with CSL to advance its lead asset, VMX-C001 (commercial launch expected in 2029), & granted CSL an exclusive option agreement with its shareholders to acquire all issued & outstanding shares of the company
As per the collaboration, CSL will fully fund the global P-III (EquilibriX-S) trial of VMX-C001 in FXa DOAC…
Shots:
Monte Rosa has collaborated with Novartis to develop novel degraders for immune-mediated diseases, leveraging Monte Rosa’s QuEEN discovery engine
As per the deal, Novartis will gain an exclusive license to an undisclosed discovery target & options to license 2 programs from Monte Rosa’s preclinical immunology portfolio
The deal is valued at ~$5.7B, with Monte…
Shots:
Approval of Optune Lua for adults with unresectable advanced/recurrent NSCLC who progressed on Pt-based regimen, was based on P-III (LUNAR) trial assessing it with PD-1/PD-L1 inhibitors or docetaxel (n=145) vs PD-1/PD-L1 inhibitors or docetaxel alone (n=146)
Trial showed an mOS (1EP) of 13.2 vs 9.9mos. in the overall population, 19 vs 10.8mos. with Optune Lua +…
Shots:
Ocugen has entered into a licensing agreement with Kwangdong Pharmaceutical for OCU400 to treat retinitis pigmentosa
As per the deal, Kwangdong will receive exclusive Korean rights to OCU400 in exchange for $7.5M in upfront & near-term milestones, $1.5M per $15M in sales, reaching ≥$180M in sales milestones, plus 25% royalties on net sales, while…
Shots:
Bio-Thera Solutions & Jamjoom Pharmaceuticals have entered into a strategic agreement to commercialize BAT2306, a biosimilar version of Novartis’ Cosentyx (secukinumab) in the Middle East & Africa (MENA)
As per the deal, Jamjoom will obtain exclusive MENA rights of BAT2306 to handle regulatory submissions, market access & commercialization, while Bio-Thera will be responsible for development…
Shots:
AVITA Medical has received European MDR CE Mark approval for Recell Go to promote healing in burns & traumatic or surgical wounds; commercialization to begin in select EU states, incl. Germany, Italy, & the UK
Recell Go is a point-of-care device that allows clinicians to create a suspension of a patient’s own skin cells from…
Shots:
Akeso has dosed its first patient with cadonilimab + lenvatinib in P-II (COMPASSION-36/AK104-225) trial against lenvatinib for the treatment of advanced HCC in pts previously treated with Tecentriq & Avastin; study is ongoing in the US, EU & China
Cadonilimab has also shown superior efficacy in combination regimens, incl. 100% DCR with FOLFOX-HAIC in resectable multinodular HCC…
Shots:
MAIA Biotechnology has reported P-II (THIO-101) trial data assessing ateganosine followed by Libtayo (cemiplimab) in pts with advanced NSCLC who progressed after ≥2 SoC therapy regimens
As of Jun 30, 2025, ateganosine (180mg) showed mPFS of 5.6 vs 2.5mos. & mOS of 17.8mos., plus 2 pts completed 33 cycles across pts of all treatment lines,…
Shots:
The CVMP has recommended Portela (relfovetmab) for alleviating osteoarthritis pain in cats, with an EC decision expected in Q4’25 & commercial launch planned for 2026
Opinion was based on superior safety & efficacy in cats across trials, incl. cats with IRIS stage 1–3 kidney disease, & showed relieved osteoarthritis pain
Portela is a long-acting…
This week, PharmaShots’ news was all about the updates on Clinical Trials, Regulatory, Pharma, MedTech, M&A, Biosimilar, and DigiHealth. Check out our full report below:
AstraZeneca Reports P-III (FLAURA2) Trial Findings on Tagrisso Regimen to Treat EGFRm NSCLC
Read More: AstraZeneca
Eli Lilly Reports P-III (BRUIN CLL-313) Trial Data on Jaypirca for 1L…

