Shots:
IMPACT Therapeutics has entered into an exclusive licensing agreement with Pharmanovia for the exclusive rights to manufacture, develop, and commercialise senaparib in EMEA, Australia, and New Zealand
As per the deal, Pharmanovia will acquire exclusive rights to manufacture, develop & commercialise senaparib across EMEA, Australia & New Zealand, with IMPACT eligible for upfront, regulatory…
NEWS
Shots:
The EC has approved Datroway (datopotamab deruxtecan) for the 1L treatment of adults with unresectable or metastatic TNBC, who are ineligible for PD-1/PD-L1 inhibitor therapy; regulatory review is ongoing in China & Japan, as well as Australia, Canada, Singapore & Switzerland as part of Project Orbis
Approval was backed by the global P-III (TROPION-Breast02)…
Shots:
Kaigene has entered into an exclusive licensing agreement with Taisho Pharmaceutical for the exclusive development & commercialization of KG006 in Japan
As per the deal, Taisho will acquire exclusive rights to develop & commercialise KG006 in Japan, with Kaigene receiving $5M upfront, up to $22M & ¥57.5B (~$351M) in development, regulatory & sales milestones,…
Shots:
Amgen announced that the CHMP issued a positive opinion recommending an expanded indication for Repatha (evolocumab) to reduce cardiovascular risk in adults with established or high risk for atherosclerotic cardiovascular disease by lowering LDL-C levels, alongside correction of other risk factors
The recommendation is supported by the P-III (VESALIUS-CV) study involving ≥12,000 pts., Repatha…
Shots:
Pfizer reported positive topline results from the pivotal P-III TRANQUILLO and TRANQUILLO 2 studies evaluating LITFULO (ritlecitinib) in pts. with NSV. Both studies (n=2,174 pts) met their co-primary endpoints, demonstrating statistically significant improvements in facial and total body repigmentation vs. PBO at 52 wks. across 271 sites globally
TRANQUILLO (n=607, ≥12yrs.) evaluated 50mg LITFULO and TRANQUILLO…
Shots:
NIPRO CORPORATION received US FDA 510(k) clearance for its ELISIO-HX dialyzer, enabling the US commercialization of HDs (Hemodialysis powered by super high-flux membrane). The clearance became effective on July 28, 2026
ELISIO-HX features NIPRO’s proprietary super high-flux membrane technology, designed to enhance the removal of larger middle-molecule uremic toxins while maintaining albumin retention. The…
Shots:
The MHRA has approved Cytokinetics’ Myqorzo (aficamten) for the treatment of adults with symptomatic (NYHA, class II-III) oHCM
MHRA assessment was based on P-III (SEQUOIA-HCM) trial of Myqorzo (n=282), showing improved exercise capacity vs PBO at 24wks., with increased peak oxygen uptake by 1.8 vs 0 ml/kg/min
Additionally, NICE has recommended aficamten for eligible…
Shots:
Relation has entered a strategic research collaboration with GSK to generate large-scale human cellular perturbation datasets to understand disease biology & discover novel therapeutic targets
Relation will generate large-scale perturbation datasets using advanced human cellular disease models & experimental systems to develop, validate, & train foundation models, incl. MORGAN, to investigate disease biology &…
Shots:
Synlogic & Caldera have agreed to merge in an all-stock transaction, forming a new holding company that will operate as Caldera Therapeutics & plans to list on Nasdaq under the ticker “CALD”
Upon closing, Synlogic, Caldera, and private placement investors are expected to own ~2.3%, ~62.8%, and ~34.9% of the combined company, respectively, with…
Shots:
Nippon has exercised its exclusive US commercialization option for tadekinig alfa in Primary Monogenic IL-18-Driven Hyperinflammatory Syndrome with NLRC4 & XIAP mutations, with AB2 Bio retaining US rights to all other indications & all rights outside the US
AB2 Bio received a $6M option fee in 2025 & will now receive a $30M option…

