Shots:
FDA has cleared Deseyne, a daily disposable soft contact lens for presbyopia that uses patented Extended Depth of Focus technology
Deseyne provides continuous near, intermediate, & distance vision through Cataltheia’s patented hyper-refractive central zone, showing a clinical advantage over multifocal lenses with minimal patient adaptation, strong comfort, & no adverse events reported in studies
Made…
NEWS
Shots:
The US FDA has granted IND clearance to initiate a P-IIa trial of 9MW1911 for the treatment of patients with mod. to sev. chronic obstructive pulmonary disease (COPD)
In the China P-IIa trial (n=80) vs PBO, 9MW1911 showed dose-proportional exposure & dose-dependent efficacy, with the RP2D (n=30) reducing mod. to sev. COPD exacerbations by…
Shots:
The MHLW has approved Sanofi and Regeneron’s Dupixent for the treatment of bronchial asthma in children (6-11yrs.) with severe or refractory disease whose symptoms are inadequately controlled with existing therapy
Approval was based on the P-III (VOYAGE) trial data in the overall population & those with a type 2 inflammation phenotype, which showed reduced…
Shots:
Italfarmaco has entered into an exclusive licensing agreement with JCR Pharmaceuticals for the development and commercialisation of givinostat in Japan
As per the deal, JCR will secure exclusive rights to commercialize givinostat, marketed as Duvyzat in US, EU & UK, for Duchenne muscular dystrophy (DMD) in Japan & will lead local execution of clinical…
Shots:
The US FDA has approved Yartemlea for the treatment of HSCT-Associated Thrombotic Microangiopathy, with US launch planned for Jan 2026. MAA is under the EMA’s review, with a decision expected in mid-2026
Approval was based on the TA-TMA Study (n=28) plus EAP (N=221 adults & pediatric pts), where 19 pts (13 adult & 6…
Shots:
The NMPA has approved Innovent's Tabosun (ipilimumab N01 injection or IBI310) + sintilimab for the neoadj. treatment of stage IIB-III resectable microsatellite instability-high (MSI-H) or mismatch repair-deficient (dMMR) colon cancer
Approval was based on the P-III (NeoShot) trial assessing ipilimumab N01 + sintilimab as neoadj. therapy in pts with MSI-H/dMMR colon cancer
Trial met…
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Repare Therapeutics has entered into a definitive asset purchase agreement with Gilead Sciences for the acquisition of Repare's RP-3467, a polymerase theta (Polθ) ATPase inhibitor, strengthening Gilead’s precision oncology pipeline
Under the Agreement, Repare will receive up to $30M in total consideration, including $25M upfront (subject to customary adjustments) and an additional $5M upon…
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The US FDA has approved Agios’ Aqvesme (mitapivat) for the treatment of anemia in adults with non-transfusion-dependent and transfusion-dependent alpha- or beta-thalassemia
Approval was based on the global P-III (ENERGIZE) and (ENERGIZE-T) studies (n=452), which met all 1EPs and 2EPs, demonstrating significant improvements in hemoglobin, fatigue, and reductions in transfusion burden vs PBO
Aqvesme…
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US FDA has granted Orphan Drug Designation (ODD) to SN BioScience’s SNB-101 for the treatment of gastric cancer, including gastroesophageal junction cancer
SNB-101 is currently under P-Ib/II development for small cell lung cancer and is being evaluated across multiple solid tumor indications in Korea, Europe and US
SNB-101 is a polymer nanoparticle formulation of…
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Foresee Pharmaceuticals reported its P-III (Casppian) Study data of FP-001 (leuprolide mesylate 42mg; administered every six months), a sustained-release GnRH agonist, met its 1EP in children with central precocious puberty (CPP)
The study showed that 94% of pts achieved serum LH suppression to <4 mIU/mL at 60 mins. following a GnRHa stimulation test at Wk.…

