Shots:
The Chinese NMPA has accepted NDA & granted priority review to savolitinib for the treatment of LA/M gastric cancer or gastroesophageal junction (GC/GEJ) adenocarcinoma pts with MET amplification who have failed ≥2 prior systemic treatments
NDA was supported by the P-II trial of savolitinib in gastric cancer pts with MET amplification in China, which met its 1EP of improved ORR by…
Shots:
Daiichi Sankyo has dosed the first patient with Enhertu ± radiotherapy in the P-III (DESTINY-Endometrial02) trial, conducted in collaboration with The GOG Foundation & ENGOT, with the GINECO as the lead ENGOT group
The trial will evaluate the efficacy and safety of Enhertu (5.4mg/kg) ± radiotherapy vs SoC CT (carboplatin & paclitaxel) ± radiotherapy…
Shots:
Jacobio Pharma entered a global exclusive licensing agreement with AstraZeneca for JAB-23E73, granting AstraZeneca exclusive development & commercialization rights outside China, while both companies will jointly develop & commercialize in China
As per the deal, Jacobio will receive $100M upfront, and is eligible up to $1.91B in development & commercial milestones, and tiered royalties…
Shots:
The EC has approved AstraZeneca’s Saphnelo (anifrolumab; 120mg, SC, QW, PFS) for the treatment of adults with SLE in combination with SoC; regulatory review is ongoing in the US & Japan
Approval was based on the P-III (TULIP-SC) trial assessing Saphnelo vs PBO in 367 pts (18-70yrs.) with mod. to sev. active, autoantibody-positive SLE while receiving SoC,…
Shots:
Neurimmune has entered into an exclusive global collaboration & licensing deal with Alexion to develop NI009, a preclinical human mAb for the treatment of AL amyloidosis
Alexion will obtain an exclusive global license to Neurimmune’s AL amyloidosis–targeting Abs, incl. NI009, with Neurimmune handling preclinical activities, early manufacturing & the FIH study, while Alexion will…
Shots:
The US FDA has accepted NDA & granted priority review to Baxdrostat as an add-on treatment of pts with uncontrolled or treatment-resistant hypertension (PDUFA: Q2’26 following use of PRV)
NDA was supported by the P-III (BaxHTN) trial assessing baxdrostat (1 or 2mg, QD, PO) vs PBO on top of SoCs in 796 pts with…
Shots:
FDA has approved perioperative Imfinzi for adults with resectable, early-stage & locally advanced (Stages II, III, IVA) G/GEJ cancers, with submission reviewed under Project Orbis & based on P-III (MATTERHORN) trial; regulatory review is ongoing in the EU & Japan
In the trial, Pts (n=948) received Imfinzi (1500mg) + FLOT or PBO + FLOT for Q4W ×…
Shots:
In 2025, the global Prescription Drugs market is projected to generate an impressive $1.13T, with steady annual growth of 3.94% expected through 2030, ultimately reaching $1.37T. Leading the pack is Keytruda, securing the first position with $29.48B, closely followed by Ozempic at $28.18B, and Eliquis, which recorded $20.69B in global sales. Fourth position is…
Shots:
The US FDA has approved Koselugo for the treatment of symptomatic, inoperable plexiform neurofibromas (PN) in adults with neurofibromatosis type 1 (NF1)
Approval was based on the P-III (KOMET) study assessing Koselugo (PO) vs PBO in 145 adults with NF1 & symptomatic, inoperable PNs across 13 countries, incl. North America, South America, Europe, Asia…
Shots:
Did you know that patients living with SLE in the EU face a two- to threefold higher risk of mortality compared to the general population? This stark reality underscores the need for therapies that are not only effective but also easier to administer
AstraZeneca’s Saphnelo has recently been recommended for approval in the EU as a…

