Shots:
The EMA has received an application for a higher dose of Wegovy (semaglutide 7.2mg, SC) to treat obesity
Application was backed by the 72wk. STEP UP trial assessing Wegovy (7.2mg) vs Wegovy (2.4mg) & PBO alongside lifestyle intervention in 1,407 adults without diabetes (BMI ≥30kg/m²), & the 72wk. STEP UP T2D trial assessing Wegovy…
NEWS
Shots:
HealthBook+ has launched PaiGE, a personal health assistant that provides real-time, personalized health insights for both pts & clinicians
PaiGE offers consumers personalized lifestyle recommendations, shareable health records, mood & lifestyle-based insights, & a secure way to seek health information, while also guiding them to track progress between visits with clinician-backed instructions & PaiGE's…
Shots:
The US FDA has received sNDA of Caplyta (lumateperone) for the prevention of relapse in schizophrenia; sNDA of Caplyta as an adjunctive therapy for MDD is under FDA’s review
sNDA was supported by withdrawal P-III (Study 304) trial assessing Caplyta (42mg, QD) for 18wk. open-label phase followed by a double-blind phase, where pts received…
Shots:
JCR Pharmaceuticals & Alexion have entered into a license agreement for JCR’s JUST-AAV capsids to develop genomic medicines
As per the deal, Alexion may use licensed capsids from the JUST-AAV platform in up to 5 genomic medicine programs in exchange for an undisclosed upfront payment, ~$225M in R&D milestones, ~$600M in sales milestones (milestones…
Shots:
Miach Orthopaedics has completed enrollment in the BEAR MOON study of BEAR Implant for the treatment of anterior cruciate ligament (ACL) tears
BEAR MOON trial, led by Cleveland Clinic, enrolled 150 pts (18–55yrs.) with complete ACL tears, randomized to receive either the BEAR Implant or autograft bone-patellar tendon-bone ACL reconstruction, with outcomes assessed at 6mos.,…
Shots:
The US FDA has approved label expansion of Farapulse PFA System to incl. treatment of drug-refractory, symptomatic persistent atrial fibrillation (AF)
Approval was backed by P-I data from the ADVANTAGE AF trial, which met safety & effectiveness endpoints in 260 pts intolerant to at least Class I/III anti-arrhythmic drug across 43 global sites; data…
Shots:
The UK’s MHRA has approved Anktiva + Bacillus Calmette-Guérin (BCG) to treat BCG-unresponsive NMIBC with CIS. MAA is under the EMA’s review & covers all 30 EEA states
Approval was based on safety & efficacy data, incl. CR & DoR, from a single-arm trial in 77 pts treated with Anktiva + BCG, with some…
Shots:
The US FDA has accepted BLA & granted priority review to tividenofusp alfa for the treatment of Hunter syndrome (MPS II), with PDUFA target action date of Jan 5, 2026
BLA was supported by a P-I/II trial of tividenofusp alfa in 47 MPS II pts, as Denali prepares for its US commercial launch. It…
Shots:
Chugai Pharmaceutical has entered into a joint research & license agreement with Gero to develop novel therapies for age-related diseases
Chugai will develop novel antibody drugs using its proprietary antibody engineering techs for novel targets discovered by Gero's AI target discovery platform, & obtain exclusive global rights to research, develop, manufacture, & commercialize antibodies…
Shots:
Celltrion has launched Osenvelt & Stoboclo, biosimilar versions of Amgen’s Xgeva & Prolia (denosumab) in the US
Stoboclo (60mg/mL) treats postmenopausal women & men with osteoporosis at high fracture risk, glucocorticoid-induced osteoporosis in both sexes, & increases bone mass in men on androgen deprivation therapy for nonmetastatic prostate cancer & women on adjuvant aromatase inhibitors…

