Novo Nordisk Reports the EMA’s Application Submission for Higher Wegovy Dose for Weight Management

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…

ByRidhi RastogiJuly 9, 2025

NEWS

HealthBook+ Launches PaiGE for Real-Time Personalized Health Insights

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…

ByRidhi RastogiJuly 9, 2025

NEWS

J&J Reports US FDA’s sNDA Submission of Caplyta for Schizophrenia Relapse Prevention

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…

ByRidhi RastogiJuly 9, 2025

NEWS

Alexion Partners with JCR Pharmaceuticals to Develop Genomic Medicines

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…

ByRidhi RastogiJuly 9, 2025

NEWS

Miach Orthopaedics Completes Patient Enrollment in BEAR MOON study of BEAR Implant for ACL Reconstruction

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.,…

ByRidhi RastogiJuly 8, 2025

NEWS

Boston Scientific’s Farapulse PFA System Receives the US FDA Approval for Pulmonary Vein and Posterior Wall Ablation in Persistent AF Patients

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…

ByRidhi RastogiJuly 8, 2025

NEWS

ImmunityBio’s Anktiva + BCG Receives the MHRA’s Approval for BCG-Unresponsive Non-Muscle Invasive Bladder Cancer Carcinoma In Situ

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…

ByRidhi RastogiJuly 8, 2025

NEWS

Denali Therapeutics Reports the US FDA’s BLA Acceptance and Priority Review of Tividenofusp Alfa for Hunter Syndrome

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…

ByRidhi RastogiJuly 8, 2025

NEWS

Chugai Pharmaceutical Partners with Gero to Develop Age-Related Disease Therapies

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…

ByRidhi RastogiJuly 8, 2025

NEWS

Celltrion Launches Osenvelt and Stoboclo (Biosimilars, Xgeva and Prolia) in the US

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…

ByRidhi RastogiJuly 8, 2025

Ridhi Rastogi

Novo Nordisk Reports the EMA’s Application Submission for Higher Wegovy Dose for Weight Management

HealthBook+ Launches PaiGE for Real-Time Personalized Health Insights

J&J Reports US FDA’s sNDA Submission of Caplyta for Schizophrenia Relapse Prevention

Alexion Partners with JCR Pharmaceuticals to Develop Genomic Medicines

Miach Orthopaedics Completes Patient Enrollment in BEAR MOON study of BEAR Implant for ACL Reconstruction

Boston Scientific’s Farapulse PFA System Receives the US FDA Approval for Pulmonary Vein and Posterior Wall Ablation in Persistent AF Patients

ImmunityBio’s Anktiva + BCG Receives the MHRA’s Approval for BCG-Unresponsive Non-Muscle Invasive Bladder Cancer Carcinoma In Situ

Denali Therapeutics Reports the US FDA’s BLA Acceptance and Priority Review of Tividenofusp Alfa for Hunter Syndrome

Celltrion Launches Osenvelt and Stoboclo (Biosimilars, Xgeva and Prolia) in the US

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