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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.,…

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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…

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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…

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Celltrion

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…

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KalVista Reports the US FDA’s Approval of Ekterly (Sebetralstat) for Treating Hereditary Angioedema

Shots: The US FDA has approved Ekterly (sebetralstat) to treat hereditary angioedema (HAE) pts (≥12yrs.), with US availability expected immediately Approval was based on P-III (KONFIDENT) study assessing Ekterly (300mg & 600mg) vs PBO in 136 HAE pts (≥12yrs.) across 20 countries & KONFIDENT-S OLE study KONFIDENT data was published in The NEJM, which showed…

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BioAtla Presents Preliminary P-I Trial Data of BA3182 in Patients with Treatment Refractory Metastatic Adenocarcinoma at ESMO 2025

Shots: BioAtla has shared ongoing P-I dose-escalation trial data on BA3182 for treatment-refractory metastatic adenocarcinoma at ESMO 2025 As of June 20, 2025, 39 pts received BA3182 (QW) in the range of 0.0026 to 0.6mg with either 0, 1, or 2 priming doses, 4–7 days before treatment; 17 received IV doses (0.0026–0.032mg) & 22 received SC doses…

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PulseSight Therapeutics Reports First Patient Dosing with PST-611 in P-I (PST-611-CT1) Trial for Dry AMD/Geographic Atrophy 

Shots: PulseSight Therapeutics has dosed first pts in the P-I (PST-611-CT1) trial to assess safety & tolerability of PST-611 in humans The P-I single ascending dose study will evaluate safety & determine maximum tolerated dose of PST-611 for P-IIa trial in 6–12 pts with dry age-related macular degeneration/geographic atrophy pts, with preliminary results expected in…

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