Skip to content Skip to footer
Subscribe Now
TelaBio
News
TELA Bio Launches OviTex Inguinal for Robotic and Laparoscopic Inguinal Hernia Repair in the EU
Shots:TELA Bio has launched OviTex Inguinal in the EU for laparoscopic & robotic-assisted inguinal hernia repair; OviTex Inguinal to be showcased at EHS 2025OviTex Inguinal is available in 2 trocar-compatible configurations, consisting of 3 or 4 layer anatomically shaped devices that provide surgeons with flexible options designed to meet pts, technique, or procedure-specific needs…
June 4, 20250Comments
Takeda
News
Takeda’s Adcetris Regimen Receives the EC’s Approval to Treat Newly Diagnosed Hodgkin Lymphoma
Shots:The EC has approved Adcetris (brentuximab vedotin) + ECADD (etoposide, cyclophosphamide, doxorubicin, dacarbazine & dexamethasone) to treat adults with newly diagnosed Stage IIb with risk factors/III/IV Hodgkin lymphoma following CHMP’s positive opinion in Apr 2025Approval was based on P-III (HD21) trial assessing Adcetris + ECADD vs escalated doses of BEACOPP in above pts,…
June 4, 20250Comments
Amber implants
News
Amber Implants Reports Trial Data of VCFix Spinal System for Treating Vertebral Compression Fractures
Shots:Amber Implants has reported 1yr. follow-up data from its trial assessing VCFix Spinal System in Germany for the treatment of vertebral compression fracturesTrial showed immediate & sustained improvements in pain, with ≥8-point decrease in NPRS along with 84-point reduction in disability scores (per ODI) at 6mos., which were sustained through 1yr. in pts with…
June 4, 20250Comments
J&J
News
J&J Presents P-III (AMPLITUDE) Trial Data of Akeega for Metastatic Castration-Sensitive Prostate Cancer (mCSPC) at ASCO 2025
Shots:The P-III (AMPLITUDE) trial assessed Akeega (niraparib & abiraterone acetate tablet) + prednisone + ADT vs PBO/AAP + ADT in 696 pts with deleterious germline or somatic HRR gene-altered mCSPC, meeting its 1EP of improved rPFSIn BRCA-altered pts (n=191), trial showed a 48% & 56% reduction in rPFS & symptomatic progression risk, respectively,…
June 4, 20250Comments
Bayer
News
Bayer Reports the US FDA’s Approval of Nubeqa for Treating Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)
Shots:The US FDA has approved Nubeqa (darolutamide) in combination with androgen deprivation therapy (ADT) ± docetaxel to treat mHSPC pts; approval process in the EU is ongoingApproval was based on the P-III (ARANOTE) trial evaluating Nubeqa (600mg, BID) + ADT (n=446) vs PBO + ADT (n=223) in 669 mHSPC ptsTrial showed a 46% reduction in rPFS (1EP),…
June 4, 20250Comments
Biosimilar (May 2025)
INSIGHTS+
Key Biosimilars Events of May 2025 
Shots:       Biosimilars are developed to be highly similar versions of approved biologics in terms of safety, purity, and potency        Biosimilars are expected to be a cost-effective alternative to the high-priced branded biologics, offering significant and much-needed cost savings to both payers and patients  Fresenius Kabi Secured the CHMP’s Positive Opinion for Bomyntra & Conexxence. Our…
June 3, 20250Comments