NEWS

AstraZeneca Reports the EC’s Approval for Perioperative Imfinzi to Treat Muscle-Invasive Bladder Cancer (MIBC)

Shots: The EC has approved Imfinzi as a perioperative treatment of MIBC; regulatory review is ongoing in Japan & other regions Approval was based on the P-III (NIAGARA) trial (n=1063) in MIBC pts randomized to either neoadj. Imfinzi + CT before cystectomy followed by adj. Imfinzi or neoadj. CT with no further treatment after surgery …

July 4, 2025

MatOrtho Receives the European CE Mark Approval for ReCerf Hip Resurfacing Arthroplasty

Shots: MatOrtho has reported the European CE Mark approval of ReCerf for hip resurfacing arthroplasty, allowing wider availability in UK, EU & markets accepting CE mark approval ReCerf was previously approved by Australia’s TGA in Nov 2024 & was used in over 1,600 pts since 2018, with highly positive patient-reported outcomes & a low 6yr. revision…

July 4, 2025

Biocon Biologics Receives the EC’s Approval for Vevzuo and Evfraxy (Biosimilars, Xgeva and Prolia)

Shots: The EC has approved Vevzuo & Evfraxy, biosimilar versions of Amgen’s Xgeva & Prolia (denosumab) following the CHMP positive opinion in Apr 2025 Approval was based on the comprehensive clinical data, which showed comparable PK, safety, efficacy & immunogenicity of Vevzuo & Evfraxy to the reference product Vevzuo prevents SREs in adults with bone-involved malignancies…

July 4, 2025

The EC Approves CuraTeQ Biologics’ Dazublys (Biosimilars, Herceptin)

Shots: CuraTeQ Biologics, a subsidiary of Aurobindo Pharma, reported EC’s approval of Dazublys, its trastuzumab biosimilar following the CHMP’s recommendation in Apr 2025 The approval was based on its demonstrated similarity to Herceptin in PK, PD, efficacy, safety, and immunogenicity Dazublys is approved for HER2-positive breast and gastric cancers, and expanding access to treatment across…

July 4, 2025

Vertex Presents Long-Term CLIMB Trial Program Data of Casgevy (Exagamglogene Autotemcel) to Treat Hemoglobinopathies at EHA 2025

Shots: The global P-I/II/III (CLIMB-121 & 111) trials assessed Casgevy in sev. SCD & TDT pts (12–35 yrs), with 2yr. post-infusion follow-up, after which pts entered the ongoing 15yr. CLIMB-131 trial, with SCD pts followed for >5.5yrs & TDT for >6yrs. In SCD, 43/45 pts were VOC-free for ≥12mos., with mean VOC-free duration of 35mos.…

July 4, 2025

Brii Biosciences Enters a Licensing Deal with Joincare Pharmaceutical for BRII-693 to Treat Bacterial Infections

Brii Biosciences has entered into a license & technology transfer agreement with Joincare to develop & commercialize BRII-693 in the Greater China region As per the deal, Joincare will handle development, regulatory activities & commercialization of BRII-693 in Greater China in exchange for an upfront payment as well as development & commercial milestones, with net…

July 4, 2025

Johnson & Johnson Seeks the EC’s Approval for Akeega to Treat Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)

The EMA has received an application for label expansion of Akeega (niraparib & abiraterone acetate tablet) + prednisone/prednisolone to treat adults with mHSPC & HRR gene alterations Submission was backed by P-III (AMPLITUDE) trial assessing Akeega + prednisone/ prednisolone + ADT vs PBO/AAP + ADT in 696 pts with deleterious germline or somatic HRR gene-altered…

July 4, 2025

CB Biotechnology to Acquire Theratechnologies for ~$254M

Shots: CB Biotechnology has entered into a definitive agreement to acquire Theratechnologies, delisting it from public markets As per the deal, Theratechnologies’ shareholders will receive $3.01/share in cash & a non-tradeable CVR of $1.19/share tied to company milestones, with total CVR payments limited to $65M, making it an aggregate of $254M, assuming full CVR payout;…

July 3, 2025

Ascletis Pharma Reports First Patient Dosing with ASC30 in P-IIa Trial for Obese or Overweight Patients

Shots: Ascletis Pharma has dosed first participants with ASC30 (PO, QD) in its US P-IIa trial for obesity (BMI ≥30kg/m^2) or overweight pts (BMI ≥27kg/m^2 but <30kg/m^2) with ≥1 weight-related comorbidity Trial will assess 2 ASC30 formulations (tablets & tablets A1), with pts starting at 1mg & undergoing weekly titrations to maintenance doses of 20 or 40mg…

July 3, 2025

mAbxience Reports the EC’s Approval of Denbrayce and Izamby (Biosimilar, Xgeva and Prolia)

Shots: The EC has approved Denbrayce & Izamby, biosimilar versions of Amgen’s Xgeva & Prolia (denosumab) following the CHMP’s recommendation Denbrayce prevents skeletal-related events in adults with bone-involved malignancies & treats giant cell tumors of bone in adults & skeletally mature adolescents Izamby is indicated to treat osteoporosis in postmenopausal women & men at increased risk…

July 3, 2025

NEWS

AstraZeneca Reports the EC’s Approval for Perioperative Imfinzi to Treat Muscle-Invasive Bladder Cancer (MIBC)

MatOrtho Receives the European CE Mark Approval for ReCerf Hip Resurfacing Arthroplasty

Biocon Biologics Receives the EC’s Approval for Vevzuo and Evfraxy (Biosimilars, Xgeva and Prolia)

The EC Approves CuraTeQ Biologics’ Dazublys (Biosimilars, Herceptin)

Vertex Presents Long-Term CLIMB Trial Program Data of Casgevy (Exagamglogene Autotemcel) to Treat Hemoglobinopathies at EHA 2025

Brii Biosciences Enters a Licensing Deal with Joincare Pharmaceutical for BRII-693 to Treat Bacterial Infections

Johnson & Johnson Seeks the EC’s Approval for Akeega to Treat Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)

CB Biotechnology to Acquire Theratechnologies for ~$254M

Ascletis Pharma Reports First Patient Dosing with ASC30 in P-IIa Trial for Obese or Overweight Patients

mAbxience Reports the EC’s Approval of Denbrayce and Izamby (Biosimilar, Xgeva and Prolia)

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