NEWS

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

Neurizon Therapeutics Licenses Monepantel from Elanco Animal Health to Accelerate NUZ-001 Commercialization

Shots: Elanco has granted Neurizon exclusive global rights to monepantel’s data package & related IP to develop & commercialize NUZ-001 & related compounds for the treatment, prevention, or palliation of ALS & other neurodegenerative diseases in humans As per the deal, Elanco will receive an upfront payment, development milestone payments of $9.75M for the initial…

July 3, 2025

Dizal Receives the US FDA’s Accelerated Approval for Zegfrovy (Sunvozertinib) to Treat EGFRm NSCLC

Shots: The US FDA has granted accelerated approval to Zegfrovy for locally advanced or metastatic NSCLC associated with EGFR exon 20 insertion mutations (exon20ins) in pts whose disease has progressed on or after Pt-based CT Approval was based on the multinational WU-KONG1 part B trial assessing Zegfrovy in above mentioned pts, which showed significant improvement…

July 3, 2025

Regeneron’s Lynozyfic (Linvoseltamab-gcpt) Receives the US FDA’s Accelerated Approval for R/R Multiple Myeloma

Shots: The US FDA has granted accelerated approval to Lynozyfic for the treatment of r/r MM pts, who have received ≥4L therapy, incl. a proteasome inhibitor, an immunomodulatory agent & an anti CD38 mAb based on P-I/II (LINKER-MM1) trial in >300 pts; a SC P-I trial portion & IV P-II dose expansion portion is ongoing In…

July 3, 2025

Vertex Pharmaceuticals’ Alyftrek Receives the EC’s Approval to Treat Cystic Fibrosis

Shots: The EC has approved Alyftrek (deutivacaftor/tezacaftor/vanzacaftor) to treat pts (≥6yrs.) with cystic fibrosis (CF), having ≥1 non-class I mutation in the CFTR gene; regulatory review is ongoing in Canada, Switzerland, Australia, & New Zealand In 2 H2H trials, Alyftrek + ivacaftor matched Kaftrio (ivacaftor/tezacaftor/elexacaftor) on ppFEV1 & showed superiority in reducing sweat chloride…

July 2, 2025

NEWS

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)

Neurizon Therapeutics Licenses Monepantel from Elanco Animal Health to Accelerate NUZ-001 Commercialization

Dizal Receives the US FDA’s Accelerated Approval for Zegfrovy (Sunvozertinib) to Treat EGFRm NSCLC

Regeneron’s Lynozyfic (Linvoseltamab-gcpt) Receives the US FDA’s Accelerated Approval for R/R Multiple Myeloma

Vertex Pharmaceuticals’ Alyftrek Receives the EC’s Approval to Treat Cystic Fibrosis

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