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LifeSignals' UbiqVue 2A System Receives FDA Clearance for Continuous Wireless Patient Monitoring

  • LifeSignals' UbiqVue 2A system, featuring a wearable biosensor, has gained FDA 510(k) clearance for continuous remote patient monitoring in diverse settings.
  • The biosensor, worn on the chest, monitors 13 physiological parameters, including SpO2, ECG, respiration rate, and body temperature, transmitting data securely to a cloud-based system.
  • The UbiqVue system aims to replace manual spot-checking with continuous, near real-time monitoring, enhancing patient safety and streamlining healthcare professional workflows.
  • LifeSignals plans to expand the UbiqVue system with additional vital signs monitoring and AI capabilities through partnerships with OEMs and service providers.

FDA Approves StemCyte's REGENECYTE, a Cord Blood Stem Cell Therapy

  • The FDA has approved StemCyte's REGENECYTE, a hematopoietic progenitor cell therapy derived from umbilical cord blood, for certain hematopoietic system disorders.
  • REGENECYTE is indicated for unrelated donor hematopoietic progenitor cell transplantation in patients with inherited, acquired, or myeloablative treatment-related disorders.
  • Clinical trials demonstrated neutrophil recovery in 76-91% of patients by day 42 and platelet recovery in 45-72% of patients by day 100 post-treatment.
  • StemCyte aims to expand its cell therapy portfolio, exploring REGENECYTE's potential in aging-related diseases, chronic fatigue syndrome, and acute stroke.

HanAll, Daewoong, and NurrOn Announce Positive Phase 1 Results for Parkinson's Disease Therapy HL192 (ATH-399A)

  • HanAll Biopharma, Daewoong Pharmaceutical, and NurrOn Pharmaceuticals completed a Phase 1 study of HL192 (ATH-399A) for Parkinson's disease, meeting primary endpoints for safety and tolerability.
  • The Phase 1 trial included single ascending dose (SAD), multiple ascending dose (MAD), and food effect components in 76 healthy participants, including older adults.
  • HL192 (ATH-399A) demonstrated a favorable safety profile with no serious treatment-related adverse events and supported once-daily dosing, paving the way for further clinical trials.
  • The companies plan to initiate the next clinical trial in people with Parkinson's disease to further evaluate the safety and efficacy of HL192 (ATH-399A).

FDA Accepts Alnylam's Vutrisiran Application for ATTR Amyloidosis with Cardiomyopathy

• The FDA has accepted Alnylam's sNDA for vutrisiran to treat ATTR amyloidosis with cardiomyopathy, setting a PDUFA date of March 23, 2025. • The application is based on Phase 3 HELIOS-B trial results, which demonstrated favorable cardiovascular outcomes and improved survival in ATTR-CM patients. • If approved, vutrisiran would be the first treatment for both polyneuropathy and cardiomyopathy manifestations of ATTR amyloidosis in the U.S. • Vutrisiran's sNDA acceptance signifies a major advancement for Alnylam, potentially expanding the drug's market and solidifying its position in the ATTR space.

Capivasertib Plus Abiraterone Extends Radiographic Progression-Free Survival in PTEN-Deficient mHSPC

  • Capivasertib combined with abiraterone and ADT significantly improved radiographic progression-free survival (rPFS) in patients with PTEN-deficient metastatic hormone-sensitive prostate cancer (mHSPC).
  • The CAPItello-281 Phase III trial demonstrated an early trend toward overall survival improvement, though data were immature at the time of analysis.
  • The safety profile of the capivasertib combination was consistent with the known profiles of each agent, according to AstraZeneca.
  • This combination marks the first AKT inhibitor to show benefit in this specific prostate cancer subtype, addressing a critical unmet need.

Capivasertib+Abiraterone as Treatment for Patients With Metastatic Hormone-sensitive Prostate Cancer and PTEN Deficiency

NCT04493853Active, Not RecruitingPhase 3
AstraZeneca
Posted 7/13/2020

Study of Capivasertib + Docetaxel vs Placebo + Docetaxel as Treatment for Metastatic Castration Resistant Prostate Cancer (mCRPC)

NCT05348577Active, Not RecruitingPhase 3
AstraZeneca
Posted 3/25/2022

FDA Accepts Alnylam's Vutrisiran sNDA for ATTR Amyloidosis with Cardiomyopathy

• The FDA has accepted Alnylam's sNDA for vutrisiran to treat ATTR amyloidosis with cardiomyopathy, granting priority review with a PDUFA date of March 23, 2025. • Vutrisiran, an RNAi therapeutic, targets transthyretin (TTR) and has shown favorable outcomes in the HELIOS-B Phase 3 trial for ATTR-CM patients. • The HELIOS-B study demonstrated that vutrisiran improved cardiovascular outcomes, survival, disease progression, and quality of life compared to placebo. • If approved, vutrisiran would be the first therapy in the U.S. for both polyneuropathy and cardiomyopathy manifestations of ATTR amyloidosis.

FDA Approves Imkeldi (Imatinib) Oral Solution for Certain Leukemias and Cancers

  • The FDA has approved Imkeldi (imatinib) oral solution, the first liquid formulation of imatinib, for treating certain forms of leukemia and other cancers.
  • Imkeldi is indicated for chronic myeloid leukemia (CML), acute lymphoblastic leukemia (ALL), myelodysplastic syndrome (MDS), and gastrointestinal stromal tumors (GIST) in adults and children.
  • The oral solution offers precise dosing, a palatable strawberry flavor, and does not require refrigeration, improving adherence and accessibility for patients.
  • This approval marks Shorla Oncology's fourth FDA approval, advancing its mission to improve existing oncology treatments through formulation re-innovation.

Kanglin Biotechnology Secures $20 Million to Advance KL003 Gene Therapy for Beta Thalassemia and Sickle Cell Disease

  • Kanglin Biotechnology has successfully completed a $20 million Series A financing to support the clinical development of KL003, a gene therapy for beta thalassemia and sickle cell disease.
  • KL003 demonstrated 100% efficacy in 17 patients in a Phase 1 study, showing a shorter time to transfusion independence and engraftment with a favorable safety profile.
  • The company anticipates initiating a Phase 2 pivotal study for KL003 in beta thalassemia in 2025, with potential for reduced manufacturing costs compared to existing gene therapies.
  • KL003 has received Pediatric Rare Disease Designation and Orphan Drug Designation from the FDA and clinical trial application approval in China for transfusion-dependent beta thalassemia.

China Approves MSD's Welireg (belzutifan) for VHL-Associated Tumors

  • China's NMPA has approved MSD's Welireg (belzutifan) for treating specific von Hippel-Lindau (VHL) disease-associated tumors in adults, offering a non-surgical option.
  • The approval is based on Phase II LITESPARK-004 trial results, demonstrating significant objective response rates in renal cell carcinoma, CNS hemangioblastomas, and pNET.
  • Welireg, a hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor, marks the 17th global approval for this indication, providing a systemic therapy option for Chinese patients.
  • MSD is continuing to investigate Welireg in advanced renal cell carcinoma and other tumor types through a comprehensive clinical development program.

GSK Seeks FDA Approval for Blenrep Combination Therapy in Multiple Myeloma

  • GSK's Blenrep, previously withdrawn, seeks FDA approval in combination with Velcade and dexamethasone for multiple myeloma patients after one prior therapy.
  • The application is based on DREAMM-7 and DREAMM-8 Phase III trials, demonstrating statistically significant improvements in progression-free survival.
  • Blenrep's combination offers a potential advantage over CAR-T therapy due to its off-the-shelf nature and simpler administration.
  • GlobalData forecasts Blenrep to generate $1.4 billion in 2030, offering new competition in the BCMA-targeted therapy landscape.

Belantamab Mafodotin Plus Pomalidomide and Dexamethasone (Pd) Versus Bortezomib Plus Pd in Relapsed/Refractory Multiple Myeloma

NCT04484623Active, Not RecruitingPhase 3
GlaxoSmithKline
Posted 10/1/2020

Evaluation of Efficacy and Safety of Belantamab Mafodotin, Bortezomib and Dexamethasone Versus Daratumumab, Bortezomib and Dexamethasone in Participants With Relapsed/Refractory Multiple Myeloma

NCT04246047Active, Not RecruitingPhase 3
GlaxoSmithKline
Posted 5/7/2020

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