Melane Sampson, Author at BioTuesdays

Developments

FDA approves launch of clinical study for Envoy’s breakthrough implanted hearing device

Envoy Medical (NASDAQ:COCH) has announced that the FDA has approved its Investigational Device Exemption application for the pivotal study of its Acclaim fully implanted cochlear implant. The company asserts that the...

November 1, 2024

Developments

USPTO issues NOA for Starton’s STAR-LLD continuous delivery system

Closely-held Starton Therapeutics has announced that the U.S. Patent and Trademark Office (USPTO) has issued a Notice of Allowance (NOA) for its U.S. patent application covering the company’s continuous delivery...

October 31, 2024

Developments

BioRestorative expands IP protecting ThermoStem cell-based metabolic disease therapy program

BioRestorative Therapies (NASDAQ:BRTX) has announced that the Israel Patent Office has issued a Notice of Allowance for a new patent application, covering several fundamental elements of its allogeneic, off-the-shelf...

October 31, 2024

Developments

FDA provides positive feedback on Appili’s ATI-1801 for CL

Appili Therapeutics (TSX:APLI; OTCPink:APLIF) announced that the FDA has provided positive feedback on the development strategy and NDA application for the company’s ATI-1801 for cutaneous leishmaniasis (CL). ATI-1801...

October 31, 2024

Developments

HOOKIPA doses first patient in Phase 2 trial of eseba-vec for head and neck cancer

HOOKIPA Pharma (NASDAQ:HOOK) has announced that the first patient has been dosed in an investigator-initiated trial (IIT) of eseba-vec as adjunct therapy for patients with minimal residual disease-positive, HPV-driven...

October 30, 2024

Developments

CalciMedica announces late-breaking positive data from Phase 2b CARPO trial

CalciMedica (NASDAQ:CALC) has announced late-breaking positive data from its Phase 2b CARPO trial of Auxora in acute pancreatitis (AP) with accompanying systemic inflammatory response syndrome (SIRS). The results are to...

October 30, 2024

Developments

FDA grants RMAT designation to Allogene’s ALLO-316 for patients with RCC

Allogene Therapeutics (NASDAQ:ALLO) has announced that the FDA granted Regenerative Medicine Advanced Therapy (RMAT) designation to its ALLO-316 for treating adult patients with CD70-positive advanced or metastatic...

October 29, 2024

Developments

Shuttle doses first patient in Phase 2 trial of Ropidoxuridine for glioblastoma

Shuttle Pharmaceuticals (NASDAQ:SHPH) has announced the successful dosing of the first three patients in its Phase 2 clinical trial of Ropidoxuridine, aimed at treating glioblastoma. Ropidoxuridine, Shuttle’s lead...

October 29, 2024

Developments

PolTREG initiates Phase 2 trial of PTG-007 targeting functional cure for children at risk of T1D

PolTREG (WSE:PTG) has launched a Phase 2 clinical trial of PTG-007, a polyclonal autologous Treg cellular therapy, in children with presymptomatic Type-1 diabetes (T1D), following approval from the European Medicines...

October 24, 2024

Executive Moves

Dr. Makoto Kuro-o joins Klotho as scientific advisor

Klotho Neurosciences (NASDAQ:KLTO) has appointed Makoto Kuro-o, MD, Ph.D., to its scientific advisory board. Dr. Kuro-o, a pioneer in the discovery of the anti-aging Klotho (s-KL) gene, will support Klotho’s mission to...

October 23, 2024

Author - Melane Sampson

FDA approves launch of clinical study for Envoy’s breakthrough implanted hearing device

USPTO issues NOA for Starton’s STAR-LLD continuous delivery system

BioRestorative expands IP protecting ThermoStem cell-based metabolic disease therapy program

FDA provides positive feedback on Appili’s ATI-1801 for CL

HOOKIPA doses first patient in Phase 2 trial of eseba-vec for head and neck cancer

CalciMedica announces late-breaking positive data from Phase 2b CARPO trial

FDA grants RMAT designation to Allogene’s ALLO-316 for patients with RCC

Shuttle doses first patient in Phase 2 trial of Ropidoxuridine for glioblastoma

PolTREG initiates Phase 2 trial of PTG-007 targeting functional cure for children at risk of T1D

Dr. Makoto Kuro-o joins Klotho as scientific advisor

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