Abby Hardy, Author at BioTuesdays

Developments

Kiniksa mavrilimumab gets FDA orphan drug designation for giant cell arteritis

Kiniksa Pharma’s (NASDAQ:KNSA) mavrilimumab received FDA orphan drug designation for the treatment of giant cell arteritis (GCA). GCA is a chronic inflammatory disease of medium-to-large arteries, which can result in...

September 15, 2020

Developments

Titan Pharma Probuphine commercialization partner inks European distribution agreement

Titan Pharmaceuticals’ (NASDAQ:TTNP) Probuphine commercialization partner, Molteni, signed an exclusive European distribution agreement with Accord Healthcare Europe for the commercialization of Sixmo, the brand name...

September 15, 2020

Developments

Frequency Therapeutics reports positive results from hearing loss study

Frequency Therapeutics (NASDAQ:FREQ) reported results from its Phase 2a clinical study of FX-322 for the treatment of sensorineural hearing loss (SNHL). The study follows a Phase 1/2 trial that demonstrated...

September 14, 2020

Developments

AVITA enrolls first patient in pivotal vitiligo trial

AVITA Therapeutics (NASDAQ:RCEL) initiated a pivotal study evaluating its RECELL system for the treatment of vitiligo, an autoimmune disease that causes loss of color or pigmentation in the skin. The study will assess...

September 14, 2020

Developments

Hepion CRV431 featured on The Bio Report podcast

The Bio Report podcast featured Hepion Pharmaceuticals’ (NASDAQ:HEPA) CRV431 for the treatment of non-alcoholic steatohepatitis (NASH), and potentially, COVID-19. “We’ve kicked off our Phase 2 trial in NASH...

September 11, 2020

Developments

VBL Therapeutics enrolls first patients in Phase 2 metastatic colorectal cancer trial

VBL Therapeutics (NASDAQ:VBLT) enrolled the first two patients in its Phase 2 trial evaluating VB-111, in combination with nivolumab, for the treatment of metastatic colorectal cancer. VB-111 is an adenovirus that...

September 10, 2020

Developments

Satsuma Pharma STS101 fails Phase 3 migraine trial

Satsuma Pharmaceuticals (NASDAQ:STSA) reported disappointing topline results from its Phase 3 trial of STS101 for the acute treatment of migraine. STS101 is a drug-device combination of dihydroergotamine mesylate (DHE)...

September 10, 2020

Developments

Precision BioSciences gets FDA fast track designation for second allogeneic CAR-T cell therapy

Precision BioSciences’ (NASDAQ:DTIL) allogeneic chimeric antigen receptor (CAR-T) cell therapy, PBCAR269A, received FDA fast track designation for the treatment of relapsed/refractory multiple myeloma. PBCAR269A...

September 9, 2020

Developments

Spero Therapeutics reports positive topline results from Phase 3 UTI and acute pyelonephritis trial

Spero Therapeutics (NASDAQ:SPRO) reported topline results from its Phase 3 ADAPT-PO trial evaluating tebipenem HBr for the treatment of complicated urinary tract infection (UTI) and acute pyelonephritis. Hospitalized...

September 8, 2020

Developments

Strongbridge Biopharma reports positive topline data from Phase 3 Cushing’s syndrome trial

Strongbridge Biopharma (NASDAQ:SBBP) reported topline data from its Phase 3 LOGICS trial evaluating RECORLEV for the treatment of endogenous Cushing’s syndrome. The study enrolled 44 patients to supplement the long-term...

September 8, 2020

Author - Abby Hardy

Kiniksa mavrilimumab gets FDA orphan drug designation for giant cell arteritis

Titan Pharma Probuphine commercialization partner inks European distribution agreement

Frequency Therapeutics reports positive results from hearing loss study

AVITA enrolls first patient in pivotal vitiligo trial

Hepion CRV431 featured on The Bio Report podcast

VBL Therapeutics enrolls first patients in Phase 2 metastatic colorectal cancer trial

Satsuma Pharma STS101 fails Phase 3 migraine trial

Precision BioSciences gets FDA fast track designation for second allogeneic CAR-T cell therapy

Spero Therapeutics reports positive topline results from Phase 3 UTI and acute pyelonephritis trial

Strongbridge Biopharma reports positive topline data from Phase 3 Cushing’s syndrome trial

Subscribe