Michelle Carr, Author at BioTuesdays

Developments

Revive oral Bucillamine flunks Phase 3 COVID-19 study

Revive Therapeutics (OTCQB:RVVTF; CSE:RVV) reported that its Phase 3 clinical study evaluating the safety and efficacy of oral Bucillamine in patients with mild- to-moderate COVID-19 did not achieve statistical...

July 6, 2023

Developments

FDA clears protocol for Acasti Phase 3 trial in aSAH

Acasti Pharma (NASDAQ:ACST) and the FDA agreed on the protocol of a Phase 3 trial of GTX-104 in patients with aneurysmal subarachnoid hemorrhage (aSAH), a rare disease with bleeding over the surface of the brain in the...

July 5, 2023

Developments

Palisade Bio completes enrollment in dose optimization study

Palisade Bio (NASDAQ:PALI) completed patient enrollment in its dose optimization study of LB1148, a broad-spectrum serine protease inhibitor that acts to neutralize digestive enzymes, potentially reducing intestinal...

July 5, 2023

Developments

RenovoRx presents positive interim Phase 3 data in pancreatic cancer

RenovoRx (NASDAQ:RNXT) presented new positive data on progression-free survival from the pivotal Phase 3 open label TIGeR-PaC study of RenovoGem (intra-arterial administration of gemcitabine) in locally advanced...

June 29, 2023

Developments

PharmaJet Tropis system authorized for 2 nucleic acid vaccines

PharmaJet’s Tropis system is now the exclusive intradermal delivery system for two authorized novel COVID-19 vaccines. They include: The world’s first plasmid DNA COVID-19 vaccine for administration in humans from Zydus...

June 28, 2023

Developments

FDA lifts clinical hold on deucrictibant for on-demand treatment of HAE

The FDA lifted the clinical hold on Pharvaris’ (NASDAQ:PHVS) IND application for deucrictibant for the on-demand treatment of hereditary angioedema (HAE) following a review of data from a preplanned interim analysis of...

June 26, 2023

Developments

FDA lifts clinical hold on DiaMedica ischemic stroke trial

The FDA has removed a clinical hold placed on DiaMedica’s (NASDAQ:DMAC) investigational new drug application for its ReMEDy2 Phase 2/3 clinical trial studying DM199 in the treatment of acute ischemic stroke (AIS) and...

June 21, 2023

Developments

Annovis Bio gets positive DSMB review of Phase 3 PD trial

A Data and Safety Monitoring Board (DSMB) recommended that Annovis Bio (NYSE:ANVS) continue its Phase 3 trial as originally designed of buntanetap, a drug for early Parkinson’s disease (PD) patients. The DSMB decision...

June 20, 2023

Developments

Precigen receives FDA breakthrough nod for AdenoVerse in RRP

The FDA granted breakthrough therapy designation for Precigen’s (NASDAQ:PGEN) investigational PRGN-2012 AdenoVerse immunotherapy for the treatment of recurrent respiratory papillomatosis (RRP). Standard-of-care for RRP...

June 20, 2023

Developments

2seventy’s CAR-T trial halted after pediatric death

2seventy bio’s (NASDAQ:TSVT) partner, Seattle Children’s Hospital, paused a Phase 1 CAR T-cell therapy trial for pediatric acute myeloid leukemia after a patient death. The child was the first to receive the second dose...

June 15, 2023

Author - Michelle Carr

Revive oral Bucillamine flunks Phase 3 COVID-19 study

FDA clears protocol for Acasti Phase 3 trial in aSAH

Palisade Bio completes enrollment in dose optimization study

RenovoRx presents positive interim Phase 3 data in pancreatic cancer

PharmaJet Tropis system authorized for 2 nucleic acid vaccines

FDA lifts clinical hold on deucrictibant for on-demand treatment of HAE

FDA lifts clinical hold on DiaMedica ischemic stroke trial

Annovis Bio gets positive DSMB review of Phase 3 PD trial

Precigen receives FDA breakthrough nod for AdenoVerse in RRP

2seventy’s CAR-T trial halted after pediatric death

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