Abby Hardy, Author at BioTuesdays

Developments

Imara gets EC orphan drug designation for sickle cell disease

Imara’s (NASDAQ:IMRA) IMR-687 received European Commission orphan drug designation for the treatment of sickle cell disease. In a statement, Imara’s president and CEO, Rahul Ballal, said the designation reinforces “the...

August 25, 2020

Feature

Axolotl Biosciences developing bioink for 3D neural tissue bioprinting

Closely-held Axolotl Biosciences is developing a bioink specifically formulated for the bioprinting of neural tissue, for biotechnology and pharmaceutical companies to use for research and development purposes. “Last...

August 25, 2020

Developments

Entera Bio reports interim data from Phase 2 osteoporosis trial

Entera Bio (NASDAQ:ENTX) reported interim results from its Phase 2 trial assessing EB613 for the treatment of osteoporosis. The trial has currently enrolled 131 postmenopausal female subjects with osteoporosis, or low...

August 20, 2020

Developments

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

Precision BioSciences’ (NASDAQ:DTIL) allogeneic chimeric antigen receptor (CAR-T) cell therapy, PBCAR0191, received FDA fast track designation for the treatment of advanced B-cell precursor acute lymphoblastic leukemia...

August 20, 2020

Developments

Kazia gets FDA fast track designation for glioblastoma

Kazia Therapeutics’ (NASDAQ:KZIA) paxalisib received FDA fast track designation for the treatment of glioblastoma. Interim data from the company’s Phase 2 trial demonstrated overall survival of 17.7 months for patients...

August 20, 2020

Developments

IntelGenx in feasibility pact with ATAI for film-based psychedelics

IntelGenx (TSXV:IGX; OTCQB:IGXT) and ATAI Life Sciences signed a feasibility agreement for the development of novel formulations of pharmaceutical-grade psychedelics, based on IntelGenx’s film technologies. Under...

August 20, 2020

Developments

Albireo Pharma ends development of elobixibat for NASH/NAFLD

Albireo Pharma (NASDAQ:ALBO) reported topline results from its Phase 2 trial evaluating elobixibat for the treatment of non-alcoholic steatohepatitis (NASH) and non-alcoholic fatty liver disease (NAFLD). The trial...

August 18, 2020

Developments

Vanda Pharma reports interim results from Phase 3 COVID-19 trial

Vanda Pharmaceuticals (NASDAQ:VNDA) reported interim results from its Phase 3 trial assessing tradipitant for the treatment of COVID-19 pneumonia. The data are based on the first 60 patients enrolled in the study, who...

August 18, 2020

Feature

Chiasma readies U.S. launch of first oral somatostatin analog for acromegaly

On the heels of an FDA approval, Chiasma (NASDAQ:CHMA) is preparing for the U.S. launch of MYCAPSSA, the first orally administered somatostatin analog for the long-term maintenance treatment of acromegaly in patients...

August 18, 2020

Developments

Mustang Bio MB-107 gets FDA rare pediatric disease designation

The FDA granted Mustang Bio’s (NASDAQ:MBIO) MB-107 rare pediatric disease designation for the treatment of X-linked severe combined immunodeficiency. Patients with X-linked severe combined immunodeficiency produce...

August 17, 2020

Author - Abby Hardy

Imara gets EC orphan drug designation for sickle cell disease

Axolotl Biosciences developing bioink for 3D neural tissue bioprinting

Entera Bio reports interim data from Phase 2 osteoporosis trial

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

Kazia gets FDA fast track designation for glioblastoma

IntelGenx in feasibility pact with ATAI for film-based psychedelics

Albireo Pharma ends development of elobixibat for NASH/NAFLD

Vanda Pharma reports interim results from Phase 3 COVID-19 trial

Chiasma readies U.S. launch of first oral somatostatin analog for acromegaly

Mustang Bio MB-107 gets FDA rare pediatric disease designation

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