Abby Hardy, Author at BioTuesdays

Developments

IntelGenx pleased with FDA meeting on NDA resubmission for RIZAPORT VersaFilm

IntelGenx (TSXV:IGX; OTCQB:IGXT) obtained clarity on the chemistry, manufacturing and controls information required for the resubmission of its RIZAPORT VersaFilm NDA during its Type A meeting with the FDA on June 10...

June 11, 2020

Executive Moves

Hepion names drug development expert, Dr. Peter Wijngaard, to its board

Peter Wijngaard Hepion Pharmaceuticals (NASDAQ:HEPA) appointed industry veteran, Dr. Peter Wijngaard, to its board of directors. “Dr. Wijngaard provided invaluable guidance to Hepion’s management team during our earlier...

June 10, 2020

Developments

IntelGenx to launch hand sanitizer business

Health Canada has cleared IntelGenx (TSXV:IGX; OTCQB:IGXT) to begin selling its liquid and gel hand sanitizer formulations, which will be produced using excess capacity at the company’s cGMP manufacturing facility in...

June 10, 2020

Developments

Karyopharm Therapeutics doses first glioblastoma patient in Phase 1/2 selinexor study

Karyopharm Therapeutics (NASDAQ:KPTI) dosed the first patient in a Phase 1/2 clinical study evaluating oral selinexor in patients with newly diagnosed or recurrent glioblastoma (GBM). This global study is expected to...

June 9, 2020

Developments

MD Anderson resumes Phase 1b trial of Soricimed’s SOR-C13

Closely-held Soricimed Biopharma reported that the MD Anderson Cancer Center has resumed its investigator-initiated trial of Soricimed’s SOR-C13. MD Anderson completed the first cohort of the dose escalation phase of...

June 9, 2020

Developments

MacroGenics margetuximab gets FDA orphan drug designation for gastric cancer

MacroGenics’ (NASDAQ:MGNX) margetuximab received FDA orphan drug designation for the treatment of gastric and gastroesophageal junction cancer. Margetuximab is currently being evaluated in a Phase 2/3 trial in...

June 5, 2020

Developments

Tenax posts positive Phase 2 levosimendan data

Tenax Therapeutics (NASDAQ:TENX) reported positive results from a Phase 2 trial evaluating levosimendan for the treatment of patients with pulmonary hypertension and heart failure with preserved ejection fraction (PH...

June 4, 2020

Developments

Idera Pharma reports positive initial Phase 2 data of tilsotolimod in colorectal cancer

Idera Pharma (NASDAQ:IDRA) reported positive preliminary data from its Phase 2 trial of tilsotolimod, in combination with Opdivo and Yervoy, in immunotherapy-naive micro-satellite stable colorectal cancer (MSS-CRC)...

June 4, 2020

Developments

Menlo Therapeutics reports positive data from Phase 2 acne vulgaris trial

Menlo Therapeutics (NASDAQ:MNLO) reported positive results from its Phase 2 trial evaluating FCD105 or the treatment of moderate-to-severe acne vulgaris. The study enrolled 447 patients who received either FCD105, a 3%...

June 4, 2020

Developments

Menlo Therapeutics ZILXI gets FDA approval for rosacea

Menlo Therapeutics’ (NASDAQ:MNLO) ZILXI received FDA approval for the treatment of inflammatory lesions of rosacea in adults. The company noted that ZILXI, a minocycline topical foam, is the first minocycline product of...

May 29, 2020

Author - Abby Hardy

IntelGenx pleased with FDA meeting on NDA resubmission for RIZAPORT VersaFilm

Hepion names drug development expert, Dr. Peter Wijngaard, to its board

IntelGenx to launch hand sanitizer business

Karyopharm Therapeutics doses first glioblastoma patient in Phase 1/2 selinexor study

MD Anderson resumes Phase 1b trial of Soricimed’s SOR-C13

MacroGenics margetuximab gets FDA orphan drug designation for gastric cancer

Tenax posts positive Phase 2 levosimendan data

Idera Pharma reports positive initial Phase 2 data of tilsotolimod in colorectal cancer

Menlo Therapeutics reports positive data from Phase 2 acne vulgaris trial

Menlo Therapeutics ZILXI gets FDA approval for rosacea

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