Abby Hardy, Author at BioTuesdays

Developments

MacroGenics submits margetuximab BLA to the FDA

MacroGenics (NASDAQ:MGNX) submitted a biologics license application (BLA) for margetuximab for the treatment of patients with metastatic HER2-positive breast cancer. The submission is based on the safety and efficacy...

December 19, 2019

Developments

Opsens gets FDA clearance to market diastolic pressure algorithm

Opsens (TSX:OPS; OTCQX:OPSSF) received 510(k) clearance from the FDA to market its diastolic pressure ratio (dPR) algorithm. The algorithm is designed to be used with Opsens’ OptoWire, a coronary guide wire used for...

December 19, 2019

Developments

Kane Biotech fulfills first major animal oral care product order from China

Kane Biotech (TSX-V:KNE) fulfilled its first major order, for $125,000 in bluestem pet oral care products, to its exclusive Chinese distribution partner, Eetoys Pet Products. Kane announced the exclusive distribution...

December 17, 2019

Developments

Avadel Pharma completes enrollment in Phase 3 narcolepsy trial

Avadel Pharmaceuticals (NASDAQ:AVDL) completed enrollment in its pivotal trial assessing FT218 for excessive daytime sleepiness and cataplexy in patients with narcolepsy. The Phase 3 study, called REST-ON, enrolled 212...

December 17, 2019

Developments

Pacira reports positive Phase 3 results for long-acting local analgesic in pediatric patients

Pacira BioSciences (NASDAQ:PCRX) reported positive results from its Phase 3 study of EXPAREL in pediatric patients undergoing spinal or cardiac surgeries. EXPAREL is a non-opioid, single-dose, long-acting local...

December 17, 2019

Developments

Eiger initiates rolling NDA for progeria drug candidate

Eiger BioPharmaceuticals (NASDAQ:EIGR) initiated a rolling NDA submission to the FDA for lonafarnib for the treatment of Hutchinson-Gilford progeria syndrome and progeroid laminopathies. Progeria is an extremely rare...

December 17, 2019

Developments

Kamada enrolls first patient in Phase 3 alpha-1 antitrypsin deficiency trial

Kamada (NASDAQ, TASE:KMDA) randomized the first patient in a pivotal clinical trial evaluating its inhaled alpha-1 antitrypsin (AAT) therapy for the treatment of alpha-1 antitrypsin deficiency (AATD). AATD is an...

December 17, 2019

Executive Moves

Indalo appoints healthcare industry veteran Michael Heffernan as board chair

Closely-held Indalo Therapeutics appointed Michael Heffernan as chair of its board of directors. “Indalo’s unique approach to treating fibrosis, combined with a highly experienced team and world-class financial backers...

December 17, 2019

Feature

Clene Nanomedicine developing first nanotherapeutic for neurodegenerative disease

Closely-held Clene Nanomedicine is developing catalytic drugs to treat neurodegenerative diseases, using its clean surface nanocrystal (CSN) therapeutics platform to increase cellular bioenergy. “We’re the first...

December 17, 2019

Developments

Kane Biotech launches anti-biofilm shampoo consumer product test

Kane Biotech (TSX-V:KNE) launched a consumer product test to evaluate the efficacy of its new shampoo on dermatitis and dandruff. Research indicates that microbial biofilms may aggravate symptoms associated with...

December 16, 2019

Author - Abby Hardy

MacroGenics submits margetuximab BLA to the FDA

Opsens gets FDA clearance to market diastolic pressure algorithm

Kane Biotech fulfills first major animal oral care product order from China

Avadel Pharma completes enrollment in Phase 3 narcolepsy trial

Pacira reports positive Phase 3 results for long-acting local analgesic in pediatric patients

Eiger initiates rolling NDA for progeria drug candidate

Kamada enrolls first patient in Phase 3 alpha-1 antitrypsin deficiency trial

Indalo appoints healthcare industry veteran Michael Heffernan as board chair

Clene Nanomedicine developing first nanotherapeutic for neurodegenerative disease

Kane Biotech launches anti-biofilm shampoo consumer product test

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