Category - Developments

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

Season’s Greetings (and JPM 2020)

Wow, what an interesting year 2019 has turned out to be!On behalf of everyone at BioTuesdays, I would like to wish you all a safe and happy holiday season. After taking a short break to spend time with family and...

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

Independent research on Helius’ PoNS treatment for TBI published

Independent research conducted at the University of Wisconsin-Madison on Helius Medical Technologies’ (NASDAQ:HSDT; TSX:HSM) translingual neurostimulation for the treatment of chronic symptoms due to mild-to-moderate...

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

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

Category - Developments

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