Category - Developments

Developments

Concert Pharmaceuticals completes alopecia areata trial

Concert Pharmaceuticals (NASDAQ:CNCE) completed its open-label trial comparing once-daily versus twice-daily dosing of CTP-543 in alopecia areata patients. Alopecia areata is an autoimmune disease that causes partial or...

December 20, 2019

Developments

Selecta completes enrollment in Phase 2 chronic refractory gout trial

Selecta Biosciences (NASDAQ:SELB) completed enrollment in its Phase 2 COMPARE trial of SEL-212 for the treatment of chronic refractory gout. SEL-212 is designed to sustain control of serum uric acid (SUA) levels in...

December 19, 2019

Developments

Aldeyra enrolls first patient in Phase 3 vitreoretinopathy trial

Aldeyra Therapeutics (NASDAQ:ALDX) enrolled the first patient in its Phase 3 GUARD trial of ADX-2191 for the prevention of proliferative vitreoretinopathy (PVR). PVR is an inflammatory disorder of the retina that leads...

December 19, 2019

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

Category - Developments

Concert Pharmaceuticals completes alopecia areata trial

Selecta completes enrollment in Phase 2 chronic refractory gout trial

Aldeyra enrolls first patient in Phase 3 vitreoretinopathy trial

MacroGenics submits margetuximab BLA to the FDA

Season’s Greetings (and JPM 2020)

Opsens gets FDA clearance to market diastolic pressure algorithm

Independent research on Helius’ PoNS treatment for TBI published

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

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