BioSpace News Archive

– Topline data from SER-109 Phase 3 study in recurrent C. difficile infection expected in August 2020; Potential to be the single pivotal study supporting FDA product registration –.

Momenta Pharmaceuticals, Inc. announced that its novel drug candidate, nipocalimab, has received rare pediatric disease designation from the U.S. Food and Drug Administration for the prevention of hemolytic disease of the fetus and newborn.

Second-Quarter 2020 Results and Highlights

MiMedx Group, Inc., an industry leader in advanced wound care and an emerging therapeutic biologics company, announced the addition of Rohit Kashyap, Ph.D., as Executive Vice President and Chief Commercial Officer, effective August 3, 2020.

HemoShear Therapeutics, a clinical stage company developing treatments for rare metabolic disorders, has received Fast Track and Rare Pediatric Disease designations from the U.S. Food and Drug Administration (FDA) for HST5040, a once-daily oral small molecule drug being developed to treat methylmalonic acidemia (MMA) and propionic acidemia (PA).

Dozens of molecules may tangle up with rogue bundles of tau, a protein that normally gives nerve fibers structure, to cause brain cell damage that contributes to neurodegenerative diseases, a new study shows.

Acerus Announces Resumption of NATESTO ® Shipments Product En Route to United States and Taiwan TORONTO--( BUSINESS WIRE )-- Acerus Pharmaceuticals Corporation (TSX:ASP, OTCQB:ASPCF), a speciality pharmaceutical company focused on the commercialization of novel prescription products for men’s health, today announced that production of new batches of NATESTO ® (testosterone nasal gel) is underway and shipments are already in transit to several key ma

AMAG Pharmaceuticals, Inc. (NASDAQ: AMAG) today announced that its second quarter 2020 financial results will be released on Thursday, August 6, 2020 before the U.S. financial markets open. Management will host a conference call and webcast at 8:00 a.m. ET to discuss the results and provide an update on recent corporate developments. Dial-in Number U.S./Canada Dial-in Number: (877) 412-6083 International Dial-in Number: (702) 495-1202 Confe

NeuBase Therapeutics, Inc. (Nasdaq: NBSE) (“NeuBase” or the “Company”), a biotechnology company developing next-generation antisense oligonucleotide (ASO) therapies using its scalable PATrOL™ platform to address genetic diseases, today announced the appointment of industry veteran William Mann, Ph.D., MBA as chief operating officer (COO). Dr. Mann will leverage his decades of experience in the biopharma industry to manage NeuBase operations and adv

Smith+Nephew (LSE: SN, NYSE: SNN), the global medical technology business, today announces the launch of the RI.HIP NAVIGATION for total hip arthroplasty (THA).