BioSpace News Archive

Bright Path Laboratories, Inc (the “Company” or “BPL”), a leader in continuous flow reactor technology, was recently accepted into the FDA’s Emerging Technology Program paving the way for the Company to bring its unique low-cost and scalable technology to the domestic API manufacturing sector.

Aptinyx Inc. (Nasdaq: APTX), a clinical-stage biopharmaceutical company developing transformative therapies for the treatment of brain and nervous system disorders, today announced that the company will host a conference call and live webcast on Monday, March 30, 2020 at 5:00 p.m. ET to report fourth quarter and full year 2019 financial results and discuss recent business highlights.

Acer Therapeutics Inc. (Nasdaq: ACER), a pharmaceutical company focused on the acquisition, development and commercialization of therapies for serious rare and life-threatening diseases with significant unmet medical needs, today announced that the Office of New Drugs (OND) of the U.S. Food and Drug Administration (FDA) has denied Acer’s appeal of the Complete Response Letter (CRL) in relation to the New Drug Application (NDA) for EDSIVO™

Acer Therapeutics Inc. (Nasdaq: ACER), a pharmaceutical company focused on the acquisition, development and commercialization of therapies for serious rare and life-threatening diseases with significant unmet medical needs, today reported financial results for the fourth quarter and full year ended December 31, 2019 and provided an update on the Company’s recent corporate developments.

Osmotica Pharmaceuticals plc (Nasdaq: OSMT) (“Osmotica” or the “Company”), a fully integrated biopharmaceutical company, today announced business highlights and financial results for the three months and full year ended December 31, 2019.

1Life Healthcare, Inc. (One Medical) (Nasdaq: ONEM) today announced financial results for the fourth quarter and full year ended December 31, 2019.

Dicerna Pharmaceuticals, Inc. (Nasdaq: DRNA) (the “Company” or “Dicerna”), a leading developer of investigational ribonucleic acid interference (RNAi) therapeutics, today announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation (ODD) to Dicerna’s DCR-A1AT for the treatment of alpha-1 antitrypsin (A1AT) deficiency

Cumberland Pharmaceuticals Inc. (NASDAQ: CPIX), a specialty pharmaceutical company focused on hospital acute care and gastroenterology, today announced fourth quarter and full year 2019 financial results.

Portola Pharmaceuticals, Inc.® (NASDAQ: PTLA) today announced proactive steps the Company is taking in support of public heath efforts to prevent furtherspread of coronavirus (or COVID-19) around the globe.

Novartis Pharmaceuticals Corporation announced a Consumer Product Safety Commission -approved corrective action plan after identifying certain blister card packages of SANDIMMUNE 100-mg soft gelatin capsules and NEORAL MODIFIED 100-mg soft gelatin capsules distributed in the US do not meet child-resistant packaging requirements, posing a potential risk of harm if children open the package and swallow the medicine.