BioSpace News Archive

The COVID-19 Research Database, including Change Healthcare, Datavant, the Health Care Cost Institute (HCCI), Healthjump, Medidata (a Dassault Systèmes company), Mirador Analytics, Office Ally, PointClickCare, SAS, StataCorp, Snowflake, and Veradigm today announced that the Reagan-Udall Foundation for the FDA has named the COVID-19 Research Database a recipient of the 2021 Innovations in Regulatory Science Award.

Alvotech Holdings S.A. (“Alvotech”), a global biopharmaceutical company focused solely on the development and manufacture of biosimilar medicines for patients worldwide, received approval for AVT02 (100 mg/mL), the company’s high concentration biosimilar to Humira® (adalimumab), from the European Commission (EC) on Nov. 15.

Elucida Oncology, a clinical-stage biotechnology company pioneering the next frontier in targeted cancer therapy, announced today that Gregory Adams, Ph.D., Chief Scientific Officer, will be presenting on Thursday, December 16th at 8:30am PST at the Antibody Engineering & Therapeutics Conference.

Bristol Myers Squibb announced that Orencia® was approved by the US. FDA for the prophylaxis, or prevention, of acute graft versus host disease, in combination with a calcineurin inhibitor and methotrexate, in adults and pediatric patients 2 years of age and older undergoing hematopoietic stem cell transplantation from a matched or 1 allele-mismatched unrelated donor.

Verrica Pharmaceuticals Inc. (“Verrica”) (Nasdaq: VRCA), today announced that the U.S. Food and Drug Administration (FDA) acknowledged that Verrica’s resubmitted New Drug Application (NDA) for VP-102 for the treatment of molluscum contagiosum (molluscum) was complete and assigned a Prescription Drug User Fee Act (PDUFA) goal date of May 24, 2022.

Navidea Biopharmaceuticals, Inc. (NYSE American: NAVB) (“Navidea” or the “Company”), today announced that it has achieved full enrollment in its NAV3-35 Phase 2b clinical study titled “Development of a Normative Database for Rheumatoid Arthritis (RA) Imaging with Tc99m Tilmanocept.”

PURE Bioscience, Inc., creator of the patented non-toxic silver dihydrogen citrate antimicrobial, reported financial results for the fiscal first quarter ended October 31, 2021.

Syndax Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company developing an innovative pipeline of cancer therapies, announced that it plans to offer and sell, subject to market and other conditions, shares of its common stock in an underwritten public offering.

Citius Pharmaceuticals, Inc. (“Citius” or the “Company”) (Nasdaq: CTXR), today reported business and financial results for the fiscal full year ended September 30, 2021.

Assertio Holdings, Inc., a leading commercial pharmaceutical company bringing differentiated products to patients, announced it has acquired Otrexup, a drug device combination single dose once weekly auto-injector, from Antares Pharma, Inc. in the Company’s first new product acquisition since 2015.