BridgeBio Pharma’s Origin Biosciences Initiates Rolling Submission of New Drug Application with the U.S. FDA for BBP-870 for the Treatment of MoCD Type A

Posted in Biotech by Medtech[y] Staff

December 03, 2019 • 2 min read

​BridgeBio Pharma, Inc. (Nasdaq: BBIO) subsidiary Origin Biosciences has initiated a rolling submission of a New Drug Application (NDA) with the United States Food and Drug Administration (FDA) for fosdenopterin (BBP-870/ORGN001) for the treatment of patients with molybdenum cofactor deficiency (MoCD) Type A....

Biogen Announces Positive Phase 2 Study Results for Cutaneous Lupus Erythematosus (CLE) and Systemic Lupus Erythematosus (SLE)

Posted in Biotech by Medtech[y] Staff

December 03, 2019 • 2 min read

​Today, Biogen Inc. (Nasdaq: BIIB) announced positive top-line results from the Phase 2 LILAC study evaluating the efficacy and safety of BIIB059, a fully humanized IgG1 monoclonal antibody (mAb) targeting blood dendritic cell antigen 2 (BDCA2) expressed on plasmacytoid dendritic cells, in patients with lupus....

Outlook Therapeutics Receives FDA Agreement for Three Special Protocol Assessments for Additional Planned Clinical Trials of ONS-5010

Posted in Biotech by Medtech[y] Staff

December 03, 2019 • 2 min read

​Outlook Therapeutics, Inc. (NASDAQ: OTLK) (the “Company”), a late clinical-stage biopharmaceutical company working to develop the first FDA-approved ophthalmic formulation of bevacizumab for use in retinal indications, today announced that it has received agreement from the U.S. Food and Drug Administration (“FDA”)...

Tusker Medical’s TULA Pediatric Ear Tubes Awarded Breakthrough Device Designation

Posted in Medical Device by Medtech[y] Staff

November 26, 2019 • 2 min read

After a successful study which evaluated the in-office placement of tympanostomy tubes in approximately 300 children ages 6 months through 12 years old, the FDA has awarded Tusker Medical breakthrough device approval for their Tula (Tubes Under Local Anesthesia) system, which delivers tympanostomy tubes (ear tubes) to young children with recurrent ear infections, in a physician’s office and under local anesthesia....