FDA Approval – San Diego Biotechnology Network

V2ACT Therapeutics(TM), LLC Announces FDA Clearance of an IND Application to proceed with a Phase 1/2a Study of V2ACT for the Treatment of Pancreatic Cancer

December 11, 2020 sandiegobiotech Comments Off

– V2ACT Therapeutics(TM), LLC is a joint venture of Genelux Corporation and TVAX Biomedical, Inc.- V2ACT is a proprietary immuno-oncology modality composed of Olvi-Vec (oncolytic immunotherapy) and V-ACT (vaccine-enhanced adoptive cell therapy).- V2ACT… […]

Agena Bioscience Granted EUA for High-Throughput, Low-Cost SARS-CoV-2 Panel

October 28, 2020 sandiegobiotech Comments Off

SAN DIEGO, Oct. 28, 2020 /PRNewswire/ — Agena Bioscience®, a global provider of low-cost and high-throughput molecular testing solutions, today announced that its MassARRAY® SARS-CoV-2 Panel for qualitative detection of the SARS-CoV-2 coronavirus h… […]

Helix Receives Expanded Emergency Use Authorization for On-site Unsupervised Self-Collection and Asymptomatic Screening with the Helix® COVID-19 Test

October 26, 2020 sandiegobiotech Comments Off

As one of the few tests with these indications, the Helix® COVID-19 Test provides organizations with significantly more flexibility in how they operate testing sites to support broad back-to-work and school screening

SAN MATEO, Calif., Oct. 26, 2020… […]

Halozyme Announces Janssen Submission For FDA Approval Of DARZALEX FASPRO(TM) (daratumumab and hyaluronidase-fihj) For The Treatment Of Patients With Light Chain (AL) Amyloidosis

September 10, 2020 sandiegobiotech Comments Off

– Follows FDA Approval of DARZALEX FASPRO(TM) Utilizing ENHANZE® Technology in May 2020 for the Treatment of Patients with Multiple Myeloma –

SAN DIEGO, Sept. 10, 2020 /PRNewswire/ — Halozyme Therapeutics, Inc. (NASDAQ: HALO) today announced that it… […]

FDA Approves First NGS-Based Companion Diagnostic for RET Fusion-Positive Non-Small Cell Lung Cancer

September 8, 2020 sandiegobiotech Comments Off

CDx approval expands clinical utility of Oncomine Dx Target Test to identify candidates for GAVRETO

CARLSBAD, Calif., Sept. 8, 2020 /PRNewswire/ — The U.S. Food and Drug Administration (FDA) has granted premarket approval to Thermo Fisher Scientific… […]

FDA Issues Emergency Use Authorization for ChromaCode’s High-Throughput HDPCR(TM) SARS-CoV-2 Real-Time PCR Assay

June 10, 2020 sandiegobiotech Comments Off

High-Definition PCR SARS-CoV-2 assay increases test throughput and reduces complexity of interpretation; ChromaCode customers enjoy inventory guarantee

CARLSBAD, Calif., June 10, 2020 /PRNewswire/ — ChromaCode, Inc., a company redefining molecular … […]

Invivoscribe Announces FDA Approval for Distribution of the LeukoStrat CDx FLT3 Mutation Assay as an IVD Kit in the United States

May 19, 2020 sandiegobiotech Comments Off

SAN DIEGO, May 19, 2020 /PRNewswire/ — Invivoscribe to offer the LeukoStrat® CDx FLT3 Mutation Assay as an FDA approved kit with analysis software.

In 2017, Invivoscribe’s LeukoStrat® CDx FLT3 Mutation Assay became the first FDA approved FLT3… […]

Neurocrine Biosciences Reports First Quarter 2020 Financial Results

May 6, 2020 sandiegobiotech Comments Off

INGREZZA® (valbenazine) First Quarter Net Product Sales of $231 Million with Approximately 41,500 TRxONGENTYS® (opicapone) Approved by the U.S. Food and Drug Administration (FDA) as a Once-Daily Adjunctive Treatment for Patients with Parkinson’s Diseas… […]

Halozyme Announces Janssen Receives FDA Approval Of DARZALEX FASPRO(TM) Utilizing Halozyme’s ENHANZE® Technology For The Treatment Of Patients With Multiple Myeloma

May 1, 2020 sandiegobiotech Comments Off

– Janssen’s DARZALEX FASPRO(TM) is a subcutaneous co-formulation of DARZALEX? and Halozyme’s ENHANZE? technology — Innovative, fixed-dose formulation demonstrates consistent efficacy to intravenous DARZALEX? with lower rate of infusion-related reactio… […]