February 14, 2018 Acad, Gov/Utilities

FDA grants priority review for Roche’s MabThera/ Rituxan (rituximab) for pemphigus vulgaris

Basel, 14 February 2018 FDA grants priority review for Roche’s MabThera/ Rituxan (rituximab) for pemphigus vulgaris Pemphigus vulgaris (PV) is a life-threatening, autoimmune condition with limited treatment options1 The FDA previously granted Breakthrough Therapy Designation and Orphan Drug Designation for MabThera/Rituxan in PV Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the US Food... Read more

February 13, 2018 Acad, Gov/Utilities Product Launch

FDA Approves New HPV Test that Detects and Identifies HPV Genotypes that put Women at High Risk for Cervical Cancer

FRANKLIN LAKES, N.J., Feb. 13, 2018 /PRNewswire/ — BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, today announced that it has received pre-market approval from the U.S. Food and Drug Administration (FDA) for the BD Onclarity™ HPV assay. The test detects 14 types of high-risk human papillomavirus (HPV) from specimens collected... Read more

February 12, 2018 Acad, Gov/Utilities Bio/Pharma/CRO

Phase II data support potential for Roche’s novel anti-VEGF/anti-angiopoietin-2 bispecific antibody, RG7716, for people with diabetic macular edema

Basel, 12 February 2018 Phase II data support potential for Roche’s novel anti-VEGF/anti-angiopoietin-2 bispecific antibody, RG7716, for people with diabetic macular edema RG7716 is the first bispecific antibody designed specifically for the treatment of retinal eye diseases RG7716 demonstrated clinically meaningful and statistically significant improvements in visual acuity Key secondary and exploratory anatomical outcomes were... Read more

January 29, 2018 Acad, Gov/Utilities Lab Top-10 M&A, Partnerships

Agilent Announces Scientific Collaboration with the University of Southern California

Agilent Announces Scientific Collaboration with the University of Southern California Collaboration aims to facilitate transformational biomedical science and engineering research SANTA CLARA, Calif., Jan. 29, 2018 Agilent Technologies Inc. (NYSE: A) today announced that it has formed a strategic scientific collaboration with the University of Southern California (USC) Michelson Center for Convergent Bioscience to create... Read more

January 29, 2018 Acad, Gov/Utilities

FDA grants Breakthrough Therapy Designation for Roche’s balovaptan in autism spectrum disorder

Basel, 29 January 2018 FDA grants Breakthrough Therapy Designation for Roche’s balovaptan in autism spectrum disorder Balovaptan has the potential to be the first pharmacotherapy to help improve core social interaction and communication in people with autism spectrum disorder Second FDA Breakthrough Therapy Designation for a Roche neuroscience medicine Roche (SIX: RO, ROG; OTCQX: RHHBY)... Read more

January 26, 2018 Acad, Gov/Utilities Bio/Pharma/CRO PR/Corporate

QIAGEN receives FDA approval to expand use of EGFR test in lung cancer

Germantown, Maryland, and Hilden, Germany, January 18, 2018 – QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced that the U.S. Food and Drug Administration (FDA) has approved a PMA supplement extending the indications for use of QIAGEN’s therascreen® EGFR RGQ PCR Kit as a companion diagnostic to guide the use of Boehringer Ingelheim’s... Read more

January 23, 2018 Acad, Gov/Utilities PR/Corporate

QIAGEN receives FDA clearance for first-ever JAK2 test for use in diagnosis of additional myeloproliferative neoplasms

Hilden, Germany, and Germantown, Maryland, January 23, 2018 – QIAGEN (NYSE: QGEN; Frankfurt Prime Standard: QIA) announced today that it has received clearance for its ipsogen JAK2 RGQ PCR Kit (ipsogen JAK2 assay) from the U.S. Food and Drug Administration (FDA) for additional use in the diagnosis of all myeloproliferative neoplasms (MPNs), which are a... Read more

January 12, 2018 Acad, Gov/Utilities Microscopy

BD Statement on FDA Warning Letter for Preanalytical Systems Business Unit

FRANKLIN LAKES, N.J., Jan. 12, 2018 /PRNewswire/ — BD (Becton, Dickinson and Company) (NYSE: BDX) issued the following statement in response to receiving a warning letter from the U.S. Food and Drug Administration for its Preanalytical Systems business unit. Richard Byrd, worldwide president of BD Preanalytical Systems said: “Ensuring the safety and quality of our products... Read more

January 4, 2018 Acad, Gov/Utilities Bio/Pharma/CRO Clinical Research/Diagn. Environ, Ag./Food & Bev Life Science Tools M&A, Partnerships

Illumina and KingMed Diagnostics Partner to Develop Next-Generation Sequencing Technology for Chinese FDA Approval

SAN DIEGO–(BUSINESS WIRE)–Illumina, Inc. (NASDAQ: ILMN) and KingMed Diagnostics (SSE: 603882.SS) today announced an agreement to jointly develop novel oncology and hereditary disease testing applications utilizing Illumina’s next-generation sequencing (NGS) technology. The collaboration is a significant step toward China Food and Drug Administration (CFDA) review and approval, and serves as a starting point to deliver... Read more