Agilent Companion Diagnostic Gains Expanded FDA Approval in Urothelial Carcinoma PD-L1 IHC 22C3 pharmDx Now Approved to Identify Certain Urothelial Carcinoma Patients for Treatment With KEYTRUDA(R) (pembrolizumab) SANTA CLARA, Calif., August 21, 2018 Agilent Technologies Inc. (NYSE: A) today announced that the U.S. Food and Drug Administration (FDA) has approved its Dako PD-L1 IHC 22C3... Read more
Chalfont St Giles, UK & Uppsala, Sweden – 21 August 2018 — The Swedish government and GE Healthcare are opening Testa Center – an innovation center in Uppsala, Sweden, to boost the commercialization of new technologies and support manufacturing capabilities in the life sciences sector. The 2500 m2 (27,000 sq. ft.) Testa Center houses four... Read more
Basel, 13 August 2018 FDA grants Breakthrough Therapy Designation for Xolair (omalizumab) for food allergies There are currently no FDA-approved treatments that help prevent severe reactions due to food allergies As many as 15 million Americans have food allergies – including approximately 6 million children – and the incidence is increasing Roche (SIX: RO, ROG;... Read more
Basel, 03 August 2018 PRIME designation granted by European Medicines Agency for RG6042 for treatment of Huntington’s disease European Medicines Agency PRIME (PRIority MEdicines) status is granted to medicines that may offer a major therapeutic advantage over existing treatments, or benefit patients without treatment options RG6042 has the potential to be the first therapy targeting... Read more
Basel, 03 August 2018 PRIME designation granted by European Medicines Agency for RG6042 for treatment of Huntington’s disease European Medicines Agency PRIME (PRIority MEdicines) status is granted to medicines that may offer a major therapeutic advantage over existing treatments, or benefit patients without treatment options RG6042 has the potential to be the first therapy targeting... Read more
ITHACA, N.Y., August 1, 2018 — Advion, Inc., a leading systems and consumables provider for the life sciences industry, is pleased to announce the new location of the company headquarters within the Cornell Business and Technology Park at 61 Brown Rd., Suite 100, Ithaca, NY 14850. Sparked by growth in demand and the need for additional... Read more
NeoLSD™ MSMS Kit is First Commercial IVD Kit to Use Mass Spectrometry to Screen for Six LSDs in Newborn Babies from a Single Dried Blood Spot Sample WHAT: PerkinElmer, Inc., a global leader in innovating for a healthier world, today announced that it received 510(k) clearance from the FDA to commercially market its NeoLSD™ MSMS... Read more
Hilden, Germany, and Germantown, Maryland, July 30, 2018 – QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced that QuantiFERON-TB® Gold Plus (QFT-Plus), the gold standard in accurate, cost-effective testing for latent tuberculosis (TB) infection, has been adopted by the International Organization for Migration (IOM) for use in screening migrants for the infection. As the United... Read more
Assist in Screening and Diagnosing ANCA-Associated Vasculitis WALTHAM, Mass. – July 25, 2018 – PerkinElmer, Inc., a global leader committed to innovating for a healthier world, today announced that its EUROIMMUN ANCA IFA and EUROPLUS Granulocyte Mosaic™ assays for use with EUROPattern microscope have received 510(k) clearance from the U.S. Food & Drug Administration (FDA).... Read more
Basel, 20 July 2018 FDA grants Breakthrough Device Designation for Roche’s Elecsys cerebrospinal fluid (CSF) assays to support the improved diagnosis of Alzheimer’s disease Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today, that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation to Elecsys® ß-Amyloid (1-42) CSF and Elecsys® Phospho-Tau (181P) CSF.... Read more