BioSpace News Archive

FDA Fast Track Designation has been granted to DAV132 for the prevention of Clostridioides difficile infection, a life-threatening condition with persistent unmet medical need, especially in cancer patients

FibroGen, Inc. (NASDAQ: FGEN) announced that the U.S. Food and Drug Administration (FDA) has informed the Company late today it has tentatively scheduled a Cardiovascular and Renal Drug Advisory Committee (CRDAC) on July 15, 2021 to review the New Drug Application (NDA) for roxadustat for the treatment of anemia of chronic kidney disease (CKD) in both dialysis-dependent and non-dialysis-dependent patients.

CM Life Sciences III Inc. announced that it priced its initial public offering of 48,000,000 units at $10.00 per unit.

TransMedics Group, Inc. announced that after the review of TransMedics’ clinical evidence from the OCS Heart EXPAND trial, the associated Continued Access Protocol results, as well as the OCS Heart PROCEED II trial, the Circulatory Systems Device Advisory Panel convened by the U.S. Food and Drug Administration has issued a favorable vote in support of approval of the OCS Heart System to the FDA’s Office of Health Technology 2.

ClearPoint Neuro, Inc. (Nasdaq: CLPT) (the “Company”), a global therapy-enabling platform company providing navigation and delivery to the brain, today congratulates uniQure N.V. on the early completion of patient enrollment in the first dose cohort of a randomized, double-blinded, Phase I/II clinical trial of AMT-130 being conducted in the United States for the treatment of early-stage Huntington’s disease.

Bio-Techne Corporation (NASDAQ: TECH) today announced it has completed the acquisition of Asuragen, Inc. The transaction included initial consideration of $215 million in cash plus contingent consideration of up to $105 million upon the achievement of certain future milestones.

Inogen Announces Participation in the 20 th Annual Needham Virtual Healthcare Conference

QIAseq DIRECT SARS-CoV-2 Kit halves both library preparation times and plasticware use Kit supports analysis of over 6,000 samples simultaneously on highest-throughput sequencers Integrates with QIAGEN Digital Insights cloud solutions to support variant detection and reporting including clade and lineage annotations across sequencing platforms

Health Canada is investigating the risk of serious heart-related issues and cancer with the use of Xeljanz and Xeljanz XR (tofacitinib).

Clean Tec Services, the central Florida-based commercial and hospitality maintenance management and cleaning specialist, has partnered with BioAssured to bring the BioAssured Certification to their extensive hotel client base.