BioCentury | Mar 16, 2020
Product Development

COVID-19 Roundup: Trial starts for Moderna, Sanofi-Regeneron and BioNTech; plus Thermo Fisher, Roche and VIB

First patients receive Moderna’s coronavirus vaccine  Moderna Inc. (NASDAQ:MRNA) said NIH has begun dosing patients in a Phase I study of mRNA-1273, the company’s vaccine against SARS-CoV-2. The trial is enrolling 45 healthy adults at...
BC Week In Review | May 4, 2017
Clinical News

FDA approves companion diagnostic for AML drug Rydapt

Invivoscribe Technologies Inc. (San Diego, Calif.) said FDA approved its Leukostrat CDx FLT3 Mutation Assay as a companion diagnostic for acute myelogenous leukemia (AML) drug Rydapt midostaurin from Novartis AG (NYSE:NVS; SIX:NOVN). The in vitro...
BC Week In Review | Feb 24, 2017
Company News

Promega, Thermo Fisher supply/service news

The U.S. Supreme Court ruled that Life Technologies Corp. is not liable for patent infringement under U.S. law for selling Promega’s kit overseas because only one of the five components were manufactured in the U.S....
BC Extra | Apr 2, 2015
Company News

Management tracks

Antibody-drug conjugate company ImmunoGen Inc. (NASDAQ:IMGN) hired Anna Berkenblit as VP and CMO. Berkenblit was SVP of clinical development at H3 Biomedicine Inc. (Cambridge, Mass.). Ear disease company Otonomy Inc. (NASDAQ:OTIC) named Dean Hakanson CMO....
BC Week In Review | Mar 23, 2015
Company News

Enzo, Thermo Fisher genomics news

The U.S. Court of Appeals for the Federal Circuit (CAFC) vacated a lower court judgment that Life Technologies Corp .’s sequencing instruments infringed Enzo’s U.S. Patent No. 5,449,767, covering DNA sequencing compounds. The appeals court...
BC Week In Review | Oct 27, 2014
Clinical News

Lyra Parainfluenza Assay regulatory update

Quidel said FDA granted 510(k) clearance to the company's Lyra Parainfluenza Assay to quantitatively detect human parainfluenza virus (HPIV) infections types 1, 2 or 3 viral RNA from nasal swab and nasopharyngeal swab specimens. The...
BioCentury | Oct 27, 2014
Finance

Waiting for better times

Poised to complete the fourth-largest European biotech IPO since 2008, the road show for Molecular Partners AG had the poor luck of coinciding with the largest one-week drop in the broader capital markets since the...
BC Week In Review | Oct 20, 2014
Clinical News

Lyra Adenovirus Assay regulatory update

Quidel said FDA granted 510(k) clearance to its Lyra Adenovirus Assay to qualitatively detect human adenovirus viral DNA isolated from nasal and nasopharyngeal swab specimens. The multiplex real-time PCR in vitro assay is available for...
BC Innovations | Sep 18, 2014
Translation in Brief

Translational tidbits

Chris Cain, Associate Editor, and Kai-Jye Lou, Senior Writer RNA sequencing standardized The FDA has convened a consortium to review the status of RNA sequencing for drug development and outline hurdles for incorporating the technology...
BC Week In Review | Aug 4, 2014
Company News

Epic Sciences board of directors update

Epic Sciences Inc. , La Jolla, Calif.   Business: Diagnostic   Appointed: Gregory Lucier as chairman, formerly chairman and CEO of Life Technologies Corp. , which Thermo Fisher Scientific Inc. acquired  ...
Items per page:
1 - 10 of 1252
BioCentury | Mar 16, 2020
Product Development

COVID-19 Roundup: Trial starts for Moderna, Sanofi-Regeneron and BioNTech; plus Thermo Fisher, Roche and VIB

First patients receive Moderna’s coronavirus vaccine  Moderna Inc. (NASDAQ:MRNA) said NIH has begun dosing patients in a Phase I study of mRNA-1273, the company’s vaccine against SARS-CoV-2. The trial is enrolling 45 healthy adults at...
BC Week In Review | May 4, 2017
Clinical News

FDA approves companion diagnostic for AML drug Rydapt

Invivoscribe Technologies Inc. (San Diego, Calif.) said FDA approved its Leukostrat CDx FLT3 Mutation Assay as a companion diagnostic for acute myelogenous leukemia (AML) drug Rydapt midostaurin from Novartis AG (NYSE:NVS; SIX:NOVN). The in vitro...
BC Week In Review | Feb 24, 2017
Company News

Promega, Thermo Fisher supply/service news

The U.S. Supreme Court ruled that Life Technologies Corp. is not liable for patent infringement under U.S. law for selling Promega’s kit overseas because only one of the five components were manufactured in the U.S....
BC Extra | Apr 2, 2015
Company News

Management tracks

Antibody-drug conjugate company ImmunoGen Inc. (NASDAQ:IMGN) hired Anna Berkenblit as VP and CMO. Berkenblit was SVP of clinical development at H3 Biomedicine Inc. (Cambridge, Mass.). Ear disease company Otonomy Inc. (NASDAQ:OTIC) named Dean Hakanson CMO....
BC Week In Review | Mar 23, 2015
Company News

Enzo, Thermo Fisher genomics news

The U.S. Court of Appeals for the Federal Circuit (CAFC) vacated a lower court judgment that Life Technologies Corp .’s sequencing instruments infringed Enzo’s U.S. Patent No. 5,449,767, covering DNA sequencing compounds. The appeals court...
BC Week In Review | Oct 27, 2014
Clinical News

Lyra Parainfluenza Assay regulatory update

Quidel said FDA granted 510(k) clearance to the company's Lyra Parainfluenza Assay to quantitatively detect human parainfluenza virus (HPIV) infections types 1, 2 or 3 viral RNA from nasal swab and nasopharyngeal swab specimens. The...
BioCentury | Oct 27, 2014
Finance

Waiting for better times

Poised to complete the fourth-largest European biotech IPO since 2008, the road show for Molecular Partners AG had the poor luck of coinciding with the largest one-week drop in the broader capital markets since the...
BC Week In Review | Oct 20, 2014
Clinical News

Lyra Adenovirus Assay regulatory update

Quidel said FDA granted 510(k) clearance to its Lyra Adenovirus Assay to qualitatively detect human adenovirus viral DNA isolated from nasal and nasopharyngeal swab specimens. The multiplex real-time PCR in vitro assay is available for...
BC Innovations | Sep 18, 2014
Translation in Brief

Translational tidbits

Chris Cain, Associate Editor, and Kai-Jye Lou, Senior Writer RNA sequencing standardized The FDA has convened a consortium to review the status of RNA sequencing for drug development and outline hurdles for incorporating the technology...
BC Week In Review | Aug 4, 2014
Company News

Epic Sciences board of directors update

Epic Sciences Inc. , La Jolla, Calif.   Business: Diagnostic   Appointed: Gregory Lucier as chairman, formerly chairman and CEO of Life Technologies Corp. , which Thermo Fisher Scientific Inc. acquired  ...
Items per page:
1 - 10 of 1252