BioCentury | Jan 16, 2021
Translation in Brief

Dyne’s POC myotonic dystrophy data; plus pulmonary T cell subset contributes to local antibody production after reinfection, DiosCURE’s COVID candidates and more

Dyne’s myotonic dystrophy antisense therapy reduces gene expressionDyne Therapeutics Inc. (NASDAQ:DYN) reported data from a new mouse model of severe disease showing its myotonic dystrophy type 1 (DM1) antisense oligonucleotide therapy reduced nuclear DMPK RNA levels...
BioCentury | Jan 16, 2021
Management Tracks

FDA’s Schiller joins Aetion; plus Novavax, NHC, NextCure, Ziopharm, ONK

Lowell Schiller left FDA to join Aetion Inc. as chief legal and regulatory officer.  For nearly the past two years, Schiller was principal associate commissioner for policy, serving briefly as acting chief counsel at the agency....
BioCentury | Jan 16, 2021
Product Development

Zymeworks showcases >45% confirmed ORRs for anti-HER2 bispecific in biliary, gastroesophageal cancers

Phase I data Zymeworks presented Friday for its bispecific anti-HER2 mAb back its ongoing and pending pivotal trials in biliary tract and gastroesophageal cancers, respectively. In an oral presentation at the American Society of Clinical Oncology...
BioCentury | Jan 16, 2021
Politics, Policy & Law

Woodcock’s appointment as acting FDA commissioner could be audition for permanent position

Politics, Policy & Law When Janet Woodcock moves into the FDA commissioner’s office next week, she will take charge, at least on an acting basis, of an agency that has been pummeled for months. President...
BioCentury | Jan 15, 2021
Product Development

Delfi and Earli series A rounds show there’s room for new entrants in early cancer detection

The debut of two more venture-backed companies developing early cancer detection tests suggests there is still appetite for new approaches, even as bigger players consolidate via M&A and prepare for commercial launch. Delfi Diagnostics Inc....
BioCentury | Jan 15, 2021
Politics, Policy & Law

New relevance, old guard: Biden throws weight behind science, puts Lander in Cabinet, keeps Collins at NIH

President-elect Joe Biden is raising the profile of science in his administration by elevating the role of presidential science advisor to a Cabinet position, naming the Broad Institute’s Eric Lander to the post, and nominating...
BioCentury | Jan 15, 2021
Regulation

Jan. 14 Quick Takes: Lexicon rises on NDA timeline for heart failure program; plus: FDA COVID reports and updates from BeiGene, Merck, Bayer

Lexicon Pharmaceuticals Inc. (NASDAQ:LXRX) gained $4.13 (105%) to $8.05 Thursday after saying data from its Phase III SOLOIST and SCORED trials of sotagliflozin could support an NDA submission as early as this year to reduce...
BioCentury | Jan 14, 2021
Finance

With €127M series B, cancer vaccine developer IO Biotech raises second-largest European venture round in the past year

IO Biotech parlayed early clinical data into a €127 million ($154.8 million) series B financing led by HBM Healthcare Investments, which will support a Phase II trial of its leading cancer vaccines in combination with...
BioCentury | Jan 13, 2021
Politics, Policy & Law

Woodcock to serve as acting FDA commissioner, Sharfstein a contender for top FDA job

David Kessler is out of the running for nomination as FDA commissioner, leaving Joshua Sharfstein as a front-runner to lead FDA, sources briefed by the Biden transition team told BioCentury. While the list of candidates...
BioCentury | Jan 13, 2021
Emerging Company Profile

LifeMine taps fungal genomes for new drug candidates

Led by Rick Klausner and Gregory Verdine, LifeMine has found drug candidates with novel mechanisms using its data science platform for mining fungal genomes. The company now has an additional $50 million to move its first programs toward...
Items per page:
1 - 10 of 19003
BioCentury | Jan 16, 2021
Translation in Brief

Dyne’s POC myotonic dystrophy data; plus pulmonary T cell subset contributes to local antibody production after reinfection, DiosCURE’s COVID candidates and more

Dyne’s myotonic dystrophy antisense therapy reduces gene expressionDyne Therapeutics Inc. (NASDAQ:DYN) reported data from a new mouse model of severe disease showing its myotonic dystrophy type 1 (DM1) antisense oligonucleotide therapy reduced nuclear DMPK RNA levels...
BioCentury | Jan 16, 2021
Management Tracks

FDA’s Schiller joins Aetion; plus Novavax, NHC, NextCure, Ziopharm, ONK

Lowell Schiller left FDA to join Aetion Inc. as chief legal and regulatory officer.  For nearly the past two years, Schiller was principal associate commissioner for policy, serving briefly as acting chief counsel at the agency....
BioCentury | Jan 16, 2021
Product Development

Zymeworks showcases >45% confirmed ORRs for anti-HER2 bispecific in biliary, gastroesophageal cancers

Phase I data Zymeworks presented Friday for its bispecific anti-HER2 mAb back its ongoing and pending pivotal trials in biliary tract and gastroesophageal cancers, respectively. In an oral presentation at the American Society of Clinical Oncology...
BioCentury | Jan 16, 2021
Politics, Policy & Law

Woodcock’s appointment as acting FDA commissioner could be audition for permanent position

Politics, Policy & Law When Janet Woodcock moves into the FDA commissioner’s office next week, she will take charge, at least on an acting basis, of an agency that has been pummeled for months. President...
BioCentury | Jan 15, 2021
Product Development

Delfi and Earli series A rounds show there’s room for new entrants in early cancer detection

The debut of two more venture-backed companies developing early cancer detection tests suggests there is still appetite for new approaches, even as bigger players consolidate via M&A and prepare for commercial launch. Delfi Diagnostics Inc....
BioCentury | Jan 15, 2021
Politics, Policy & Law

New relevance, old guard: Biden throws weight behind science, puts Lander in Cabinet, keeps Collins at NIH

President-elect Joe Biden is raising the profile of science in his administration by elevating the role of presidential science advisor to a Cabinet position, naming the Broad Institute’s Eric Lander to the post, and nominating...
BioCentury | Jan 15, 2021
Regulation

Jan. 14 Quick Takes: Lexicon rises on NDA timeline for heart failure program; plus: FDA COVID reports and updates from BeiGene, Merck, Bayer

Lexicon Pharmaceuticals Inc. (NASDAQ:LXRX) gained $4.13 (105%) to $8.05 Thursday after saying data from its Phase III SOLOIST and SCORED trials of sotagliflozin could support an NDA submission as early as this year to reduce...
BioCentury | Jan 14, 2021
Finance

With €127M series B, cancer vaccine developer IO Biotech raises second-largest European venture round in the past year

IO Biotech parlayed early clinical data into a €127 million ($154.8 million) series B financing led by HBM Healthcare Investments, which will support a Phase II trial of its leading cancer vaccines in combination with...
BioCentury | Jan 13, 2021
Politics, Policy & Law

Woodcock to serve as acting FDA commissioner, Sharfstein a contender for top FDA job

David Kessler is out of the running for nomination as FDA commissioner, leaving Joshua Sharfstein as a front-runner to lead FDA, sources briefed by the Biden transition team told BioCentury. While the list of candidates...
BioCentury | Jan 13, 2021
Emerging Company Profile

LifeMine taps fungal genomes for new drug candidates

Led by Rick Klausner and Gregory Verdine, LifeMine has found drug candidates with novel mechanisms using its data science platform for mining fungal genomes. The company now has an additional $50 million to move its first programs toward...
Items per page:
1 - 10 of 19003