BioCentury | Jan 16, 2021
Product Development

Arcus’ CD73 inhibitor challenges AZ’s oleclumab, at least six others follow in oncology: Data Byte

As Arcus becomes the second company to report clinical data for a CD73 inhibitor in pancreatic cancer behind front-runner AstraZeneca, at least six more teams have early-stage clinical programs targeting the immuno-metabolism modulating receptor. An...
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 16, 2021
Product Development

Jan. 15 Quick Takes: Darzalex gains first FDA approval for form of amyloidosis; plus Thermo Fisher, Lilly, DBV, Dr. Reddy’s, Alexion, Taiho, Astellas-Actinium

FDA granted accelerated approval to Darzalex Faspro daratumumab/hyaluronidase-fihj from Johnson & Johnson (NYSE:JNJ) and Genmab A/S (CSE:GMAB; NASDAQ:GMAB) to treat newly diagnosed light-chain amyloidosis. It is the first and only therapy for the indication, according to Genmab,...
BioCentury | Jan 16, 2021
Finance

Greenwood-led fund to allow Dana-Farber to invest later in homegrown IP

Luba Greenwood, the Roche and Verily alum turned fund manager, told BioCentury that Dana-Farber’s new $10 million fund will give the institute a vehicle that allows it to participate in later rounds for its spinouts. The new...
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
Product Development

Readout for Arcus’ pancreatic cancer program could spur Gilead to exercise option

Early data showing clinical efficacy of a combination from Arcus in pancreatic cancer increases the likelihood that Gilead will exercise its option on the biotech’s potentially first-in-class molecule targeting CD73. An interim readout from the...
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