BioCentury | Apr 13, 2021
Regulation

Competence & continuity at CDER; plus BIO 3.0, AACR and 2Q preview: a BioCentury podcast

On the latest BioCentury This Week podcast, BioCentury editors discuss what Patrizia Cavazzoni’s appointment as permanent director of FDA’s Center for Drug Evaluation and Research means for the biopharma...
BioCentury | Apr 10, 2021
Product Development

Bispecific constructs move beyond T cell engagers at AACR

T cell engagers have dominated the bispecific antibody scene for the past five years, but the industry is starting to branch out into next-generation structures that offer new functions and potential improvements over first-generation compounds. ...
BioCentury | Mar 25, 2021
Management Tracks

Slaoui stepping back from all biopharma roles, expresses ‘deep regrets’ following sexual harassment claim

Former Operation Warp Speed leader Moncef Slaoui implied that he is taking a leave of absence from all his professional roles following his termination as Galvani’s chairman by GSK due to sexual harassment allegations. Slaoui, a 30-year...
BioCentury | Mar 18, 2021
Translation in Brief

With NCATS ‘ready,’ Austin readies to depart agency he built to join Flagship

After leading the National Center for Advancing Translational Medicine for nearly a decade, Christopher Austin is stepping down as director of the NIH group to become CEO-partner at Flagship Pioneering. Austin has been the only permanent...
BioCentury | Mar 9, 2021
Politics, Policy & Law

Former FDA chiefs ask Biden to name permanent commissioner

Six former FDA heads have written to President Joe Biden urging him to nominate a permanent FDA commissioner. The letter, sent Monday, does not endorse a specific candidate, but it does express confidence...
BioCentury | Mar 1, 2021
Deals

With Phase III started in head and neck cancer, Debiopharm partners lead program with Germany’s Merck

Debiopharm will bank €188 million ($226.6 million) for pipeline development now that the biotech has partnered lead program xevinapant with Merck KGaA, adding the German biopharma’s resources to the molecule’s evaluation in a Phase III...
BioCentury | Feb 13, 2021
Product Development

Howdy partner: MD Anderson’s evolving industry collaboration strategy

The shifting balance between oncology candidates and patients available for trials, and the rise of complex modalities, is shaping the way MD Anderson builds partnerships and develops new assets. University of Texas MD Anderson Cancer...
BioCentury | Feb 11, 2021
Politics, Policy & Law

Cancer KOLs urge Biden to name Woodcock permanent FDA commissioner

Acting FDA Commissioner Janet Woodcock has picked up a powerful endorsement in a public campaign for President Joe Biden to delete the “acting” part of her title. Nobel laureate James Allison and Mikael Dolsten, CSO...
BioCentury | Feb 5, 2021
Emerging Company Profile

Apros: Engineering tissue-targeted TLR agonists

Apros is developing a suite of tissue-targeted TLR7 agonists for indications ranging from cancer to infectious disease that aim to avoid systemic toxicities that have plagued the drug class.  Lead candidate APR003, a TLR7 agonist...
BioCentury | Jan 29, 2021
Politics, Policy & Law

Advocates call for permanent FDA commissioner, line up behind Woodcock, Sharfstein

Patient groups and medical product developers are calling on President Joe Biden to quickly nominate a permanent FDA commissioner, and many are taking sides in a competition that they believe has come down to two...
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