BioCentury | Oct 17, 2020
Politics, Policy & Law

Getting FDA back on track

Regardless of the outcome of the elections, FDA is likely to have a new commissioner next year, one who will step into a leadership vacuum that is exhausting the agency’s supply of credibility and...
BioCentury | Sep 10, 2020
Product Development

Master protocols should not be a one-off phenomenon confined to COVID-19

This is the fourth article in BioCentury’s 28th Annual Back to School package. In the opening piece, BioCentury called on biopharma to convert its COVID response to a new era of efficient drug development. ...
BioCentury | Aug 14, 2020
Translation in Brief

Hesperos applies organ-on-a-chip tech to ALS, Sinopharm details interim COVID-19 vaccine readout and more

Hesperos’ Human-on-a-Chip techIn an Advanced Therapeutics paper, a University of Central Florida team led by Hesperos Inc. co-founder and chief scientist James Hickman tested the efficacy of...
BioCentury | Jun 27, 2020
Product Development

A mechanistic view of four compounds that disrupt interleukin pathways to treat severe COVID-19

Master protocols for COVID-19 clinical trials are testing half a dozen molecules that aim to prevent respiratory distress in patients with severe disease by targeting the host immune system -- four of these compounds intervene...
BioCentury | Oct 19, 2019
Politics, Policy & Law

Democrats, Republicans use marathon hearing to preview 2020 drug pricing debates

During an eight-hour Energy & Commerce hearing on Oct. 17, Democrats and Republicans previewed and rehearsed arguments about drug pricing that they will be making in town hall meetings and stump speeches across the country...
BioCentury | Aug 13, 2019
Clinical News

Taltz tops Tremfya in psoriasis but data may not change prescribing habits

Eli Lilly said Taltz was superior to J&J's Tremfya in treating psoriasis at 12 weeks in the Phase IV IXORA-R trial, but the data may not move the needle on physicians’ prescribing habits. The data...
BioCentury | Jul 11, 2019
Product Development

How Zymeworks aims to take on Roche’s $10B HER2 franchise

Zymeworks is going head to head with one of the biggest commercial cancer franchises -- Roche’s Herceptin trastuzumab and Perjeta pertuzumab -- as it pursues clinical proof-of-concept for its protein engineering platform. Pivotal readouts in...
BioCentury | Jun 7, 2019
Politics, Policy & Law

Levitating Levin: new chair’s ambitious plans to elevate BIO

Jeremy Levin has been talking for years about ways to elevate biopharma business practices and public policy to bypass obstacles that hold back biomedical innovation. As BIO’s new chair, he has a chance to try...
BioCentury | Dec 7, 2018
Tools & Techniques

Germline editing gets technical

As the smoke clears from Jiankui He’s bombshell germline editing announcement, the gap between where the gene editing field is now and where it would need to be to support responsible germline editing has become...
BioCentury | Oct 29, 2018
Preclinical News

Cas9-reactive Tregs could mitigate Cas9 immunogenicity concerns

Charite - Universitaetsmedizin Berlin researchers point to a potential strategy for staving off an immune system attack against CRISPR-associated protein 9-based gene editing therapies: pitting a patient's pre-existing Cas9-reactive Treg cells against Cas9-reactive effector T cell...
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