BioCentury | Jun 17, 2020
Politics, Policy & Law

COVAX created to try to avoid global bidding frenzy for COVID-19 vaccines

Panic buying of vaccines by high income countries, mopping up supply and squeezing out lower income countries, is the nightmare postscript to COVID-19 that international health agencies envisage could play out if steps aren’t taken...
BioCentury | May 30, 2020
Product Development

The critical path to COVID-19 therapies

The path to safe, effective COVID-19 therapies is crowded and poorly marked. There is an urgent need to fast-track a manageable number of therapies, illuminate every step along the route, and create signposts for research,...
BioCentury | Apr 22, 2020
Politics, Policy & Law

Lawmakers urge FDA to expedite COVID-19 vaccine testing, consider challenge trials

Thirty five members of the House of Representatives have signed a letter urging FDA to adopt expedited methods of testing COVID-19 vaccine candidates, including considering challenge trials of healthy individuals who are deliberately infected with...
BioCentury | Apr 10, 2020
Politics, Policy & Law

Piloting a new course to reimbursing antibiotics

The shockingly fast speed at which COVID-19 turned from a regional breakout to a global pandemic with no treatments has made it easy to imagine a similar epidemic arising from multi-drug resistant bacteria, adding new...
BioCentury | Feb 21, 2020
Emerging Company Profile

Montis: Exploring an untouched macrophage subset in immuno-oncology

Montis launched with €8.4 million and a concept that puts an immuno-oncology spin on the tumor vasculature, marking the second company seeded by oncology-focused Droia Ventures in as many weeks. Droia, which teamed up with...
BioCentury | Nov 16, 2019
Regulation

Stephen Hahn’s road to White Oak

The path to Stephen Hahn’s confirmation as FDA commissioner is enveloped in clouds of flavored vapor, littered with piles of Impossible Burgers, and passes tanks filled with precocious fish. The Trump administration’s policies on regulating...
BC Extra | Nov 1, 2019
Politics & Policy

Trump administration shifts Sharpless to make way for Hahn

The Trump administration has launched a game of musical chairs that is intended to clear a path for Stephen Hahn to be confirmed as FDA commissioner. When the music stops, it is possible that Hahn...
BioCentury | Aug 16, 2019
Product Development

ACRES’ plan to harmonize clinical trials across many lands

With the launch of its clinical site accreditation program, ACRES has taken the first step toward its larger goal of creating a clinical research infrastructure that is digitally connected and operates under a single set...
BioCentury | May 2, 2019
Politics, Policy & Law

Gottlieb: How a cultural shift is transforming FDA’s drug reviews

A decade ago, the FDA secured new tools, resources, and authorities to implement a watershed change in how the agency approached the drug review process. The novel framework turned on a more active approach to...
BC Extra | Apr 16, 2019
Politics & Policy

FDA’s Sharpless vows continuity

“While my title may be acting commissioner, I assure you that I’m not acting as if this is a temporary or part time job,” Ned Sharpless told FDA staff Tuesday. In an all-hands speech at...
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