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...
BioCentury | Feb 1, 2019
Politics, Policy & Law

Focusing on cures

A Massachusetts Institute of Technology-led consortium is finalizing pilot programs that are intended to serve as models for overcoming two major hurdles to implementing performance-based contracts for curative therapies in the United States. The goal...
BioCentury | Jan 12, 2019
Finance

We all fall down

After an exuberant third quarter that put biotech indexes near their 2015 highs, all market cap tiers fell in 4Q18, eliminating the first nine month’s gains and losing $291.2 billion in aggregate value. Median losses...
BC Extra | Dec 11, 2018
Politics & Policy

FDA considering easing use of foreign references for biosimilars

FDA announced new policies to boost the U.S. market for biosimilars Tuesday, and said it is considering easing rules that make it difficult and expensive for biosimilars manufacturers to use biologics manufactured outside the U.S....
BioCentury | Nov 10, 2018
Regulation

Alkermes adcomm reveals SPCD paradox

Disagreement between FDA and Alkermes plc on how the data were analyzed took center stage at the panel meeting on the depression drug ALKS 5461. But the meeting also flushed out a chicken-and-egg problem for...
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