BioCentury | Sep 30, 2020
Politics, Policy & Law

Former FDA leaders call out White House for undermining FDA

Hours before the first presidential debate, seven former FDA commissioners called out the “deeply troubling ways” the White House is pressuring the agency in its decisions related to COVID-19 countermeasures....
BioCentury | Sep 19, 2020
Politics, Policy & Law

Azar clips wings of FDA, CDC, NIH and other health agencies

In a move that former government officials are interpreting as a power grab that could signal a reduction in the ability of public health agencies to act independently, HHS Secretary Alex Azar has revoked the...
BioCentury | Aug 21, 2020
Regulation

Data Bytes: FDA approving new drugs at rapid clip in 2020

This week’s two surprise setbacks for therapies under FDA review are unlikely to derail what is shaping up to be one of FDA’s largest annual classes of new molecular entity approvals. FDA had approved 36...
BioCentury | Jun 11, 2020
Deals

Cullinan adds first-in-class asset in hot NK cell checkpoint space

The latest addition to Cullinan’s oncology portfolio is a mAb against MICA that’s set to become the first compound in the clinic against the NK cell target. Through a deal announced on Thursday, Cullinan Oncology...
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...
BioCentury | Jul 13, 2019
Finance

How crossover, insider support and big money correlated with performance across 1H19 IPOs

The performance of 1H19 IPOs point toward a continuation of a dual-class system where biotechs backed by deep-pocketed VCs and crossover investors can tap the public market at will and generate stronger after-market performance than...
BioCentury | Jun 29, 2019
Finance

Specialists and strong fundamentals must carry the sector in 3Q19

Heading into the third quarter, specialist biotech investors are in the driver’s seat, and their stances on whether to trim or spend in the down market are split. After recovering at the start of the...
BioCentury | Jun 7, 2019
Finance

Alexandria parlays growing life sciences real estate holdings into a flurry of VC deals

Alexandria has been leveraging its growing life sciences real estate revenues and relationships with leading VC firms to become the most prolific biotech investor, and it shows no signs of slowing down. Over its 25-year...
BioCentury | May 17, 2019
Product Development

Pushing China to the forefront: When a first-in-China regulatory strategy makes sense

As reforms in China shorten clinical and regulatory timelines for biotechs across the board, the country has a growing chance to become the first stop for regulatory approvals of first-in-class drugs. The decision to do...
BioCentury | Apr 6, 2019
Finance

Room to rally in 2Q

Strong small and mid-cap performance coupled with robust M&A has brought the sector back from 4Q18 correction territory, and chances are good for the momentum to continue given the ample capital ready to be recycled...
Items per page:
1 - 10 of 98