BioCentury | Oct 24, 2020

Advice now, consent later, on COVID-19 vaccines

FDA’s Oct. 22 vaccines advisory committee meeting was principally intended to reassure the public that career staff will make decisions about COVID-19 vaccines and will not be influenced by political preferences or timetables. A second...
BioCentury | Oct 22, 2020
Politics, Policy & Law

Protecting biomedical innovation as a national security asset

In recent years, it has become fashionable to focus on the high price of new treatments for certain cancers and rare diseases. Many observers ask why it is that U.S. citizens should subsidize the rest...
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 | Oct 13, 2020
Product Development

$1B AMR Action Fund to assess first investments in 1Q21

The $1 billion AMR Action Fund remains on track to begin assessing investment opportunities in 1Q21 aimed at addressing antimicrobial resistance. In July, 23 pharmas banded together to create the fund to bridge the gap between Phase...
BioCentury | Oct 6, 2020
Politics, Policy & Law

Pfizer’s Bourla, FDA’s Hahn say science, not politics, should drive COVID vaccine decisions

Albert Bourla pushed back Tuesday on President Donald Trump’s assertions that vaccine developers have complained to him about FDA’s COVID-19 guidance. The chairman and CEO of Pfizer Inc. (NYSE:PFE) also disagreed with Trump’s claims that the...
BioCentury | Oct 3, 2020
Politics, Policy & Law

McMurry-Heath calls for increased transparency on vaccine evaluations

Amid questions of whether FDA has been compromised by political pressure to approve a COVID-19 vaccine ahead of the U.S. presidential election, industry leaders are calling for increased transparency regarding...
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 29, 2020
Distillery Therapeutics

Small molecule kinase inhibitor for cystic fibrosis with splicing mutation

DISEASE CATEGORY: Pulmonary INDICATION: Cystic fibrosis (CF) A small molecule inhibitor of four kinases that regulate splicing could treat CF caused by the most common disease-associated CFTR splicing...
BioCentury | Sep 26, 2020
Politics, Policy & Law

Warp Speed’s Slaoui expects two COVID-19 vaccines this year, rebuts Sen. Warren

Two COVID-19 vaccines and two drugs that reduce mortality from the disease will be authorized by the end of 2020, Moncef Slaoui, chief scientific adviser to Operation Warp Speed, predicted in an interview...
BioCentury | Sep 24, 2020
Politics, Policy & Law

Trump contradicts Hahn, says White House will decide on COVID-19 vaccine rules

The Trump administration’s top public health officials spent Wednesday morning trying to persuade the Senate and the American people that career staff will make COVID-19 vaccine decisions free from political influence.  The heads of FDA...
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