BioCentury | Nov 21, 2020
Product Development

Could an approval of Biogen’s Alzheimer’s therapy still be an option?

For almost any other compound, the nearly unanimous advisory committee vote that Biogen’s Alzheimer’s therapy aducanumab suffered would make its chances of approval vanishingly small. But this mAb...
BioCentury | Nov 21, 2020
Politics, Policy & Law

Fate of Trump’s 11th hour drug price rules uncertain

If they withstand withering legal challenges from the biopharmaceutical industry, hospitals and medical groups, and overcome steep logistic obstacles, rules released by the Trump administration Friday...
BioCentury | Nov 20, 2020
Product Development

Phase III COVID-19 vaccine data kick-start next phase: mapping efficacy to antibody levels

Efficacy data from the first two Phase III trials of COVID-19 vaccines shattered expectations and validated mRNA as a vaccine modality. The findings also mark the start of the search for correlates of protection. An...
BioCentury | Nov 19, 2020
Product Development

EUAs for BioNTech-Pfizer, Moderna COVID-19 vaccines, readouts from AZ and J&J could come in December

The U.S. government is finalizing plans for review, allocation prioritization, and distribution in December of two COVID-19 vaccines in the wake of the completion of a Phase III trial of an mRNA vaccine candidate from...
BioCentury | Nov 19, 2020
Product Development

COVID-19 vaccines that could report Phase III data before Moderna, Pfizer-BioNTech products become broadly available

Strong efficacy data from the two leading COVID-19 vaccines suggest the window for testing additional vaccine candidates in the U.S. could soon start to close. Of the more than 200 vaccines in development for COVID-19,...
BioCentury | Nov 13, 2020
Product Development

A huge sigh of relief, but a long road ahead: AZ’s Pangalos on COVID-19 in a BioCentury audio interview

The interim data from Pfizer and BioNTech showing 90% efficacy this week was at the same time a big step and a baby step for the field, according to Mene Pangalos, who sees a long...
BioCentury | Nov 11, 2020
Product Development

Nov. 10 Quick Takes: Tezepelumab meets in asthma Phase III; plus a call for speedy trial results, updates on COVID vaccines from Sinovac, CureVac and more

AZ, Amgen rise on asthma dataTezepelumab from AstraZeneca plc (LSE:AZN; NYSE:AZN) and Amgen Inc. (NASDAQ:AMGN) met the primary endpoint of a statistically significant reduction in annualized asthma exacerbation...
BioCentury | Nov 7, 2020
Regulation

Aducanumab panel criticizes FDA as it rebukes Alzheimer’s candidate

FDA’s advisers not only roundly rebuffed Biogen’s Alzheimer’s candidate aducanumab, tanking its odds of approval, they also lambasted the agency for bias in its presentation of the analyses. In Friday’s meeting of the Peripheral and...
BioCentury | Nov 5, 2020
Product Development

FDA signals relatively clear path ahead for Alzheimer’s therapy aducanumab

FDA appears to be leaning toward approval of the first theoretically disease-modifying therapy for Alzheimer’s disease, or any neurodegenerative disorder, based on two incomplete Phase III trials, one...
BioCentury | Nov 5, 2020
Politics, Policy & Law

HHS proposes regulation sunset rule that could create uncertainty for industry, paralyze FDA

A proposed rule released Wednesday seeks to make regulations from FDA and other HHS agencies automatically sunset 10 years after they have  gone into effect unless the agencies undertake a cumbersome, time-consuming process to renew...
Items per page:
1 - 10 of 6450