BioCentury | Oct 28, 2020
Deals

Supply constraints loom as Regeneron reports positive data on COVID-19 mAb

...the trial met all of the first nine endpoints in the statistical hierarchy, which assessed virologic...
...changes to dosing in the ongoing outpatient clinical trial due to the limited supply of REGN-COV2.Virologic...
BioCentury | Oct 24, 2020
Regulation

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 23, 2020
Product Development

What’s next for targeted protein degradation

As targeted protein degradation grows up, the field is going after harder targets and new mechanisms of action. Over the last year, a series of Phase I/II readouts from front-runner Arvinas Inc. (NASDAQ:ARVN),...
BioCentury | Oct 15, 2020
Product Development

Oct. 14 Quick Takes: FDA approves first Ebola therapy; plus Vertex tumbles after hours on AAT discontinuation

Regeneron’s Ebola mAb cocktail approvedFDA approved Inmazeb atoltivimab/maftivimab/odesivimab-ebgn from Regeneron Pharmaceuticals Inc. (NASDAQ:REGN) to treat Zaire ebolavirus infection. The mAb cocktail had raised the chance of survival vs. ZMapp, a mAb combination used as a control, in...
BioCentury | Sep 8, 2020
Management Tracks

Black Diamond names Humphrey CMO; plus Edmondson to lead chemistry at Nimbus, Recce, Amarna and more

Rachel Humphrey has joined Black Diamond Therapeutics Inc. (NASDAQ:BDTX) as CMO. Karsten Witt, who has been SVP of clinical development and acting CMO since May 2019, will become SVP of non-clinical development. Previously, Humphrey was...
BioCentury | Sep 7, 2020
Product Development

WuXi AppTec’s Yang on COVID-19 pushing the gates open on data sharing: a BioCentury audio interview

WuXi AppTec’s Steve Yang says the collaborations taking place during COVID-19 could not only open the door to more data sharing, but lay the groundwork for understanding which assays have the most translational...
BioCentury | Aug 20, 2020
Product Development

Roche broadens Regeneron’s reach in COVID-19 antibody deal

By partnering with Roche, Regeneron is broadening the reach of its COVID-19 antiviral antibody cocktail outside the U.S., gaining manufacturing capacity to deliver a total number of doses that could extend into the millions and...
BioCentury | Jul 31, 2020
Regulation

Regulators agree on endpoints for COVID-19 therapeutics trials

International regulators have agreed upon the best endpoints for use in clinical trials for COVID-19 therapeutics, with mortality the key endpoint for hospitalized patients, while testing in mild patients should focus on disease progression or...
BioCentury | Jul 21, 2020
Product Development

First inhaled interferon COVID-19 readout bolsters case for class, but more robust data needed

Data suggesting an inhaled IFNB1 product from Synairgen can reduce the chance a patient with COVID-19 develops severe disease gave a jolt to the biotech’s shares Monday, but more statistically robust data are still needed...
BioCentury | Jul 7, 2020
Product Development

Four late-stage COVID-19 vaccine trial protocols harmonized, Fauci says

...about 1,050 non-hospitalized COVID-19 patients in the U.S., Brazil, Mexico and Chile; and will assess virologic...
Items per page:
1 - 10 of 1610
BioCentury | Oct 28, 2020
Deals

Supply constraints loom as Regeneron reports positive data on COVID-19 mAb

...the trial met all of the first nine endpoints in the statistical hierarchy, which assessed virologic...
...changes to dosing in the ongoing outpatient clinical trial due to the limited supply of REGN-COV2.Virologic...
BioCentury | Oct 24, 2020
Regulation

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 23, 2020
Product Development

What’s next for targeted protein degradation

As targeted protein degradation grows up, the field is going after harder targets and new mechanisms of action. Over the last year, a series of Phase I/II readouts from front-runner Arvinas Inc. (NASDAQ:ARVN),...
BioCentury | Oct 15, 2020
Product Development

Oct. 14 Quick Takes: FDA approves first Ebola therapy; plus Vertex tumbles after hours on AAT discontinuation

Regeneron’s Ebola mAb cocktail approvedFDA approved Inmazeb atoltivimab/maftivimab/odesivimab-ebgn from Regeneron Pharmaceuticals Inc. (NASDAQ:REGN) to treat Zaire ebolavirus infection. The mAb cocktail had raised the chance of survival vs. ZMapp, a mAb combination used as a control, in...
BioCentury | Sep 8, 2020
Management Tracks

Black Diamond names Humphrey CMO; plus Edmondson to lead chemistry at Nimbus, Recce, Amarna and more

Rachel Humphrey has joined Black Diamond Therapeutics Inc. (NASDAQ:BDTX) as CMO. Karsten Witt, who has been SVP of clinical development and acting CMO since May 2019, will become SVP of non-clinical development. Previously, Humphrey was...
BioCentury | Sep 7, 2020
Product Development

WuXi AppTec’s Yang on COVID-19 pushing the gates open on data sharing: a BioCentury audio interview

WuXi AppTec’s Steve Yang says the collaborations taking place during COVID-19 could not only open the door to more data sharing, but lay the groundwork for understanding which assays have the most translational...
BioCentury | Aug 20, 2020
Product Development

Roche broadens Regeneron’s reach in COVID-19 antibody deal

By partnering with Roche, Regeneron is broadening the reach of its COVID-19 antiviral antibody cocktail outside the U.S., gaining manufacturing capacity to deliver a total number of doses that could extend into the millions and...
BioCentury | Jul 31, 2020
Regulation

Regulators agree on endpoints for COVID-19 therapeutics trials

International regulators have agreed upon the best endpoints for use in clinical trials for COVID-19 therapeutics, with mortality the key endpoint for hospitalized patients, while testing in mild patients should focus on disease progression or...
BioCentury | Jul 21, 2020
Product Development

First inhaled interferon COVID-19 readout bolsters case for class, but more robust data needed

Data suggesting an inhaled IFNB1 product from Synairgen can reduce the chance a patient with COVID-19 develops severe disease gave a jolt to the biotech’s shares Monday, but more statistically robust data are still needed...
BioCentury | Jul 7, 2020
Product Development

Four late-stage COVID-19 vaccine trial protocols harmonized, Fauci says

...about 1,050 non-hospitalized COVID-19 patients in the U.S., Brazil, Mexico and Chile; and will assess virologic...
Items per page:
1 - 10 of 1610