BioCentury | Jul 8, 2020
Product Development

NIH, Warp Speed streamline preventive mAb, vaccine testing via clinical trial network

On the back of its first COVID-19 mAb investment, Operation Warp Speed launched a clinical trial network with NIH on Wednesday to streamline testing of the modality in prophylactic settings. The COVID-19 Prevention Trials Network...
BioCentury | Jul 8, 2020
Product Development

Novavax gets another boost with $1.6B contract from Operation Warp Speed

While Novavax has yet to bring a vaccine to market, the company remains on a meteoric trajectory most recently marked by a $1.6 billion contract with BARDA and the DoD for its COVID-19 vaccine. The...
BioCentury | Jul 8, 2020
Product Development

Operation Warp Speed secures thousands of antibody doses, millions more likely needed

Operation Warp Speed’s deal for Regeneron’s COVID-19 neutralizing antibody cocktail could provide the U.S. government enough doses to treat the expected number of hospitalized patients over the next year, but tens of millions more will...
BioCentury | Jul 7, 2020
Product Development

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

In a live-streamed conversation, NIH director Francis Collins and NIAID director Anthony Fauci discussed progress in standardizing protocols of Phase III trials for COVID-19 vaccines, as well as the ongoing need for therapies that can...
BioCentury | Jul 2, 2020
Product Development

First Phase III data for an IL-6 mAb in COVID-19 disappoint

A Phase III miss for IL-6 inhibitor Kevzara may not reflect a broader problem with the target or the strengthening theory that immune modulators are the best line of defense against severe forms of COVID-19....
BioCentury | Jul 1, 2020
Regulation

June 30 Quick Takes: Another first for Ultragenyx; plus approvals for Genentech’s Phesgo, Keytruda, Bavencio and Ultomiris

Ultragenyx’s Dojolvi wins FDA approval for rare disease FDA approved Dojolvi triheptanoin (UX007) from Ultragenyx Pharmaceutical Inc. (NASDAQ:RARE) to treat long-chain fatty acid oxidation disorders, making it the first drug approved for the indication. The...
BioCentury | Jun 30, 2020
Product Development

Low-stakes 2018 deal with Regeneron leads to bump for Kiniksa on pericarditis readout

Pivotal data for rilonacept in recurrent pericarditis put Kiniksa on track to bring its first program to market and gain rights from Regeneron to additional indications. Kiniksa Pharmaceuticals Ltd. (NASDAQ:KNSA) shares rose $2.97 (13%) to...
BioCentury | Jun 27, 2020
Translation in Brief

Regeneron enhances checkpoint therapy with CD28 bispecifics; plus NIH funds Alzheimer’s brain mapping, Genentech and more

Regeneron combines CD28 bispecifics with PD-1 mAb  In its latest paper covering anti-CD28 bispecific antibodies, Regeneron Pharmaceuticals Inc. (NASDAQ:REGN) showed in Science Translational Medicine that the bispecifics could boost anti-PD-1 efficacy. Bispecifics against CD28 and...
BioCentury | Jun 26, 2020
Product Development

21st century pandemic, prehistoric clinical trials

The U.S. is trying to fight a 21st century pandemic with prehistoric clinical trials -- and achieving the kind of efficiency you might expect. In the last six months, tens of thousand of patients have...
BioCentury | Jun 24, 2020
Finance

AsclepiX aims for basket of retinal indications with $35M series A

AsclepiX intends to use its $35 million series A round for proof-of-concept studies of its lead product in three retinal disease indications, while also developing peptides into therapeutic candidates for oncology. Spun out of The...
Items per page:
1 - 10 of 1723
BioCentury | Jul 8, 2020
Product Development

NIH, Warp Speed streamline preventive mAb, vaccine testing via clinical trial network

On the back of its first COVID-19 mAb investment, Operation Warp Speed launched a clinical trial network with NIH on Wednesday to streamline testing of the modality in prophylactic settings. The COVID-19 Prevention Trials Network...
BioCentury | Jul 8, 2020
Product Development

Novavax gets another boost with $1.6B contract from Operation Warp Speed

While Novavax has yet to bring a vaccine to market, the company remains on a meteoric trajectory most recently marked by a $1.6 billion contract with BARDA and the DoD for its COVID-19 vaccine. The...
BioCentury | Jul 8, 2020
Product Development

Operation Warp Speed secures thousands of antibody doses, millions more likely needed

Operation Warp Speed’s deal for Regeneron’s COVID-19 neutralizing antibody cocktail could provide the U.S. government enough doses to treat the expected number of hospitalized patients over the next year, but tens of millions more will...
BioCentury | Jul 7, 2020
Product Development

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

In a live-streamed conversation, NIH director Francis Collins and NIAID director Anthony Fauci discussed progress in standardizing protocols of Phase III trials for COVID-19 vaccines, as well as the ongoing need for therapies that can...
BioCentury | Jul 2, 2020
Product Development

First Phase III data for an IL-6 mAb in COVID-19 disappoint

A Phase III miss for IL-6 inhibitor Kevzara may not reflect a broader problem with the target or the strengthening theory that immune modulators are the best line of defense against severe forms of COVID-19....
BioCentury | Jul 1, 2020
Regulation

June 30 Quick Takes: Another first for Ultragenyx; plus approvals for Genentech’s Phesgo, Keytruda, Bavencio and Ultomiris

Ultragenyx’s Dojolvi wins FDA approval for rare disease FDA approved Dojolvi triheptanoin (UX007) from Ultragenyx Pharmaceutical Inc. (NASDAQ:RARE) to treat long-chain fatty acid oxidation disorders, making it the first drug approved for the indication. The...
BioCentury | Jun 30, 2020
Product Development

Low-stakes 2018 deal with Regeneron leads to bump for Kiniksa on pericarditis readout

Pivotal data for rilonacept in recurrent pericarditis put Kiniksa on track to bring its first program to market and gain rights from Regeneron to additional indications. Kiniksa Pharmaceuticals Ltd. (NASDAQ:KNSA) shares rose $2.97 (13%) to...
BioCentury | Jun 27, 2020
Translation in Brief

Regeneron enhances checkpoint therapy with CD28 bispecifics; plus NIH funds Alzheimer’s brain mapping, Genentech and more

Regeneron combines CD28 bispecifics with PD-1 mAb  In its latest paper covering anti-CD28 bispecific antibodies, Regeneron Pharmaceuticals Inc. (NASDAQ:REGN) showed in Science Translational Medicine that the bispecifics could boost anti-PD-1 efficacy. Bispecifics against CD28 and...
BioCentury | Jun 26, 2020
Product Development

21st century pandemic, prehistoric clinical trials

The U.S. is trying to fight a 21st century pandemic with prehistoric clinical trials -- and achieving the kind of efficiency you might expect. In the last six months, tens of thousand of patients have...
BioCentury | Jun 24, 2020
Finance

AsclepiX aims for basket of retinal indications with $35M series A

AsclepiX intends to use its $35 million series A round for proof-of-concept studies of its lead product in three retinal disease indications, while also developing peptides into therapeutic candidates for oncology. Spun out of The...
Items per page:
1 - 10 of 1723