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...

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...

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...

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...

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....

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...

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...

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...

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...

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...