Now that Novavax Inc. has received an emergency use authorization (EUA) from the U.S. FDA allowing adults to receive the adjuvanted vaccine to ward off severe acute COVID-19, it’s time for the CDC to weigh in. Once its Advisory Committee on Immunization Practices meets July 19 to discuss the vaccine and make a policy recommendation, the vaccine will be available on the market.
The data safety monitoring board overseeing Contrafect Corp.’s phase III study of exebacase, a hydrolase stimulator for treating Staphylococcus aureus bacteremia, recommended the study be stopped. In an interim analysis, the board said the conditional power of the study was below the prespecified threshold for futility.
Lenzilumab, Humanigen Inc.’s lead candidate, undershot statistical significance on the primary endpoint in the U.S. NIH-sponsored ACTIV-5/BET-B study of treating hospitalized COVID-19 patients. The Short Hills, N.J.-based company’s stock (NASDAQ:HGEN) crumpled in the wake of the results.
Areteia Therapeutics Inc. has launched to put its lead candidate, dexpramipexole, an oral treatment for eosinophilic asthma, through a phase III trial. Areteia was created by Knopp Biosciences LLC, which has put the small-molecule eosinophil maturation inhibitor through a phase II study, and also by Population Health Partners. Areteia has both the development and commercial rights to dexpramipexole.
Seven fatalities that could be related to hemorrhagic events in Macrogenics Inc.’s phase II trial of the monoclonal antibody enoblituzumab for treating head and neck cancer has led to the study’s closure.
In a new licensing deal cut with Swedish Orphan Biovitrum AB (Sobi), ADC Therapeutics SA is getting a $55 million up-front payment and could receive $50 million more upon regulatory approval of Zynlonta (loncastuximab tesirine) in third-line diffuse large B-cell lymphoma by the European Commission.
Three serious adverse events have led the U.S. FDA to place a clinical hold on Diamedica Therapeutics Inc.’s phase II/III study of DM-199, a synthetic form of human tissue kallikrein-1 for treating acute ischemic stroke. The blood pressure in three participants dropped to a significantly low level shortly after receiving an I.V. dose of the therapy. All three bounced back to normal within minutes of stopping the I.V.
Skyhawk Therapeutics Inc. has cut a deal with Sanofi SA to discover and develop small molecules to treat targets in oncology and immunology, adding to its lengthy list of partnerships.
To build on its hematology pipeline in treating blood cancers, Astrazeneca plc is acquiring Teneotwo Inc. in a deal that could reach $1.27 billion. Teneotwo is part of Ancora Biotech LLC, which has some other affiliate Tens in the stable, including Teneofour Inc. That company is developing TNB-738, an anti-CD38 enzyme inhibitor. Teneoten Inc. is developing an anti-HBV/CD3 therapy. Both are available for partnering or sale, Ben Buelow, Ancora co-founder, told BioWorld. He co-founded the company with this father, Roland.
