Drug Development
The company’s aztreonam-avibactam matched the cure rate of a meropenem-based regimen in patients with drug-resistant infections.
FEATURED STORIES
Mixed headlines have plagued the cell and gene therapy space of late. We believe that a renewed case of optimism is not only warranted but essential if these therapies are to reach their full potential.
Through substantial leadership turnover and workforce cuts, the FDA has continued to support the advanced therapy sector, actively working to remove obstacles to innovation.
With immunology and inflammation blockbusters like AbbVie’s Skyrizi and Rinvoq reeling in nearly $7 billion combined in the third quarter, the pipeline-in-a-product strategy has never been more attractive.
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THE LATEST
Three physicians filed a lawsuit against the FDA alleging the organization acted outside its authority and with their ability to practice medicine by discouraging the use of ivermectin to treat COVID-19.
The week began with positive updates in the vaccine development space against various infectious diseases from Emergent, Merck, Affinivax and Ocugen.
AstraZeneca and Ionis reported that their NEURO-TTRansform Phase III trial in hereditary transthyretin-mediated amyloid polyneuropathy hit its co-primary endpoints.
In the coming 12 months, Rain expects to have an interim readout for a Phase II study of its liposarcoma therapy, milademetan, and a pivotal readout for its Phase III trial of the same compound.
Thursday, a committee of advisors for the CDC voted unanimously for children and teens, ages six to 17 to receive Moderna’s COVID-19 vaccine.
CVS Health has seen about 40% patient diversity in the work it has done so far, Josh Rose, VP and head of decentralized clinical trials, site solutions and strategy told BioSpace.
Pfizer inked an Equity Subscription Agreement with France-based Valneva. They also updated their Collaboration and License deal for a Lyme disease vaccine that was announced in April.
Extension data from the Phase II TOPAZ trial showed that apitegromab yielded sustained and continued benefits in non-ambulatory patients with types 2 and 3 spinal muscular atrophy (SMA).
The FDA’s decision is based on positive results from two induction and one maintenance clinical study of AbbVie’s Skyrizi for Crohn’s disease.
BioSpace spoke with Janssen’s Fiona Elwood about the company’s myasthenia gravis candidate nipocalimab, which is currently recruiting for two Phase III trials.