Drug Development
Infigratinib topped “even the most optimistic expectations” for efficacy and safety in the late-stage PROPEL 3 study in achondroplasia, Truist Securities analysts said Thursday.
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Analysts, investors and scientists are eager for Biogen’s 2026 BIIB080 readout. Even if successful, executives warn that there are many more steps before the Alzheimer’s therapy could reach the market.
With a clutch of key data and planned regulatory applications this year from Avidity Biosciences, REGENXBIO and Capricor Therapeutics, CureDuchenne CSO Michael Kelly sees “momentum” in the Duchenne muscular dystrophy pipeline, as Sarepta’s Elevidys leaves the door open.
After advancing in lockstep through the pandemic, the fortunes of the biotechs have diverged as their use of COVID-19 windfalls has taken shape.
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Researchers are expressing concern about a subvariant of Omicron dubbed BA.2 that appears to be tearing through Denmark. For that and more COVID-19 news, continue reading.
Taysha said the data for TSHA-101 is the “first-ever to support the bicistronic vector approach in humans delivering both HEXA and HEXB genes in the endogenous ratio.”
Moderna invested heavily in mRNA technology to manufacture some 900 million doses of the COVID-19 vaccine. Now, the company has created an mRNA-based vaccine to prevent HIV.
The company initiated the use of splenic nerve simulation last month as part of a small clinical trial at the NHS Greater Glasgow & Clyde Health Board in Scotland.
Alzamend Neuro is looking to commence a Phase II multiple ascending dose study of lead compound, AL001, in Alzheimer’s disease during the second quarter of this year.
The studies are of the U2 combination Ukoniq (umbralisib) and ublituximab for chronic lymphocytic leukemia (CLL) and non-Hodgkin’s lymphoma (NHL).
The FDA is calling the study a phase II trial and says the company must run a rodent genotoxicity study before it can continue.
Although most of the news about the effectiveness and endurance of COVID-19 vaccines has focused on antibody titers, not as much has been reported on their effect on other parts of the immune system that offer longer-term protection, such as T cells. For that and more, continue reading.
Pfizer hopes to step in to ensure that no trade secrets are disclosed when the regulatory agency begins to share that information.
Biogen and its partner Eisai Company released additional details about the Phase IV post-marketing study of the drug.