Drug Development

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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 studied the behavior of protein cells in the brain and found a significant difference in those who have had dementia and those who have not, particularly in their ability to clean themselves.
Every week there are numerous scientific studies published. Here’s a look at some of the more interesting ones.
GlaxoSmithKline said early research shows its monoclonal antibody is demonstrating efficacy against the newest strain of COVID-19.
In the CRL, the FDA indicated that the single registrational trial (106 Phase III) did not provide sufficient proof of efficacy to demonstrate benefit.
Research continues to reveal how COVID-19 affects different people with different health issues, both short-term and long-term.
The Phase III DISCREET study evaluated the efficacy of Otezla in adults who have been diagnosed with moderate to severe plaque psoriasis and genital psoriasis.
The FDA’s decision is based on positive results from two Phase III trials, the PROTECT and CONSTANT, on the drug’s efficacy.
The 12-month data showed that 50 mg of zuranolone was well-tolerated among adults with MDD.
The company plans to move it into Phase III studies in APOL1-mediated kidney disease, including FSGS, in the first quarter of 2022.
It may take two to four weeks before experts have enough data to know whether Omicron is a bigger threat than Delta. Much of what is known is based on lab tests and models of the virus’ spike protein mutations.