Clinical research
In the CRL, the FDA indicated that the single registrational trial (106 Phase III) did not provide sufficient proof of efficacy to demonstrate benefit.
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.
Parkinson’s disease has been immensely challenging for biotech companies. A high rate of late-stage attrition in trials has led to a lack of approved therapies for the disease.
ImmunoGen shares positive results from its Phase III SORAYA trial, which is evaluating the use of mirvetuximab soravtansine for treating ovarian cancer.
One day after falsified information regarding its Phase I/II breast cancer data circulated online, Olema Pharmaceuticals released its topline data for a potential best-in-class complete estrogen receptor antagonist.
Adagio claims that none of the mutations found in Omicron are linked with escape from ADG20 neutralization in vitro.
Two biopharma companies developing therapeutics in the oncology space begin the week with strong signals in Phase II.
PRESS RELEASES
