Global immunology firm Argenx shared positive topline results from the company’s ongoing study on the use of efgartigimod for generalized myasthenia gravis (gMG).
Tetra Bio-Pharma announced that the company’s investigational new drug involving cannabinoids, QIXLEEF, received guidance to strengthen its nonclinical and toxicological data from the U.S. Food and Drug Administration, which brings the aerosol botanical therapy closer to marketing approval.
Biogen reported new data from a long-term extension phase of the Phase III clinical studies of Aduhelm (aducanumab) for Alzheimer’s disease.
Incyte Corporation reported that the U.S. Food and Drug Administration pushed back the review of the company’s supplemental New Drug Application for Opzelura (ruxolitinib cream) for vitiligo.
Bristol Myers Squibb and Nektar Therapeutics released disappointing news about their joint Phase III PIVOT IO-001 study evaluating a dual therapy of the immunotherapy drug bempegaldesleukin in combination with Opdivo (nivolumab) compared with Opdivo alone to treat unresectable or metastatic melanoma.
Sanofi and partner Swedish Orphan Biovitrum shared positive topline results from their ongoing Phase III trial on a candidate drug for patients diagnosed with severe hemophilia A.
Valneva is advancing toward U.S. FDA accelerated approval of the France-based biologics company’s VLA1553 after the specialty vaccine was shown to be safe and effective against mosquito-transmitted chikungunya disease, in a published analysis of Phase III results.
Astellas Pharma Inc. announced topline results from the Phase 3 SKYLIGHT 4 clinical trial investigating the long-term safety of fezolinetant, an investigational oral, nonhormonal compound being studied for the treatment of moderate to severe vasomotor symptoms associated with menopause (VMS) which will support future regulatory filing submissions.
The U.S. Food and Drug Administration accepted for review Pfizer Inc.’s Prior Approval Supplement to the Biologics License Application for ABRILADA (adalimumab-afzb) as an interchangeable biosimilar to Humira (adalimumab).
An Omicron-specific booster could be ready by August, the CEO of U.S. biotech firm Moderna told Reuters, but the firm is still gathering clinical data to determine whether that vaccine would offer better protection than a new dose of the existing jab.
