FDA Needs More Data on Sulopenem for Uncomplicated UTI
The NDA submission was supported by data from the phase 3 SURE1 clinical trial.
Neurological Disorders
AAN: Race May Affect Response to Anti-CD20 Therapy for MS, NMOSD
B-cell repopulation occurs more often in African American vs White patients between 6 and 12 months after anti-CD20 infusion
Panzyga Approved for Chronic Inflammatory Demyelinating Polyneuropathy
The approval was based on data from a study that compared 2 different maintenance dosages of Panzyga in 142 adults with CIDP.
Experimental Drug for Alzheimer Disease Shows Promise
After six to 12 months of treatment with the drug, patients no longer had amyloid protein plaques.
Trehalose Designated Orphan Drug for ALS
SLS-005 contains the active ingredient trehalose, a low molecular weight disaccharide that crosses the blood brain barrier, stabilizes proteins and activates autophagy.
FDA Issues Complete Response Letter for Libervant
Libervant is a buccally administered soluble film of diazepam used to treat acute uncontrolled seizures in patients with refractory epilepsy on stable AED regimens.
MPR Weekly Dose Podcast Episode 47
This week we have remdesivir news; A new opioid and spinal muscular atrophy treatments are approved; A sublingual epinephrine treatment; And the latest on Biogen’s investigational Alzheimer disease treatment. Also, we have a brief summary of the other drugs in the pipeline from the past week.
Aducanumab BLA for Alzheimer Disease Submitted for FDA Review
Biogen has submitted its Biologics License Application (BLA) to the Food and Drug Administration (FDA) for aducanumab as a treatment of Alzheimer disease (AD).
Novel Therapy for Alzheimer Disease Agitation Gets Breakthrough Designation
The FDA has granted Breakthrough Therapy designation to AXS-05 (Axsome Therapeutics) for the treatment of Alzheimer disease (AD) agitation.
FDA Approves DBS Neurostimulation System With Brain Signal Tracking
The FDA has approved the Percept™ PC Deep Brain Stimulation (DBS) system (Medtronic) with BrainSense™ technology for neurological disorders.
