DEA Proposes Less Opioid Production, More Marijuana for Research in 2020
The Drug Enforcement Administration (DEA) is proposing a reduction in the amount of Schedule II controlled substances that can be manufactured in the US next year.
All articles by Diana Ernst, RPh
Ofatumumab Bests Teriflunomide in Head-to-Head MS Trials
Findings from the phase 3 ASCLEPIOS I and II studies showed that treatment with ofatumumab (Novartis) resulted in a highly significant and clinically meaningful reduction in the number of confirmed relapses, compared with teriflunomide, a pyrimidine synthesis inhibitor, in patients with relapsing forms of multiple sclerosis.
Myobloc Approved for the Treatment of Chronic Sialorrhea
The Food and Drug Administration (FDA) has approved Myobloc (rimabotulinumtoxinB injection; US WorldMeds) for the treatment of chronic sialorrhea in adults.
Potential First-in-Class Treatment for Tourette Syndrome Gets Fast Track Status
The Food and Drug Administration (FDA) has granted Fast Track designation to ecopipam (Emalex Biosciences), an investigational agent for the treatment of Tourette syndrome (TS).
Trial Investigating Fosmetpantotenate for Rare Neurologic Disorder Misses Primary End Point
A phase 3 trial evaluating an investigational therapy for the treatment of pantothenate kinase-associated neurodegeneration did not meet its primary or secondary end points.
FDA Rejects Supplemental New Drug Application for Tasimelteon in Jet Lag Disorder
The FDA has rejected the supplemental New Drug Application for Hetlioz (tasimelteon; Vanda Pharmaceuticals) for the treatment of jet lag disorder.
Physician Attitudes Toward Herpes Zoster Vaccination Examined Over a Decade of Availability
Only 29% of 2016 survey respondents reported that they strongly agreed that the burden of herpes zoster in patients aged 50 to 59 years old is sufficient to make a vaccine important.
FDA Issues Statement Regarding Data Manipulation in Recently Approved Gene Therapy for SMA
According to the Food and Drug Administration (FDA), AveXis Inc, the manufacturer of the gene therapy Zolgensma, was aware of an issue related to “data manipulation” prior to approval, but did not inform the Agency until after the product was approved.
Galcanezumab Beneficial for Treatment-Resistant Migraine in Phase 3 Trial
Galcanezumab was found to be beneficial in patients with treatment-resistant migraine, according to results from the phase 3 CONQUER study.
Diroximel Fumarate for Relapsing Remitting MS Shows Good Tolerability in Phase 3 Study
Treatment with diroximel fumarate was associated with significantly fewer days of key gastrointestinal symptoms, according to topline results from a phase 3 study evaluating the GI tolerability.
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