How ketamine trials are providing a blueprint for suicidal ideation research
NIMH’s Dr Elizabeth Ballard discusses how ketamine has laid the groundwork for a new paradigm of suicide research.
Neurology
Inhibikase doses first subject in Phase Ib Parkinson’s treatment trial
The trial will evaluate the safety, pharmacokinetics and tolerability of IkT-148009 in 24 Parkinson’s patients.
Regulatory roundup: Novartis’s breast cancer SERD tumbles after Phase I/Ib termination
Johnson & Johnson’s RVS vaccine and Enanta’s revised plans in NASH are among other assets...
Biogen’s tofersen fails to meet primary goal in Phase III ALS trial
The company says that trends favouring tofersen were found across several secondary and exploratory measures.
Roche’s Enspryng lowers disease relapses in Phase III NMOSD trials
Enspryng demonstrated a favourable safety and tolerability profile in Phase III SAkuraStar and SAkuraSky trials.
Takeda to stop Phase II trials of TAK-994 due to safety signal
Takeda will assess the risk-benefit profile of the oral therapy, which obtained breakthrough status from US FDA in July.
AbbVie’s Qulipta Set to Become Blockbuster in the Migraine Market
Qulipta is the first and only oral CGRP receptor antagonist specifically developed for the preventive treatment of migraine.
Biogen reports positive Phase II data of non-opioid pain drug in SFN
Vixotrigine 200mg dose met the primary endpoint while 350mg failed to achieve the goal, with both doses being well tolerated.
Newron commences trial of evenamide in schizophrenia patients
The trial is designed to assess the efficacy, tolerability and safety of the new chemical entity in nearly 200 subjects.
AC Immune reports positive data from Alzheimer’s disease drug trial
Semorinemab was well-tolerated and had a tolerable safety profile in the Phase II trial.
Regulatory roundup: Alexion ALS drug sees approval prospects plummet
GlobalData’s Investigative News team reviews recent events that impacted a drug’s path to regulatory approval.
