Today, the US Food and Drug Administration approved Miplyffa (arimoclomol), an oral medication for the treatment of Neimann-Pick disease, type C (NPC). 20 September 2024
US neuroscience company BioXcel Therapeutics has announced a new clinical prioritization and an update on its late-stage development programs for the treatment of agitation with BXCL501. 20 September 2024
Stalicla, a privately-held Swiss biotech, today announced that Dr Paulo Fontoura will be joining its drug development team as chief scientific and clinical development advisor. 19 September 2024
US clinical stage CNS drug developer Athira Pharma is taking decisive action following the company’s announcement of disappointing data from the Phase II/III LIFT-AD clinical trial of fosgonimeton to treat Alzheimer’s disease (AD). 18 September 2024
The US Food and Drug Administration (FDA) has approved Ocrevus Zunovo (ocrelizumab and hyaluronidase-ocsq) for the treatment of relapsing multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS), from Swiss pharma giant Roche. 16 September 2024
US pharma major Eli Lilly has announced a $1 billion expansion of its manufacturing site in Limerick, Ireland, to increase production of biologic active ingredients, including those for its recently approved treatment for early symptomatic Alzheimer's disease. 13 September 2024
US neurological diseases specialist Ovid Therapeutics has announced the promotion of Meg Alexander to president and chief operating officer (COO). 12 September 2024
The global migraine market in mature economies is projected to grow from $9.2 billion in 2023 to $16.4 billion by 2033, according to a report from GlobalData. 10 September 2024
Cartesian Therapeutics today announced that the US Food and Drug Administration (FDA) has granted Rare Pediatric Disease designation to Descartes-08 for the treatment of juvenile dermatomyositis (JDM). 9 September 2024
California’s Lykos Therapeutics is still trying to regroup after being rocked by the US Food and Drug Administration’s (FDA) rejection of midomafetamine (MDMA) capsules for the treatment of post-traumatic stress disorder (PTSD). 6 September 2024
The cost of prescribed dependency-forming medicines has decreased by £410 million ($539.6 million) since 2015/16, according to newly released data from the UK’s National Health Service (NHS). 6 September 2024
Shares in US biopharma Axsome Therapeutics, a biopharmaceutical company developing and delivering novel therapies for the management of CNS disorders, closed 7% higher on Wednesday. 5 September 2024
Mid-Atlantic BioTherapeutics (MABT) has announced a collaboration with Accelero Biostructures to identify novel inhibitors of USP30, a protein linked to neurological disorders and other conditions. 5 September 2024
Praxis Precision Medicines shared positive top-line results for its Phase II, proof of concept study evaluating relutrigine in SCN2A and SCN8A developmental and epileptic encephalopathy (DEE) patients. 4 September 2024
Janssen Pharmaceutical, a unit of healthcare giant Johnson & Johnson has revealed that its, esketamine nasal spray in patients with treatment-resistant depression failed to demonstrate a statistically valid treatment effect compared to placebo in a late-stage trial. 25 September 2018
A new study from the US Centers for Disease Control and Prevention says that the burden of Alzheimer’s disease and related dementias will double by 2060. 24 September 2018
With World Alzheimer’s Day fast approaching, drugmakers and patients around the world are raising awareness of the challenges faced, and the progress made, in combating this most intractable of conditions. 20 September 2018
The US Food and Drug Administration (FDA) has underlined that it is serious about ensuring appropriate and rational prescribing of opioids to counteract their misuse, as the agency approved new safety measures governing their use. 19 September 2018
Japan’s Sosei and licensing partner Allergan are suspending clinical development activities with HTL0018318 after a surprise toxicology result. 18 September 2018
Findings from the largest global survey to date investigating perceptions of Alzheimer's disease show that most adults (62%) are worried that they may develop Alzheimer's, while nearly the same proportion believe it is likely a cure will be developed in their lifetime (60%). 18 September 2018
Supernus Pharmaceuticals has entered into a merger agreement to acquire Biscayne Neurotherapeutics, a privately-held company developing a novel treatment for epilepsy. 14 September 2018
In the runup to World Alzheimer’s Day, industry analyst GlobalData has provided a report on the state of research in this therapy area. 14 September 2018
The US Food and Drug Administration has extended the Prescription Drug User Fee Act (PDUFA) goal date for its review of the New Drug Application (NDA) of Parkinson’s disease candidate Inbrija (levodopa inhalation powder) from October 5, 2018 to January 5, 2019. 14 September 2018
VistaGen Therapeutics), a biotech with a pipeline focused on antidepressants, has acquired a late-stage drug candidate from Pherin Pharmaceuticals with the goal of treating social anxiety disorder (SAD), which affects 15 million Americans. 13 September 2018
Swiss pharma giant Novartis has published full results from the Phase III Gilenya (fingolimod) PARADIGMS study in the New England Journal of Medicine (NEJM). 13 September 2018
Illustrating the challenges of developing medicines to fight Alzheimer’s disease, a new analysis found that between 1998 and 2017, there were 146 unsuccessful medicines in clinical trials for Alzheimer’s disease. 13 September 2018
USA-based Harmony Biosciences, a part of the Paragon Biosciences corporate family, presented encouraging new data on its investigational drug pitolisant at the 7th International Symposium on Narcolepsy. 12 September 2018
Developing drugs to treat central nervous system (CNS) disorders on average required 20% more time than other drugs that won marketing approval in the USA from 2000 through 2017, and took 38% longer to win that approval, a new study shows. 11 September 2018
A key vote in the US House of Representatives this week could open up research opportunities in the USA for drugmakers exploring the clinical potential of cannabis. 11 September 2018
Amid patient criticism of a failure to reach a deal over Ocrevus (ocrelizumab) for primary progressive multiple sclerosis (PPMS), Swiss pharma giant Roche has blamed a lack of flexibility within the system for getting drugs reimbursed on the UK’s National Health Service (NHS). 9 September 2018
Ironshore Pharmaceuticals, a wholly-owned subsidiary of Canada’s Highland Therapeutics, has appointed Scott Evangelista to the position of president and chief operating officer (COO). 7 September 2018
The Federal Circuit on Thursday upheld a New Jersey federal judge’s decision finding that Supernus Pharmaceuticals patents related to its anti-epilepsy drug are valid and infringed by generics maker TWi Pharmaceuticals, saying that the court did not improperly give a related case preclusive effect. 7 September 2018
Following a string of disappoints in the development of in-licensed compound laquinimod, Israel’s Teva Pharmaceutical Industries has returned rights on the product to Swedish originator. 6 September 2018