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
In a holiday-shortened week, there were still a bunch of important announcements, among which was the US approval of Neurocrine Sciences’ movement disorder drug Ingrezza, two lots of bad news for OncoMed and Bristol-Myers Squibb offloaded two product candidates as well as entering a research collaboration with Apexigen. 17 April 2017
American biotech firm Biogen has acquired from Bristol-Myers Squibb an exclusive license for BMS-986168, a therapy candidate in Alzheimer’s disease (AD) and progressive supranuclear palsy (PSP). 13 April 2017
The US Food and Drug Administration has approved Ingrezza (valbenazine) capsules for the treatment of adults with tardive dyskinesia (TD). 12 April 2017
David Hung, the founder and former chief executive of Medivation, an oncology-focused biopharma bought by US pharma giant Pfizer for $14 billion last year, has switched his attention to dementia in his role. 11 April 2017
USA-based Marinus Pharmaceuticals, a biotech company focused on developing treatments for epilepsy and neuropsychiatric disorders, has appointed Lorianne Masuoka as chief medical officer. 11 April 2017
Ireland’s Health Service Executive (HSE) National Drugs Management Program (NDMP) and Neurology Program have introduced a national reimbursement scheme which will facilitate access for patients with multiple sclerosis (MS) to approved high cost treatments. 7 April 2017
Botox (onabotulinumtoxinA), a treatment which made its name for its aesthetic potential in reducing facial wrinkles, is to be taken into Phase III trials in major depressive disorder (MDD). 7 April 2017
On April 6, 2017, the British Court of Appeal upheld Flynn Pharma’s right to stop the parallel importation into the UK of Pfizer’s Epanutin (phenytoin sodium) anti-epileptic drug for resale as Phenytoin Sodium Flynn. 7 April 2017
Briviact (brivaracetam) has been accepted for use in Ireland as an add-on treatment for partial onset seizures (POS) with or without secondary generalized seizures in adults with epilepsy. 6 April 2017
Ligand Pharmaceuticals has entered into commercial license and supply agreements with Marinus Pharmaceuticals, granting rights to use Ligand’s Captisol in the formulation of its intravenous (IV) ganaxolone. 6 April 2017
Japanese drugmakers Eisai and Meiji Seika Pharma have entered into a license agreement for the commercialization of ME2125 (safinamide) for the treatment of Parkinson’s disease in Japan and Asia. 5 April 2017
Mallinckrodt has reached an agreement in principle with the US Drug Enforcement Administration (DEA) and the US Attorneys' Offices (USAOs) for the Eastern District of Michigan and the Northern District of New York regarding controlled substances. 4 April 2017
The US Food and Drug Administration has approved Austedo (deutetrabenazine) tablets for the treatment of chorea associated with Huntington’s disease, Teva Pharmaceutical has announced. 4 April 2017
Ireland-headquartered Shire has announced that its partner in Japan, Shionogi , has received the approval of the Japanese Ministry of Health, Labor and Welfare to manufacture and market Intuniv (guanfacine hydrochloride prolonged release). 4 April 2017
Most of the headline grabbing news last week focussed on approvals of new medicines and some exciting clinical trial results. Among these were the approvals of Roche’s Ocrevus for multiple sclerosis, Tesaro’s Zejula for treatment of recurrent ovarian cancer and Sanofi’s Dupixent for atopic dermatitis. Also stirring interest was clinical data on Vertex’ combination of tezacaftor and ivacaftor. 2 April 2017
The US Food and Drug Administration (FDA) has approved Ocrevus (ocrelizumab) to treat adult patients with relapsing forms of multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS). 29 March 2017
Newron Pharmaceuticals has released positive detailed results of a Phase IIa study with its unique sodium channel blocker, evenamide (NW-3509), in patients with schizophrenia. 27 March 2017