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
The Parkinson’s disease treatment market value across the eight major countries of the USA, France, Germany, Italy, Spain, the UK, Japan, and Brazil will reach $4.7 billion by 2022, driven primarily by an aging population and increasing disease prevalence, new research shows. 2 July 2015
Eolas Therapeutics, Inc. announced today that is has entered into a worldwide license and partnership agreement with AstraZeneca on the Eolas’ orexin-1 receptor antagonist (EORA) program for smoking cessation and other anti-addiction indications. 1 July 2015
USA-based CNS specialist Avanir Pharmaceutical released top-line data from the PRISM II study showing that treatment with Nuedexta (dextromethorphan hydrobromide/ quinidine sulfate) was associated with a statistically significant reduction in symptoms of pseudobulbar affect (PBA) in patients with traumatic brain injury (TBI) or stroke. 30 June 2015
Swiss drug major Roche has announced positive results from two pivotal studies of ocrelizumab compared with interferon beta-1a in people with relapsing multiple sclerosis. 30 June 2015
Swiss pharma giant Novartis has entered into an agreement to acquire Spinifex Pharmaceuticals, a USA and Australia-based, privately held development stage company. 29 June 2015
There was positive news flow for Japanese drug major Daiichi Sankyo this week, with the announcement of approval for its stoke medication in Europe and the filing in Japan for its in-licensed epilepsy drug candidate. 26 June 2015
The European Commission has granted marketing authorization approval for Fycompa (perampanel) from Eisai as a once-daily adjunctive therapy for primary generalized tonic-clonic (PGTC) seizures in adults and adolescents with idiopathic generalized epilepsy. 25 June 2015
The US Food and Drug Administration is warning that permanent loss of skin color may occur with use of the Daytrana patch (methylphenidate transdermal system) for attention-deficit hyperactivity disorder (ADHD). 25 June 2015
Japanese drug major Daiichi Sankyo has entered into a collaboration with fellow Japan-based Maruishi Pharmaceutical to commercialize the general anesthesia analgesic, remifentanil injection generic. 24 June 2015
Japanese drug major Eisai has received approval from the US Food and Drug Administration for an indication expansion regarding the use of its in-house developed antiepileptic agent Fycompa (perampanel hydrate). 22 June 2015
Sandoz, the generics unit of Swiss drug major Novartis, yesterday announced the US launch of Glatopa, the first generic version of Teva Pharmaceutical Industries’ Copaxone. 19 June 2015
A collaboration between experts at the University of Southampton, UK, and the research charity MRC Technology, will target new treatments for Alzheimer’s disease. 19 June 2015
The US Court of Appeals for the Federal Circuit has again found that US Patent No 5,800,808, related to a method of manufacturing glatiramer acetate, the active ingredient of Israel-based Teva Pharmaceutical Industries blockbuster multiple sclerosis drug Copaxone, is invalid as indefinite. 18 June 2015
US drug major Eli Lilly announced that its investigational medicine for the prevention of migraines met its primary endpoint in a Phase IIb study in episodic migraine. 18 June 2015
Based on reviews of additional safety reports from patients treated with the anti-seizure drug Potiga (ezogabine), the US Food and Drug Administration has determined that the potential risks of vision loss due to pigment changes in the retina and of skin discoloration can be adequately managed by following the current recommendations in the Potiga labeling. 17 June 2015
The US Food and Drug Administration has told Hungary’s largest drugmaker Gedeon Richter and Allergan that it will require a three-month extension to complete its review of data supporting the resubmission of the New Drug Application (NDA) for cariprazine. 17 June 2015
Teva Pharmaceutical Industries has announced positive top-line results from the pivotal clinical study Aim to Reduce Movements in Tardive Dyskinesia (ARM-TD) designed to evaluate the efficacy of SD-809 (deutetrabenazine) in the treatment of moderate to severe tardive dyskinesia. 16 June 2015
The US Food and Drug Administration has approved US generic drugmaker Impax Laboratories’ Zomig (zolmitriptan) Nasal Spray for use in pediatric patients 12 years of age and older for the acute treatment of migraine with or without aura. 16 June 2015
A responder analysis of data from two Phase III clinical trials evaluating Northera (droxidopa) for patients with symptomatic neurogenic orthostatic hypotension (nOH) was presented today at the 19th International Congress of Parkinson’s Disease and Movement Disorders. 16 June 2015