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
Results from a five-year study with US biotech firm Biogen Idec’s Tecfidera show strong and sustained efficacy in a broad range of patients living with relapsing-remitting multiple sclerosis. 12 September 2014
US biotech firm Biogen Idec has reported data confirming its Plegridy gives provides treatment effects that are maintained beyond the first year of the study in patients with relapsing multiple sclerosis. 12 September 2014
Netherlands-headquartered independent drugmaker Norgine has agreed to sell all rights in the UK for Somnite (nitrazepam mixture oral suspension BP) and the commercial rights in the UK and Ireland for Camcolit (lithium carbonate) to Essential Pharma. 11 September 2014
Swiss pharma giant Novartis has presented new data at the joint ACTRIMS-ECTRIMS meeting in Boston, USA, reinforcing the clinical importance of measuring brain shrinkage (brain volume loss) in multiple sclerosis (MS). 10 September 2014
USA-based pharma company Ligand Pharmaceuticals has expanded its global license agreement with chronic disease specialist CURx Pharmaceuticals to include the development and commercialization of Ligand’s Captisol-enabled lamotrigine program, a drug for hospital-based seizures. 10 September 2014
Neurological biopharma specialist XenoPort is to enter into an agreement with the National Institute on Alcohol Abuse and Alcoholism (NIAAA) to conduct a clinical trial of its drug Horizant (gabapentin enacarbil) in the treatment of alcohol use disorder. 10 September 2014
Fellow Japanese drugmakers Meiji Seika Pharma and Takeda Pharmaceutical have finalized a co-promotion agreement in Japan regarding Rozerem (ramelteon, TAK-375) for treatment of insomnia that Takeda currently manufactures and markets. The financial terms were not disclosed. 8 September 2014
US specialty drugmaker Depomed says that Judge Kentaji Brown Jackson of the federal district court for the District of Columbia has granted the company’s motion for summary judgment in the company's law suit against the US Food and Drug Administration seeking an order requiring the FDA to grant Gralise (gabapentin) orphan drug exclusivity for the management of post-herpetic neuralgia (PHN). 7 September 2014
Japanese drugmaker Eisai (TYO: 4523) says its US subsidiary has entered into an agreement to divest its US and Puerto Rican rights for the antiepileptic agent Zonegran (zonisamide) to Concordia Pharmaceuticals, a privately-held biotech firm. 7 September 2014
US drugmaker Mallinckrodt reported that a Phase III efficacy trial of investigational MNK-155 met the study’s primary endpoint of improved pain scores versus placebo over the first 48 hours following bunionectomy (p 5 September 2014
US pharma company AbbVie has entered a novel R&D collaboration with recently-formed Calico, intended to help the two companies discover, develop and bring to market new therapies for patients with age-related diseases, including for neurodegeneration and cancer. 4 September 2014
US biotech firm ACADIA Pharmaceuticals says that the US Food and Drug Administration has granted Breakthrough Therapy designation to Nuplazid (pimavanserin) for the treatment of Parkinson’s disease psychosis. 3 September 2014
Danish CNS specialist Lundbeck said today that Northera (droxidopa) capsules for oral use are now available through its US subsidiary for health care providers to prescribe in the USA. 2 September 2014
Belgium’s largest drugmaker UCB said today that the US Food and Drug Administration has approved a supplemental New Drug Application (sNDA) for Vimpat (lacosamide) C-V as monotherapy in the treatment of partial-onset seizures in patients with epilepsy aged 17 years and older. 1 September 2014
Privately-held US drugmakers Tau Therapeutics and Xdynia announced today that they have merged; the surviving entity in the merger, Tau Therapeutics, has been renamed Cavion. Financial terms were not disclosed. 29 August 2014
USA-based Concert Pharmaceuticals has achieved a $2 million milestone under its development and license agreement for AVP-786 which it holds with Avanir Pharmaceuticals, the second earned under the agreement. 26 August 2014
Ireland-headquartered biotech firm Alkermes has submitted a New Drug Application to the US Food and Drug Administration for approval of aripiprazole lauroxil, the company’s investigational, novel, once-monthly, long-acting injectable atypical antipsychotic for the treatment of schizophrenia. 26 August 2014
Ireland-headquartered generics major Actavis on Friday confirmed that it has filed an Abbreviated New Drug Application with the US Food and Drug Administration seeking approval to market rotigotine extended-release transdermal film. 23 August 2014
The attention-deficit hyperactivity disorder (ADHD) therapeutics market value will rise from $6.9 billion in 2013 to $9.9 billion by 2020, with broadening diagnostic criteria a key driver of growth, new research indicates. 22 August 2014
A judge in US federal court has issued a temporary restraining order following the US Food & Drug Administration’s decision to allow the sale of generic versions of Precedex, produced by Hospira. 21 August 2014