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
Japanese pharma major Eisai (TYO: 4523) said on Friday that construction of a new production facility has been completed in Suzhou, Jiangsu, China. 29 November 2014
Japanese drug major Daiichi Sankyo and Belgian drugmaker UCB have entered into an agreement to jointly commercialize Vimpat (lacosamide) for epilepsy patients in Japan. 28 November 2014
French drugmaker Ipsen says that the US Food and Drug Administration has accepted for review its supplemental Biologics License Application (sBLA) for Dysport (abobotulinumtoxinA) in the treatment of upper limb spasticity in adult patients. 28 November 2014
John Andrews, consultant editor of The Economist, opened the Global Crisis of Depression conference by citing the 92 billion-euro ($115 billion) annual cost of the disease to Europe - this is the magnitude of the crisis contemporary society is dealing with. 27 November 2014
The UK’s National Institute for Health and Care Excellence (NICE) has recommended Selincro (nalmefene) from Danish CNS specialist Lundbeck for alcohol dependence. 26 November 2014
US drugmaker Supernus Pharmaceuticals has sued generic drug makers Zydus Pharmaceuticals (USA) and Indian parent Cadila Healthcare for infringement of three patents covering its antiepileptic drug Trokendi (topiramate) XR. 25 November 2014
The UK’s independent medical research charity MRC Technology and Chinese drugmaker Yabao Pharmaceutical have entered into an exclusive license agreement. 24 November 2014
A total of 10 new medicines have been recommended for approval at the November 2014 meeting of the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP). 22 November 2014
The US Food and Drug Administration has approved Hysingla ER (hydrocodone bitartrate), an extended-release (ER) opioid analgesic to treat pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. 21 November 2014
French pharma major Sanofi is today outlining its intention to launch high-potential new medicines and vaccines that could result in up to 18 new launches for the company between 2014-2020, at an IR Thematic Seminar on New Medicines in Boston, USA. 20 November 2014
Danish biopharmaceutical company Forward Pharma has filed a law suit against US biotech major Biogen Idec and its European subsidiaries alleging infringement of its German utility model DE 20 2005 022 112 due to Biogen Idec's marketing of Tecfidera (dimethyl fumarate) in Germany. 18 November 2014
The US Food and Drug Administration on Friday approved French pharma major Sanofi subsidiary Genzyme’s Lemtrada (alemtuzumab) for the treatment of patients with relapsing forms of multiple sclerosis (MS). 15 November 2014
US drugmaker Mallinckrodt says it has been informed by the Food and Drug Administration that the agency has reason to believe that the company’s methylphenidate hydrochloride extended-release tablets, USP may not be therapeutically equivalent to the category reference drug, Johnson & Jonson’s Concerta. 13 November 2014
The US Food and Drug Administration has approved the supplemental New Drug Applications (sNDAs) from US health care giant Johnson & Johnson’s subsidiary Janssen for Invega Sustenna (paliperidone palmitate) for monotherapy or adjunctive therapy in schizoaffective disorder. 13 November 2014
Ireland-headquartered generics major Actavis has had its Supplemental New Drug Application for Saphris (asenapine) for the acute treatment of manic or mixed episodes in bipolar I disorder in pediatric patients, aged 10-17 accepted by the US Food and Drug Administration. 13 November 2014
Ironshore Pharmaceuticals & Development, part of Canada-based specialty pharma company Highland Therapeutics, has reported positive top-line results from its recently completed Phase III study. 11 November 2014
The safety profile of adjunctive Japanese drugmaker Eisai’s Zonegran (zonisamide) in pediatric patients with partial epilepsy is confirmed by pooled data published in the European Journal of Paediatric Neurology (EJPN). 10 November 2014
At its meeting last week, the European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) made recommendations on products that contain Factor VIII and discussed a fatality in a patient treated with Tecfidera. 9 November 2014
Japanese drug major Eisai has expressed “utmost disappointment” that the German Federal Joint Committee (G-BA) has decided that the additional benefit for its new generation anti-epileptic drug (AED) Fycompa (perampanel) has not been proven. 6 November 2014
US rare and infectious disease specialist Sarepta Therapeutics remains a strong contender in the Duchenne muscular dystrophy (DMD) treatment market, despite a delay in the development of its novel, exon-skipping drug eteplirsen from the end of this year, says an analyst. 6 November 2014