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
Cannabidiol specialist GW Pharmaceuticals has revealed it plans to charge around $32,500 per year for Epidiolex (cannabidiol), a new oral therapy for certain forms of epilepsy. Shares in the UK-based firm are up over 3% for the week. 10 August 2018
Ironshore Pharmaceuticals & Development has been given the green light to market Jornay PM (methylphenidate) to treat attention deficit hyperactivity disorder (ADHD) in the USA. 10 August 2018
Shares in Sarepta Therapeutics were up 12% at lunchtime on Thursday, after the RNA therapy specialist announced a $30 million deal with Lacerta Therapeutics which added three CNS gene therapies to its pipeline. 9 August 2018
Digital medicine company Akili Interactive Labs, an independent affiliate of the biotech company PureTech Health, has announced an additional $13 million worth of investment in its ongoing Series C funding campaign, which now totals $68 million. 9 August 2018
Industry analyst GlobalData has drawn attention to a pioneering stem cell trial for Parkinson’s disease underway at Kyoto University Hospital in Japan. 8 August 2018
Danish CNS specialist Lundbeck saw its shares fall as much as 10% early this morning, after reporting what appear to be strong financial results for first-half 2018, that beat analysts’ expectations but which nevertheless failed to impress investors. 8 August 2018
Following on from a series of measures aimed at challenging the ongoing opioid addiction epidemic in the USA, the US Food and Drug Administration announced new action on Monday, with a set of revised scientific recommendations. 7 August 2018
USA-based Acadia Pharmaceuticals has entered into an exclusive North American License Agreement for the development and commercialization of the Australian biotech firm Neuren Pharmaceutical’s trofinetide for Rett syndrome and other indications. 7 August 2018
Alzheon, a privately-held biopharmaceutical company with a focus on Alzheimer's, announced on Monday that researchers had discovered a naturally-occurring substance in the human brain that suppresses the production of a protein linked to the disease. 6 August 2018
Alzheon, a privately-held American biopharmaceutical company, has announced its hiring of former IVAX president Neil Flanzraich as vice chairman of the board. 6 August 2018
In a filing with the Securities and Exchange Commission, US neurological diseases specialist Acorda Therapeutics reported updates on its litigation with Netherlands-headquartered drugmaker Mylan and its affiliates, as well as other, relating to multiple sclerosis drug Ampyra (dalfampridine) Orange Book-listed patents. 6 August 2018
Titan Pharmaceuticals has entered into an amendment of the previously announced definitive asset purchase, supply and support agreement with Italian firm L Molteni & C through which Molteni acquired the European intellectual property related to Probuphine (buprenorphine). 3 August 2018
The Australian government has added Fycompa (perampanel), a once-daily epilepsy treatment from Eisai, to the Pharmaceutical Benefits Scheme (PBS). 1 August 2018
Novartis announced on Tuesday the approval of its game-changing migraine prevention therapy Aimovig (erenumab) by the European Medicines Agency (EMA). 31 July 2018
Danish CNS specialist Lundbeck and Japanese drugmaker Otsuka have announced the European Commission approval of Rxulti (brexpiprazole) for the treatment of schizophrenia in adults. 31 July 2018
The US Food and Drug Administration’s acceptance of Merck KGaA’s (MRK: DE) resubmitted application for Mavenclad (cladribine), seven years after the original application, is seen as a positive in terms of the German drugmakers future in the multiple sclerosis therapy sector. 31 July 2018
Both Russian and global pharmaceutical producers operating in the local market have called on the national government to ease the process of registration of drugs in Russia, reports The Pharma Letter’s local correspondent. 30 July 2018
New York-based Tonix Pharmaceuticals suffered a more than 65% drop in share price after announcing on Friday its Phase III study of Tonmya (cyclobenzaprine HCl) would be stopped. 30 July 2018
Well-publicized cases involving children needing cannabis-based treatments to reduce their suffering have led the UK to change its stance on these medicines for patients with an exceptional clinical need. 30 July 2018