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 drug major Shionogi has entered into a collaborations and licensing agreement with US biotech firm Egalet Corp for the development and potential commercialization of multiple oral abuse-deterrent hydrocodone opioid product candidates using Egalet’s proprietary technology. 28 November 2013
German pharma and chemicals firm Merck KGaA says it is increasingly counting on partnerships with Israeli biotech companies, as demonstrated by its cooperation with Metabomed and ChanBio, both of which have today joined the Merck Serono Israel Bioincubator. 26 November 2013
Israel’s Teva Pharmaceutical Industries, the world’s largest generic drugmaker, this morning strongly denied a report by The Marker claiming that profits from its brand-named multiple sclerosis treatment Copaxone (glatiramer acetate) will drop by 42% in 2014. 25 November 2013
New research cannot establish a close connection between the use of antidepressant medication - the so-called SSRIs - during the course of pregnancy and the risk of having a child with autism, reports EurekAlert, quoting a study published in the journal Clinical Epidemiology. 25 November 2013
US biotech company Biogen Idec saw its shares leap 10% to an all-time high of nearly $278 on Friday, as the company received positive news regarding its long fight to gain market exclusivity in Europe for its new multiple sclerosis drug Tecfidera (BG-12; dimethyl fumarate). 25 November 2013
The US Food and Drug Administration has issued a complete response letter regarding the New Drug Application for cariprazine, submitted by USA-based Forest Laboratories and Hungary’s largest drugmaker Gedeon Richter. 21 November 2013
US clinical-stage biotech firm Aphios says it has spun-off a subsidiary, Amylon, to finance, develop and commercialize APH-1104 for mild to moderate Alzheimer’s disease and other CNS disorders, for which it says patents are pending. 21 November 2013
Japan’s Otsuka Pharmaceutical (TYO: 4768) and partner Lundbeck (LUN: CO) have received approval from the European Commission for their Abilify Maintena (aripiprazole), an intramuscular once-monthly injectable formulation for maintenance treatment of schizophrenia in adult patients stabilized with oral aripiprazole. 21 November 2013
US generics major Mylan has launched dexmethylphenidate hydrochloride extended-release (ER) capsules, 30mg, which is the first generic version of Swiss pharma giant Novartis' Focalin XR. 18 November 2013
In what is seen as an exception to conventional international rulings, the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) has issued new guidance to prescribers, pharmacists and patients in relation to anti-epileptic drugs (AEDs). 18 November 2013
The US District Court for the District of Delaware has ruled in favor of Cadence Pharmaceuticals in the company's patent infringement law suit against Exela Pharma Sciences relating to its Ofirmev (acetaminophen) Injectable, a drug used for the management of mild-to-moderate pain. 17 November 2013
French drug discovery company Oncodesign has entered into a research collaboration and exclusive license option with Belgian drugmaker UCB (Euronext Brussels: UCB). 13 November 2013
US biotech firm Zalicus saw its shares plunge 71.5% in early trading, after the company revealed announced top-line results from two Phase II clinical studies of Z160 in chronic pain indications. 11 November 2013
Due to the growth of the elderly population worldwide, the number of post-herpetic neuralgia (PHN) incident cases in the seven major markets (7MM) will increase by 20.22% over the next decade, from 241,808 cases in 2012 to 290,684 in 2022, forecasts research and consulting firm GlobalData. 11 November 2013
The US Food and Drug Administration on Friday approved Sunovion Pharmaceutical’s (a subsidiary of Japanese drug major Dainippon Sumitomo) Aptiom (eslicarbazepine acetate) as an add-on medication to treat seizures associated with epilepsy. 9 November 2013
US drug major Bristol-Myers Squibb says it is “evolving its strategic focus in R&D to ensure continued leadership in delivering innovative medicines for patients with serious disease,” dropping new research in the areas of diabetes, hepatitis C and neuroscience. 8 November 2013
Danish CNS drug specialist Lundbeck has reported revenues of 11.67 billion Danish kroner ($2.11 billion) for the first nine months of 2013, up 7% from 10.96 billion kroner in the same period in 2012, with new product sales rising 41%. 6 November 2013
The loss of US and European market exclusivity of three sales-leading neuropathic pain (NP) agents - combined with a lack of transformative emerging therapies forecast to launch specifically for NP, will contribute to a slight market decline during the 2012-2022 study period. 5 November 2013
Gabapentin, already widely prescribed for epilepsy and pain, appears to be safe and effective in the treatment of alcohol dependence, studies have found. 5 November 2013
Japanese drug major Eisai says it has filed an application for its already marketed anti-Alzheimer's drug Aricept (donepezil hydrochloride) in Japan, requesting a new indication expansion to use the agent in the treatment of dementia with Lewy bodies. 1 November 2013