After US biotech major Biogen scrapped development of its experimental Alzheimer’s drug aducanumab in March last year, but resuming development in October, the company has now announced an agreement to acquire an early-stage central nervous system (CNS) candidate from Pfizer. 13 January 2020
A group of three new treatments for acute migraine have been assessed by the Institute for Clinical and Economic Review (ICER) to deem what a fair US price for these yet-to-be-launched medicines might look like. 13 January 2020
The US Department of Justice (DoJ) revealed on Friday that it has obtained more than $3 billion in settlements and judgments from civil cases involving fraud and false claims against the government in the fiscal year ending September 30, 2019. 11 January 2020
California’s Neurocrine Biosciences and Swiss firm Idorsia (SIX: IDIA) have amended a 2019 deal related to the investigational epilepsy drug ACT-709478. 10 January 2020
China's National Medical Products Administration (NMPA) has recently approved Shanghai Green Valley Pharmaceuticals’ brown algae-extracted drug – oligomannate (GV-971) – for mild to moderate Alzheimer's disease. 9 January 2020
Family-controlled Spanish pharma company Esteve today announced the signing of an agreement to acquire 100% of the shares of specialty pharmaceutical company Riemser Pharma from Ardian, a leading independent investment company. 8 January 2020
CNS specialist AlzeCure Pharma has exclusively in-licensed a vanilloid receptor subtype 1 (VR1) project targeting neuropathic pain from fellow Swedish company Acturum Life. 7 January 2020
Japanese mid-sized drugmaker Kyowa Kirin today said its marketing authorization application (MAA) for istradefylline (KW-6002) as an adjunctive treatment to levodopa-based regimens in adult patients with Parkinson’s disease (PD) experiencing “OFF” time, has been validated by the European Medicines Agency (EMA) and is now under review. 6 January 2020
US biotech Axsome Therapeutics is set to close 2019 with a share price worth around 40 times more than its value at the start of the year. 30 December 2019
Japanese pharma major Eisai on Friday announced that JAMA Network Open (www.jamanetwork.com) published results of SUNRISE 1 (Study 304), a pivotal Phase III head-to-head study that compared its just US-approved Dayvigo (lemborexant) to placebo and an active comparator in patients with insomnia disorder that showed the therapy significantly improved both sleep onset and sleep maintenance compared with placebo. 30 December 2019
The US Food and Drug Administration yesterday approved Ubrelvy (ubrogepant) tablets for the acute (immediate) treatment of migraine with or without aura (a sensory phenomenon or visual disturbance) in adults. 24 December 2019
The US Food and Drug Administration has approved the New Drug Application (NDA) for the orexin receptor antagonist Dayvigo (lemborexant), ahead of the Prescription Drug User Fee Act (PDUFA) date set for December 27, 2019. 23 December 2019
US RNA-targeted drug developer Ionis Pharmaceuticals yesterday revealed that Biogen, a collaboration partner for neurological diseases, has licensed IONIS-MAPTRx, an antisense therapy designed to selectively reduce production of microtubule-associated protein tau (MAPT), or tau, in the central nervous system. 20 December 2019
Minerva Neurosciences yesterday announced disappointing Phase IIb trial of MIN-117 in adult patients suffering from moderate to severe major depressive disorder (MDD) and presenting with symptoms of anxious distress failed to meet its primary and key secondary endpoints. 19 December 2019
Californian company Adamas Pharmaceuticals closed 43% down after Tuesday’s trading, despite the firm announcing that a Phase III trial had met its primary endpoint. 18 December 2019
Sweden’s BioArctic has initiated a research collaboration with Japan Eisai (TYO: 4523) aimed at further studying the unique profile of the investigational drug candidate BAN2401. 17 December 2019
USA-based genetics medicines developer Wave Life Sciences saw its shares crash more than 55% to $26.79 by close of trading Monday, after announcing the discontinuation of two trials in Duchenne muscular dystrophy (DMD). 17 December 2019
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