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
Axovant Sciences today announced that its chief executive Officer David Hung has resigned to pursue other opportunities and has also resigned from the company’s board of directors. 12 February 2018
The latest to join the ranks of failure in the search for a meaningful treatment for Alzheimer’s disease is Boehringer Ingelheim, which today announced that its Phase II Alzheimer’s disease trials with investigational compound BI 409306 had not met their efficacy endpoints. 9 February 2018
Biogen said yesterday it would halt development of Tysabri (natalizumab) as a potential treatment for ischemic stroke, on the back of weak Phase II data. 8 February 2018
FDA commissioner Scott Gottlieb issued a warning on Tuesday about the herbal remedy kratom, saying the latest scientific analyses provide strong evidence of the compounds’ opioid properties. 7 February 2018
In contrast to much of the stock market, Zogenix was looking for further gains rather than consolidation as trading progressed into the afternoon on Tuesday. 6 February 2018
Ireland-incorporated drugmaker Allergan was up 2% premarket on light volume in response to its announcement of positive results from a Phase III clinical trial, ACHIEVE I, evaluating ubrogepant in adult patients experiencing a single migraine attack. 6 February 2018
UCB and a syndicate of Belgian and international investors have founded a new firm, Syndesi Therapeutics, to be based at the Centre d’Entreprises et d’Innovation (CEI) in Louvain-la-Neuve, Belgium. 1 February 2018
Following the unanimous advice of Australia’s Advisory Committee on Medicines Scheduling in August 2015, an important change that will help save lives comes into effect today for medicines containing codeine, said Minister for Health Greg Hunt and chief medical officer Brendan Murphy in a joint statement. 1 February 2018
Japanese drugmaker Hisamitsu Pharmaceuticals, along with US subsidiary Noven Pharmaceuticals, say their transdermal patch for the treatment of schizophrenia (HP-3070, generic name: asenapine maleate) has achieved the primary endpoint of the Phase III clinical trial in the USA. 1 February 2018
The pRED research base of Switzerland’s Roche has scored an R&D win in the form of US FDA Breakthrough status for balovaptan for autism spectrum disorder (ASD). 30 January 2018
Sunovion Pharmaceuticals has revealed positive top-line data from its Phase III trial of Parkinson’s disease (PD) candidate APL-130277. 30 January 2018
Takeda Pharmaceutical and its co-development partner Zinfandel Pharmaceutical have announced that the Phase III TOMMORROW trial of pioglitazone has been brought to a premature end. 26 January 2018
Karyopharm Therapeutics is to sell its investigational oral SINE compound KPT-350 to fellow Massachusetts-based biotech firm Biogen in a deal worth up to $217 million. 25 January 2018
The US Food and Drug Administration (FDA) has issued a complete response letter (CRL) for the New Drug Application (NDA) for CAM2038, investigational buprenorphine weekly and monthly depot injections, for the treatment of adults with opioid use disorder (OUD), developed by Swedish drugmaker Camurus. 23 January 2018
Novartis late yesterday announced positive results from the Phase IIIb LIBERTY study assessing the efficacy and safety of erenumab (AMG 334) 140mg in patients with episodic migraine who had experienced two to four previous preventive treatment failures, due to lack of efficacy or intolerable side effects. 23 January 2018
Shares in neurological diseases specialist Acorda Therapeutics closed up nearly 9% on Friday following reports that a host of companies are interesting in taking over the US biotech. 22 January 2018
With the opioid abuse situation now spreading to many countries beyond the USA, Australia's medicines' regulator, the Therapeutic Goods Administration (TGA), has issued a discussion paper on the use and misuse of prescription strong opioids such as oxycodone and whether there is a need for specific regulatory responses. 22 January 2018
The UK BioIndustry Association (BIA) has been granted permission by the Supreme Court to intervene in its review of Warner-Lambert Company LLC v Generics (UK) Ltd and Actavis. 16 January 2018