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
Top-line results show the primary efficacy endpoint was met in a Phase III clinical study (Study 342) conducted for submission in Japan, which evaluated antiepileptic drug (AED) Fycompa (perampanel) as monotherapy for partial-onset seizures. 28 November 2018
New York-based cell and gene therapy specialist Axovant Sciences has agreed a new strategic partnership with Yposkesi, a Contract Development & Manufacturing Organization (CDMO) specializing in gene therapy vector manufacturing. 28 November 2018
People with Alzheimer’s disease using strong opioids have twice the risk of hip fracture compared to non-opioid users, a new study from the University of Eastern Finland shows. 26 November 2018
The opioid use disorder market (OUD) is expected to experience solid growth over the next 10 years, expanding from $1.8 billion in 2017, to $4.8 billion in 2027 at a compound annual growth rate (CAGR) of 10.3%, says analyst. 26 November 2018
In the USA alone, more than 10% of adults or adolescents take antidepressants, and fully two-thirds of these people do not respond to first-line treatment, normally a selective serotonin reuptake inhibitor (SSRI) such as Zoloft (sertraline) or Celexa (citalopram). 26 November 2018
Swedish drugmaker Camurus (STO: CAMX) today said that the European Commission has granted marketing authorization for Buvidal (CAM2038), with news of the approval sending the firm’s shares soaring 9.38% to 89.80 Swedish kronor. 22 November 2018
Weeks after a US Food and Drug Administration (FDA) panel overwhelmingly voted in support of the benefit-risk profile of Sage Therapeutics’ Zulresso (brexanolone) in postpartum depression (PPD), the agency has delayed a decision on whether to approve it. 21 November 2018
Japanese drug major Astellas Pharma has announced the launch of the Astellas Global Health Foundation (AGHF), a new international philanthropic organization dedicated to improving access to health in underserved global communities. 21 November 2018
As expected, following a positive recommendation from its advisory panel in September, the European Medicines Agency has granted approval for Emgality (galcanezumab), in the treatment of migraines. 19 November 2018
Japanese pharma major Takeda Pharmaceutical has formed a drug discovery collaboration with Wales-based Cardiff University to identify new approaches for treating schizophrenia and other psychiatric disorders. 19 November 2018
Glenmark Pharmaceuticals has been granted final approval by the US Food and Drug Administration for teriflunomide tablets, 7mg and 14mg, a generic version of French pharma major Sanofi’s multiple sclerosis drug Aubagio. 16 November 2018
US drugmaker AbbVie has teamed up with a UK drug discovery and development company focused on selectively targeting deubiquitylating enzymes (DUBs). 15 November 2018
Generic drugmakers Actavis and Mylan have prevailed in a patent dispute against Warner-Lambert, part of the Pfizer group of companies. 14 November 2018
Although the glioblastoma (GBM) treatment market is small with many unmet needs, it is expected to grow from $662.0 million in 2017 to $1.4 billion in 2027 across the eight major markets (8MM) at a compound annual growth rate (CAGR) of 7.5%. 12 November 2018
The US Food and Drug Administration (FDA) has issued a complete response letter (CRL) to US biopharma Trevena in relation to the opioid painkiller, oliceridine. 5 November 2018
US biopharma Sage Therapeutics looks all but certain to secure US approval for Zulresso (brexanolone) in postpartum depression after Food and Drug Administration (FDA) advisory committees supported its benefit-risk profile by 17 votes to one. 5 November 2018