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
UK-based C4X Discovery Holdings saw its shares climb 4.55% to 52.80 pence, after announcing a collaboration with PhoreMost, a UK-based biopharmaceutical company dedicated to drugging ‘undruggable’ disease targets. 25 June 2019
The Institute for Clinical and Economic Review (ICER) has issued a report into the cost effectiveness of Johnson & Johnson’s novel depression therapy Spravato (esketamine). 21 June 2019
The US Food and Drug Administration (FDA) has issued a new draft guidance on its assessment of the benefit-risk of opioid pain medications amid the addiction crisis in the USA. 21 June 2019
The US cost-effectiveness group Institute for Clinical and Economic Review (ICER) yesterday released a Final Evidence Report assessing the comparative clinical effectiveness and value of Swiss pharma giant Novartis’ Mayzent (siponimod) for the treatment of secondary progressive multiple sclerosis (SPMS). 21 June 2019
US gene therapy company Axovant Sciences has signed a strategic partnership with Yposkesi, a French contract development and manufacturing organization (CDMO). 20 June 2019
The UK’s Competition and Markets Authority (CMA) has accused competitors King and Auden Mckenzie of sharing out between them the supply of nortriptyline to a large pharmaceutical wholesaler. 20 June 2019
Shionogi has announced the approval for Intuniv (guanfacine hydrochloride) for the treatment of attention deficit hyperactivity disorder (ADHD) with an additional indication in adult patients in its domestic market. 18 June 2019
An Expert View on a burgeoning area that should tempt life science investors and professionals to leave their prejudice behind and take a closer look, from Jeannette VanderMarel, co-founder of The Green Organic Dutchman, the world’s largest organic cannabis producer, and chief executive of 48North Cannabis. 15 June 2019
A key milestone has been reached in the launch of the recently-approved postpartum depression (PPD) therapy Zulresso (brexanolone), as the Drug Enforcement Administration (DEA) has listed the product on “Schedule IV” of the Controlled Substances Act. 14 June 2019
In the latest sign that the consumption of cannabis for medicinal purposes is being legitimized, the Church of England has reversed its previous policy of refusing to invest in schemes seeking to profit from the drug’s use. 11 June 2019
Portugal’s Bial and Japan-based licensee Eisai have announced new clinical practice data from the Euro-Esli study of Zebinix (eslicarbazepine acetate). 7 June 2019
UK-incorporated specialty pharma firm Mallinckrodt says it has “reached an agreement in principle” with the US Department of Justice (DOJ) to pay $15.4 million relating to allegations of kickbacks. 6 June 2019
Opioid manufacturer Insys Therapeutics has agreed to a global resolution to settle the government’s separate criminal and civil investigations, the Department of Justice announced today. 6 June 2019
The US Food and Drug Administration has approved Emgality (galcanezumab-gnlm) solution for injection for the treatment of episodic cluster headache in adults. 5 June 2019
Clinical trial results reveal that a medication used to treat Alzheimer’s disease may also be an effective therapy for individuals addicted to opioids. The findings are published in The American Journal on Addictions. 5 June 2019
Mitsubishi Tanabe Pharma announced today the withdrawal of the Marketing Authorization Application (MAA) of Radicava (edaravone) for the treatment of amyotrophic lateral sclerosis (ALS) in the European Union (EU). 30 May 2019
Juvenescence, a privately-held investment firm with a focus on increasing healthy human longevity, has announced the creation of a new biotech company to target the epigenetic underpinnings of neurodegeneration. 29 May 2019
The US Food and Drug Administration has approved a supplemental New Drug Application (sNDA) for Vraylar (cariprazine) for expanded use to treat depressive episodes associated with bipolar I disorder (bipolar depression) in adults. 29 May 2019
US pharma major has signed a licensing agreement to acquire the exclusive worldwide rights for CNTX-0290 from privately-held US pain specialist Centrexion Therapeutics Corporation. 28 May 2019