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
Eisai has announced signing a cooperation agreement with Pharmstandard, a leading Russian pharmaceutical company, relating to the localized production of Eisai products in Russia. 7 April 2016
Highland Therapeutics has announced positive clinical data from the first of two Phase III pivotal trials of a next-generation methylphenidate called Benjorna under development as the first attention deficit hyperactivity disorder (ADHD) formulation designed for dosing before bedtime. 6 April 2016
US drugmaker Endo International saw its shares fall 6.7% to $26.54 in early trading on Thursday, after the USA’s competition regulator sued the company for violating antitrust regulations. 31 March 2016
The benefits of using Nuplazid (pimavanserin) for psychosis associated with Parkinson’s disease outweigh the risks, according to a vote of the US Food and Drug Administration Psychopharmacologic Drugs Advisory Committee. 30 March 2016
The US Food and Drug Administration has issued a complete response letter (CRL) for the supplemental new drug application (sNDA) to include new data in the clinical trials section of the US label of Brintellix (vortioxetine) for treating certain aspects of cognitive dysfunction in adults with major depressive disorder (MDD). 30 March 2016
Italian CNS-focused drug developer Newron Pharmaceuticals and its partners Zambon and US WorldMeds have received a complete response letter from the US Food and Drug Administration relating to their Parkinson’s disease treatment Xadago (safinamide). 30 March 2016
The substance abuse treatment pipeline is dominated by therapies for nicotine and alcohol addiction, with the 34 and 32 products in respective active development combining to produce over 50% of the total pipeline. 30 March 2016
Today, US President Barack Obama joins individuals in recovery, family members, medical professionals, law enforcement officials and other leaders at the National Rx Drug Abuse and Heroin Summit in Atlanta, Georgia. 29 March 2016
US biopharma company XenoPort has entered into a license agreement under which Indian drug major Dr Reddy’s Laboratories will be granted exclusive US rights for the development and commercialization of XenoPort’s clinical-stage oral new chemical entity, XP23829. 29 March 2016
More young people than ever are taking drugs for depression in the developed world but recent studies have come up with some disturbing findings that cast a dark shadow over their use. 29 March 2016
Privately-held US drug developer FORUM Pharmaceuticals has released disappointing top-line results from two Phase III clinical trials in patients with cognitive impairment in schizophrenia (CIS). 26 March 2016
Commonly-used anti-depressants known as selective serotonin reuptake inhibitors (SSRIs) do not increase the risk of cardiovascular conditions among young and middle-aged people, a new study has revealed. 24 March 2016
Geropharm, one of Russia’s largest drugmakers, has signed an agreement with VTB, Russia’s leading state-owned bank, on the provision of a loan for the building of a new pharmaceutical plant in Russia, which is expected to be one of the largest in the country. 23 March 2016
In a continuing effort to educate prescribers and patients about the potential risks related to opioid use, the US Food and Drug Administration yesterday announced required class-wide safety labeling changes for immediate-release (IR) opioid pain medications. 23 March 2016
The Asia-Pacific (APAC) Alzheimer’s disease market will grow from $3 billion in 2014 to $5.1 billion in 2021, representing a robust compound annual growth rate (CAGR) of 7.9%, new research indicates. 23 March 2016
The US subsidiary of Japanese pharma major Eisai has agreed to revise the joint promotion agreement with Switzerland’s Helsinn Healthcare for their chemotherapy-induced nausea and vomiting (CINV) franchise. 22 March 2016
Ember Therapeutics, a New York-based pharmaceutical company developing targeted therapies for osteoarthritis, kidney fibrosis and other regenerative medicines, has entered into a definitive agreement for the acquisition of Migralex. 22 March 2016
UK specialty drugmaker Martindale Pharma has announced the re-launch of its methadone oral solution product in Scandinavia via its strategic partner Unimedic AB. 21 March 2016