US pharma giant Pfizer has won its first trial in the USA relating to claims that its antidepressant Zoloft (sertraline) caused birth defects. 20 April 2015
Privately-owned MedDay Pharma’s Phase III experimental drug MD1003 in patients with progressive multiple sclerosis met its primary endpoint. 20 April 2015
Japan’s Center for iPS Cell Research Application (CiRA) of Kyoto University looks set to earn as much as 20 billion yen (around $168 million) from the country’s largest drugmaker, Takeda Pharmaceutical. 19 April 2015
Switzerland-based Actelion says it is accelerating its clinical development efforts in the field of immunological disorders, following a broad scientific, medical and commercial evaluation of a series of its selective S1P1 receptor modulators, discovered in-house. 19 April 2015
Danish CNS specialist Lundbeck has entered into an exclusive worldwide license agreement with privately-held US biotech start-up Ovid Therapeutics for gaboxadol. 19 April 2015
USA-based Pacira Pharmaceuticals revealed that it has received a subpoena from the US Department of Justice, US Attorney’s Office for the District of New Jersey. 19 April 2015
The US Food and Drug Administration yesterday approved the first generic version of Israel-based Teva Pharmaceutical Industries’ Copaxone (glatiramer acetate injection), used to treat patients with relapsing forms of multiple sclerosis (MS). 17 April 2015
The first drugs to treat hearing conditions could be available by 2020, according to a new report launched today by charity Action on Hearing Loss (formerly RNID). 16 April 2015
The global market for Duchenne muscular dystrophy therapies will expand at a compound annual growth rate of 160.5%, according to research and consulting firm GlobalData. 15 April 2015
US biopharma company Lexicon Pharmaceuticals and partner pharma major Bristol-Myers Squibb have selected a development candidate for neuropathic pain as part of their neuroscience drug discovery and development alliance. 15 April 2015
US specialty drugmaker Depomed has entered into a settlement agreement with Actavis in patent infringement litigation related to Actavis' Abbreviated New Drug Application seeking approval to market generic versions of Depomed's Gralise (gabapentin). 13 April 2015
The European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) has completed a review confirming a small increase in the risk of cardiovascular problems, such as heart attacks and strokes, in patients taking high doses of ibuprofen. 13 April 2015
Neurotrope says that it had received Orphan Drug designation by the US Food and Drug Administration for its lead proprietary drug candidate, bryostatin, in the treatment of Fragile X syndrome (FXS). 10 April 2015
New Zealand’s Pharmaceuticals Management Agency PHARMAC will begin funding for the prostate cancer treatment abiraterone (Zytiga) from May 1, 2015, potentially benefiting up to 1,000 men annually. 9 April 2015
Mitochondrial and neuromuscular specialist Santhera has received Fast Track designation from the US Food and Drug Administration for Raxone/Catena (idebenone) for Duchenne muscular dystrophy. 9 April 2015
UK-based cannabinoid-focused pharma company GW Pharmaceuticals is entering an important phase of its business development, according to a report by investment analysts Edison. 8 April 2015
US drugmaker Perrigo says it has received final approval from the US Food and Drug Administration of its Abbreviated New Drug Application for hydromorphone HCI extended-release tablets.. 8 April 2015
Ireland-headquartered drugmaker Shire has reached an agreement with the US Food and Drug Administration on a clear regulatory path for SHP465 (triple-bead mixed amphetamine salts) for attention-deficit hyperactivity disorder (ADHD). 8 April 2015
Indian drug major Dr Reddy's Laboratories and its subsidiary, Promius Pharma, have filed three 505(b)(2) New Drug Applications with the US Food and Drug Administration. 8 April 2015
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