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
Australia-based Prana Biotechnology has announced positive results of its Reach2HD Phase II clinical trial investigating PBT2 as a treatment for Huntington disease. 18 February 2014
MedImmune, the global biologics research and development arm of Anglo-Swedish drug major AstraZeneca, has entered into a three-year collaboration with the Clinical and Translational Science Institute at the University of California, San Francisco. 17 February 2014
New Zealand’s Pharmaceutical Management Agency PHARMAC is seeking feedback on a proposal to fund paliperidone depot injection (Invega Sustenna) from May 1, 2014, in conjunction with a price decrease on risperidone depot injection (Risperdal Consta), both through a provisional agreement with Janssen-Cilag Pty, a local unit of US health care giant Johnson & Johnson. 14 February 2014
US biotech firm GenVec says it has achieved the third milestone in its collaboration with Swiss drug major Novartis for the development of treatments for hearing and balance disorders. 13 February 2014
The US Food and Drug Administration’s joint Arthritis Advisory Committee and Drug Safety and Risk Management Advisory Committee was split on whether the data show adequate differences in cardiovascular risk among non-steroidal anti-inflammatory drugs to support labeling change for NSAIDs due to cardiovascular risk. 12 February 2014
The US Department of Justice is investigating Israel drugmaker Teva Pharmaceutical Industries’ marketing and sales practices for Parkinson’s disease drug Azilect (rasagiline) and its blockbuster multiple sclerosis drug Copaxone (glatiramer acetate), the company has revealed in a filing with the US Securities and Exchange Commission. 11 February 2014
Japanese drugmaker Hisamitsu Pharmaceutical’s has announced the results of a Phase II clinical study for a transdermal drug for the treatment of Parkinson’s disease in Japan 10 February 2014
Approval for the generic version of Eli Lilly’s Cymbalta duloxetine by the US health regulator (The Pharma Letter December 12, 2013) has come as a shot in the arm for Indian drug majors, who have been waiting for India to pass the Mental Healthcare Bill, reports TPL’s Indian correspondent. 10 February 2014
Shares of Ireland-headquartered Shire fell 2.4% to £30.67 in early trading, after the company presented disappointing top-line results from two pivotal Phase III investigational studies evaluating the efficacy and safety of Vyvanse (lisdexamfetamine dimesylate) capsules (CII) versus placebo as an adjunctive treatment for major depressive disorder (MDD) in adults who inadequately responded to antidepressant monotherapy with a SSRI or SNRI. 7 February 2014
Shares of UK-based cannabis-based drug developer GW Pharmaceuticals fell 3,9% to 287.39 pence this morning, after it announced financial results for its first fiscal quarter ended December 31, 2013, posting a net loss of £2.8 million ($4.7 million) compared to a profit after tax of £2.1 million for the like 2012 period. 5 February 2014
US biotech firm Amarantus Bioscience has released positive clinical data for eltoprazine in a Phase IIa clinical study for adult attention deficit hyperactivity disorder (ADHD). 4 February 2014
US biotech firm Biogen Idec’s Tecfidera (dimethyl fumarate) has been approved by the European Commission for relapsing-remitting multiple sclerosis, the most common form of multiple sclerosis. 3 February 2014
Privately-held Spanish drugmaker Ferrer has executed two agreements, one with South Korea’s Ildong Pharmaceuticals and the other with Ergomed Clinical Research of the UK to support further clinical studies of lorediplon in patients with insomnia. 3 February 2014
The US Food and Drug Administration on Friday approved US drugmaker Vanda Pharmaceutical's Hetlioz (tasimelteon), a melatonin receptor agonist, to treat non-24- hour sleep-wake disorder (“non-24”) in totally blind individuals. 3 February 2014
US drugmaker Forest Laboratories, together with Merz Pharma and Adamas Pharmaceuticals, has filed a law suit for infringement of patents related to its dementia and Alzheimer’s disease drug Namenda XR (memantine). 2 February 2014
Privately-held US company Edison Pharmaceuticals has entered into a new strategic alliance valued up to $4.295 billion with Japanese drug major Dainippon Sumitomo Pharma for the development of drugs targeting cellular energy metabolism. 31 January 2014
US drugmaker Avanir Pharmaceuticals has submitted a New Drug Application to the US Food and Drug Administration for approval of AVP-825, its Breath Powered investigational drug-device combination product for the acute treatment of migraine. 30 January 2014
Belgian drugmaker UCB and US biotech firm Biogen Idec have signed exclusive agreements granting UCB the right to commercialize Biogen Idec products in South Korea, Hong Kong, Thailand, Singapore, Malaysia and Taiwan, and both develop and commercialize products in China. 30 January 2014
Israel’s Teva Pharmaceutical Industries says that the US Food and Drug Administration has approved its supplemental New Drug Application for three-times-a-week Copaxone (glatiramer acetate) 40mg/mL, a new dose of its best-selling multiple sclerosis drug. 29 January 2014
Danish CNS drug specialist Lundbeck (LUND: CO) and Japanese drug maker Otsuka (TYO: 4768) have revealed positive top-line Phase III trial data on the investigational compound brexpiprazole. 24 January 2014