Ireland-headquartered generics major Actavis is filing an emergency appeal to the US Court of Appeals for the Second Circuit to overturn a ruling that it must discontinue distribution of Namenda (memantine HCl). 16 December 2014
Ireland-headquartered generic drugmaker Actavis confirmed that Judge Robert Sweet of the US District Court for the Southern District of New York (New York City) has announced an intent to issue a preliminary injunction apparently requiring the company to continue distribution of Namenda (memantine HCl) immediate-release tablets. 12 December 2014
The Alzheimer's Drug Discovery Foundation (ADDF) and the Alzheimer's Society UK announced new funding to explore the possibility of using a commonly prescribed drug which treats erectile dysfunction as the next treatment for dementia. 12 December 2014
Alzheimer’s Research UK, the country’s leading dementia research charity, has launched a global clinical trials fund to fast-track research into new dementia treatments. 12 December 2014
The US Food and Drug Administration is warning that the antipsychotic drug ziprasidone (marketed under the brand name Geodon by pharma giant Pfizer, and its generics) is associated with a rare but serious skin reaction that can progress to affect other parts of the body. 11 December 2014
Pharmaceutical companies will suffer an estimated $65 billion drop in sales by 2019 due to the patent expiries of several leading drugs, new research shows. 11 December 2014
Ireland-headquartered drugmaker Shire has achieved positive results in a Phase III trial of guanfacine hydrochloride extended release (GXR) in attention-deficit/hyperactivity disorder in children and adolescents. 10 December 2014
Japanese drug maker Otsuka and Danish CNS specialist Lundbeck have announced Phase III study results evaluating the efficacy of investigational compound brexpiprazole as adjunctive treatment to antidepressant therapy (ADT) in patients with major depressive disorder (MDD). 10 December 2014
US drugmaker Supernus Pharmaceuticals says that it has received a Paragraph IV Notice Letter from privately-held generic drugmaker Par Pharmaceutical advising Supernus of the filing by Par of an Abbreviated New Drug Application seeking approval for topiramate extended-release capsules. 9 December 2014
Positive primary efficacy and safety data from the latest Phase III study evaluating Belgian drugmaker UCB‘s brivaracetam (fixed doses of 100 and 200mg/day with no up-titration) as adjunctive treatment in adult epilepsy patients with partial-onset seizures were presented at the 68th Annual Meeting of the American Epilepsy Society in Seattle. 8 December 2014
The US Food and Drug Administration approved the labeling update of Abilify Maintena (aripiprazole) for extended-release injectable suspension. The drug is marketed by Danish CNS drug specialist Lundbeck and Japanese drugmaker Otsuka Pharmaceutical. 8 December 2014
The US subsidiary of Swedish drug developer Orexo says that, in the ISTART Phase III study, Zubsolv (buprenorphine and naloxone) sublingual tablet (CIII) demonstrated comparable patient retention in treatment at day 15 versus Suboxone film (Reckitt Benckiser’s buprenorphine and naloxone brand). 7 December 2014
Credit Suisse has released a biotech research report from analysts Jason Kantor and Jeremiah Shepard that has their top picks for upside potential in the biotech segment for 2015. 5 December 2014
The current pipeline of treatments for Parkinson’s disease is a site of great innovation, with 37% of 302 products holding first-in-class status, according to business intelligence provider GBI Research. 5 December 2014
The German Institute for Quality and Efficiency in Health Care (IQWiG) examined in a dossier assessment whether Danish CNS specialist Lundbeck’s Selincro (nalmefene) offers an added benefit over the appropriate comparator therapy for people with alcohol dependence, drawing a negative conclusion. 4 December 2014
US biotech firm Biogen Idec has said that it will pursue a Phase III program for its Alzheimer’s disease drug BIIB037 following a successful Phase Ib trial. 3 December 2014
Switzerland-based drug developer GeNeuro has entered into a strategic partnership with French independent pharma company Servier, worth a potential $455 million, to develop and market GNbAC1 in multiple sclerosis (MS). 3 December 2014
The UK prime minister David Cameron is to announce a £15 million ($24 million) commitment to a new fund to boost dementia research in the Autumn Statement, which will be made tomorrow. 2 December 2014
US drug major Eli Lilly and AstraZeneca have enrolled the first patient into AMARANTH, a Phase II/III study of an oral beta secretase cleaving enzyme inhibitor being developed to treat Alzheimer’s disease. 2 December 2014
The US subsidiary of Japanese drug maker Otsuka has acquired US CNS specialist Avanir Pharmaceuticals for $3.5 billion in an all-cash tender offer. 2 December 2014
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