The US Food and Drug Administration yesterday approved the first generic versions of drug major Eli Lilly’s antidepressant Cymbalta (duloxetine delayed-release capsules). 12 December 2013
Danish CNS specialist Lundbeck and Japanese drugmaker Otsuka Pharmaceutical say they will further expand their collaboration to include the development of Lu AF20513, an investigational vaccine candidate against Alzheimer's disease. 11 December 2013
The UK has today announced a new £3 million ($4.9 million) Dementia Consortium bringing together research experts from the charitable, academic and private sectors to expedite development of new drugs for dementia. 11 December 2013
The European Commission has imposed fines of 10.8 million euros ($14.8 million) on the US health care giant Johnson & Johnson and 5.5 million euros on Swiss drug major Novartis over pay-for-delay deal. 11 December 2013
Israel’s Teva Pharmaceutical Industries is itself bracing for competition from copies to its best-selling multiple sclerosis drug Copaxone, yesterday providing its current outlook for financial performance for 2014. 11 December 2013
Danish CNS specialist Lundbeck has released results from FOCUS, a new study showing that Brintellix (vortioxetine) met its primary endpoint in demonstrating superiority over placebo in a composite score of two tests, the Digit Symbol Substitution Test (DSST) and Rey Auditory Verbal Learning Test (RAVLT), that measure cognitive function in adults with major depression. 11 December 2013
The development program for MK-8931, a novel investigational oral beta-amyloid precursor protein site-cleaving enzyme (BACE) inhibitor from US pharma giant Merck & Co is set to continue as planned. 10 December 2013
US drug developer Proteostasis Therapeutics has entered into a worldwide collaboration with biotech major Biogen Idec to research and develop therapeutic candidates based on the inhibition of Usp14. 10 December 2013
Italian drug developer Newron Pharmaceuticals and its partner, family-owned Italian drugmaker Zambon have filed Marketing Authorization Application for safinamide with the European Medicines Agency. 9 December 2013
In final draft guidance issued on Friday, the UK drugs watchdog the National Institute for Health and Care Excellence (NICE) has recommended the use of French drug major Sanofi subsidiary Genzyme’s multiple sclerosis drug Aubagio (teriflunomide) for National Health Service use. 8 December 2013
Use of Allergan’s Botox (botulinum toxin type A) for the prophylactic treatment of chronic migraine will increase modestly in the major pharmaceutical markets (USA, France, Germany, Italy, Spain, the UK and Japan) through 2022, despite lingering clinical and market access hurdles. 6 December 2013
Given that results from three late-stage studies of edivoxetine did not meet the primary study objective of superior efficacy in depression after eight weeks therapy, US drug major Eli Lilly says it will not proceed with development of the drug as adjunctive treatment for major depressive disorder (MDD). 6 December 2013
Revealing an earlier agreement yesterday, Israel’s Teva Pharmaceutical Industries and Japan’s largest drugmaker Takeda Pharmaceutical says that they are now working on further deals relating to the licensing of rights to Takeda to commercialize Teva’s glatiramer acetate (the active ingredient of blockbuster multiple sclerosis drug Copaxone) in Japan. 5 December 2013
Best known as the world’s biggest generic drugmaker, Israel’s Teva Pharmaceutical Industries yesterday announced that 15 new projects have entered its development pipeline from its New Therapeutic Entities (NTE) program. 5 December 2013
UK drugs watchdog the National Institute for Health and Care Excellence (NICE) is calling on Genzyme, the biotech subsidiary of French drug major, to provide more information on its multiple sclerosis drug Lemtrada (alemtuzumab). 5 December 2013
The US Food and Drug Administration is warning the public that the anti-seizure drug Onfi (clobazam) can cause rare but serious skin reactions that can result in permanent harm and death. The drug was launched in the USA in late 2011 by Danish CNS drug specialist Lundbeck. 4 December 2013
UK drugmaker Shire says that its subsidiary Shire US Inc has entered into an agreement to supply an authorized generic version of its product Adderall XR (mixed amphetamine salts) with Sandoz. 3 December 2013
US drugmaker Forest Laboratories is acquiring exclusive rights in the USA for Saphris (asenapine) sublingual tablets, a treatment for adult patients with schizophrenia or acute bipolar mania, from pharma giant Merck & Co. 2 December 2013
New Zealand’s Pharmaceutical Management Agency PHARMAC is seeking feedback on the following proposals on access to certain drugs, all with a proposed implementation date of February 1, 2014: 2 December 2013
US health care giant Johnson & Johnson’s (NYSE: JNJ) Europe-based subsidiary Janssen Pharmaceutica has presented new data on the company’s schizophrenia drug Xeplion (paliperidone palmitate), showing that earlier treatment can play a substantial role in improving outcomes in people with schizophrenia. 30 November 2013
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