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
German family-owned drugmaker Grunenthal has entered into a collaboration with Chilean company Proteus SA and the USA-based Boston Children’s Hospital for neosaxitoxin, a novel anesthetic for local anesthesia and post-operative pain management. 13 June 2015
Pfizer has released disappointing top line results from a Phase III study which evaluated the efficacy, safety, and tolerability of Pristiq (desvenlafaxine succinate sustained-release formulation) in pediatric patients aged seven to 17 with major depressive disorder. 12 June 2015
Axovant Sciences, which is 80% owned by Bermuda-based privately-held Roivant Sciences, saw its shares nearly double in value after the dementia drug developer said its initial public offering raised $315 million, more than Axovant had expected. 12 June 2015
A state court jury in the USA has ruled that pharma giant Pfizer was not responsible for the birth defects in a child whose mother used Zoloft (sertraline) during pregnancy. 12 June 2015
In draft guidance issued today for consultation, the UK Institute for Health can care Excellence (NICE) has asked Danish CNS drug specialist Lundbeck to provide more information about its drug vortioxetine (trade name Brintellix) for treating major depressive episodes in adults. 10 June 2015
Israel-headquartered generics giant Teva Pharmaceutical Industries had a busy day yesterday, when it announced the launch of two products in the USA. 3 June 2015
The US Federal Trade Commission has reached a settlement resolving its antitrust suit charging Cephalon with illegally blocking generic competition to its blockbuster sleep-disorder drug Provigil (modafinil). 29 May 2015
The US Court of Appeals for the Federal Circuit has upheld the District Court of Delaware’s earlier ruling on Par Pharmaceuticals’ generic of Exelon (rivastigmine transdermal system), manufactured by Novartis. 27 May 2015
Data for once-daily, anti-epileptic drug Zebinix (eslicarbazepine acetate) from Japanese drug major Eisai shows it to be effective and well tolerated in elderly people with partial onset seizures (POS). 26 May 2015
Otonomy has announced disappointing top-line results from its Phase IIb trial evaluating OTO-104 in patients with unilateral Ménière's disease. 26 May 2015
High blood-glucose levels could be linked to the risk of Alzheimer’s disease and other forms of dementia, according to two recently-published studies. 26 May 2015
A panel of the US Court of Appeals for the Second Circuit has issued a ruling upholding a December 15, 2014, preliminary injunction requiring Ireland-headquartered generics major Actavis to continue distribution of its Alzheimer’s disease drug Namenda (memantine HCl) immediate-release tablets. 25 May 2015
The benefit assessment by Germany's Federal Joint Committee (G-BA) indicated that US biotech firm PTC Therapeutics’ Translarna (ataluren) provided a benefit for ambulatory patients aged five years and older with nonsense mutation Duchenne muscular dystrophy (nmDMD). 22 May 2015
Since early last year, Australia’s Therapeutic Goods Administration (TGA) has been monitoring reports of melanoma in patients being treated with natalizumab and encouraged consumers and health professionals to report all such cases. 21 May 2015
The US Food and Drug Administration has approved the New Drug Application for atypical antipsychotic Invega Trinza (paliperidone palmitate) from Johnson & Johnson subsidiary Janssen Pharmaceuticals under priority review for schizophrenia. 20 May 2015
The US Food and Drug Administration has approved Pernix Therapeutics’ Treximet (sumatriptan and naproxen sodium) for use in pediatric patients 12 years of age and older for the acute treatment of migraine with or without aura. 16 May 2015
US biotech major Amgen has released the first results from its global Phase II, double-blind, placebo-controlled study evaluating the efficacy and safety of AMG 334 for the prevention of episodic migraine. 15 May 2015
CNS specialist Zambon and its partner, fellow Italy-based Newron Pharmaceuticals have announced the launch of Xadago (safinamide) in Germany for the treatment of mid- to late-stage Parkinson’s disease (PD). 15 May 2015
The treatment market value for fibromyalgia across the seven major markets (7MM) of the USA, France, Germany, Italy, Spain, the UK and Japan, will expand from $1.8 billion in 2013 at a tepid compound annual growth rate (CAGR) of 0.72% to reach $1.9 billion by 2023. 14 May 2015