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
The European Federation of Pharmaceutical Industries and Associations (EFPIA) has come out in support of the Danish company, saying it regrets the General Court (GC) of the European Union’s decision to uphold the European Commission’s classification of the Lundbeck patent settlement agreements as restrictions of competition “by object” thereby judging them to be unlawful. 9 September 2016
The General Court of the European Union has upheld a 2013 decision to fine the Danish central nervous system specialist Lundbeck for violating competition law over its anti-depressant drug Cipramil (citalopram). 8 September 2016
Biogen is preparing to present research collected from more than 16,000 multiple sclerosis (MS) patients across Europe, the largest study to capture the widespread impact of the disease. 8 September 2016
US biotech firm AnTolRx has signed a Series A funding agreement with pharma giant Pfizer, Orion Equity Partners and JDRF, the leading global organization funding type 1 diabetes (T1D) research. 8 September 2016
Tonix Pharmaceuticals has announced preliminary top-line AFFIRM Phase III trial results, showing that its TNX-102 SL (cyclobenzaprine HCl sublingual tablets) in patients with fibromyalgia has failed to achieve its goals. 7 September 2016
US pharma giant Pfizer said today that Dr Ole Isacson, a world-renowned scientist and thought leader in neurology, will become chief scientific officer of the Neuroscience Research unit and senior vice president, effective September 16. 7 September 2016
The US Food and Drug Administration has granted Breakthrough Therapy designation to SAGE-547 for the treatment of postpartum depression (PPD) from US clinical-stage biotech Sage Therapeutics. 7 September 2016
The market for attention deficit hyperactivity disorder (ADHD) across the seven major markets (7MM) of the US, France, Germany, Italy, Spain, the UK, and Japan, is set to experience an increase from around $6.1 billion in 2014 to $13.9 billion by 2024, at a compound annual growth rate of 8.5%. 7 September 2016
Despite government reassurances that British businesses and universities will have certainty over future research funding in the face of Brexit, concerns are coming forward that cessation of European Union funding – particularly under the Horizon 2020 scheme - will impact R&D activities in the UK. 6 September 2016
Alvogen said today it has launched Remurel (glatiramer acetate), the first generic equivalent of Copaxone, Teva Pharmaceutical Industries’ blockbuster multiple sclerosis drug, in Central and Eastern Europe. 5 September 2016
The US Food and Drug Administration has granted Fast Track designation for biotech major Biogen’s aducanumab, its investigational treatment for early Alzheimer’s disease (AD). 2 September 2016
Netherlands-incorporated Mylan has received another boost in its aim to market a generic version of Teva Pharmaceutical Industries' multiple sclerosis (MS) treatment Copaxone (glatiramer acetate) 40 mg/mL. 2 September 2016
Canada is experiencing a growing number of opioid overdoses and deaths across the country, and days such as the International Overdose Awareness Day are bringing needed attention to this crisis. 1 September 2016
Sunovion Pharmaceuticals, a US subsidiary of Japanese pharma company Sumitomo Dainippon, has signed a definitive agreement to acquire Canadian drugmaker Cynapsus Therapeutics. 1 September 2016
Amidst concerns about death and overdose risks from narcotic painkillers taken with certain antianxiety or sedative drugs, the US Food and Drug Administration has issued a strong “Boxed Warning” of combination usage. 1 September 2016
Ireland-incorporated Allergan and its partner Adamas Pharmaceuticals have come to a settlement with privately-held US generics drugmaker Amneal Pharmaceuticals over a copy of Alzheimer’s disease drug Namzaric (memantine and donepezil hydrochloride). 31 August 2016
Bernstein analyst Tim Anderson and team wonder if Pfizer winning the bidding war for Medivation with its $14 billion offer (announced last Monday) is “something to be proud of,” reported Barron’s magazine. 28 August 2016
Daiichi Sankyo and UCB have filed an application for partial amendment of approval to use lacosamide (brand name: Vimpat) tablets 50mg and 100mg) in monotherapy for partial-onset seizure (including secondary generalized seizures) in patients with epilepsy. 27 August 2016
Privately-held US biotech Denali Therapeutics has announced a series of previously undisclosed collaborations and licensing deals – including an agreement with Genentech, a unit of Swiss pharma giant Roche, over a Parkinson’s disease treatment. 26 August 2016