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
A team of 22 scientists from 11 research institutes led by Bazbek Davletov, a professor now at the University of Sheffield, created and characterized a new molecule that was able to alleviate hypersensitivity to inflammatory pain. 1 November 2013
US biotech firm ACADIA Pharmaceuticalssays that new date published in the on-line edition of The Lancet today from its pivotal Phase III -020 Study with pimavanserin in patients with Parkinson’s disease psychosis (PDP) demonstrated significant and clinically meaningful benefits and showed the drug was safe and well tolerated in patients with PDP. 1 November 2013
Biotie Therapies says that its partner, Lundbeck has expanded its existing alliance with Otsuka Pharmaceutical to include development and commercialization of nalmefene, its alcohol dependence drug treatment, in Japan. 31 October 2013
Tougher regulations proposed this month by the US Food and Drug Administration regarding combination drugs that contain hydrocodone as an active ingredient could dampen sales as prescribing restrictions increase, according to Fitch Ratings. 30 October 2013
Danish CNS drug specialist Lundbeck says that the US Food and Drug Administration has approved its Sabril (vigabatrin) as add-on therapy for the treatment of refractory complex partial seizures (CPS) in children 10 years of age and older. 29 October 2013
Ablynx says its partner Boehringer Ingelheim has dosed the first healthy volunteers in a Phase I clinical trial evaluating a Nanobody for the treatment of Alzheimer's disease, triggering a milestone payment of €5 million to Ablynx. 29 October 2013
Austrian drugmaker AOP Orphan and privately held Spanish drugmaker Ferrer Internacional are expanding their partnership to include the marketing of the anti-psychotic drug Adasuve in Central and Eastern Europe. 29 October 2013
At its October month-end meeting, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) issued a number of recommendations, including positive opinions for Opsumit and Brintellix. 27 October 2013
Eisai says the US Food and Drug Administration has approved the US supply of the epilepsy drug Zonegran (zonisamide) from its EMEA Knowledge Center in the UK. 15 October 2013
Dainippon Sumitomo Pharma/Sunovion/Takeda Pharmaceutical’s atypical antipsychotic Latuda (lurasidone) will experience significant uptake in the bipolar disorder market, according to a new report from Decision Resources. 15 October 2013
AstraZeneca has released results of a Phase III long-term safety and tolerability study of the once-daily 25mg dose of naloxegol in patients with non-cancer pain and opioid-induced constipation. 15 October 2013
The delay for the generic version of GlaxoSmithKline’s Advair coupled with the advances in the company’s investigational product in Alzheimer’s disease has prompted analysts Panmure Gordon to recommend the company's stock. 11 October 2013
US specialty pharma firm Acura Pharmaceuticals saw its shares leap as much as 28% after it said that it has entered into distinct settlement agreements with each of Par Pharmaceutical and Impax Laboratories to settle Acura's patent infringement action pending against them in the US District Court for the District of Delaware. 11 October 2013
Denmark-based CNS specialist Lundbeck and partner Japan’s Otsuka Pharmaceutical have announced the continuation of the development program of Lu AE58054 for the treatment of Alzheimer's disease, initiating the first out of four currently planned Phase III clinical trials with the compound in Alzheimer's disease. 10 October 2013
Actavis has filed an Abbreviated New Drug Application with the US Food and Drug Administration for buprenorphine hydrochloride and naloxone HCl sublingual film, a generic version of Reckitt Benckiser's Suboxone. 9 October 2013
Biogen Idec presented data showing that Tecfidera continues to offer consistent and strong efficacy combined with a favorable safety profile in a broad range of patients with relapsing-remitting multiple sclerosis, including those patients who are newly diagnosed with the disease. 4 October 2013
The District Court of the Hague has issued a favorable ruling for Teva Pharmaceutical Industries in a patent revocation action brought by Mylan seeking a court judgment that Teva’s patent for its Copaxone is invalid. 4 October 2013
French drug major Sanofi and its subsidiary Genzyme announced positive new data from the TOPIC study of its once-daily, oral Aubagio (teriflunomide) at the 29th Congress of the European Committee for Research and Treatment in Multiple Sclerosis (ECTRIMS), 3 October 2013
Among surveyed US nephrologists, familiarity with Swiss drug major Roche's Mircera is low, but is still second highest among six late-stage renal therapies in development. 2 October 2013