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
US drugmaker Upsher-Smith Laboratories has entered into a preclinical development agreement with Denmark-based CNS drug specialist Lundbeck to further its research program related to protein kinase inhibitors. 2 October 2013
The US Food and Drug Administration approved Brintellix on Monday, co-marketed by Takeda and Lundbeck to treat adults with major depressive disorder. 1 October 2013
Nippon Shinyaku and Pfizer have concluded an exclusive sales promotion consignment contract in Japan for Tramal Capsule, a cancer pain and chronic pain treatment. 30 September 2013
US Senator Charles Grassley has written to two drug companies on behalf of an Iowa hospital that is not receiving required discounts on two drugs, despite a federal program to help uninsured patients. 27 September 2013
A German unit of Spain’s largest drugmaker Almirall, Hermal GmbH and Germany’s National Association of Statutory Health Insurance Funds agreed this week on a reimbursement amount for the medicine cannabis-based prescription multiple sclerosis spasticity drug Sativex. 25 September 2013
Biotie Therapies has revealed the outcome of its planned portfolio review, following its success earlier in the year with the approval and launch of Selincro in Europe by Lundbeck and the exercise by Belgium’s UCB of its license for tozadenant (SYN115), for which Biotie received a $20 million milestone. 24 September 2013
Israel-based Teva Pharmaceutical Industries has gained a favorable ruling in its patent infringement lawsuit against US generic drugmaker Mylan over its Azilect patent which covers methods of treating Parkinson’s disease. 24 September 2013
US pharma major Merck & Co has received a Complete Response Letter from the US Food and Drug Administration for the resubmission of the New Drug Application for sugammadex sodium injection, Merck’s investigational medicine for the reversal of neuromuscular blockade induced by rocuronium or vecuronium. 23 September 2013
Researchers will test promising drugs aimed at preventing Alzheimer’s and identify and validate biological targets for novel therapies, with around $45 million in new funding from the USA’s National Institutes of Health. 20 September 2013
Sweden’s Medivir (Nasdaq OMX: MVIR) and privately-held Spanish drugmaker Ferrer Internacional have entered a license and distribution agreement for the commercialization of Adasuve (Staccato loxapine) in the Nordic region. 19 September 2013
Sunovion Pharmaceuticals, a US subsidiary of Japan's Dainippon Sumitomo Pharma (TYO: 4506), says that two completed Phase III trials of eslicarbazepine acetate (ESL) as a monotherapy treatment (Studies 093-045 and 093-046) met their primary endpoint. 18 September 2013
UK drugs watchdog the National Institute for Health and Care Excellence (NICE) is calling on Genzyme, a subsidiary of French drug major Sanofi (Euronext: SAN), to provide more information on its multiple sclerosis drug Aubagio (teriflunomide), which has recently been approved by the European Commission (The Pharma Letter September 2). 18 September 2013
French drug major Sanofi (Euronext: SAN) and its USA-based biotech subsidiary Genzyme revealed this morning (September 17) that the European Commission has granted marketing authorization for their multiple sclerosis drug Lemtrada (alemtuzumab). 17 September 2013
The multiple sclerosis (MS) therapeutics market has been forecast to increase at a compound annual growth rate (CAGR) of 11.6% over the next six years, increasing from a value of $8.1 billion in 2012, to reach a value of $17.6 billion by 2019, according to a new report added to the offering of Companiesandmarkets.com 17 September 2013
French drugmaker Ipsen (Euronext: IPN) has released positive clinical trial results for the treatment of carcinoid syndrome with Somatuline (lanreotide). 17 September 2013
New Zealand's Pharmaceutical Management Agency PHARMAC has announce the approval of an agreement with the local subsidiary of French drug major Sanofi (Euronext: SAN) to fund Rilutek (riluzole) for the treatment of amyotrophic lateral sclerosis (ALS, also known as motor neurone disease) from October 1, 2013 subject to the restrictions outlined below. 11 September 2013
The US Food and Drug Administration has approved the US supply of Japanese pharma major Eisai's (TYO: 4523) epilepsy drug Fycompa (perampanel) from its EMEA (Europe, Middle East, Africa, Russia and Oceania) Knowledge Centre based in Hatfield, UK. The Hatfield site will manufacture six different strengths of tablet for export to the USA. 11 September 2013
US biotech firm Amicus Therapeutics (Nasdaq: FOLD) has entered a collaboration with Biogen Idec (Nasdaq: BIIB) to discover, develop and commercialize novel small molecules for the treatment of Parkinson's disease. Financial terms of the deal were not disclosed. 11 September 2013