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 US Food and Drug Administration has approved an updated label for pharma giant Pfizer’s Embeda (morphine sulfate and naltrexone hydrochloride) extended-release (ER) capsules, for oral use, CII, to include abuse-deterrence studies. 19 October 2014
Stigma, ignorance and a severe lack of doctors in India have long marred mental health care projects across the country. An otherwise herculean task for the government, India has taken the first step to integrate mental health into public health, reports The Pharma Letter’s India correspondent. 18 October 2014
Ireland-headquartered generics major Actavis confirmed that it has filed an Abbreviated New Drug Application with the US Food and Drug Administration seeking approval to market a methylphenidate for extended-release oral suspension. 16 October 2014
Anglo-Swedish drug major AstraZeneca, together with its global biologics R&D arm MedImmune, has entered into four new collaborations with the University of Cambridge. 16 October 2014
The patent battle over Israel-based Teva Pharmaceutical Industries’ multiple sclerosis drug Copaxone (glatiramer acetate) was heard by the US Supreme Court yesterday. 16 October 2014
The Parkinson’s disease pharmacotherapy market will grow 5% annually from $2.3 billion in 2013 to $3.8 billion in 2023, new research finds. 15 October 2014
There was good news for Japanese drugmaker Eisai yesterday, as the US Food and Drug Administration granted priority review for two of the companies products. 15 October 2014
Ireland-based pharma company Shire announced the winners of the 2014 Excellence in ADHD Patient Group Awards to coincide with World Mental Health Day on Friday. 13 October 2014
Funding for newer and more effective multiple sclerosis (MS) treatments has been approved by PHARMAC, New Zealand’s Pharmaceutical Management Agency. 13 October 2014
Hikma Pharmaceuticals has entered into a partnership with Japanese pharma major Eisai for the distribution of Fycompa (perampanel), Eisai’s first-in-class epilepsy treatment, in the Middle East. 13 October 2014
On October 8, 2014, Anglo-Swedish pharma major AstraZeneca finally terminated its collaborative research and license agreement with Targacept entered into December 27, 2005, as amended, the USA-based clinical stage company revealed in a Security and Exchange Commission filing. 12 October 2014
At its October meeting, the European Medicines Agency’ Pharmacovigilance Risk Assessment Committee (PRAC) concluded three safety reviews. 10 October 2014
New Zealand’s Pharmaceutical Management Agency PHARMAC has announced the approval of an agreement with the local subsidiary of Swiss pharma giant Novartis involving the listing of nine new products and amendments to the listing of seven other products. 10 October 2014
The overall pain market will maintain $38 billion in sales in 2028 across the major pharmaceutical markets (USA, France, Germany, Italy, Spain, the UK and Japan), new research indicates. 10 October 2014
In an early benefit assessment pursuant to the Act on the Reform of the Market for Medicinal Products (AMNOG), the German Institute for Quality and Efficiency in Health Care (IQWiG) examined whether Swiss pharma giant Novartis’ multiple sclerosis drug Gilenya (fingolimod) offers an added benefit over the appropriate comparator therapy in this patient group. 10 October 2014
The UK’s National Institute for Health and Care Excellence (NICE) has updated its guidance for the NHS’ management of multiple sclerosis. 9 October 2014
Australian regulator the Therapeutic Goods Administration (TGA) has completed a review of the cardiovascular risks associated with the use of the non-steroidal anti-inflammatory drugs (NSAIDs) diclofenac, naproxen, ibuprofen, celecoxib, etoricoxib, indomethacin, meloxicam and piroxicam. 8 October 2014
The US Food and Drug Administration has designated a product from stem cell treatment developer BrainStorm Cell Therapeutics (Nasdaq: BCLI) as a Fast Track product for the treatment of amyotrophic lateral sclerosis (ALS, or Lou Gehrig's Disease). 7 October 2014
Israeli generics giant Teva Pharmaceutical Industries has concluded an extensive evaluation of its current and future capabilities, affirming its long-term commitment to being a leader in the central nervous system and respiratory therapeutic sectors. 7 October 2014