The US Food and Drug Administration on Friday granted approval for Japanese pharma major Eisai’s Lenvima (lenvatinib) to treat patients with progressive, differentiated thyroid cancer (DTC). 14 February 2015
US biotech major Biogen Idec’s Indian subsidiary has received approval of the first oral therapy for multiple sclerosis, Tecfidera (dimethyl fumarate), from the Drug Controller General of India (DCGI), for people with relapsing-remitting multiple sclerosis (RRMS). 13 February 2015
US gene therapy start-up company Voyager Therapeutics has entered into a major strategic collaboration with biotech firm Genzyme to discover, develop and commercialize novel gene therapies for severe CNS disorders. 12 February 2015
Swedish drug developer Orexo has laid the foundations to accelerate growth of its Zubsolv (buprenorphine and naloxone) product, according to research from investment intelligence firm Edison Equity Research. 10 February 2015
Neurological biopharma company Anavex Life Sciences has confirmed positive preclinical data for lead candidate ANAVEX 2-73 in epilepsy. 10 February 2015
The drug Gleevec (imatinib mesylate) is well known not only for its effectiveness against chronic myeloid leukemia (CML) and acute lymphoblastic leukemia, but also for the story behinds its development. 10 February 2015
Stiff competition from China is undermining the Indian bulk drug industry. While imports from China are growing at over 30%, Indian exporters maintain that it is difficult to crack the Chinese market, reports The Pharma Letter’s India correspondent. 8 February 2015
Belgian drugmaker UCB has announced positive top-line results from two Phase III studies of Neupro (rotigotine transdermal patch) in patients in China with early- and advanced-stage idiopathic Parkinson’s disease. 5 February 2015
Danish CNS specialist Lundbeck (LUN: CO) reported fourth-quarter 2014 sales of 3.25 billion Danish kroner (495.0 million), down 9% (-12% in local currencies), but beating the 3.12 billion kroner projected by analysts polled by Reuters. 5 February 2015
US biologics specialist Repligen revealed in a filing with the Securities and Exchange Commission that pharma giant Pfizer is terminating its 2012 agreement for the development of compounds to treat spinal muscular atrophy (SMA). 3 February 2015
The US Food and Drug Administration on Friday approved UK drugmaker Shire’s Vyvanse (lisdexamfetamine dimesylate) capsules (CII), the first and only medication for the treatment of moderate to severe binge eating disorder (BED) in adults, shown to significantly reduce the mean number of binge days per week. 31 January 2015
Ireland-headquartered drugmaker Shire has received fast-track designation from the US Food and Drug Administration for its SHP609 (idursulfase-IT). 27 January 2015
While current treatments for Alzheimer’s disease are only able to ease symptoms temporarily, tau-based vaccines may offer a new and more effective way to treat AD in the early course of the disease, says an analyst. 27 January 2015
Japanese drugmaker Otsuka Pharmaceutical has established a direct presence in Australia. A new office has been opened in Sydney to bring innovative new medicines to patients in Australia and as a foundation on which to build a larger, long-term presence in Australia and elsewhere in Oceania. 27 January 2015
US drugmaker Supernus Pharmaceuticals says that it has sued generic drug makers Taiwan-based TWi Pharmaceuticals and TWi International for infringement of four patents covering its antiepileptic drug Oxtellar XR. 22 January 2015
Belgium’s largest pharma company UCB today announced regulatory filings in the USA and the European Union for its investigational antiepileptic drug brivaracetam. 21 January 2015
The US Supreme Court has reversed the Federal Circuit Court’s judgment on Israel-based Teva Pharmaceutical Industries’ Copaxone (glatiramer acetate injection). 21 January 2015
Following a public comment period, the USA’s Federal Trade Commission has approved a final order settling charges that Swiss pharma major Novartis’ consumer health care products joint venture with UK peer GlaxoSmithKline would likely be anticompetitive. 21 January 2015
Fresenius Kabi, a unit of the Germany-headquartered Fresenius Group, has received approval from the US Food and Drug Administration to market neostigmine methylsulfate injection. 20 January 2015
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