The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended six new medicines for marketing authorization at its January 2016 meeting, two of which – for Empliciti and Coagadex – will becovered in separate stories. 30 January 2016
Pharmaceutical companies have been accused of failing to report the high risk of suicide among youngsters who take SSRI antidepressants. 29 January 2016
Neos Therapeutics said the US Food and Drug Administration has approved its oral treatment of attention-deficit/hyperactivity disorder (ADHD) in patients six years and older. 28 January 2016
The US Food and Drug Administration is conferring with European regulators after a Phase I clinical study, conducted by French clinical research organization Biotrial, recently resulted in the death of one enrolled subject and neurological injury to four others. 25 January 2016
Shares of Ireland-incorporated biotech Alkermes plunged 44.2% to $33.71 by the close of trading on Thursday, wiping nearly $4 billion from its market capitalization, after it announced disappointing preliminary top-line results from FORWARD-3 and FORWARD-4. 22 January 2016
Troubled US drugmaker MannKind Corp saw its share rise 12.3% to $0.89, after it announced that it has entered into a collaboration and license agreement with a newly-formed entity, Receptor Life Sciences. 21 January 2016
Netherlands-incorporated Mylan has announced the US launch of felbamate tablets USP, 400mg and 600mg, which is the generic version of Swedish drugmaker Meda Pharma’s Felbatol Tablets. 21 January 2016
Finland’s Biotie Therapies saw its shares rocket 88% to 0.28 euros in early trading, after US biotech Acorda Therapeutics announced it has reached agreement to acquire the company. 19 January 2016
EMD Serono, the North American biopharma business of Germany’s Merck KGaA, has taken on the sole rights to Rebif (interferon beta-1a) in the USA as of January 1. 19 January 2016
In a serious safety failure during a Phase I trial of a pain drug under development by Bial Portela, Portugal’s largest drugmaker, of the six healthy volunteers taking part, all were taken to hospital, with one in intensive care and described as brain-dead, who subsently died. 16 January 2016
The Psychopharmacologic Drugs Advisory Committee (PDAC) of the US Food and Drug Administration has voted 12 to five in favor of approving Probuphine, the first long-acting, subdermal buprenorphine implant for the maintenance treatment of opioid addiction, in stable patients receiving 8mg or less per day of buprenorphine. 14 January 2016
CNS specialist Zambon and its partner, fellow Italy-based Newron Pharmaceuticals announced the launch of Xadago (safinamide) in Switzerland, the second market to see the Parkinson’s treatment debut after Germany. 13 January 2016
Boehringer Ingelheim has signed an exclusive agreement with the USA’s Arena Pharmaceuticals to conduct joint research to identify drug candidates targeting an undisclosed G protein-coupled receptor (GPCR), which belongs to the group of orphan CNS receptors. 13 January 2016
Pharma giant Pfizer said it is pouring in a total of $46 million into four early-stage research companies in a bid to expand its R&D investments. 11 January 2016
Shares of USA-based biotech firm Athersys rose 21.4% to $1.25 on Friday after it announced a lucrative partnership and license agreement with Japan’s Healios. 11 January 2016
Takeda Pharmaceutical and privately-held NsGene have signed a research agreement to develop encapsulated cell therapies for the potential treatment of Parkinson’s disease. 9 January 2016
US biotech major Biogen has entered into a multi-year research collaboration around neuronal epigenetics with privately-held Rodin Therapeutics. 7 January 2016
Shares in India-based Suven Life Sciences shares gained over 3% on the Bombay Stock Exchange after the company announced it has secured product patents from Canada, South Korea and African Regional Intellectual Property Organization (ARIPO) related with the New Chemical Entities (NCEs) to treat disorders associated with neurodegenerative diseases. 5 January 2016
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