Australia's medicines regulator, the Therapeutic Goods Administration, has today published an interim decision on a proposal to up-schedule codeine-containing medicines. 1 October 2015
Health Canada is informing Canadians that the drug label for the multiple sclerosis (MS) drug Gilenya (fingolimod) has been updated with new safety information on the risk of skin cancer, as well as a rare brain infection known as progressive multifocal leukoencephalopathy (PML). 1 October 2015
Chromocell Corp has entered into a license and collaboration agreement with Japanese drug major Astellas Pharma for the development and commercialization of therapeutics to treat neuropathic and other pain conditions. 30 September 2015
Shares in Newron Pharmaceuticals dropped nearly 4.4% on the Swiss Exchange after the company said the US regulators have extended the review of its Parkinson's disease drug by three months. 30 September 2015
Cloud Pharmaceuticals, a US cloud-based drug design and development company, and Switzerland-based THERAMetrics Holding today announced a strategic collaboration focusing on the design and development of therapeutics for orphan central nervous system (CNS) diseases and other indications. 29 September 2015
Swiss pharma company AC Immune has entered into a research collaboration agreement with the Nestlé Institute of Health Sciences (NIHS) to develop a novel, minimally invasive Tau diagnostic assay for early diagnosis of Alzheimer’s disease. 23 September 2015
Grünenthal has received approval from the European Commission for Zalviso (sufentanil sublingual tablet system) for the management of acute moderate to severe post-operative pain in adult patients. 22 September 2015
The US Food and Drug Administration is investigating the use of the pain medicine tramadol in children aged 17 years and younger, because of the rare but serious risk of slowed or difficult breathing. 22 September 2015
Sun Pharmaceutical Industries and Strides Arcolab have entered into a definitive agreement related to erstwhile Ranbaxy’s ‘Solus’ and ‘Solus Care’ divisions operating in the central nervous system (CNS) segment in India. 21 September 2015
AcelRx Pharmaceuticals has announced the monetization of the expected royalty stream from the sales of Zalviso (sufentanil sublingual tablet system) in the European Union by its commercial partner, German family-owned Grunenthal. 21 September 2015
Shire says that the European Commission has granted marketing authorization for its once-daily, non-stimulant Intuniv for the treatment of attention deficit hyperactivity disorder (ADHD). 21 September 2015
The US Food and Drug Administration yesterday approved Vraylar (cariprazine) capsules, an atypical antipsychotic from Gedeon Richter and Allergan, for the acute treatment of manic or mixed episodes associated with bipolar I disorder and for treatment of schizophrenia in adults. 18 September 2015
Chinese specialty drugmaker Yabao Pharmaceutical has entered into an exclusive license with privately held Canadian firm Primary Peptides to develop and commercialize innovative products targeting PTEN nuclear translocation for the treatment of stroke. 17 September 2015
The US Food and Drug Administration is making changes to the requirements for monitoring, prescribing, dispensing, and receiving the schizophrenia medicine clozapine, to address continuing safety concerns and current knowledge about a serious blood condition called severe neutropenia. 16 September 2015
Shares of UK-based GW Pharmaceuticals rose more than 10% to 621.50 pence by mid-afternoon after the company announced positive top line results from an exploratory Phase IIa placebo-controlled clinical trial of cannabidiol (CBD). 15 September 2015
US drug developer FORUM Pharmaceuticals said yesterday that, during verbal discussions with the US Food and Drug Administration, it was advised that studies investigating the use of encenicline in Alzheimer’s disease (AD) have been placed on clinical hold. 15 September 2015
The US Food and Drug Administration’s Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management Advisory Committee on Friday voted unanimously to support the approval of Xtampza ER (oxycodone extended-release capsules). 12 September 2015
The US Food and Drug Administration has determined that the New Drug Application for the combination product of Abilify (aripiprazole) embedded with an ingestible sensor in a single tablet from privately-held US firm Proteus Digital Health, is sufficiently complete to allow for a substantive review and is considered filed as of September 8, 2015. 11 September 2015
The UK High Court in London dealt a major blow to US pharma giant Pfizer when it ruled that claims of patent protection for the use of its Lyrica (pregabalin) as a pain treatment were invalid, according to reports by Reuters and other newswires. 10 September 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