US drug maker Depomed saw its shares climb more than 12% to $14.76 on Tuesday, on the news that the firm had received a positive court ruling relating to its Gralise (gabapentin). 20 August 2014
Insomnia treatment Belsomra (suvorexant) from US pharma giant Merck & Co has the potential to become a first-line therapy for insomnia following approval by the US Food and Drug Administration last week, although it will need to build physician confidence to encourage uptake, according to an analyst with research and consulting firm GlobalData. 18 August 2014
The US Food and Drug Administration has approved US biotech firm Biogen Idec’s (Nasdaq: BIIB) Plegridy (peginterferon beta-1a), a new treatment for people with relapsing forms of multiple sclerosis (RMS), the company announced on Friday. 17 August 2014
The German Institute for Quality and Efficiency in Healthcare (IQWiG) has said that epilepsy drug Fycompa (perampanel) from Japanese drug major Eisai provides "no additional benefit" over appropriate comparators to treat partial onset seizures, with or without secondarily generalized seizures, in patients with epilepsy aged 12 years and older. 17 August 2014
US drugmaker Alexza Pharmaceuticals has provided an update on its European Medicines Agency post-approval studies for its antipsychotic drug candidate Adasuve inhalation powder, pre-dispensed (Staccato loxapine). 14 August 2014
Pharma giant Merck & Co has received US Food and Drug Administration approval for its insomnia treatment Belsomra (suvorexant) for adults. 14 August 2014
New antidepressants and antipsychotics will offset a steep decline in sales following genericization of unipolar depression medication, according to research carried out by Decision Resources Group. 14 August 2014
The Australian Minister for Health, Peter Dutton, has announced the opening of a new round of dementia research grants and invited groups of researchers to apply for the National Health and Medical Research Council’s (NHMRC) new Dementia Research Team Grants, worth up to A$6.5 million ($6.0 million) each over five years. 8 August 2014
In its early benefit assessment, the German Institute for Quality and Efficiency in Health Care (IQWiG) has examined whether US biotech firm Biogen Idec’s new drug Tecfidera (dimethyl fumarate) for multiple sclerosis (MS) offers an added benefit over the appropriate comparator therapy specified by the Federal Joint Committee (G-BA). 8 August 2014
Global generics leader Teva Pharmaceutical Industries yesterday confirmed that it has received the first paragraph IV notice for its three-times-a-week Copaxone (glatiramer acetate) injection 40mg/mL product from Indian drugmaker Dr Reddy’s Laboratories. 8 August 2014
New Zealand’s Pharmaceutical Management Agency PHARMAC is seeking feedback on a funding proposal involving five treatments for multiple sclerosis (MS), including two new treatments that are not currently funded – natalizumab and fingolimod. 7 August 2014
Regulus Therapeutics has entered into a new collaboration agreement with fellow US biotech firm Biogen Idec to expand its research focused on identifying microRNAs as biomarkers for multiple sclerosis (MS) under its Regulus microMarkers division. 5 August 2014
French regulators are attempting to discourage the over-consumption and misuse of hypnotic benzodiazepines by recommending a reduction in the reimbursement rate to 15%. 1 August 2014
The US Food and Drug Administration has performed a general Good Manufacturing Practices (GMP) inspection and a Pre-Approval Inspection (PAI) at US generic drugmaker Impax Laboratories’ manufacturing facility in Taiwan. 30 July 2014
Canada’s Minister of Health, Rona Ambrose, has issued a national Call for Proposals to improve the prescribing practices for prescription drugs that have a high risk of abuse or addiction. 29 July 2014
UK-based consumer goods giant Reckitt Benckiser plans to spin off its USA-based pharmaceutical business, the company announced along with its half-year 2014 financial results. 28 July 2014
USA-based specialty pharma firm AcelRx Pharmaceuticals says that the US Food and Drug Administration has issued a Complete Response Letter for its New Drug Application for pain management product Zalviso (sufentanil sublingual tablet system). 28 July 2014
Merck Serono, the biotech unit of Germany’s Merck KGaA, says it is continuing its strategic alliance with San Raffaele University and Research Hospital in Milan, Italy, originally established in 2004. 24 July 2014
US biotech firm Biogen Idec said that the European Commission has approved its subcutaneous injectable Plegridy (peginterferon beta-1a) for the treatment of adults with relapsing-remitting multiple sclerosis. 24 July 2014
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