UK-based biotech firm F-star has announces a collaborative agreement with the US start-up Denali Therapeutics to research and develop antibodies for the delivery of medicines across the blood-brain barrier (BBB) into the central nervous system (CNS). 25 August 2016
The US Patent and Trademark Office (PTO) has ruled in favor of Netherlands-incorporated Mylan by invalidating two of Teva Pharmaceutical Industries' patents for the multiple sclerosis (MS) treatment Copaxone (glatiramer acetate). 25 August 2016
Swiss pharma giant Novartis has announced positive Phase III results showing the efficacy of its BAF312 (siponimod) candidate in secondary progressive multiple sclerosis (SPMS). 25 August 2016
The focus of research has shifted significantly away from established and moderately severe Alzheimer’s disease to the much earlier stages of the illness and in some cases when symptoms are very mild or even absent. People have called this “Prodromal” Alzheimer’s disease or “Asymptomatic” Alzheimer’s disease. 24 August 2016
The worldwide market for attention-deficit hyperactivity disorder (ADHD) will grow from the $14 billion 2015 valuation to $25 billion by 2024, says a new report from Persistence Market Research. 23 August 2016
Although opioids continue to dominate the chronic pain market, adverse events associated with the drug such as the potential for abuse mean the treatment space is rife with unmet needs, which is encouraging pharmaceutical companies to explore innovative alternatives to opioids. 23 August 2016
AstraZeneca and Eli Lilly have received US Food and Drug Administration fast-track designation for the development program in Alzheimer’s disease for AZD3293, an oral beta secretase cleaving enzyme (BACE) inhibitor currently in Phase III clinical trial. 22 August 2016
The use of esketamine as a treatment for major depressive disorder (MDD) could transform the treatment landscape and prevent thousands of people from taking their own lives, according to scientists at Janssen Pharmaceuticals. 20 August 2016
Indivior saw its share price rocket by 20% to £361.80 on Wednesday morning after announcing positive top-line Phase III results for its new opiod addiction drug. 18 August 2016
The US Food and Drug Administration (FDA) has granted esketamine, an investigational antidepressant medication, Breakthrough Therapy Designation for the treatment of major depressive disorder with imminent risk for suicide. 16 August 2016
Sorrento Therapeutics has entered into a binding term sheet to acquire Semnur Pharmaceuticals through its subsidiary Scintilla Pharmaceuticals, to further deepen its pain management pipeline. 16 August 2016
In the USA, the Delaware District Court confirmed the validity of US patent RE38,551 related to Vimpat (lacosamide), Belgian pharma company UCB’s anti-epileptic drug. 15 August 2016
The US Food and Drug Administration, with information received from the European Medicines Agency (EMA) and the French national medicines agency (ANSM), has completed a comprehensive review of safety information relevant to the investigational new drug BIA 10-2474 and the potential implications for related drugs under investigation in the USA. 12 August 2016
Endo International said today that, based on an August 11, 2016 discussion with the US Food and Drug Administration, the company has decided to withdraw its supplemental New Drug Application (sNDA) relating to specific abuse deterrent labeling for its opioid antagonist Opana ER without prejudice to re-filing. 12 August 2016
The US Food and Drug Administration (FDA) has created a model Drug Facts Label (DFL) to help drugmakers submit new drug applications for over-the-counter (OTD) versions of a drug that combats the effects of an opioid overdose. 11 August 2016
Astellas Pharma has submitted a new drug application to the Ministry of Health, Labor and Welfare in Japan for extended-release tablets of quetiapine fumarate (FK949E) for the indication of improvement of depressive symptoms associated with bipolar disorder. 10 August 2016
The US Food and Drug Administration has given the nod for Japanese pharma major Eisai and US biotech Biogen to take their investigational oral beta-secretase cleaving enzyme (BACE) inhibitor E2609 into Phase III studies in Alzheimer’s. 10 August 2016
Findings from three studies have been published which suggest that Vyndaqel (tafamidis), a drug being developed by US pharma giant Pfizer, could slow the progression of a rare neurodegenerative disease. 9 August 2016
Alkermes has submitted a supplemental New Drug Application (sNDA) to the US Food and Drug Administration for a two-month dosing interval of Aristada (aripiprazole lauroxil) extended-release injectable suspension for the treatment of schizophrenia. 9 August 2016
Sorrento Therapeutics has entered into a binding term sheet to acquire fellow USA-based SCILEX Pharmaceuticals, through its subsidiary Scintilla Pharmaceuticals. 8 August 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