Shares of Reata Pharmaceuticals rocketed yesterday, after it said it will seek FDA approval for drug candidate omaveloxolone (omav) for the treatment of Friedreich’s ataxia (FA) following Monday’s announcement of positive data from its registrational clinical trial. 15 October 2019
Last week’s deal-making news included Akcea Therapeutics and majority owner Ionis Pharmaceuticals joining forces with US pharma giant Pfizer on cardiovascular and metabolic diseases research. Also, bluebird bio entered into a gene editing deal with Denmark’s Novo Nordisk to tackle hemophilia A. Regulatory news included Swiss giant Novartis announcing that its much-anticipated anti-VEGF treatment Beovu (brolucizumab) for wet age-related macular degeneration had received approval from the Food and Drug Administration. On the M&A front, investors applauded on Thursday when US biotech Ra Pharma agreed to a $2.1 billion takeover offer from Belgium’s UCB. 13 October 2019
The US Food and Drug Administration on Friday approved Reyvow (lasmiditan) tablets for the acute (active but short-term) treatment of migraine with or without aura (a sensory phenomenon or visual disturbance) in adults. 12 October 2019
Privately-held US pain specialist Neumentum has entered into a global licensing agreement with Janssen Pharmaceutica and McNeil Consumer Pharmaceuticals, both part of US healthcare giant Johnson & Johnson, for the rights to an oral analgesic, JNJ-10450232, plus a portfolio of backup compounds. 10 October 2019
US biotech firm Ra Pharmaceutical saw its shares roar ahead 103% to $46.14 in pre-market trading today, on the news that it has agreed to a takeover by Belgium’s largest pharma firm UCB. 10 October 2019
The USA’s Institute for Clinical and Economic Review (ICER) has published its first annual report on Unsupported Price Increases (UPI) of prescription drugs in the United States, showing that Humira (adalimumab) and Rituxan (rituximab) topped the list of costliest medicines. 9 October 2019
Acorda Therapeutics failed in its appeal to have the US Supreme Court overturn a decision that had invalidated patents protecting its multiple sclerosis (MS) drug Ampyra (dalfampridine). 8 October 2019
The Roche therapy Ocrevus (ocrelizumab) was only approved in 2017, but it has already become the multiple sclerosis (MS) market leader in its class, recording sales of $1.72 billion in the first half of 2019. 4 October 2019
A supplemental New Drug Application (sNDA) has been submitted to the US Food and Drug Administration seeking a new indication for Spravato (esketamine) CIII nasal spray for the rapid reduction of depressive symptoms in adult patients with major depressive disorder (MDD) who have active suicidal ideation with intent, says the drug’s developer Janssen. 3 October 2019
Swedish startup Lobsor Pharmaceuticals expects to complete registration in the Nordic region for its lightweight Parkinson’s disease therapy Lecigon (levodopa/carbidopa/entacapone) this month. 2 October 2019
US healthcare giant Johnson & Johnson and its Janssen Pharmaceutical Companies yesterday announced a $20.4 million settlement agreement with the Ohio counties of Cuyahoga and Summit that resolves all of the counties’ claims with no admission of liability and removes the company from the bellwether federal trial against drugmakers blamed for the US opioid crisis scheduled to begin October 21, 2019. 2 October 2019
Heron Therapeutics has resubmitted its New Drug Application (NDA) to the US Food and Drug Administration for HTX-011, an investigational agent for the management of postoperative pain. 1 October 2019
The US National Institutes of Health (NIH) has awarded a grant of up to $4.6 million to Sydney University spinout Kinoxis Therapeutics, under an initiative aimed at combating the epidemic of opioid addiction in America. 30 September 2019
Otsuka Pharmaceutical today announced that its USA-based, indirect subsidiary Avanir Pharmaceuticals has reported disappointing results from the second study of its Phase III clinical development program investigating the efficacy, safety and tolerability of AVP-786 (deudextromethorphan hydrobromide [d6-DM]/quinidine sulfate [Q]) for the treatment of moderate-to-severe agitation in patients with Alzheimer's dementia. 27 September 2019
Avanir Pharmaceuticals was charged for paying kickbacks to a physician to induce prescriptions of its drug Nuedexta (dextromethorphan hydrobromide/quinidine sulfate), the US the Department of Justice announced on Thursday. 27 September 2019
The cost-effectiveness watchdog for England and Wales has ruled that Novartis’ anti-CGRP migraine therapy is too expensive at its current price to be provided on the National Health Service (NHS). 26 September 2019
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