Neurological
Refine Search
Biotechnology
Novartis today announced data from HER-MES X, the first and only randomized, double blind, double-dummy, active-controlled, parallel-group Phase IV study of Aimovig (erenumab) against topiramate, a generic anticonvulsant, in patients with episodic and chronic migraine. 8 November 2021
Biotechnology
US CNS-focussed drug biotech Amylyx Pharmaceuticals says it has now submitted a New Drug Application (NDA) to the US Food and Drug Administration for AMX0035 for the treatment of amyotrophic lateral sclerosis (ALS). 3 November 2021
Biotechnology
US biopharma company Neurocrine Biosciences has presented new data from its movement disorder program for tardive dyskinesia at the 2021 Psych Congress scientific meeting. 1 November 2021
Biotechnology
Japanese biotech start-up Aculys Pharma today announced the closing of a $60 million Series A financing led by SoftBank Vision Fund 2 and joined by Catalys Pacific, HBM Healthcare Investments, Global Founders Capital, Sumitomo Mitsui Trust Investment, and ANRI. 1 November 2021
Pharmaceutical
Israel’s Teva Pharmaceutical Industries has announced results from the pivotal Phase III Risperidone Subcutaneous Extended-release (RISE) study comparing TV-46000/mdc-IRM once monthly (q1m) and TV-46000/mdc-IRM once every two months (q2m) with placebo (1:1:1) in patients with schizophrenia who underwent stabilization on oral risperidone, which showed the treatment (overall, q1m or q2m) significantly prolonged time to relapse, decreased proportions of patients with impending relapse at week 24 and demonstrated significant increase in proportions maintaining stability. 1 November 2021
Biotechnology
Apart from financial results, clinical trial results were much in evidence among the news last week. Novartis’ already-marketed canakinumab missed Phase III clinical goals in lung cancer for a second time. Sanofi and Regeneron released new data on their Dupixent in the treatment of eosinophilic esophagitis along with plans for regulatory filings. Also, there was disappointment in the Alzheimer’s space, when US biotech Cortexyme last Tuesday reported missed endpoints in a Phase II/III of its candidate atuzaginstat. Meantime, the announcement that Alnylam’s long-time chief executive John Maragonore was leaving after 19 years came as a big surprise. 31 October 2021
Pharmaceutical
Shares of US pharma firm AbbVie closed up 4.2% at $114.15 on Friday after it released top-line results from two Phase IIU clinical trials, Study 3111-301-001 and Study 3111-302-001, evaluating the efficacy and safety of cariprazine (marketed as Vraylar) as an adjunctive treatment for patients with major depressive disorder (MDD), but which saw mixed results. 30 October 2021
Biotechnology
US drugmaker AbbVie has announced better than expected financial results for the third quarter of 2021, pushing the firm’s shares up 2.9% to $112.60 before the opening bell this morning. 29 October 2021
Pharmaceutical
Japan’s largest drugmaker Takeda Pharmaceutical today announced financial results for the first half of fiscal year 2021 (period ended September 30, 2021). Based on the strong first half results, the company also confirmed its fiscal year 2021 management guidance. 28 October 2021
Pharmaceutical
In October 2016, Gabriel Baertschi left his role as president and general manager of AstraZeneca in Japan to take the top job at Germany’s Grünenthal Group. 27 October 2021
Biotechnology
Having risen nearly 50% over the last six month to $57.68, US biotech Cortexyme saw its shares tank 72% to $16.18 in after-hours trading yesterday, after it revealed that its investigational oral Alzheimer’s candidate failed to achieve a clinical goal. 27 October 2021
Pharmaceutical
Israel’s Teva Pharmaceutical Industries and German drug developer MODAG GmbH have signed an exclusive worldwide licensing and development agreement for MODAG's lead compound anle138b and a related compound, sery433. 27 October 2021
Biotechnology
Of the significant news last week, US biopharma company Atea Pharmaceuticals on Monday announced disappointing Phase III results with its COVID-19 antiviral candidate AT-527, which is partnered with Swiss giant Roche. Last Sunday, US biotechs Biogen and Ionis Pharma released mixed new data on their amyotrophic lateral sclerosis (ALS) candidate tofersen (BIIB067). There was better news from Valneva, which presented positive new Phase III results for its coronavirus virus vaccine VLA2001 and from Sio Gene Therapies on Thursday, when it released early-stage results for AXO-AAV-GM1 in the treatment of gangliosidosis. 24 October 2021
Biotechnology
US clinical-stage drug developer Sio Gene Therapies has presented positive interim data from its ongoing Phase I/II study of AXO-AAV-GM1, its adeno-associated viral vector (AAV)9-based gene therapy candidate for the treatment of GM1 gangliosidosis. 22 October 2021
Biotechnology
Looking ahead to the potential implications of Biogen’s landmark approval in Alzheimer’s (AD), industry analyst GlobalData has conducted research into the market potential for a next-generation candidate. 21 October 2021
Biotechnology
The US medicines cost watchdog the Institute for Clinical and Economic Review (ICER) today released a Final Evidence Report assessing the comparative clinical effectiveness and value of eculizumab and efgartigimod for the treatment of generalized myasthenia gravis (gMG). 20 October 2021
Biotechnology
Biogen’s novel Alzheimer’s (AD) therapy is struggling to clear the launch pad, generating just $300,000 in the first quarter in which it became available. 20 October 2021
Pharmaceutical
Following recent discussions with the US regulator, Sage Therapeutics and partner Biogen said yesterday they plan to submit a New Drug Application (NDA) to the US Food and Drug Administration for zuranolone (SAGE-217), an investigational two-week, once-daily therapeutic, in the second half of 2022. 20 October 2021
Pharmaceutical
Japanese drugmaker Sumitomo Dainippon Pharma and Nashville, USA-based BehaVR have signed definitive agreements to develop and commercialize both prescription digital therapeutics and general wellness products for treatment of social anxiety disorder (SAD), generalized anxiety disorder (GAD), and major depressive disorder (MDD) with the goal of bringing much needed tools to tackle the escalating global anxiety and depression crisis. 20 October 2021
Pharmaceutical
Physics-based US software specialist Schrödinger and Centessa Pharmaceuticals, together with the latter’s subsidiary Orexia Therapeutics, today announced an exclusive collaboration focused on the discovery of novel therapeutics targeting the orexin-2 receptor (OX2R). 18 October 2021
Pharmaceutical
Japanese drugmaker Eisai has announced that the amyotrophic lateral sclerosis (ALS) treatment Rozebalamin for Injection (mecobalamin) has been launched in Japan as a treatment for slowing progression of functional impairment in amyotrophic lateral sclerosis. 21 November 2024
Pharmaceutical
Germany's Merck has spent more than 25 years researching and developing solutions for advancing multiple sclerosis (MS) care. 21 November 2024
Pharmaceutical
Swiss pharma giant Novartis today announced an upgrade to its mid-term guidance, in advance of its Meet Novartis Management event for investors and analysts in London. 21 November 2024
Pharmaceutical
Sage Therapeutics will down tools on its dalzanemdor program, after the Phase II DIMENSION trial missed both primary and secondary endpoints. 21 November 2024
Pharmaceutical
New York-based Mind Medicine, a company developing MM120, a form of LSD (lysergide d-tartrate), for mental health conditions, has announced the appointment of Gregg Pratt, as chief regulatory and quality assurance officer. 19 November 2024
Biotechnology
Last week saw US pharma major AbbVie release disappointing Phase II trial results on its emraclidine in schizophrenia, which benefited Bristol Myers Squibb. Also on the research front, Germany’s Merck KGaA and Abbisko’s pimicotinib showed positive results in tenosynovial giant cell tumor (TGCT). M&A news saw German BioNTech punting $800 million upfront to acquire China based oncology focused Biotheus. Also of note, US drugmaker Halozyme Therapeutics made an unsolicited takeover bid for Evotec, valuing the German firm, at around 2 billion euros. 17 November 2024
Biotechnology
The European Medicines Agency’s (EMA) human medicines committee (CHMP) made a number of recommendations at its November meeting, notable among which was a reversal of a previous rejection of Alzheimer’s drug Leqembi (lecanemab). 15 November 2024
Pharmaceutical
Germany’s Merck KGaA was trading 5% lower as Thursday’s trading day neared its end, after the company announced its third-quarter financial results and outlook for the rest of the year. 14 November 2024
Biotechnology
Swiss clinical-stage biopharma AC Immune saw its shares gain 8% to $3.38 in US trading this morning, after it released positive interim safety and immunogenicity data from the Phase II VacSYn clinical trial evaluating ACI-7104.056. 14 November 2024
Biotechnology
The US Food and Drug Administration (FDA) has granted accelerated approval of PTC Therapeutics’ gene therapy for the treatment of AADC (aromatic L-amino acid decarboxylase) deficiency, making it the first-ever gene therapy approved in the USA that is directly administered to the brain. 14 November 2024
Pharmaceutical
Digital therapeutics company GAIA has announced the signing of a licensing agreement for attexis with fellow German firm MEDICE Arzneimittel Pütter. 14 November 2024
Biotechnology
Cambridge, USA-based Vesalius Therapeutics has entered into a multi-target strategic alliance with the UK’s GSK to discover and develop novel treatments for Parkinson's disease, and another undisclosed neurodegenerative indication. 13 November 2024
Biotechnology
Neurogene has announced positive interim clinical data in the first four participants in the low-dose cohort of its ongoing Phase I/II open-label trial designed to evaluate NGN-401 gene therapy for the treatment of female pediatric patients with Rett syndrome. 13 November 2024
Biotechnology
Trace Neuroscience, a newly launched biopharma based in San Francisco, aims to advance treatments for neurodegenerative diseases, starting with amyotrophic lateral sclerosis (ALS). 12 November 2024
Pharmaceutical
US drugmaker AbbVie was trading more than 11% lower early on Monday afternoon in New York. 11 November 2024
Pharmaceutical
The Parkinson’s disease (PD) therapeutic landscape is heavily genericized, leaving substantial unmet needs in neuroprotective and disease-modifying therapies (DMTs), says data and analytics company GlobalData in an overview of ongoing PD research.. 11 November 2024
Pharmaceutical
Life science investors can be divided into two groups: those who bought Novo Nordisk stock before GLP-1s hit the big time, and those who wish they had. 10 November 2024
Pharmaceutical
Jazz Pharmaceuticals has reported third-quarter revenue of $1 billion, a 9% increase over the prior year, fueled by strong performance in its key sleep and epilepsy portfolios. 7 November 2024
Biotechnology
US clinical-stage drug developer Acumen Pharmaceuticals has appointed Amy Schacterle as chief regulatory officer and head of quality, reporting to Jim Doherty, president and chief development officer at Acumen. 7 November 2024
Pharmaceutical
Intra-Cellular Therapies has announced positive results from Study 304 evaluating the efficacy and safety of Caplyta (lumateperone) 42mg for the prevention of relapse in adult patients with schizophrenia. 6 November 2024
Sign up to receive email updates
Join industry leaders for a daily roundup of biotech & pharma news
Today's issue
Company Spotlight
A US biotech company dedicated to creating oral drugs with an emphasis on indications in virology and immunology.
Copyright © The Pharma Letter 2024 | Headless Content Management with Blaze