Neurological
Refine Search
Pharmaceutical
In a filing with the US Securities and Exchange Commission (SEC), central nervous system specialist Axsome Therapeutics reveals proposed labeling has been received for its depression candidate AXS-05 (bupropion/dextromethorphan). 28 June 2022
Pharmaceutical
Russia plans to begin a second stage of clinical trials of an innovative drug for the treatment of Parkinson's disease and which was developed by scientists from Novosibirsk and Tomsk. According to scientists, this is the world’s first drug that can stop the development of the disease. 28 June 2022
Pharmaceutical
Danish firm Lundbeck and Japan’s Otsuka Pharmaceutical brought some rare good news in a challenging disease as they announced positive results from a Phase III trial of brexpiprazole in the treatment of agitation in patients with Alzheimer's-type dementia. 27 June 2022
Pharmaceutical
Regulatory news last week included a US Food and Drug Administration (FDA) advisory panel voting against approval of Acadia Pharmaceuticals’ Nuplazid for the treatment of Alzheimer’s associated with psychosis (ADP). Also, the FDA put a surprise clinical hold on a trial of Sarepta Therapeutics’ Duchenne muscular dystrophy (DMD) drug candidate SRP-5051 (vesleteplirsen). Among important research news, AstraZeneca and partner Ionis Pharmaceuticals announced positive results from a Phase III trial evaluating their rare disease candidate eplontersen. Meantime, Enanata Pharmaceuticals has filed a patent infringement suit against Pfizer relating to the latter’s highly successful COVID-10 antiviral Paxlovid. Troubled Belgian biotech Galapagos last Wednesday announced not one, but two acquisitions – CellPoint and AboundBio – aiming to expand into CAR-T therapeutics. 26 June 2022
Pharmaceutical
The US Food and Drug Administration (FDA) has unveiled an Action Plan for Rare Neurodegenerative Diseases including Amyotrophic Lateral Sclerosis (ALS). 24 June 2022
Biotechnology
Belgian drugmaker UCB was trading 3% lower on Friday afternoon as markets digests its acceptance of the need to revise its 2022 financial guidance to a more pessimistic outlook. 24 June 2022
Pharmaceutical
Shares in Athira Pharma, a US biopharma focused on developing small molecules to restore neuronal health and slow neurodegeneration, closed nearly 70% lower on Wednesday. 23 June 2022
Biotechnology
invoX Pharma, a wholly-owned subsidiary of Sino Biopharmaceutical that is focused on research and development (R&D) and business development activities outside of China, today announced that it has entered into a definitive agreement to acquire all of the issued and outstanding shares of F-star Therapeutics’ common stock. 23 June 2022
Biotechnology
Among significant news last week, US biotech Alnylam Pharmaceutical on Monday revealed that the Food and Drug Administration has approved its rare disease drug Amvuttra (vutrisiran). Japan’s Shionogi entered into a landmark collaboration to expand global access to its antibiotic cefiderocol. Swiss pharma giant Roche last Wednesday released new data on its Alzheimer’s disease candidate crenezumab that once again proved a failure. Also, rumors surfaced on Friday that US biotech Seagen is in talks with US pharma giant Merck & Co about a possible acquisition of the company with which it already has research collaborations. 19 June 2022
Pharmaceutical
The US Food and Drug Administration (FDA) Psychopharmacologic Drugs Advisory Committee (PDAC) meeting to discuss the case for approval of pimavanserin for the treatment of hallucinations and delusions associated with Alzheimer’s disease psychosis (ADP) resulted in a decisive negative vote of 9 to 3, noting that the evidence presented does not support a conclusion that pimavanserin is effective for the treatment of hallucinations and delusions in the ADP population. 18 June 2022
Biotechnology
Switzerland-headquartered biotech Addex Therapeutics today announced that it has terminated the Phase IIb/III study evaluating dipraglurant as a potential treatment for dyskinesia associated with Parkinson’s disease (PD-LID) due to the slow recruitment of patients. 17 June 2022
Biotechnology
Swiss drugmaker Roche has announced the results of a trial run in collaboration with Banner Alzheimer’s Institute, the University of Antioquia in Colombia and the National Institute on Aging. 16 June 2022
Pharmaceutical
Nuplazid (pimavanserin), which is approved for the treatment of Parkinson’s disease psychosis, could struggle to gain a new nod in Alzheimer’s after agency briefing notes revealed doubts over the developer’s submission. 16 June 2022
Pharmaceutical
LifeArc and the UK Dementia Research Institute (UK DRI) have today launched a new partnership to accelerate development of new diagnostic tests, treatments, and devices from scientific research discoveries to benefit people with dementia, which around 900,000 people in the UK are living with. 16 June 2022
Biotechnology
RNAi therapeutics company Alnylam Pharmaceuticals today announced that the US Food and Drug Administration (FDA) approved Amvuttra (vutrisiran), an RNAi therapeutic administered via subcutaneous injection once every three months (quarterly) for the treatment of the polyneuropathy of hereditary transthyretin-mediated (hATTR) amyloidosis in adults. 14 June 2022
Pharmaceutical
Amylyx Pharmaceuticals’ shares closed down 3.9% at $13.00 on Monday, despite announcing it has received the first regulatory approval for its Albrioza (sodium phenylbutyrate and ursodoxicoltaurine), from Health Canada, for the treatment of amyotrophic lateral sclerosis (ALS). 14 June 2022
Pharmaceutical
At the annual meeting of the American Headache Society (AHS), central nervous system specialist Impel Pharmaceuticals is to outline one oral presentation and three posters from the Phase III STOP 301 trial. 10 June 2022
Biotechnology
Shares in Boston, USA-based biotech Praxis Precision Medicines closed down 78% at $1.88 on Monday, after the company said that a Phase II/III trial of PRAX-114 monotherapy for major depressive disorder (MDD) missed its primary endpoint. 7 June 2022
Pharmaceutical
Italian CNS-focused drug developer Newron Pharmaceuticals saw its shares gain 6.9% to 1.55 Swiss francs this morning, after it announced encouraging interim results from the first 100 patients in its world-first, international, six-week, open-label, randomized, rater-blinded, multicenter study of evenamide as an add-on to an antipsychotic in patients with moderate to severe treatment-resistant schizophrenia (TRS) who were not responding to current antipsychotic medication. 7 June 2022
Biotechnology
Prothena has an intriguing Alzheimer’s vaccine, dubbed PRX123, which is yet to enter the clinic but which scientists believe could stop the development of both Abeta and tau in the brain. 6 June 2022
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