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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
The US Department of Veterans Affairs (VA) has placed the first new Food and Drug Administration-approved treatment option for amyotrophic lateral sclerosis (ALS) in more than 20 years on its National Formulary for coverage. 30 November 2017
Biotechnology
Switzerland’s Novartis today has published in the prestigious New England Journal of Medicine positive results from the Phase III STRIVE study, which is designed to evaluate the firm’s migraine candidate erenumab. 30 November 2017
Biotechnology
US biotech major Biogen has entered into a global license and collaboration agreement with Ireland-incorporated biotech firm Alkermes to develop and commercialize ALKS 8700 as a treatment for multiple sclerosis. 27 November 2017
Pharmaceutical
Aside from issues concerning how to enforce second medical patents, the validity issues at the core of the Warner-Lambert case are on their way to the UK Supreme Court and have potentially significant implications for pharma patents, writes Andrew Hutchinson, a patent litigation partner at Simmons & Simmons LLP, in an Expert View piece. 23 November 2017
Biotechnology
A damning assessment of the cost-benefit of vesicular monoamine transporter-2 (VMAT2) inhibitors for management of tardive dyskinesia (TD) has been released by USA-based not-for-profit Institute for Clinical and Economic Review (ICER). 22 November 2017
Pharmaceutical
New York-listed Acorda Therapeutics has formally ended development of tozadenant for Parkinson's disease, days after the company’s Phase III trial program was effectively halted due to worrying safety data. 21 November 2017
Pharmaceutical
Last week’s most interesting news included a mega licensing deal by Germany’s Bayer, which acquired rights to Loxo Oncology’s cancer candidate larotrectinib for up to $1.55 billion. There was also a great deal of news on the regulatory front, with Heron Therapeutics gaining US Food and Drug Administration approval for its CINV drug Cinvanti. Celgene and bluebird bio were granted Breakthrough and PRIME designation for their multiple myeloma candidate bb2121, and FDA approval came through for AstraZeneca’s asthma drug Fasenra and Ultragenyx’ Sly syndrome treatment Mepsevii. 19 November 2017
Pharmaceutical
Acorda Therapeutics, which last week suffered a significant setback with its Phase III program of Parkinson’s disease drug tozadenant, on Friday announced a $40 million royalty monetization with HealthCare Royalty Partners (HCR) and a $13 million royalty monetization with Denmark’s Lundbeck. 18 November 2017
Pharmaceutical
Egalet says its share move up a hefty 38.55% after announcing positive top-line trial results from a Phase III safety study of its abuse-deterrent oxycodone formulation Egalet-002. 17 November 2017
Pharmaceutical
With the number of opioid-related deaths in Canada set to exceed 3,000, the nation’s government has announced new measures to tackle the epidemic but admits that these alone will not change the current course of events. 16 November 2017
Pharmaceutical
The US healthcare system is not ready for potential breakthrough dementia treatments, according to a new Rand Corporation study released yesterday. 16 November 2017
Pharmaceutical
Acorda Therapeutics yesterday announced that it has increased the frequency of blood cell count monitoring for participants to weekly in its Phase III program of tozadenant for Parkinson’s disease. 16 November 2017
Biotechnology
Russia’s largest biotech firm Biocad has sent a package of documents for re-registration of the price of a number of vital medicines down by 50% to 91%. 15 November 2017
Pharmaceutical
The US Food and Drug Administration (FDA) has approved the first drug with a digital ingestion tracking system. 14 November 2017
Pharmaceutical
Tech entrepreneur and world’s richest man Bill Gates has announced a $50 million contribution to the UK-based Dementia Discovery Fund. 13 November 2017
Pharmaceutical
In the field of M&A last week, attracting a great deal of attention was debt-ridden Canadian firm Valeant Pharmaceuticals International's sale of its subsidiary Sprout Pharmaceuticals. The regulatory arena saw US Food and Drug Administration approvals for: Roche’s cancer drug Alecensa; Seattle Genetics’ Adcetris for lymphoma; and Dynavax’ hepatitis B drug Heplisav-B. Sage Therapeutics’ Phase III trial of brexanolone in postpartum depressive disorder raised questions on what this would mean for Marinus Pharmaceuticals, and Sanofi’s deal with Principia Biopharma for a novel multiple sclerosis candidate PRN2246 also raised comments. 12 November 2017
Biotechnology
The European Medicines Agency has concluded its review of the multiple sclerosis medicine Zinbryta (daclizumab) and confirmed further restrictions to reduce the risk of serious liver damage, the EMA announced on Friday. 11 November 2017
Biotechnology
Sage Therapeutics scored a massive win for its investors and potentially for patients too as its Phase III trials in postpartum depression met their primary endpoints. 10 November 2017
Pharmaceutical
The US Food and Drug Administration has accepted for review the New Drug Application (NDA) for dasotraline, a novel dual-acting dopamine and norepinephrine reuptake inhibitor (DNRI) being evaluated for the treatment of attention deficit hyperactivity disorder (ADHD) in children, adolescents and adults by US drugmaker Sunovion Pharmaceuticals. 10 November 2017
Pharmaceutical
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended seven new drugs for approval, including two orphan medicines and one biosimilar, at its November 2017 meeting. 10 November 2017
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