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Biotechnology
Cassava Sciences, a US biotech developing a novel, investigational treatment for Alzheimer’s disease (AD) dementia, was trading 83% lower at midday on Thursday. 25 November 2024
Biotechnology
A patient in Neurogene’s ongoing Phase I/II trial for Rett syndrome—who was dosed on November 5 with 3E15 vg of NGN-401—has now died from a treatment-related serious adverse event (SAE). 25 November 2024
Pharmaceutical
Lexicon Pharmaceuticals has announced a major strategic shift, prioritizing its late-stage pipeline following a rejection by the US Food and Drug Administration (FDA). 25 November 2024
Pharmaceutical
Japanese mid-size drugmaker Otsuka Pharmaceutical announced that it has entered into an exclusive worldwide licensing agreement with Ionis Pharmaceuticals for rights to manufacture and market Ionis' ulefnersen (ION363), a drug candidate under development for the treatment of patients with amyotrophic lateral sclerosis (ALS) caused by mutation of the fused in sarcoma (FUS) gene. 23 November 2024
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
The US Food and Drug Administration's Peripheral and Central Nervous System Drugs Advisory Committee yesterday voted 13 to three to approve drug giant Merck & Co's (NYSE: MRK) investigational insomnia medicine suvorexant at doses of 15mg and 20mg, but voted eight to seven (with one abstention) against the 30mg and 40mg doses, saying that these were not safe. 23 May 2013
Pharmaceutical
Japanese drugmaker Otsuka Pharmaceutical (TYO: 4578)) and Denmark's Lundbeck (LUND: DC) today (May 22) announced results from a preliminary analysis that showed statistically significant reductions (p<0.0001) in total psychiatric hospitalization rates in patients diagnosed with schizophrenia who were converted to once-monthly Abilify Maintena - an extended-release injectable suspension formulation of aripiprazole - compared to previous treatment with daily standard-of-care (SOC) oral antipsychotics. These data were presented in a poster at the 166th American Psychiatric Association Annual Meeting in San Francisco. 22 May 2013
Biotechnology
US biotech company Biogen Idec (Nasdaq: BIIB) has submitted a Biologics License Application (BLA) to the US Food and Drug Administration for approval of Plegridy (peginterferon beta-1a), the company's pegylated subcutaneous injectable candidate for relapsing forms of multiple sclerosis (RMS). 21 May 2013
Pharmaceutical
USA-based XenoPort (Nasdaq: XNPT) saw its shares fall 12.7% to $5.89 in mid-morning trading on Monday (May 20), after it revealed top-line results from its pivotal Phase III clinical trial of arbaclofen placarbil (AP) for the treatment of patients with spasticity due to multiple sclerosis (MS), which failed to demonstrate demonstrating that AP provided statistically significant improvement relative to placebo in the co-primary endpoints of the study. 21 May 2013
Pharmaceutical
Danish CNS specialist Lundbeck (LUND: DC) and partner Takeda Pharmaceutical (TYO: 4502), Japan's largest drugmaker, are presenting new data on four pivotal studies on Brintellix (vortioxetine), a novel investigational drug, at the 2013 Annual Meeting of the American Psychiatric Association (APA) in San Francisco, taking place May 18-22, demonstrating efficacy at doses of 15mg and 20mg per day including an improvement of overall functioning. 20 May 2013
Generics
US drugmaker Impax Laboratories (Nasdaq: IPXL) says that its generics division, Global Pharmaceuticals, commenced shipment of an authorized generic version of Zomig (zolmitriptan) tablets and orally disintegrating tablets, 2.5mg and 5mg, in the USA, as part of a distribution, license, development and supply agreement with Anglo-Swedish drug major AstraZeneca (LSE: AZN). 20 May 2013
Pharmaceutical
The impending publication of the fifth edition of the American Psychiatric Association's (APA) Diagnostic and Statistical Manual of Mental Disorders (DSM-V) later this month may affect diagnosis rates of conditions such as attention-deficit hyperactivity disorder (ADHD), both in the USA and worldwide, says new analysis by GBI Research. 16 May 2013
Pharmaceutical
Privately-held US firm Arbor Pharmaceuticals says that the US Food and Drug Administration has approved its New Drug Application for Nymalize (nimodipine) oral solution, marking the first NDA approval for the company. 15 May 2013
Pharmaceutical
New market entrants are set to defend the neurodegenerative diseases market from the looming patent cliff, leading global market revenue to increase from $8.8 billion in 2012 to $11 billion in 2018, according to a new analysis by GBI Research. 15 May 2013
Pharmaceutical
Ireland-headquartered Shire plc (LSE: SHP) said yesterday (May 13) that its single-daily dose long-acting prodrug stimulant, Elvanse (lisdexamfetamine dimesylate), is accepted for use within the National Health Service (NHS) in Scotland as part of a comprehensive treatment program for attention-deficit hyperactivity disorder (ADHD) in children aged six years of age and over when response to previous methylphenidate treatment is considered clinically inadequate. 14 May 2013
Generics
Endo Health Solutions (Nasdaq: ENDP) announced Friday (May 10) that the US Food and Drug Administration has denied a Citizen Petition filed by its subsidiary, Endo Pharmaceuticals, regarding the potential approval of additional non-abuse deterrent formulations of generic oxymorphone, the active ingredient of its Opana. Endo's shares fell 5.3% to $34.97 on the news. 13 May 2013
Pharmaceutical
US drug major Eli Lilly (NYSE: LLY) revealed that Phase III clinical trial results from enzastaurin's PRELUDE study, which explored the molecule as a monotherapy in the prevention of relapse in patients with diffuse large B-cell lymphoma (DLBCL), failed to show a statistically significant increase compared to placebo in disease-free survival in patients at high risk of relapse following rituximab-based chemotherapy. 10 May 2013
Pharmaceutical
US and European psychiatrists and US managed care organization (MCO) pharmacy directors surveyed by advisory firm Decision Resources agree that a therapy's ability to support abstinence is one of the attributes that most influences their decisions regarding prescribing and formulary status determinations, respectively, in the treatment of alcohol addiction. 10 May 2013
Pharmaceutical
Japanese drug major Eisai's (TYO: 4523) antiepileptic drug (AED) Fycompa (perampanel), shows a clear therapeutic benefit in difficult-to-treat patients with partial epilepsy, according to the investigators of two new analyses on early clinical experience of perampanel, presented on May 9 at the joint meeting of the German and Austrian Societies for Epileptology and the Swiss League Against Epilepsy in Interlaken, Switzerland. Perampanel was approved for use in the Europe Union in July 2012 and is now prescribed in several European countries, including Germany, Austria and Switzerland. 10 May 2013
Pharmaceutical
The US subsidiary of Israeli generics giant Teva Pharmaceuticals Industries (NYSE: TEVA) has entered into an exclusive US license and supply agreement for USA-based Alexza Pharmaceuticals (Nasdaq: ALXA) Adasuve (Staccato loxapine) inhalation powder 10mg for the acute treatment of agitation associated with schizophrenia or bipolar I disorder in adults. 9 May 2013
Pharmaceutical
Shares of US drugmaker Baxter International (NYSE: BAX) fell 2.5% to $68.58 in New York trading on May 7, having fallen as much as 3.3% in the morning, after it said that the Phase III clinical study of immunoglobulin (IG), Gammagard, did not meet its co-primary endpoints of reducing cognitive decline and preserving functional abilities in patients with mild to moderate Alzheimer's disease, marking another disappointment in finding improved treatment of the condition. 8 May 2013
Pharmaceutical
While high disease prevalence is encouraging pharmaceuticals companies to enter into the attention-deficit hyperactivity disorder (ADHD) market, a lack of understanding surrounding the condition is making drug development problematic, states GBI Research in a new report focusing on the disease market. 8 May 2013
Pharmaceutical
UK-based GW Pharmaceuticals (AIM: GWP) says that it has received commercialization approval for its cannabinoid-based prescription medicine Sativex from the authorities in Italy for the treatment of moderate to severe spasticity in multiple sclerosis (MS) patients who have not responded adequately to other anti-spasticity medications. 7 May 2013
Pharmaceutical
A law suit against pharmaceutical giant Pfizer (NYSE: PFE), for the permanent and devastating injuries their minor son suffered from birth defects allegedly caused by the firm's prescription antidepressant Zoloft (sertraline), that was prescribed to the mother during her pregnancy, has been launched by the boy's parents, Kori and Jami Wolcott, residents of Rochester, New York, according to law firm Lieff Cabraser Heimann & Bernstein. 7 May 2013
Generics
The US Food and Drug Administration is alerting health care providers and patients that medications including and related to valproate sodium, an epilepsy treatment, can cause decreased IQ scores in children whose mothers took the drugs during pregnancy. 7 May 2013
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