Neurological
Refine Search
Biotechnology
Genzyme, a subsidiary of French drug major Sanofi (Euronext: SAN) today reported top-line results from the Phase III TOWER study (n=1169) showing that once-daily treatment with teriflunomide (proposed trade name Aubagio) 1mg produced a statistically significant reduction in annualized relapse rate (36.3%, p<0.0001) and risk of sustained accumulation of disability (31.5%, p=0.0442) as measured by EDSS in patients with relapsing forms of multiple sclerosis. 1 June 2012
Pharmaceutical
US psychiatrists surveyed by advisory firm Decision Resources indicate that they would prescribe Roche/Chugai's bitopertin to 28% of their patients with negative symptoms of schizophrenia, which is equivalent to a patient share of approximately 17% of the diagnosed schizophrenia population. 30 May 2012
Pharmaceutical
Although the death toll is relatively low for people who suffer from traumatic brain injury (TBI), it can have severe, life-long consequences for brain function. TBI can impair a patient's mental abilities, impact memory and behavior, and lead to dramatic personality changes. And long-term medical treatment carries a high economic cost. 30 May 2012
Generics
US health care giant Johnson & Johnson's (NYSE: JNJ) Janssen Therapeutics division has received a complete response letter for the US Food and Drug Administration for a Supplemental New Drug Application (sNDA) for an 800mg tablet formulation of Prezista (darunavir). 30 May 2012
Generics
US generics drug major Mylan (Nasdaq: MYL) has entered into a settlement agreement with Sunovion Pharmaceuticals, a unit of Japanese drugmaker Dainippon Sumitomo Pharma (4506: JP), that will resolve the parties' patent litigation in connection with Mylan Specialty's Abbreviated New Drug Application for levalbuterol hydrochloride inhalation solution, 0.31mg/3mL, 0.63mg/3mL, 1.25g/3mL and 1.25mg/0.5mL, a generic version of Sunovion's Xopenex which is indicated for the treatment or prevention of bronchospasm. 30 May 2012
Biotechnology
USA-based Rainbow BioSciences, the biotech subsidiary of Rainbow Coral Corp (OTCBB: RBCC) revealed yesterday that it is continuing due diligence toward an agreement to help develop a promising new treatment for traumatic brain injury (TBI), as concern continues to grow over the troubling incidence of TBI among athletes and soldiers. 29 May 2012
Pharmaceutical
Danish CNS drug specialist Lundbeck (LUND: DC) announced this morning that its investigational compound Lu AE58054 has met its primary endpoint in a fixed dose, randomized, placebo-controlled clinical study in 278 patients suffering from Alzheimer's disease. Lu AE58054 is a novel, selective 5HT6 receptor antagonist with a different mechanism of action than currently available Alzheimer's medications. 29 May 2012
Pharmaceutical
At its regular monthly meeting last week, the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) issued a number of positive opinions on new medicinal products, including the following: 27 May 2012
Pharmaceutical
A significantly lower proportion of subjects experiencing treatment failure whilst receiving UK specialty drugmaker Shire's (LSE: SHP) attention-deficit hyperactivity disorder (ADHA) treatment Vyvanse (lisdexamfetamine dimesylate) in the randomized withdrawal period, compared to those subjects receiving placebo, new data demonstrate. 24 May 2012
Pharmaceutical
The UK subsidiary of Belgian drugmaker UCB (Euronext Brussels: UCB) yesterday announced two new projects that aim to help meet the needs of the epilepsy community and improve the lives of people with epilepsy. 21 May 2012
Generics
Ireland-headquartered Warner Chilcott (Nasdaq: WCRX) has filed suit against USA-based Watson Pharmaceuticals (NYSE: WPI) on May 16, in the US District Court for the District of New Jersey seeking to prevent Watson from commercializing its Abbreviated New Drug Application for it contraceptive product prior to the expiration of US Patent Nos 5,552,394 and 7,704,984. 20 May 2012
Biotechnology
US biotech company Biogen Idec (Nasdaq: BIIB) and Ireland-based partner Elan (NYSE: ELN) said that a global risk management program that updates the risk of their Tysabri (natalizumab)-associated progressive multifocal leukoencephalopathy (PML), an infrequent but serious brain infection that usually leads to death or severe disability, in people with multiple sclerosis (MS) has been published in the New England Journal of Medicine. 20 May 2012
Pharmaceutical
Janssen Pharmaceuticals, a unit of health care major Johnson & Johnson yesterday announced the results of an investigational Phase III study suggesting that Nucynta ER (tapentadol) extended-release tablets were significantly more effective than placebo in providing pain management among adults with chronic moderate to severe, painful diabetic peripheral neuropathy (DPN). Results of the study were presented at the 31st Annual Scientific Meeting of the American Pain Society being held May 16-19 in Honolulu, Hawaii. 18 May 2012
Pharmaceutical
A collaboration of the US National Institutes of Health (NIH), Banner Alzheimer's Institute (BAI), University of Antioquia in Colombia and Swiss drug major Roche's (ROG: SIX) subsidiary Genentech has announced the first-ever prevention trial in cognitively healthy individuals who are destined to develop Alzheimer's disease because of their genetic history. 17 May 2012
Pharmaceutical
In what was a busy news day for Italian drug developer Newron Pharmaceuticals SpA (SIX: NWRN), the company has updated on its licensing deal with fellow Italy-based Zambon, presented new data on its Parkinson's disease drug candidate safinamide, rights to which had previously been vested in Merck Serono which returned them last year (The Pharma Letters October 24, 2011, and April 9, 2012), and announced the departure of its chief executive. 15 May 2012
Pharmaceutical
Danish CNS drug specialist Lundbeck A/S (LUND: DC) yesterday announced positive top-line results from three recently completed Phase III clinical studies of Lu AA21004, an investigational drug for the treatment of adults with major depressive disorder (MDD) using dosages from 10mg to 20mg. 15 May 2012
Pharmaceutical
Confirming previous negative guidance (The Pharma Letter January 12), UK drugs watchdog the National Institute for Health and Clinical Excellence (NICE), has today (11 May) published final guidance in which it recommends against the routine National Health Service use of French pharma major Sanofi's (Euronext: SAN) Jevtana (cabazitaxel) in combination with prednisone or prednisolone as a second line treatment for prostate cancer. 11 May 2012
Pharmaceutical
The US Food and Drug Administration's Arthritis Advisory Committee yesterday voted unanimously (11 to 0) against approval of US drugmaker Regeneron Pharmaceuticals' (Nasdaq: REGN) Arcalyst (rilonacept) injection for subcutaneous use for the proposed indication for the prevention of gout flares in patients initiating uric acid-lowering therapy 9 May 2012
Biotechnology
The German Institute for Quality and Efficiency in Health Care (IQWiG) in the past few days issued a mixed batch of opinions for backing the use three drugs under Germany's new legislation, the Act on the Reform of the Market for Medicinal Products (AMNOG). 9 May 2012
Pharmaceutical
Spain's leading drugmaker Almirall (ALM: MC) has reported a 5.9% decrease in sales for the first quarter of 2012 to 200.2 million euros ($262.5 million), mainly due to Spanish reforms and generic competition. This figure is up on the company's previous guidance, and the stock gained a modest 0.5% to 6.47 euros in morning trading. 9 May 2012
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
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