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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
Generics
US specialty and generics drugmaker Watson Pharmaceuticals (NYSE: WPI) has entered an accord with Moksha8, based in Sao Paulo, Brazil, that will expand Watson's commercial presence in Latin America's two largest markets, Brazil and Mexico. 6 October 2010
Pharmaceutical
A new report launched in the European Parliament shows inefficiencies in the treatment of chronic pain result in increasing health care costs and prolonged patient suffering. 6 October 2010
Pharmaceutical
In a move that aims to reduce R&D overheads, UK pharma giant GlaxoSmithKline (LSE: GSK) has spun out staff and patents relating to investigational pain relief products into a new company, Convergence Pharmaceuticals, which was officially launched yesterday, in exchange for an 18% stake, in the new firm. 5 October 2010
Pharmaceutical
Belgian company Galapagos NV (Euronext: GLPG) said yesterday that its affiliate, Argenta Discovery, has entered into a drug discovery service agreement with Janssen Pharmaceutica, a subsidiary of US health care giant Johnson & Johnson (NYSE: JNJ), aimed at delivering novel cancer drug candidates. The news was welcomed by investors, as Galapagos' shares rose 3.7% to an all-time high of 12.18 euros in morning trading following the announcement. 5 October 2010
Pharmaceutical
In a further re-evaluation of its research priorities, US drugs giant Merck & Co (NYSE: MRK) has returned worldwide rights to develop and commercialize Ampakine compounds for the treatment of schizophrenia and depression to fellow USA-based Cortex Pharmaceuticals (OTCBB: CORX). 5 October 2010
Pharmaceutical
There was a bunch of negative and good news coming out of the European Medicines Agency (EMEA) yesterday, with its Committee for Medicinal Products for Human Use (CHMP) giving the thumbs down for German drug major Merck KGaA's (FWB: MRK) cladribine for use in the treatment of multiple sclerosis, but supporting the continued use of two flu vaccines, as well as issuing a ban of GlaxoSmithKline's Avandia (rosiglitazone (see separate story today). 24 September 2010
article
As populations age, the number of patients suffering from dementia is set to increase sharply. In Germany alone, there are already 1.1 million people with dementia (1.3% of the population), according to government figures. By 2030 the total is likely to have reached 1.7 million. 24 September 2010
Pharmaceutical
Analysts at Nomura have described the US Food and Drug Administration's approval of Swiss drug major Novartis' (NOVN: VX) Gilenya (fingolimod), the first oral treatment for multiple sclerosis to get US clearance (The Pharma Letter September 22) as the dawn of a new 'Gillennium' for MS. 24 September 2010
Pharmaceutical
In what is a positive news day for Swiss drug major Novartis (NOVN. VX), the company announced this morning that it has received US Food and Drug Administration approval for its oral multiple sclerosis (MS) treatment Gilenya (fingolimod) 0.5 mg daily, a first-line treatment for relapsing forms of MS - the most common forms of the disease. 22 September 2010
Pharmaceutical
A landmark report on the global economic impact of dementia finds that Alzheimer's disease and other dementias are exacting a massive toll on the global economy, with the problem set to accelerate in coming years. The worldwide costs of dementia will exceed 1% of global Gross Domestic Product (GDP) in 2010, at $604 billion, and increase to $1,000 billion a year by 2030. Action is needed from governments around the world, the report urges. 22 September 2010
Pharmaceutical
According to statistics, the population aged 60 and above in China reached 167.14 million in 2009, accounting for 12.5% of the total It rose by 7.25 million (0.5%) compared with that in 2008. In 2009, the population aged above 80 in China reached 18.99 million. The GDP per capita of developed countries with a large aging population is usually $5,000-$10,000. Among over 70 countries with large aging populations, 36% have the GDP per capita of over $10,000. By contrast, the GDP per capita of China was less than $4,000 in 2009, which indicates that China has entered the aging society ahead of time. 21 September 2010
Pharmaceutical
The US Food and Drug Administration's Endocrinologic and Metabolic Drugs Advisory Committee yesterday voted nine to five against approval of Arena Pharmaceutical (Nasdaq: ARNA) and Japanese drugmaker Eisai's (TYO: 4523) obesity drug lorcaserin, sending the US firm's shares tumbling 43% to $2.14 and casting another blow for weight loss products. 17 September 2010
Pharmaceutical
Danish drugmaker Lundbeck A/S (LUND: DC) says that its partner Mochida Pharmaceutical (4534: JP) has filed a New Drug Application (escitalopram for the treatment of depression with the Japanese Ministry of Health, Labor and Welfare (MHLW). If approved, it is expected that escitalopram in Japan would be a meaningful contribution to Lundbeck's financial performance already in the period 2012-2014. 17 September 2010
Pharmaceutical
UK pharmaceutical giant GlaxoSmithKline (LSE: GSK) sustained a double dose of bad news yesterday, after the UK' drugs watchdog the National Institute for Health and Clinical Excellence (NICE) rejected approving the firm's Revolade (eltrombopag) for use under the National Health in England and Wales because it is too expesnive, and its antidepressant drug candidate, under development with the USA's Neurocrine Biosciences (Nasdaq: NBIX), failed in a Phase II study. 15 September 2010
Pharmaceutical
Adding albuterol, a compound commonly used to treat asthma and other respiratory diseases and the active ingredient of now off-patent Ventolin from GlaxoSmithKline, to an existing treatment for patients with multiple sclerosis - Copaxone (glatiramer acetate from Teva Pharmaceutical Industries - appears to improve clinical outcomes, according to a report in the September issue of Archives of Neurology, one of the JAMA/Archives journals. 15 September 2010
Pharmaceutical
The UK's National Health Service drug watchdog the National Institute for Health and Clinical Excellence (NICE) has asked US drug major Bristol-Myers Squibb and Japan's Otsuka Pharmaceuticals to provide more data on the effectiveness of their product Abilify (aripiprazole), as a treatment for schizophrenia in people aged 15 to 17 years. 14 September 2010
Pharmaceutical
Swiss drug major Novartis (NOVN. VX), which is in a race to bring oral multiple sclerosis drugs to the market with Germany's Merck KGaA (FWB: MRK), has received approval from the Russian health authority, the Federal Service on Surveillance in Healthcare and Social Development, for Gilenya (fingolimod; also using the brand name Gilenia) 0.5mg once-daily oral therapy for the treatment of relapsing remitting MS. 13 September 2010
Pharmaceutical
Noscira, a Spanish firm Grupo Zeltia (ZEL: MC) subsidiary specialized in R&D drugs to treat neurodegenerative diseases, has been granted US Food and Drug Administration fast track status for its neuroprotector drug Zentylor (tideglusib) to treat progressive supranuclear palsy (PSP), a fast-advancing fatal degenerative brain disorder. A Phase II trial with tideglusib in PSP commenced in December 2009 and is currently in progress. 13 September 2010
Pharmaceutical
The US Federal District Court has ruled in favor of Danish drugmaker H Lundbeck (LUND: DC) and found no violation of the antitrust laws in the company's acquisition of NeoProfen (ibuprofen lysine) Injection (10mg/mL), a drug used in premature infants with patent ductus arteriosus (PDA), a condition in which a blood vessel in the heart fails to close after birth. 13 September 2010
Pharmaceutical
Scientists have discovered a small molecule that helps human cells get rid of the misfolded, disfigured proteins implicated in Alzheimer's disease and other neurodegenerative ailments. This potential drug could have applications for other conditions as well. 10 September 2010
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