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Biotechnology
US companies Arrowhead Pharmaceuticals and Sarepta Therapeutics have announced a global licensing and collaboration agreement. 26 November 2024
Pharmaceutical
US central nervous system (CNS) disorders specialist Axsome Therapeutics today released encouraging late-stage results for its narcolepsy candidate AXS-12 (reboxetine), sending its shares edging up 2.6% to $100.00 in pre-market activity. 26 November 2024
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
The US Food and Drug Administration has approved German independent drug major Boehringer Ingelheim's Mirapex ER (pramipexole dihydrochloride) extended-release tablets, a new once-daily treatment option for the signs and symptoms of early idiopathic Parkinson's disease. The drug is not indicated in advanced PD. 23 February 2010
Pharmaceutical
DURECT and Nycomed amend Posidur deal to separate funding and control of US and EU clinical programs
Switzerland-headquartered Nycomed and the USA's DURECT have amended the licensing agreement entered into between the parties in November 2006 covering the development and commercialization of Posidur (also known as Saber [bupivacaine] or Optesia), an investigational drug for the treatment of post-surgical pain. 23 February 2010
Pharmaceutical
In what was clearly a good couple of days for Swiss drug major Novartis, the company revealed last Friday that Tasigna (nilotinib) 20mg capsules has been granted priority review by the US Food and Drug Administration for the treatment of adult patients with newly-diagnosed Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase, meaning the drug's standard approval time will be cut from 10 to six months, and this morning stated that a like status was approved for its multiple sclerosis drug Gilenia (fingolimod; FTY720). It also said today that the agency has cleared its vaccine Menveo for active immunization to prevent invasive meningococcal disease. 22 February 2010
Pharmaceutical
The European Medicines Agency (EMEA) Committee for Medicinal Products for Human Use (CHMP) announced a number of decisions resulting from its February 15-19 meetings, including recommending the granting of a conditional marketing authorization for a fifth pandemic vaccine, Humenza (split virion, inactivated, AF03 adjuvanted influenza H1N1 pandemic vaccine), from Sanofi Pasteur, a unit of French drug major Sanofi-Aventis, intended for the prophylaxis of influenza in an officially declared pandemic situation. This recommendation was made using an emergency procedure which fast-tracks evaluation of new vaccines developed during a pandemic. 22 February 2010
Pharmaceutical
UK drugs giant GlaxoSmithKline and partner XenoPort have received a negative response from the US Food and Drug Administration regarding their marketing application for their restless legs syndrome (RLS) drug. 18 February 2010
Pharmaceutical
For the treatment of moderate to severe Alzheimer's disease, a combination therapy that delays nursing home admission at 19 months would earn 43 percent patient share, according to surveyed US neurologists carried out by advisory firm Decision Resources. In comparison, in Europe, such an agent would earn a slightly lower patient share of 30 percent, according to surveyed European neurologists. This lower share estimate is possibly a result of higher price sensitivity of European markets. 18 February 2010
Pharmaceutical
The USA's Federal Trade Commission has sent letters to 11 companies that promote various omega-3 fatty acid supplements, telling them they should review their product packaging and labeling to make sure they do not violate federal law by making baseless claims about how the supplements benefit children's brain and vision function and development. 18 February 2010
Pharmaceutical
Neuropathic pain - brighter future for pipeline drugs with market to double in value to $5.2 billion
The neuropathic pain market is forecast to more than double in value from 2008 to total $5.2 billion by 2018 across the seven major markets - the USA, Japan, and the five leading European Union (France, Germany, Italy, Spain and the UK), according to a new report from Datamonitor. Although the USA will provide the greatest increase in value over this period, Japan and the five EU markets will post double-digit compound annual growth rates. 17 February 2010
Biotechnology
UK biotechnology firm Vernalis has announced the placing of 30 million ($46.3 million) in new shares to fund the reacquisition of European Union royalties on its antimigraine drug frovatriptan (trade name Frova) from Paul Capital, and to progress its development pipeline. This placing and transaction substantially strengthen Vernalis' cash position, ahead of IN STEP trial data in March, enabling the company to become debt free and to extend its cash runway beyond 2012, commented analysts at Edison Investment Research. 15 February 2010
Pharmaceutical
Switzerland's Debiopharm Group has granted an exclusive, worldwide (excluding Japan) licence to Swiss drug major Novartis for the development, manufacture and commercialization of Debio 025 (alisporivir), a selective, first-in-class cyclophilin (Cyp) inhibitor with a potent anti-hepatitis C virus (HCV) effect. The product is currently in Phase IIb clinical development for the treatment of hepatitis C. 9 February 2010
Pharmaceutical
Irish drugmaker Elan saw its share price drop 5.8% to 5.05 euros, after it was revealed that the US Food and Drug Administration had found that the risk of a potentially fatal brain disorder with the firm's multiple sclerosis drug Tysabri (natalizumab) increases as patients receive more infusions and called for stronger warnings. The agency did, however, reiterate its views that the benefits for MS patients associated with the drug still outweigh the risks. 8 February 2010
Pharmaceutical
Estimates of pain care treatment costs exceed $1 billion annually in the USA, according to two presentations at the American Academy of Pain Medicine's 26th Annual Meeting. One evaluated intrathecal drug delivery (a targeted medicine delivery system) that could save costs over time. The other analyzed the differences between the costs of treatment for chronic pain treatments. 5 February 2010
Pharmaceutical
In a new study, 60mg of Cymbalta (duloxetine HCl) taken once daily significantly reduced chronic low back pain, as measured by the Brief Pain Inventory (BPI) average pain rating, compared with placebo. 5 February 2010
Pharmaceutical
The US Food and Drug Administration has approved Canadian company Labopharm's Oleptrol (trazodone hydrochloride) extended release tablets, a novel once-daily formulation of the antidepressant trazodone, for the treatment of major depressive disorder (MDD) in adults. Oleptrol utilizes Contramid, Labopharm's clinically validated technology that controls the release of active substances within oral medications. 4 February 2010
Pharmaceutical
The US Food and Drug Administration yesterday granted marketing authorization for Danish insulin giant Novo Nordisk's Victoza (liraglutide) for the treatment of type 2 diabetes in adults, and also for US firm BioSpecific Technologies' Xiaflex (collagenase clostridium histolyticum) for a debilitating hand condition. 3 February 2010
Generics
The UK subsidiary of global drugs behemoth Pfizer has today launched six generic medicines for its pharmacy and dispensing customers. These drugs have been introduced into Pfizer's Established Products Business Unit portfolio of over 80 off-patent medicines, following agreements between Pfizer and generic medicine manufacturers Aurobindo Pharma and Claris Lifesciences last year, the firm noted. 3 February 2010
Generics
A recent drug safety warning from the UK's Medicines and Healthcare products Regulatory Agency (MHRA) on the dangers of switching immunosuppressants calls into question the safety of the Department of Health's proposal for Automatic Generic substitution. 2 February 2010
Pharmaceutical
UK drug giant GlaxoSmithKline received two pieces of good news from the US Food and Drug Administration last Friday related to its breast cancer drug Tykerb (lapatinib) and Lamictal XR (lamotrigine), currently indicated for epilepsy and for maintenance treatment of bipolar I disorder. 1 February 2010
Pharmaceutical
Belgian drugmaker UCB says that it plans to accelerate its US transition to a purely specialty-focused biopharmaceutical company and will exit the American primary care market, effective March 1. 1 February 2010
Pharmaceutical
Sales of multiple sclerosis disease-modifying therapies exceeded $6.0 billion in 2008 across the seven major markets (USA, Japan, France, Germany, Italy, Spain and the UK). Market research group Datamonitor anticipates the combination of continuing strong historical growth dynamics and the uptake of the first oral therapies to result in the market value peaking at $8.4 billion in 2013 before the advent of biosimilars. 1 February 2010
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