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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
Shareholders of struggling pain-management firm Anesiva have approved the merger with Arcion Therapeutics, first announced in the summer. In connection with the deal, Anesiva stockholders also approved a one-for-40 reverse stock split, which will be effected upon the close of the merger. 8 December 2009
Pharmaceutical
US drug majors Bristol-Myers Squibb and Pfizer are planning to submit a European application for regulatory approval of apixaban for the prevention of venous thromboembolism (VTE) after orthopedic surgery in the first half of 2010. 7 December 2009
Pharmaceutical
New research shows that drug major Abbott Laboratories Meridia (sibutramine), a popular weight-loss drug, has caused a significantly increased number of heart attacks, strokes, resuscitated cardiac arrests or deaths in obese patients getting the drug and should, therefore, be pulled from the market immediately, claims the US advocacy group Public Citizen, in a petition to the Food and Drug Administration yesterday. 4 December 2009
Pharmaceutical
Multiple sclerosis patients still face inequity of access to innovative treatments in Europe. There is a clear demarcation between Western Europe, where around 45% of patients are treated and Central/Eastern Europe where only 5% to 25% do so. 4 December 2009
Biotechnology
December 4, 2009
US biotechnology firm Biogen Idec is continuing its fight to gain control of Facet Biotech, increasing its offer to $17.50 per share in cash, representing a rise of $3.00 per share, or 21%, over its previous bid. Biogen said that this is its 'best and final offer,' but was nevertheless reject by the board of Facet. The offer will expire on December 16. 4 December 2009
Pharmaceutical
The US Food and Drug Administration has approved Anglo-Swedish drug major AstraZeneca's once-daily blockbuster drug Seroquel XR (quetiapine fumarate) extended release tablets as adjunctive (add-on) treatment to antidepressants in adults with major depressive disorder (MDD). 4 December 2009
Generics
The US Federal Trade Commission today announced a proposed consent order settling charges that Watson Pharmaceutical' of Robin Hood Holdings, owner of Arrow Pharmaceuticals, would have harmed consumers by eliminating future competition for important generic drugs used to treat Parkinson's disease notably (cabergoline) and the side effects of chemotherapy (dronabinol). The Commission's order requires the firms to sell assets related to the two drugs to FTC-approved buyers and to ensure the acquirers have the means to compete effectively in the future. 4 December 2009
Pharmaceutical
development and commercialization of TC-5214, Targacept's late-stage investigational product for major depressive disorder (MDD). 3 December 2009
Biotechnology
UK Department of Health's 'money back' deal for MS drugs questioned; failing people with the disease
December 23, 2009
In 2002, the UK's National Institute for Clinical Excellence (NICE) ruled that certain drugs for the treatment of multiple sclerosis were not cost effective. In response, the Department of Health set up an observational study called the Risk Sharing Scheme. The aim of the study was to observe the effects of these drugs (over a 10-year period) and if the four drugs in question failed to perform as promised then the manufacturers would share the risk of any potential negative outcomes by subsidising their future cost to the National Health Service. The scheme promised to make these drugs available to all those with MS who fitted the study criteria. 3 December 2009
Pharmaceutical
The USA's Galenea and Japan's Otsuka Pharmaceutical plan to further extend their R&D collaboration through 2011. This latest extension increases the term of the deal to seven years and brings the total committed funding to around $90 million. 3 December 2009
Biotechnology
German drug major Bayer Schering Pharma said today that the Chinese State Food and Drug Administration (SFDA) has approved Betaferon (interferon beta-1b) therapy for patients with relapsing-remitting multiple sclerosis (MS). Bayer plans to launch Betaferon in China by mid 2010. Betaferon is already available in more than 100 countries around the world. 1 December 2009
Pharmaceutical
In a move that will delay the approval of German drug major Merck KGaA's multiple sclerosis drug cladribine, the US Food and Drug Administration has issued a 'refuse to file' letter on the firm's New Drug Application for the compound as a therapy for relapsing forms of MS. 1 December 2009
Pharmaceutical
UK cannabinoid-based drugmaker GW Pharmaceuticals says that the results of a clinical study of Sativex in the treatment of cancer pain have been published in the Journal of Pain and Symptom Management. The authors of the paper conclude that 'this study shows that Sativex is efficacious for relief of pain in patients with advanced cancer pain not fully relieved by strong opioids.' Preliminary results from this study have previously been announced by GW. 25 November 2009
Pharmaceutical
Driven by the continued dominance of opioids that include immediate-release morphine and novel fast acting opioid reformulations, the cancer pain drug market will UK and Japan, according to research and advisory firm Decision Resources. 25 November 2009
Pharmaceutical
Cannabis Science, an emerging US pharmaceutical cannabis company, is hailing the call by the American Medical Association's House of Delegates for 'marijuana's status as a federal Schedule I controlled substance be reviewed with the goal of facilitating the conduct of clinical R&D of cannabinoid-based medicines."
Richard Cowan, Cannabis Science chief financial 24 November 2009
Pharmaceutical
The European Medicines Agency (EMEA) says it has started a review of sibutramine-containing anti-obesity medicines (marketed in Europe under trade names such as Reductil, Zelium, Reduxade), because preliminary data suggest a possible increased risk of serious cardiovascular events. The decision to do so came at the agency's November 16-19 meetings, which also saw decisions on a number of other drugs, reported separately today. under the heading of 'Meeting highlights.' 23 November 2009
Biotechnology
Following its November 16-19 meetings, the European Medicines Agency (EMEA) says it has reviewed further data on the centrally authorized pandemic vaccines, Celvapan (from Baxter International), Focetria (from Novartis) and Pandemrix (from GlaxoSmithKline). The Agency has reaffirmed that they have a positive balance of benefits and risks in the context of the current H1N1 influenza pandemic. 23 November 2009
Pharmaceutical
US FDA clears new indications for B-MS/Otsuka's Abilify and Pfizer's Geodon 23 November 2009
Pharmaceutical
Japanese drug major Astellas Pharma has filed a New Drug Application with the Pharmaceuticals and Medical Device Agency (PMDA) in Japan for ASP8825 (gabapentin enacarbil), also known as XP13512, as a potential treatment for restless legs syndrome (RLS). 20 November 2009
Pharmaceutical
The European Medicines Agency(EMEA) has been formally notified by Otsuka Pharmaceutical Europe, a unit of the Japanese drugmaker, of its decision to withdraw its application for an extension of indication for the centrally authorized medicine Abilify (aripiprazole) tablets, orodispersible tablets and oral solution. 20 November 2009
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