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The US Food and Drug Administration's Psychopharmacologic Drugs Advisory Committee (PDAC) has voted narrowly (nine to eight, with one abstention) to recommend that USA-based Alexza Pharmaceuticals' (Nasdaq: ALXA) Adasuve (Staccato loxapine) be approved for use as a single dose in 24 hours when used with the FDA recommended Risk Evaluation and Mitigation Strategy (REMS), for the treatment for agitation in patients with schizophrenia or bipolar mania. The news saw Alexza's shares leap 25% to $0.78 by close of trading yesterday. 15 December 2011
Pharmaceutical
The global attention deficit hyperactivity disorder (ADHD) therapeutics market was valued at $3.86 billion in 2010, according to a new report from GlobalData, which forecasts this to expand at a compound annual growth rate (CAGR) of 8.0% over the next eight years, to reach $7.11 billion by 2018. 14 December 2011
Biotechnology
Japanese mid-sized drugmaker Mochida Pharmaceutical (TYO: 4534) saw its shares jump 5.8% to 900 yen, after the company said it had entered into a license agreement with US drug giant Merck & Co (NYSE: MRK) relating to a portfolio of drug candidates invented by Mochida for the potential treatment for type-2 diabetes. 14 December 2011
Pharmaceutical
Anglo-Swedish drug major AstraZeneca (LSE: AZN) has out-licensed AZD4694, its late-stage radiopharmaceutical imaging candidate, to USA-based Neoprobe Corp (NYSE Amex: NEOP). AZD4694 is a Flourine-18 labeled radiotracer discovered by AstraZeneca to support development of potential treatments for Alzheimers disease. 13 December 2011
Biotechnology
US health care major Abbott Laboratories (NYSE: ABT) has entered into a second mega-million dollar licensing deal with closely-held biotech firm Reata Pharmaceuticals, this time gaining access to the latter's early-stage molecules showing promise treating chronic diseases like rheumatoid arthritis and multiple sclerosis, the companies said Sunday, according to the Wall Street Journal, although as yet there are no official press statements by either company. 12 December 2011
Biotechnology
Paris, France-based Cellectis genome engineering specialist (Alternext: ALCLS) has signed a license agreement with Swiss drug major Novartis (NOVN: VX) for the patents of the family WO 90/11354 covering certain uses of homologous recombination. This technology, which belongs to the Pasteur Institute and for which Cellectis owns exclusive rights, makes it possible to introduce new characteristics into genomes. 7 December 2011
Pharmaceutical
US federal rules and regulations related to transparency of prescription drug studies and prohibitions on off-label marketing are the focus of papers in the December 2011 issue of Health Affairs. In addition, a separate study examines the effect of prior authorization restrictions on the use of antipsychotic drugs. 5 December 2011
Pharmaceutical
UK NICE says Novartis MS drug Gilenya not cost effective, but backs extended use of Roche's MabThera
In further draft guidance published today (December 1), UK drugs watchdog the National Institute for Health and Clinical Excellence (NICE) says it has not been able to recommend Swiss drug major Novartis' (NOVN: VX) Gilenya (fingolimod) that could reduce relapses in some people who have a particular type of multiple sclerosis. The guidance is open to consultation until January 5, 2012. 1 December 2011
Pharmaceutical
After one year on the market, share of Swiss drug major Novartis' (NOVN: VX) Gilenya (fingolimod), the only oral disease-modifying agent (DMA) for the treatment of multiple sclerosis (MS), continues to increase, although not significantly, compared to six months ago, notes a new study by BioTrends Research (a Decision Resources unit). 30 November 2011
Biotechnology
Ireland-based neuroscience focused biotechnology company Elan Corp (NYSE: ELN) and the UK's University of Cambridge have announced plans to create The Cambridge-Elan Center for Research Innovation. Elan will invest $10 million over the first five years of the initial 10-year collaboration. 29 November 2011
Pharmaceutical
USA-based Pozen (Nasdaq: POZN) has entered into an accord with Canada's CPPIB Credit Investments (CII) to sell the company's right to receive future royalty payments arising from US sales of MT 400, including migraine drug Treximet, (sumatriptan/naproxen sodium) which incorporates the US company's MT 400 technology. 28 November 2011
Pharmaceutical
Finland-based Biotie Therapies (Nasdaq-OMX: BTH1V) says that, as it had already expected following disappointing clinical trial results, Belgian drugmaker UCB (Euronext Brussels: UCB) has confirmed that it does not intend to exercise its option to license its hydroxyphenylpyruvate dioxygenase (HPPD) inhibitor SYN118, under development for the treatment of Parkinson's disease. 25 November 2011
Pharmaceutical
In 2010, the global pain management market was worth approximately $28.6 billion, representing a compound annual growth rate (CAGR) of 5.3% between 2002 and 2010, according to a new report from business information firm GBI Research. By 2017, the global pain management market is estimated to reach $35.1 billion, indicating a CAGR of 3.0% between 2010 and 2017. 24 November 2011
Pharmaceutical
US drugmaker Transcept Pharmaceuticals (Nasdaq: TSPT) saw its shares jump 11% to $7.34 yesterday, after it said that the Food and Drug Administration has approved Intermezzo (zolpidem tartrate sublingual tablet) C-IV for use as needed for the treatment of insomnia when a middle-of-the-night awakening is followed by difficulty returning to sleep. 24 November 2011
Pharmaceutical
Belgian drugmaker UCB (Euronext Brussels: UCB) has acquired the key pharmaceutical assets of closely-held, UK based drug developer Lectus Therapeutics via a licence and acquisition agreement. 23 November 2011
Pharmaceutical
Danish CNS drug specialist Lundbeck (LUND: DC) and its new partner Japan's Otsuka Pharmaceutical (TYO: 4768).revealed yesterday that the US Food and Drug Administration has determined that a new drug application (NDA) for Otsuka's investigational once-monthly aripiprazole depot formulation for the indication of maintenance treatment of schizophrenia in adults is sufficiently complete to permit a substantive review. 23 November 2011
Pharmaceutical
Independent French drugmaker Pierre Fabre says that the Australian regulator the Therapeutic Goods Administration (TGA) has granted market authorization milnacipran for the treatment of fibromyalgia. 22 November 2011
Generics
US generics drugmaker Mylan (Nasdaq: MYL) says it has settled a patent litigation law suit with the US subsidiary of Swiss pharma major Novartis (NOVN: VX) related to Vivelle-Dot (estradiol transdermal system USP, twice-weekly, 0.025mg/day, 0.0375mg/day, 0.05mg/day and 0.075mg/day and 0.1mg/day), an estrogen patch to relieve symptoms of menopause. 21 November 2011
Pharmaceutical
Ireland-headquartered drugmaker Shire (LSE: SHP) has entered into an agreement with Japan's Shionogi (TKO: 4507) to co-develop and co-commercialize certain of Shire's attention-deficit hyperactivity disorder (ADHD) medicines in Japan. 21 November 2011
Pharmaceutical
Following the announcement of Switzerland-based Newron Pharmaceuticals (SIX: NWRN) regaining the global commercial rights to safinamide from Merck Serono, a division of Germany's Merck KGaA (MRK: DE: The Pharma Letter October 24), the company says it has received unsolicited approaches from a number of pharmaceutical and biopharmaceutical companies regarding licensing the compound and/or entering into discussions which could lead to an M&A transaction. 18 November 2011
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
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