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Pharmaceutical
Nortriptyline, a second-generation tricyclic antidepressant, has been found to cause a 10-fold increase in suicidal thoughts in men when compared to its competitor escitalopram. These findings are published in the open access journal BMC Medicine. 14 October 2009
Pharmaceutical
USA-based Vanda Pharmaceuticals has entered into an exclusive agreement for Swiss drug major Novartis to buy back commercialization and development rights to Fanapt (iloperidone) in the USA and Canada. Fanapt, an atypical anti-psychotic, was approved by the US Food and Drug Administration earlier this summer for the acute treatment of schizophrenia in adults. The US anti-psychotic market is valued at around $14 billion a year. 13 October 2009
Pharmaceutical
German drug major Bayer Schering Pharma will provide its development candidate florbetaben, a so called PET (positron emission tomography) tracer, to the Swiss-based biopharmaceutical company AC Immune SA, to support a clinical trial in the field of Alzheimer's disease (AD). Financial terms of the deal were not disclosed. 12 October 2009
Pharmaceutical
San Diego, USA-based ACADIA Pharmaceuticals and Canadian biotechnology firm Biovail have said they will continue the development of their Parkinson's disease investigational drug pimavanserin despite disappointing top-line results from the first Phase III PDP trial announced in September. The companies also intend to pursue adjunctive therapy with pimavanserin for schizophrenia as a third indication in the collaboration. 7 October 2009
Pharmaceutical
Switzerland's Santhera Pharmaceuticals, which is focused on orphan neuromuscular diseases, has announced the final closing of its acquisition of Oy Juvantia Pharma of Turku, Finland. Santhera issued 105,973 previously reserved shares from its authorized share capital to Juvantia investors, as announced when exercising its option to acquire Juvantia on August 17, 2009 (The Pharma Letter August 17 and 25). 5 October 2009
Biotechnology
Swiss drug major Novartis has revealed that data from a two-year, late-stage study showed that its oral drug FTY720 (fingolimod) was significantly superior to placebo in reducing relapses and disability progression in patients with relapsing-remitting multiple sclerosis (MS). 1 October 2009
Pharmaceutical
AstraZeneca says that its once-daily Serooquel XR (quetiapine fumarate extended-release tablets) and Seroquel have been approved under the European Mutual Recognition Procedure for the prevention of recurrence of bipolar disorder in patients whose manic, mixed or depressive episode has responded to quetiapine treatment. 30 September 2009
Pharmaceutical
US health care giant Abbott Laboratories has reached a definitive agreement with the Solvay Group for Abbott to acquire Belgium-based chemicals, plastics and drugs group Solvay's pharmaceuticals business for 4.5 billion euros ($6.6 billion) in cash, providing Abbott with a large and complementary portfolio of pharmaceutical products and a significant presence in key global emerging markets. 28 September 2009
Generics
The US Court of Appeals for the Federal Circuit has affirmed the Summary Judgment decision of No Inequitable Conduct in patent litigation involving Anglo-Swedish drug major AstraZeneca's blockbuster schizophrenia and bipolar drug Seroquel (quetiapine fumarate) tablets. 28 September 2009
Pharmaceutical
Global drugs behemoth Pfizer says that its agreement with Japan's Eisai to provide Aricept (donepezil) to patients suffering from Alzheimer's disease will continue without interruption. Under this redefined alliance, which resolves a previously-disclosed dispute, Pfizer and Eisai will continue to co-promote Aricept in the USA, Japan and key markets in Europe, and the former will continue to have an exclusive license to sell the drug in the other countries where it has rights. 25 September 2009
Biotechnology
The research-based pharmaceutical industry in Germany is spending ever more on R&D, according to the country's trade association, the VFA. Susan Knoll, communications manager, said that association 'members are devoting record sums to R&D. 2008 saw another increase: German R&D expenditure jumped by almost 7% to 4.84 billion euros ($7.16 billion), or 13 million euros a day. 25 September 2009
Generics
The chronic pain drug market will experience modest 4% annual growth from 2008 to 2018 in the USA, France, Germany, Italy, Spain, the UK and Japan. Although the market will increase over the next decade, generic erosion will constrain sales of key branded agents such as Johnson & Johnson's Topamax (topiramate) and Pfizer's Celebrex (celecoxib), according to a new report from research and advisory firm Decision Resources 24 September 2009
Pharmaceutical
Anglo-Swedish drug major AstraZeneca entered into an exclusive worldwide license agreement with California, USA-based Nektar for two drug development programs: NKTR-118, a late-stage investigational product being evaluated for the treatment of opioid-induced constipation; and the NKTR-119 program, an early stage project that is intended to deliver products for the treatment of pain without constipation side effects. 22 September 2009
Pharmaceutical
After four years' work, Germany's Institute for Quality & Efficiency in Healthcare (IQEH, an independent scientific institute) has delivered a report on high blood pressure that could affect millions of people in Germany. Every second German suffers from high blood pressure, according to an estimate by the Robert Koch Institute. The IQEH's report could have far-reaching consequences as it will inform health insurers' decision on which high blood pressure treatments patients will be granted. 20 September 2009
Pharmaceutical
France's leading independent drugmaker Servier's Valdoxan (agomelatine), the first in a new generation of antidepressants for over a decade, has been shown to be more effective )than one of the most widely prescribed antidepressants of all time, fluoxetine (Prozac from Eli Lilly). 19 September 2009
Pharmaceutical
The US Food and Drug Administration has issued a complete response letter regarding the French drug major Sanofi-Aventis's New Drug Application for Cilytri (eplivanserin), thus delaying approval in the USA of the investigational drug. Eplivanserin was reviewed as a potential treatment for patients with chronic insomnia characterized by difficulties with sleep maintenance. 17 September 2009
Biotechnology
Dublin, Ireland-headquartered drugmaker Elan says that it has cured an 'unintended breach of its multiple sclerosis drug Tysabri (natalizumab) collaboration agreement with US firm Biogen Idec that had been identified by the US District Court for the Southern District of New York. The MS drug is expected to generate annual revenues of $1 billion this year. 15 September 2009
Pharmaceutical
The UK's GW Pharmaceuticals says that results from two clinical studies of Sativex, the firm's lead cannabinoid product, were presented at Europe's leading multiple sclerosis (MS) conference, the 25th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS), which took place in Dusseldorf, Germany, from 9-12 September. The outcome of these MS spasticity studies were first reported by GW earlier this year. 14 September 2009
Pharmaceutical
A new analysis of data from a clinical trial of Merck KGaA's oral drug cladribine has underscored its potential as a treatment for multiple sclerosis, say researchers. 14 September 2009
Pharmaceutical
New data further demonstrate the efficacy of Swiss drugmaker Nycomed's Instanyl (intranasal fentanyl spray) in the management of breakthrough cancer pain. The data which were presented at the 6th congress of the European Federation of Chapters of the International Association for the Study of Pain (EFIC) are from a multinational, crossover trial comparing Instanyl with oral transmucosal fentanyl citrate (OTFC) for the treatment of breakthrough pain in patients with cancer. The study concludes that pain relief was significantly greater for Instanyl compared to OTFC at all time points: 11 September 2009
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
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