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Pharmaceutical
The Australian Therapeutic Goods Administration (TGA) has granted approval for USA-based Biogen Idec's (Nasdaq: BIIB) Fampyra (fampridine) 10mg modified release tablet, for the symptomatic improvement of walking ability in adult patients with multiple sclerosis (MS) who have shown improvement after eight weeks of treatment. 18 May 2011
Generics
The last few days have seen US generic drug major Mylan (Nasdaq: MYL) introduce copy versions of several significant drugs in the USA, through its subsidiary Mylan Pharmaceuticals. 17 May 2011
Generics
German drugmaker Stada Arzneimittel (SAZ: GR) is negotiating with family-owned Grunenthal the purchase of a branded product portfolio including the associated sales structures for numerous national markets in Central and Eastern Europe as well as in the Middle East. Stada expects to pay around 360 million euros ($522 million) in cash for the portfolio including sales structures and various pipeline products. 16 May 2011
Pharmaceutical
Austrian pharmaceutical producer Ever Neuro Pharma is considering building a plant for the production and packaging of its flagship drug Cerebrolysin, a peptide preparation with neurotropic activity, in the Russian city St Petersburg. Cerebrolysin is a recognized IV treatment for stroke, dementia and brain injuries. 16 May 2011
Pharmaceutical
Family-owned German drugmaker Grunenthal has today launched Palexia SR (tapentadol prolonged release) for the oral treatment of adults with severe chronic pain, which can only be adequately managed with opioid analgesics. Palexia SR is the first in a new class of centrally acting analgesics called MOR-NRI, which has two mechanisms of action in one molecule; both mu-opioid receptor (MOR) agonism and noradrenaline reuptake inhibition (NRI). 16 May 2011
Pharmaceutical
As part of its latest budget announcement, Australia's federal government has allocated A$2.2 billion ($2.37 billion) funding for mental health, under a five-year reform package. These reforms are aimed at improving the lives of thousands of Australians with mental illness by: 11 May 2011
Pharmaceutical
Japanese drug major Shionogi (TKO: 4507) reported its unconsolidated fiscal year 2011 (ended March) results showing: 9.4% growth in revenues to 249.99 billion yen ($3.1 billion); a 22.7% rise in operating profit to 60.44 billion yen; a 20.8% increase in current profit to 60.34 billion yen; and 2.2% growth in net income to 41.66 billion yen, or 124.39 yen a share. 10 May 2011
Pharmaceutical
Closely-held UK-based drug discovery firm Heptares Therapeutics says it has signed an exclusive option agreement with Ireland-headquartered Shire (LSE: SHP) for a novel adenosine A2A antagonist discovered by Heptares and currently in preclinical development. 10 May 2011
Biotechnology
The global neurotechnology industry grew to a value of $149.8 billion in 2010, up 3.2% on the previous year, according to NeuroInsights' seventh annual investment guide and market analysis of the global neurological disease and psychiatric illness markets. 10 May 2011
Pharmaceutical
US drugmaker Alkermes (Nasdaq: ALKS) and Ireland-based Elan Corp (NYSE: ELN) revealed this morning that they have executed a definitive agreement under which Alkermes will merge with Elan Drug Technologies (EDT), the drug formulation and manufacturing business unit of Elan, in a cash and stock transaction currently valued at around $960 million. Alkermes and EDT will be combined under a new holding company incorporated in Ireland, which will be named Alkermes plc. 9 May 2011
Generics
USA-based Impax Laboratories (Nasdaq: IPXL) confirmed on Friday that Alza Corp, a division of health care giant Johnson & Johnson (NYSE: JNJ) has filed a second suit for patent infringement against the firm in the US District Court for the District of Delaware with regard to Concerta (methylphenidate hydrochloride) extended-release 18, 27 and 36mg tablets. 9 May 2011
Pharmaceutical
US biopharma company Targacept (Nasdaq: TRGT) says that Anglo-Swedish drug major AstraZeneca (LSE: AZN) will not exercise its option to license its product candidate TC-5619, a potential treatment for schizophrenia. As a result, Targacept retains full rights to the compound, a highly selective alpha7 neuronal nicotinic receptor modulator. 4 May 2011
Pharmaceutical
Japanese drug major Eisai (TYO: 4523) says that the US Food and Drug Administration has issued a Complete Response Letter to Teikoku Pharma USA regarding the New Drug Application of the Aricept Patch (donepezil transdermal system). The Aricept Patch was developed by Teikoku and its subsidiaries and, along with Eisai, has seeking approval of the weekly Aricept Patch for the treatment of mild, moderate and severe stages of Alzheimer's disease. 27 April 2011
Pharmaceutical
Scientists at the Fisher Center for Alzheimer's Disease Research at The Rockefeller University, USA, led by Paul Greengard and Jennifer Warner-Schmidt, have shown that anti-inflammatory drugs, which include ibuprofen, aspirin and naproxen, reduce the effectiveness of the most widely used class of antidepressant medications, the selective serotonin reuptake inhibitors, or SSRIs, taken for depression and obsessive-compulsive disorder and anxiety disorders. 27 April 2011
Pharmaceutical
The US Food and Drug Administration on Friday approved the use of Sanofi-Aventis (Euronext: SAN) vaccine unit Sanofi Pasteur's Menactra in children as young as nine months for the prevention of invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y and W-135. Menactra already is approved for use in people aged two through 55 years. 26 April 2011
Biotechnology
Biogen Idec shares leap, as 1st-qtr 2011 earnings rocket, boosted by Tysabri; and by MS drug results
Shares of US biotech firm Biogen Idec (Nasdaq: BIIB) soared 20% to $104.11 in pre-market trading last Thursday (ahead of the Easter holidays), after the company announced its first quarter 2011 results showing that GAAP diluted earnings per share were $1.20, an increase of 50% over the first quarter of 2010. 26 April 2011
Biotechnology
A vaccine that has the potential to stop Alzheimer's disease progression could be available within a few years, according to reports in the UK's Daily Mail and Daily Express newspapers. The product in question, known as CAD106, comes from the research laboratories of Zurich, Switzerland-based biotechnology firm Cytos Biotechnology (SWX: CYTN), which is also developing anti-smoking, obesity and flu vaccines. 26 April 2011
Pharmaceutical
There were two pieces of negative news for Swiss drug major Novartis (NOVN: VX) yesterday, when the company received a negative ruling from the UK drug rationing watchdog for its kidney cancer drug, and the firm withdrew its application to resurrect European approval for a pain drug that had previously been pulled from the market in 2007. 20 April 2011
Pharmaceutical
Scientists from the Florida, USA, campus of The Scripps Research Institute have developed the first of a new class of highly selective compounds that effectively suppresses the severity of multiple sclerosis (MS) in animal models. The new compound could provide new and potentially more effective therapeutic approaches to multiple sclerosis and other autoimmune diseases that affect patients worldwide. The study appeared April 17, 2011, in an advance on-line edition of the journal Nature. 18 April 2011
Pharmaceutical
Following up on a previously announced intention, UK pharma giant GlaxoSmithKline (LSE: GSK) says it has identified the non-core over-the-counter (OTC) medicines brands that it intends to divest as the company focuses its Consumer Healthcare business around a portfolio of fast-growing priority brands and the emerging markets. 18 April 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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