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Researchers at the USA's Mayo Clinic have found that dopamine agonists used in treating Parkinson's disease result in impulse control disorders in as many as 22 percent of patients. Mayo Clinic first reported on this topic in 2005. The follow-up study was published online in the February 2011 issue of Parkinsonism and Related Disorders. 25 March 2011
Pharmaceutical
Alzheimer's patients in England and Wales can now be prescribed treatment when presenting with mild stages of the disease. New guidance from the National Institute for Health and Clinical Excellence (NICE), which was announced last year (The Pharma Letter January 18) came into effect yesterday, marking a significant change to an earlier 2007 ruling which restricted access to medication for patients with moderate disease only. 24 March 2011
Biotechnology
Australia's Prana Biotechnology (ASX: PBT) has announced the publication of new data on the ability of PBT2 to repair the damage in an Alzheimer's affected brain thereby facilitating the restoration of cognition in Alzheimer's disease (AD). 22 March 2011
Pharmaceutical
Swiss pharma major Novartis (NOVN: VX) this morning announced that the European Commission has granted approval its Gilenya (fingolimod) 0.5mg daily as a disease modifying therapy in patients with highly active relapsing-remitting multiple sclerosis (RRMS) despite treatment with beta interferon, or in people with rapidly evolving severe RRMS. 21 March 2011
Pharmaceutical
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) yesterday told Belgian drugmaker UCB (Euronext Brussels: UCB) that Xyrem (sodium oxybate) will not be recommended as a treatment for fibromyalgia syndrome in adults in the European Union. 18 March 2011
Pharmaceutical
Within a couple of weeks of finally acquiring King Pharmacueticals for $3.6 billion, global drugs behemoth Pfizer (NYSE: PFE) has been obliged to pull sales of the recently launched opiod painkiller Embeda (morphine sulfate and naltrexone hydrochloride). 18 March 2011
Pharmaceutical
UK pharma giant GlaxoSmithKline (LSE: GSK) yesterday announced positive, top-line results of the ADVANCE-Parkinson's Disease Phase III clinical study, conducted by US partner Impax Pharmaceuticals (Nasdaq: IPXL) of IPX066 versus immediate-release (IR) carbidopa-levodopa (CD-LD) in advanced PD patients experiencing motor fluctuations. 16 March 2011
Pharmaceutical
Austrian firm AFFiRiS' Alzheimer's vaccine candidate AD02 showed indicative evidence for potential efficacy in a Phase I clinical trial, as demonstrated by the analysis of the data from secondary clinical study endpoints. 14 March 2011
Pharmaceutical
Janssen-Cilag International, a subsidiary of US health care giant Johnson & Johnson (NYSE: JNJ), says that Xeplion (paliperidone palmitate, already sold under the brand name Invega Sustenna), a once monthly, long-acting injectable, antipsychotic, has received approval from the European Commission for the treatment of schizophrenia. 10 March 2011
Pharmaceutical
US drug giant Merck & Co (NYSE: MRK) says that the Food and Drug Administration has accepted for review its New Drug Application for Saflutan (tafluprost), an investigational preservative-free prostaglandin analogue ophthalmic solution. 10 March 2011
Pharmaceutical
USA-based Repligen (Nasdaq: RGEN) saw its shares plummet 29.1% to $3.48 by mid-afternoon trading yesterday, after the company announced results of a Phase IIb clinical trial of RG2417, an oral formulation of uridine, in patients with bipolar depression. The study did not demonstrate a statistically-significant improvement in the symptoms of depression in all patients receiving RG2417 when compared to placebo over the eight-week treatment period. 8 March 2011
Pharmaceutical
New data suggest that the epilepsy drug US drug major Johnson & Johnson's (NYSE: JNJ) Topamax (topiramate) and its generic versions (sold by the likes of Mylan, Teva and Watson) increase the risk for the birth defects cleft lip and cleft palate in babies born to women who use the medication during pregnancy, the US Food and Drug Administration warned on Friday. 7 March 2011
Pharmaceutical
North Carolina, USA-based Targacept (Nasdaq: TRGT) which is developing novel NNR Therapeutics, yesterday announced the termination of its strategic alliance agreement with UK drugs giant GlaxoSmithKline (LSE: GSK), effective in May 2011. 4 March 2011
Pharmaceutical
In a second licensing deal this year, Japan's largest drugmaker Takeda Pharmaceutical (TSE: 4502) has entered into an exclusive collaboration with USA-based Intra-Cellular Therapies (ITI) to develop and commercialize selective phosphodiesterase type 1 (PDE1) inhibitors, discovered by the latter and in preclinical testing, for the treatment of cognitive impairment associated with schizophrenia. This agreement is targeted worldwide, but ITI has retained the option to co-promote with Takeda in the USA. 3 March 2011
Pharmaceutical
In a further setback for German drug major Merck KGaA (MRK: DE) in its aim to bring an oral multiple sclerosis drug to the market, its US affiliate, EMD Serono, announced today that it received a complete response letter (CRL) from the US Food and Drug Administration on the New Drug Application for Cladribine Tablets, as a therapy for relapsing-remitting MS. 2 March 2011
Pharmaceutical
Ireland headquartered specialty drugmaker Shire (LSE: SHP) has received US Food and Drug Administration approved the use of once-daily Intuniv (guanfacine) as adjunctive therapy to stimulants for the treatment of attention deficit hyperactivity disorder (ADHD) in children and adolescents aged six to 17 as part of a total treatment program. 2 March 2011
Pharmaceutical
A Regional Court in Rio de Janeiro declined to extend the validity of two patents relating to Sanofi-Aventis (Euronext: SAN)/Bristol-Myers Squibb's (NYSE: BMY) antihypertensive Aprovel (irbesartan) and Pfizer's (NYSE: PFE) atypical antipsychotic Geodon (ziprasidone). 2 March 2011
Generics
Patients who start on generic antidepressants are as likely to keep taking their medication as prescribed as those who start on brand-name drugs, an Express Scripts (Nasdaq: ESRX) study shows. The company's analysis provides further proof that greater use of generics could significantly reduce wasteful health care spending while maintaining positive health outcomes. The study was published in the March issue of the Journal of Managed Care Pharmacy. 2 March 2011
Generics
Ireland-based Elan (NYSE: ELN) says a subsidiary has entered into a settlement and license agreement with Celgene (Nasdaq: CELG) resolving the patent infringement litigation involving the breast cancer drug Abraxane (protein-bound paclitaxel). Elan initiated legal action in 2006 against Abraxis BioScience, which was acquired by Celgene last year for $2.9 billion (The Pharma Letter July 1, 2010). 28 February 2011
Pharmaceutical
Drugmaker Forest Laboratories (NYSE: FRX) has entered a deal to acquire fellow USA-based Clinical Data (Nasdaq: CLDA) in a deal worth as much as $1.2 billion that should also bring the former a key antidepressant drug to replace its blockbuster drug Lexapro (escitalopram), which loses patent protection next year. 23 February 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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