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Pharmaceutical
US drugmakers Ironwood Pharmaceuticals (Nasdaq: IRWD) and Forest Laboratories (NYSE: FRX) have submitted a New Drug Application to the US Food and Drug Administration for linaclotide, a guanylate cyclase type-C (GC-C) agonist, for the treatment of irritable bowel syndrome with constipation (IBS-C) and chronic constipation (CC). 10 August 2011
Biotechnology
US biotech Biogen Idec (Nasdaq: BIIB) and health care giant Abbott Laboratories (NYSE: ABT ) have announced positive top-line results from SELECT, a global, registrational Phase IIb clinical trial designed to evaluate the investigational compound daclizumab high-yield process (DAC HYP) in people with relapsing-remitting multiple sclerosis (RRMS) over one year. The news saw Biogen's shares rise 1.6% to $89.43 and those of Abbott gain 1.0% to $48.56. 10 August 2011
Pharmaceutical
In provisional draft guidance published last Friday, UK drugs watchdog the National Institute for Health and Clinical Excellence (NICE) said it does not recommend that Swiss drug major Novartis' (NOVN: VX) Gilenya (fingolimod), licensed to treat people who have a particular type of multiple sclerosis, should be prescribed on the National Health Service. This is because there are uncertainties over its clinical effectiveness and, based on the available evidence, it would not be a cost effective use of NHS resources, the NICE stated. 7 August 2011
Biotechnology
Privately-held UK biotech firm Biotica Technology says that it has regained full rights from global drugs behemoth Pfizer (NYSE: PFE) to its rapamycin analogue program, including transfer of data and materials. 5 August 2011
Pharmaceutical
The cancer pain therapeutics market is forecast to show steady growth until 2017, says a new report from GlobalData, which estimates that the global sector was worth $2,448 million in 2010, and is forecast to expand at a compound annual growth rate (CAGR) of 3.7% over the next seven years, to reach $3,152 million by 2017. 4 August 2011
Pharmaceutical
California, USA-based MAP Pharmaceuticals (Nasdaq: MAPP) says that its New Drug Application for Levadex (which contains a novel formulation of dihydroergotamine), its orally inhaled drug for the potential acute treatment of migraine in adults, has been accepted for filing by the US Food and Drug Administration, with a Prescription Drug User Fee Act (PDUFA) goal date of March 26, 2012. 3 August 2011
Pharmaceutical
Commenting on the failure of Teva Pharmaceutical Industries' (Nasdaq: TEVA) Phase III trial for multiple sclerosis drug candidate laquinimod (BRAVO) to meet the primary endpoint of reducing annualized relapse rates (ARR) versus placebo (The Pharma Letter August 2), Nomura analyst Amit Roy sees the drug as no threat to Swiss drug major Novartis' (NOVN: VX) already marketed Gilenya (fingolimod). He has a buy rating on Novartis, with a share price target of 65.00 Swiss francs, compared to the current 48.50 franc level. 2 August 2011
Pharmaceutical
There were mixed but largely disappointing Phase III trial results for Israel-based Teva Pharmaceutical Industries (Nasdaq: TEVA) regarding its experimental multiple sclerosis drug laquinimod, which failed to reduce MS relapses any better than placebo. 2 August 2011
Biotechnology
Switzerland's Actelion (SIX: ATLN) said this morning that the primary endpoint - reduction in the number of new active inflammatory lesions in the brain - has been met with its selective S1P1 receptor agonist, ponesimod, in a Phase IIb dose-finding study in patients with relapsing-remitting multiple sclerosis. As a result, the company, Europe's largest biotech, said it will plant to move the drug into Phase III testing. 2 August 2011
Pharmaceutical
The global pain treatment market recorded sales of $22.0 billion in 2010, rising at a compound annual growth rate of 8.9% from 2005, according to a new report from companiesandmarkets.com, titled The Pain Market Outlook to 2016 1 August 2011
Pharmaceutical
There was disappointment for Japanese drug major Eisai (TYO: 4523) last week when the US Food and Drug Administration has issued a Refusal to File letter in response to the company's New Drug Application for perampanel (E2007), an investigational drug, for the treatment of partial-onset seizures associated with epilepsy which was submitted in May 2011. Perampanel is a highly selective non-competitive AMPA-type glutamate receptor antagonist, discovered and being developed by Eisai. 1 August 2011
Pharmaceutical
UK pharma major GlaxoSmithKline's Trobalt (retigabine) has been recommended for use in the UK's National Health Service to help control seizures in adult epilepsy patients, by the drug watchdog the National Institute for Health and Clinical Excellence (NICE). The drug should be prescribed as an add-on treatment option if other medicines have been ineffective or produced unmanageable side effects, the NICE said. 29 July 2011
Pharmaceutical
Unconfirmed press reports indicate that Canada's Valeant Pharmaceutical International (NYSE: VRX) is seeking yet another acquisition, this time setting its sights on Sweden's Meda (OMX: MEDA A), which has itself been buying products, as well as US specialty drug firm Alaven for $350 million last year. Meda's shares rose 12% to 79.35 Swedish kronor in early trading this morning, but the firm has not confirmed any talks. 27 July 2011
Pharmaceutical
The European subsidiary of US biotech firm Biogen Idec (Nasdaq: BIIB) has received conditional approval from the European Commission for Fampyra (prolonged-release fampridine tablets) to improve walking in adult patients with multiple sclerosis (MS) who have walking disability (Expanded Disability Status Scale 4-7). Fampyra will be available in Europe, on a country-by-country basis, beginning with Germany in September 2011, with other countries following. 26 July 2011
Pharmaceutical
The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has agreed to a recall of Vimpat 15mg/ml syrup, marketed by Belgian drugmaker UCB (Euronext Brussels: UCB) because of a quality defect in some batches leading to uneven distribution of the active substance lacosamide in the syrup. Doctors are advised to contact their patients to switch them to Vimpat film coated tablets whenever possible. 25 July 2011
Generics
Backed by factors like patent expiration of drugs and aging population, the US generics market will expand at a compound annual growth rate (CAGR) of 10% during 2010-2013, says a new report from market analysts RNCOS. 23 July 2011
Pharmaceutical
Yesterday saw a batch of recommendations from the European Medicines Agency's advisory body, including on: Takeda's (TYO: 4502) Actos (pioglitazone) and other brands with the same active ingredient; GlaxoSmithKline's (LSE: GSK) flu vaccine Pandemrix and Pfizer's (NYSE: PFE) smoking cessation product Champix (varenicline). 22 July 2011
Pharmaceutical
USA-based Icagen (Nasdaq: ICGN) saw its shares plunge 23% to $5.96 in premarket trading yesterday on the news that it has entered into a definitive merger agreement with global drugs behemoth Pfizer (NYSE: PFE), which already owns around 11% of the firm, targeting year-end for completion of the deal. 21 July 2011
Pharmaceutical
The US subsidiary of Japanese drug major Shionogi (TKO: 4507) has entered into an agreement to acquire all currently marketed products from USA-based Victory Pharma, including seven treatments for pain and two for infectious diseases, including the latter's lead product Naprelan (naproxen sodium). A couple of years ago Shionogi made a $150 million offer to acquire Victory, but it did not proceed to completion due to 'unforeseen' events that occurred after the merger transaction was initiated (The Pharma Letter May 28, 2009). 19 July 2011
Pharmaceutical
USA-based Alkermes (Nasdaq: ALKS) 'will be a dramatically different company, with a broad portfolio of diverse and significant commercial products and pipeline candidates to drive growth and profitability,' the firm stated at a meeting with investors and analysts in Boston, USA, yesterday. 19 July 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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