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In what could come as good news for patients suffering from Huntington's disease, scientists from the UK and USA have discovered a new method to treat the neurodegenerative disease that affects muscle coordination and leads to cognitive decline and dementia, and eventually death. In two separate studies, the researchers say their findings could potentially help slow down the development of Huntington's disease as well as Parkinson's and Alzheimer's diseases. The research is presented in the journal Current Biology. 26 June 2011
Generics
US branded and generics drugmaker Watson Pharmaceuticals (NYSE: WPI) says it is investing around $44 million in the expansion of its Salt Lake City, Utah, Watson Laboratories site. This facility is Watson's state-of-the-art pharmaceutical research, development and manufacturing facility for transdermal patches and topical gels. 23 June 2011
Pharmaceutical
Jubilant Biosys, a Bengaluru-based subsidiary of India's Jubilant Life Sciences, and Anglo-Swedish drug major AstraZeneca (LSE: AZN), yesterday announced another successful delivery of an early stage milestone in the pain therapeutic area, under a collaboration deal signed in 2009 and triggering an undisclosed payment to the Indian firm. 23 June 2011
Pharmaceutical
German drug major Merck KGaA (MRK: DE) said yesterday that, following feedback from regulatory authorities, the company has decided to no longer pursue the global approval process of Cladribine Tablets for the treatment of relapsing-remitting multiple sclerosis (MS). 23 June 2011
Biotechnology
US biotech firm Biogen Idec (Nasdaq: BIIB) and Ireland-based Elan (NYSE: ELN) said yesterday that the European Commission has approved the inclusion of anti-JC virus (JCV) antibody status as an additional factor to aid in stratifying patients at risk for developing progressive multifocal leukoencephalopathy (PML) in the Summary of Product Characteristics (SmPC) for their multiple sclerosis drug Tysabri (natalizumab) in the European Union. 23 June 2011
Pharmaceutical
Global drugs behemoth Pfizer (NYSE: PFE) says its blockbuster neuropathic pain drug Lyrica (pregabalin) met its primary endpoint of positive efficacy in reducing central neuropathic pain following spinal cord injury compared to placebo in a Phase III study. Further analysis will be conducted on these initial results, the firm added. 22 June 2011
Pharmaceutical
After a significant delay, drugs behemoth Pfizer (NYSE: PFE) and partner Acura Pharmaceuticals (Nasdaq: ACUR) have finally received marketing approval from the US Food and Drug Administration for Oxecta, a tamper-resistant formulation of oxycodone. Oxecta is indicated for the management of acute and chronic moderate to severe pain where the use of an opioid analgesic is appropriate. 21 June 2011
Pharmaceutical
US drug developer Concert Pharmaceuticals says that it has achieved a $4 million milestone in its strategic alliance with UK pharma giant GlaxoSmithKline (LSE: GSK) for its HIV protease inhibitor (HIV-PI) development program, as part of a two-year old accord that could generate a total of up to $1 billion for the US firm (The Pharma Letter June 2, 2009). 21 June 2011
Pharmaceutical
Ortho-McNeil-Janssen Pharmaceuticals, a unit of US health care giant Johnson & Johnson (NYSE: JNJ), which has been plagued by a plethora of over-the-counter product recalls in the past year or so that have cost the group around $900 million in sales, says it is initiating a voluntary recall of one lot of the anti-psychotic drug Risperdal (risperidone) 3mg tablets, marketed by the company and one lot of generic risperidone 2mg tablets, sold by Patriot Pharmaceuticals, a wholly-owned subsidiary of Ortho-McNeil-Janssen. 20 June 2011
Pharmaceutical
The UK's drug watchdog body the National Institute for Health and Clinical Excellence (NICE) last week issued draft guidance suggesting that GlaxoSmithKline's (LSE: GSK) epilepsy drug Trobalt (retigabine) and USA-based The Medicine Company's (Nasdaq: MDCO) heart drug Angiox (bivalirudin) should be available for use on the National Health Service. 20 June 2011
Generics
US drugmaker Watson Pharmaceuticals (NYSE: WPI) confirmed on Friday that the US District Court for the District of Nevada denied a request from Duramed Pharmaceuticals, a subsidiary of Israeli generics giant Teva Pharmaceutical Industries (Nasdaq: TEVA), for a preliminary injunction and request for a temporary restraining order preventing Watson's launch of a generic version of the contraceptive Seasonique (levonorgestrel/ethinyl estradiol and ethinyl estradiol. Teva's shares fell 4% to 163.80 shekels on the news. 20 June 2011
Pharmaceutical
USA-based neurosciences firm Cortex Pharmaceuticals. (OTCBB: CORX) has entered into a new agreement with independent French drugmaker Laboratoires Servier to sell its remaining rights to the jointly discovered high impact Ampakine compound, CX1632 (S47445). 15 June 2011
Pharmaceutical
Following backing from a US Food and Drug Administration advisory panel last summer (The Pharma Letter August 12, 2010), the FDA issued a complete response letter but has now approved UK pharma giant GlaxoSmithKline (NYSE: GSK) and partner Valeant Pharmaceuticals International's (NYSE/TSX: VRX) Potiga (ezogabine) tablets, a potassium channel opener, as adjunctive treatment of partial-onset seizures in patients aged 18 years and older. 13 June 2011
Pharmaceutical
The US subsidiary of Belgian pharmaceutical manufacturer UCB SA (Euronext Brussels: UCB) last week pleaded guilty to the off-label promotion of its epilepsy drug Keppra (levetiracetam) and will pay more than $34 million to resolve criminal and civil liability arising out of its illegal conduct, the Department of Justice announced. 13 June 2011
Pharmaceutical
USA-based Chelsea Therapeutics International's (Nasdaq: CHTP) shares soared 16% to $4.87 early Friday after analysts at Roth Capital tripled their price target of the stock to $18, following positive Phase III data for its neurology drug Northera (droxidopa). Also, shares of Micromet (NasdaqGS: MITI) leapt 14% to $6.05 on good Phase II results for its leukemia drug candidate blinatumomab. 13 June 2011
Pharmaceutical
US drugmaker Somaxon Pharmaceuticals (Nasdaq: SOMX) has entered into an exclusive collaboration with Canada's Paladin Labs (TSX: PLB) under which Paladin will commercialize Silenor (doxepin) for the treatment of insomnia characterized by difficulty with sleep maintenance in Canada, South America and Africa. 13 June 2011
Pharmaceutical
US health care major Abbott Laboratories (NYSE: ABT) says that interim efficacy and safety results from a long-term, 54-week, Phase III open-label study of its investigational treatment for advanced Parkinson's disease showed that patients treated with levodopa-carbidopa intestinal gel (LCIG) for 12 weeks reported a decrease in "off" time and an increase in "on" time without troublesome dyskinesias. The results were reported at the International Congress of Parkinson's Disease and Movement Disorders in Toronto. 10 June 2011
Pharmaceutical
Switzerland based Merck Serono, a division of Germany's Merck KGaA (MRK: DE), has entered into a collaboration with Munich-based drug developer Affectis Pharmaceuticals for the development and commercialization of oral compounds targeting P2X7 receptors, which are believed to be involved in neuroinflammation observed in some neurodegenerative diseases. 8 June 2011
Pharmaceutical
USA-based stem cell development firm Neuralstem (NYSE Amex: CUR) has signed an exclusive agency licensing agreement with Japan's Summit Pharmaceuticals International (SPI), a wholly owned subsidiary of Sumitomo Corp, for domestic rights to a potential antidepressant. 8 June 2011
Generics
Indian generics drug major Dr Reddy's Laboratories (NYSE: RDY) yesterday announced that it has launched three copy products in the US market, two of which address central nervous system disorders and the third breast cancer. The drugs are: 8 June 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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