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UK drugs giant GlaxoSmithKline has amended its agreement with Denmark's Genmab A/S for the co-development and commercialization of ofatumumab, which already marketed as Arzerra for the treatment of chronic lymphocytic leukemia (CLL). Under the new terms, GSK will take responsibility for developing ofatumumab in autoimmune indications whilst continuing to jointly develop ofatumumab with Genmab in oncology indications. 2 July 2010
Pharmaceutical
USA-based Forest Laboratories and Hungary headquartered partner Gedeon Richter recently announced top-line results from a Phase II placebo and positive comparator-controlled, parallel-arm, double-blind, dose-response clinical trial of the novel, investigational NR2B-selective NMDA (N-methyl D-aspartate) receptor antagonist, radiprodil (RGH-896), for the treatment of neuropathic pain associated with diabetic peripheral neuropathy (DPNP). Treatment with radiprodil did not show statistically significant or clinically meaningful reductions in mean daily pain scores, the primary endpoint, compared to placebo for any of the dosages studied. 2 July 2010
Pharmaceutical
USA-based Arena Pharmaceuticals has reached an agreement with Japanese drug major Eisai worth potentially $1.37 billion to fund commercialization of an obesity drug that could become Arena's first marketed product. 1 July 2010
article
Futura Medical, a UK developer of innovative products for consumer health care, has signed a development agreement with UK drug giant GlaxoSmithKline for the development of TPR100, the company's novel, topically applied product for pain relief. 1 July 2010
Pharmaceutical
Reports abounded yesterday speculating that US health care major Abbott Laboratories is exploring the sale of the vaccines operations is acquired along with its $6.2 billion purchase of Belgium's Solvay Pharmaceuticals, which was completed earlier this year (The Pharma Letter February 16). 30 June 2010
Biotechnology
June 30, 2010
In a move that will help Australia's Prana Biotechnology progress its planned Phase II clinical program in Alzheimer's disease, the firm says that it had reached an agreement with leading clinical research provider Quintiles Transnational that will see the latter subscribe for up to $2 million in new Prana shares. 30 June 2010
Generics
The US Food and Drug Administration has approved the first generic version of Pfizer's Effexor XR (venlafaxine), a drug for the treatment of major depressive disorder, for Israeli firm Teva Pharmaceutical Industries, which said it expects to start shipping the drug from tomorrow (July 1) as per the terms of it 2006 'pay-to-delay' agreement with Wyeth (now owned by Pfizer). 30 June 2010
Generics
of its June 21-24 meetings, which included several positive opinions to recommend backing approval of new drugs, as well extensions of indications and generic copies. 28 June 2010
Pharmaceutical
Between 1998 and 2007, psychotropic medications were associated with 429 adverse drug reactions (ADRs) in children aged under 17 in Denmark. Researchers writing in the open access journal BMC Research Notes found that more than half of these were serious and several were birth defects - suggesting that tighter controls on the prescription of psychotropic medications to pregnant women may be required. 25 June 2010
Pharmaceutical
Anglo-Swedish drug major AstraZeneca and US firm Targacept, have started enrollment of the first patient in the Phase III clinical development program for TC-5214, a nicotinic channel blocker, being developed by the two companies under a deal signed last year which could earn Targacept more than $1.24 billion (The Pharma Letter December 3, 2009). 24 June 2010
Pharmaceutical
Coming five years after the Canadian regulatory approval for neuropathic pain associated with multiple sclerosis, the UK's Medicines and Healthcare Products Regulatory Agency (MHRA) has granted GW Pharma a license to launch Sativex, a cannabis-based product, for the treatment of spasticity in patients with multiple sclerosis, which it did this week with partner German drug major Bayer (The Pharma Letter June 21). 24 June 2010
Pharmaceutical
French drugmaker Ipsen has released top-line results of GuidAge, the longest (five years) and largest (2,854 subjects) European study in the prevention of Alzheimer's dementia (AD). The aim of this study was to assess the efficacy of a 5-year treatment with EGb 761 in the prevention of AD in a population of elderly aged 70 or more, with memory complaint spontaneously expressed to their family physician and who lived at home at the inclusion in the study. 23 June 2010
Pharmaceutical
A Food and Drug Administration's panel of advisers has voted unanimously that the benefits of independent German drug major Boehringer Ingelheim's female sexual dysfunction drug flibanserin do not outweigh side effects, including fatigue, depression and fainting spells. 21 June 2010
Pharmaceutical
San Diego, USA-based Cypress Bioscience has entered into an exclusive North American licensing deal for the development and commercialization of Israeli company BioLineRx' novel antipsychotic (BL-1020, hereafter CYP-1020), a potential breakthrough treatment for schizophrenia. The news lifted BioLinexRx' share price 10.4% to 4.62 shekels this morning. 21 June 2010
Pharmaceutical
Following UK approval of the product just last Friday, GW Pharmaceuticals today announced the UK launch of Sativex, its prescription-only oromucosal spray for the treatment of spasticity due to multiple sclerosis (MS). 21 June 2010
Pharmaceutical
According to documents released yesterday, ahead of a US Food and Drug Administration advisory review panel meeting on Friday (June 18), agency reviewers said that independent German drug major Boehringer Ingelheim's flibanserin, a drug directed for low female sex drive, failed to meet one of two co-primary efficacy endpoints. 17 June 2010
Pharmaceutical
In the multiple sclerosis drug market, Novartis/Mitsubishi Tanabe Pharma's oral disease-modifying therapy Gilenia (fingolimod/FTY-720) remains on track to achieve blockbuster status by 2018, following a recent positive recommendation by a US Food and Drug Administration panel regarding the drug's safety and efficacy in the treatment of relapsing forms of the disease (The Pharma Letter June 11). 16 June 2010
Biotechnology
The US Food and Drug Administration yesterday approved UK drug giant GlaxoSmithKline's Jalyn, a single-capsule combination of dutasteride (0.5mg) and tamsulosin (0.4mg) to treat symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate. GSK expects to make the product available during the second half of 2010. 15 June 2010
Pharmaceutical
Some of the world's leading pharmaceutical companies last Friday unveiled a ground-breaking collaboration to help speed research into new treatments diseases of the brain such as Alzheimer's, Parkinson's to override competitive concerns and share the findings of their investigations. 14 June 2010
Pharmaceutical
US RNAi-based drug development firm RXi Pharmaceuticals has announced the company's new focused RNAi therapeutic strategy at the Jefferies 2010 Global Life Sciences Conference. 14 June 2010
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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