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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
Biotechnology
US biotech firm Nutra Pharma Corp (OTC.BB:NPHC), which is developing treatments for adrenomyeloneuropathy, HIV, multiple sclerosis and pain, said yesterday that it has begun the drug registration process in India for its Nyloxin line of pain relievers. 20 August 2010
Biotechnology
US biotech firm Biogen Idec has entered into an exclusive, worldwide license agreement with Knopp Neurosciences under which it will develop and commercialize KNS-760704 (dexpramipexole) for the treatment of amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig's disease, and potentially other indications. 19 August 2010
Biotechnology
In a second acquisition this year, US drugmaker BioMarin Pharmaceutical (Nasdaq: BMRN) says that it has bought ZyStor Therapeutics, a privately-held biotechnology company developing enzyme replacement therapies (ERT) for the treatment of lysosomal storage disorders. ZyStor's lead product candidate is ZC-701, a novel fusion of insulin-like growth factor 2 and alpha glucosidase (IGF2-GAA) in development for metabolic disorder Pompe disease. 19 August 2010
Pharmaceutical
The last few days have seen a spate of bad news for US drug major Eli Lilly, which yesterday said it will halt development of its potential Alzheimer's drug semagacestat, a gamma secretase inhibitor, because preliminary results from two ongoing long-term Phase III studies showed it did not slow disease progression and was associated with worsening of clinical measures of cognition and the ability to perform activities of daily living. 18 August 2010
Pharmaceutical
Following the recent US Food and Drug Administration delay in approving ProStrakan's Abstral (The Pharma Letter June 3), the company now awaits an FDA judgment on its sublingual fentanyl product by September 4, and a positive would be one of the few items of good news the Scottish company has heard from the USA this year, comments UK consultancy EvaluatePharma's EP Vantage. 18 August 2010
Pharmaceutical
Nearly one million children in the USA are potentially misdiagnosed with attention-deficit hyperactivity disorder simply because they are the youngest - and most immature - in their kindergarten class, according to new research by a Michigan State University economist. 17 August 2010
Generics
US drug major Eli Lilly suffered a blow last week, when the US District Court for the District of New Jersey ruled against the company in its patent litigation for Strattera (atomoxetine). In the case of Eli Lilly and Company versus Actavis Elizabeth LLC, et al, the court ruled that Lilly's '590 patent, or method-of-use patent, for Strattera is invalid. The patent had been set to expire in May of 2017. 16 August 2010
Pharmaceutical
The US Food and Drug Administration last week issued a warning that UK drugs giant GlaxoSmithKline's Lamictal (lamotrigine), approved to treat seizures and bipolar disorder, can cause aseptic meningitis, an inflammation of the protective membranes (meninges) that cover the brain and spinal cord not caused by bacterial infection. 16 August 2010
Pharmaceutical
Privately-held Canadian biopharmaceutical firm Alectos Therapeutics says it has entered into a research collaboration with US drug giant Merck & Co to identify and develop compounds that modulate O-linked N-acetylglucosaminidase (O-GlcNAcase) an enzyme that is believed to be involved in the development of Alzheimer's disease and potentially other disorders. 13 August 2010
Pharmaceutical
A US Food and Drug Administration advisory committee has voted unanimously to recommend UK drugs giant GlaxoSmithKline and Valeant Pharmaceuticals' Potiga (ezogabine) as adjunctive treatment for adults with partial-onset seizures.
After a review of the safety data, including urinary retention, infection and kidney stones, the majority of Committee members voted that urinary retention could be mitigated by patient monitoring and discussed how this could be addressed. The Committee also voted unanimously that monitoring should not be instituted for infection and kidney stones.
"We are encouraged by the Advisory Committee's assessment of the efficacy and safety of ezogabine and await a decision by the FDA," said Atul Pande, senior vice president, Neurosciences Medicines Development Center, North America Pharmaceuticals, GSK, adding: "For appropriate patients, we believe ezogabine could offer an important adjunctive treatment option for partial-onset seizures that are not well-controlled."
Sales forecasts range from $200 million to $800 million
Global sales of drugs to treat epilepsy reached nearly $13 billion last year, according to health care data firm IMS Health. Analysts have forecast peak annual sales for Potiga ranging from $200 million to $800 million. Valeant, which is in the process of a merger with Canada's Biovail, will receive up to 50% of US sales revenues under a development deal with GSK signed in 2008, which generated an upfront $125 million for Valeant.
'We think (Potiga) will be a good growth driver in neurology,' said Morningstar analyst Meera Venu, reported by Reuters. She has forecast $600 million in annual sales for the drug by 2019. Valeant shares declined 1.3% to $57.89 on the news, while GSK's stock fell 2.4% to $36.51 in US trading yesterday.
Clinical data
The Peripheral and Central Nervous System Drugs Advisory Committee reviewed efficacy data from three pivotal studies of ezogabine and an integrated safety data base including all patients who had at least one dose of the drug. Overall, ezogabine, as adjunctive therapy at a daily dose of 600mg, 900mg or 1,200mg, reduced the median number of partial-onset seizures in adults with epilepsy not adequately controlled on one to three concomitant anti-epileptic drugs compared to placebo (standard therapy).
The FDA specifically asked the Committee to comment on risks associated with urinary retention. In the pivotal trials, urinary retention occurred at a rate of 0.9% in patients receiving ezogabine compared to 0.5% on placebo. In all studies of patients with partial-onset seizures, including open-label studies, five patients required catheterization (four on ezogabine and one on placebo). The Committee recommended that patient monitoring for these events would be appropriate, with special attention given to specific groups that may be predisposed to urinary retention.
In the pivotal trials, the most frequently reported adverse events with the use of ezogabine in combination with other AEDs (occurring in at least 5% of subjects and at least twice the placebo rate) were dizziness (23%), fatigue (15%), confusion (9%), vertigo (8%), tremor (8%), abnormal coordination (7%), double vision (7%, disturbance in attention (6%), memory impairment (6%) and visual blurring (5%). In addition, somnolence occurred in 22% of patients on ezogabine compared to 12% on placebo.
The FDA, which usually follows advisory panel advice, is expected to make a final decision by August 30. About 3 million Americans have epilepsy, and 50 million globally, with partial-onset seizures accounting for 57% of seizure cases. Seizures can be controlled with medicines, but an estimated 30% of patients do not find adequate relief with current drugs.
The product, known as retigabine outside the USA, is also under review by the European Medicines Agency, Valeant noted in a press statement. 12 August 2010
Generics
As a result of generic erosion for key agents such as Pfizer's Effexor XR (venlafaxine), Eli Lilly/Boehringer Ingelheim's Cymbalta/Xeristar (duloxetine) and Forest Laboratories/Lundbeck's Lexapro/Cipralex/Seroplex (escitalopram), the unipolar depression drug market will decrease in size by nearly 10% over the next decade in the USA, France, Germany, Italy, Spain, the UK and Japan, according to a new report from Decision Resources. 12 August 2010
Pharmaceutical
Dublin, Ireland-based specialty biopharmaceutical company Shire is divesting global rights to its Daytrana (methylphenidate transdermal system) to Noven Pharmaceuticals of the USA. Daytrana, which is approved and marketed in the US for the treatment of attention-deficit hyperactivity disorder (ADHD) in children and adolescents, will continue to be available for patients through Noven. 11 August 2010
Pharmaceutical
Angelini Labopharm announced yesterday that its antidepressant Oleptro (trazodone hydrochloride extended-release tablets), a novel once-daily formulation, is now commercially available in the USA, where the antidepressant market is valued at over $11 billion a year. The drug, which was approved by the Food and Drug Administration in February, is indicated for the treatment of major depressive disorder (MDD) in adults. 10 August 2010
Pharmaceutical
In a move designed to advance the company's leadership and growth in pain management, Endo Pharmaceuticals plans to acquire all outstanding shares of fellow USA-based Penwest Pharmaceuticals for $5.00 in cash per share, or an estimated enterprise value of approximately $144 million at the time of deal close. Penwest has been working with Endo since 1997 on the development and commercialization of Opana (oxymorphone), a narcotic pain medicine used to treat moderate-to-severe pain, and receives a royalty stream on net sales of the product. 10 August 2010
Pharmaceutical
Irish drugmaker Elan Corp announced this morning that it will retire up to $500 million in outstanding debt due to mature in November 2011 and November 2013, through a combination of cash on hand and proceeds of a contemplated refinancing. 10 August 2010
Pharmaceutical
USA-based GenVec saw its share price rise 12% to $0.57 in pre-market trading last Friday, after the company announced a new agreement for the supply of services relating to development materials with Swiss drug major Novartis, related to the companies' previously-signed collaboration in hearing loss and balance disorders. (The Pharma Letter January 20). 9 August 2010
Generics
After reaching a peak value of $6.3 billion in 2011, the schizophrenia drug market will decline to $5.2 billion in 2019, owing to the loss of patent protection for most atypical antipsychotics on the market, says health care advisory firm Decision Resources. 8 August 2010
Pharmaceutical
In the UK, hospital stays for people with bipolar disorder cost taxpayers 207 million ($324.2 million) a year, according to the research sponsored by AstraZeneca presented yesterday. The National Health Service spends just 7% (25 million) of the total costs for bipolar disorder on medicines versus 60% on hospital admissions. The findings of the research are important as the NHS has been told to identify 15-20 billion of cost savings by the end of the 2013-14 financial year. 5 August 2010
Biotechnology
German biopharmaceutical company Antisense Pharma says that the US Food and Drug Administration has issued an Investigational New Drug-authorization for clinical studies with its trabedersen for patients with high-grade glioma. This entitles the company to include US-American clinics both in the Phase III study SAPPHIRE and in further studies. 4 August 2010
Pharmaceutical
Surveyed physicians anticipate an increase in their use of combination therapy for the treatment of generalized anxiety disorder (GAD), says advisory firm Decision Resources. According to its new report entitled Treatment Algorithms in Generalized Anxiety Disorder, surveyed psychiatrists anticipate increased use of combination therapy will include atypical antipsychotics for treatment-refractory patients through 2012. 4 August 2010
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