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Pharmaceutical
The strain of opioid use disorder (OUD), a chronic neurological disorder characterized by the compulsive, repeated use of opioid drugs, has weighed heavily on many countries in recent years, especially the USA. 27 November 2024
Biotechnology
US clinical stage biotech Alector saw its shares tumble 35% to $2.57 by close of trading yesterday, as it announced disappointing results from the INVOKE-2 Phase II clinical trial evaluating the safety and efficacy of AL002 in slowing disease progression in individuals with early Alzheimer’s disease (AD). 27 November 2024
Biotechnology
PTC Therapeutics has announced that its Phase II trial for utreloxastat, aimed at treating amyotrophic lateral sclerosis (ALS), failed to meet its primary endpoint. 27 November 2024
Biotechnology
US companies Arrowhead Pharmaceuticals and Sarepta Therapeutics have announced a global licensing and collaboration agreement. 26 November 2024
Pharmaceutical
US central nervous system (CNS) disorders specialist Axsome Therapeutics today released encouraging late-stage results for its narcolepsy candidate AXS-12 (reboxetine), sending its shares edging up 2.6% to $100.00 in pre-market activity. 26 November 2024
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
The European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) is recommending further restrictions on the use of the multiple sclerosis medicine Zinbryta (daclizumab) following a review of the medicine’s effects on the liver. 28 October 2017
Pharmaceutical
PDL BioPharma has submitted an unsolicited proposal to acquire fellow US drugmaker Neos Therapeutics for $10.25 per share in cash. 27 October 2017
Generics
Mylan is set to open Thursday’s trading more than 1% up on the previous close. 26 October 2017
Biotechnology
US biotech firm Alzheon has announced the publication of clinical results demonstrating that ALZ-801 achieved levels of therapeutic efficacy with favorable safety and tolerability profile for use as an orally-administered medicine for the treatment of Alzheimer’s disease. 25 October 2017
Biotechnology
US biopharma major AbbVie and portfolio company Alector, a privately owned biotech, today announced a global strategic collaboration to develop and commercialize medicines to treat Alzheimer’s disease and other neurodegenerative disorders. 24 October 2017
Biotechnology
Switzerland-based Idorsia today announced its financial results and an update on its research progress, which represent the business activity in the three and a half months since the demerger from Actelion on June 15, 2017, following the $30 billion acquisition by Johnson & Johnson. 24 October 2017
Biotechnology
Japanese and US pharma majors Eisai and Biogen say they have expanded their existing agreement to jointly develop and commercialize investigational Alzheimer’s disease treatments. 23 October 2017
Pharmaceutical
US President Donald Trump on Tuesday said his nominee to head the Office of National Drug Control Policy, Representative Tom Marino (Republican, Pennsylvania.), has backed out of the position, two days after media reports revealed the congressman had pushed legislation gutting the US Drug Enforcement Administration's ability to target opioid distributors not abiding by regulations. 18 October 2017
Pharmaceutical
Teva Pharmaceutical Industries has submitted a Biologics License Application (BLA) to the US Food and Drug Administration for fremanezumab, an anti-calcitonin gene-related peptide (anti-CGRP) monoclonal antibody for the preventive treatment of migraine. 17 October 2017
Pharmaceutical
Attempts to reassure investors by the chief executive of AcelRx Pharmaceuticals could not stop the share price of the USA-based specialty pharma company from falling off a cliff on Thursday. 13 October 2017
Pharmaceutical
US pharma giant Pfizer received good news today, when the US Food and Drug Administration granted approval for a new formulation of its top-selling drug Lyrica (pregabalin), which in December next year is facing patent expiry. 12 October 2017
Generics
Shares of specialty pharma firm BioDelivery Sciences International were up mid-morning, after it announced that it has entered into a Settlement Agreement over its opioid dependence treatment. 12 October 2017
Biotechnology
The global Alzheimer’s disease (AD) market, worth $2.9 billion in 2016, is set to reach $14.8 billion by 2026, rising at a compound annual growth rate (CAGR) of 17.5%, across the 7 seven main markets (7MM: USA, Japan, France, Germany, Italy, Spain, and UK.). 10 October 2017
Pharmaceutical
Eliciting comment last week was news that a US judge had reversed an earlier ban on the marketing of cholesterol treatment Praluent in a long-running court battle between Amgen and the drug’s makers – Regeneron and Sanofi and ordering a re-trial. Also attracting attention was mid-stage data on Capricor Therapeutics’ Duchenne muscular dystrophy agent CAP-1002; strong Phase III results with Zogenix’ rare epilepsy drug candidate ZX008; and positive results for Ablynx’ rare blood disorder candidate caplacizumab. 8 October 2017
Pharmaceutical
Eisai’s US subsidiary has signed an exclusive licensing agreement with Uruguay-headquartered Grupo Biotoscana for Eisai's oncology and neurology products in Latin America. 5 October 2017
Generics
Two companies have been granted approval for the copycat versions of the Teva Pharmaceutical Industries (NYSE: TEVA) multiple sclerosis drug Copaxone (glatiramer acetate) 40mg/mL in Europe. 5 October 2017
Generics
Market activity on Wednesday underlined the importance of a US Food and Drug Administration (FDA) approval of a generic drug from Mylan. 4 October 2017
Biotechnology
company Merck says it plans to invest 35 million euros ($41.1 million) in a new production line for the aseptic filling of biotech medicines under isolator at its manufacturing site of Bari, Italy. 4 October 2017
Pharmaceutical
Dr Nicola Davies explores pharmaceutical development in mental health, with a focus on factors that influence the road to pharma-psych innovation. 3 October 2017
Pharmaceutical
Biohaven Pharmaceutical today reported disappointing top-line results from its Phase II/III clinical trial evaluating trigriluzole compared to placebo for the treatment of patients with spinocerebellar ataxia (SCA). 2 October 2017
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