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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
Biotechnology
US CNS focused biotech firm Zogenix (Nasdaq: ZGNX) saw its shares almost triple in value on Friday after the company said that a late-stage trial of a treatment for a rare type of epilepsy met its main goal. 2 October 2017
Pharmaceutical
Last week saw AbbVie entering a patent settlement with Amgen relating to the latter’s biosimilar version of blockbuster drug Humira. US Food and Drug Administration acceptance for review of Eisai’s cancer drug Lenvima in a new indication, and FDA approval for Eli Lilly’s new breast cancer drug Verzenio also figured in the news. Also attracting attention was news on the failure of Axovant Sciences’ Alzheimer’s disease candidate intepirdine. 1 October 2017
Pharmaceutical
Science writer David Levine provides the latest quarterly Special Report piece, looking at the drug prices in one therapy area that are getting on people's nerves so much that they might prompt drastic action from the White House to bring down the cost of medicines across the board. 29 September 2017
Pharmaceutical
There was an emphasis on good times ahead in the communications put out by Merck KGaA as the German life sciences and pharma company welcomed analysts and investors to its 2017 Capital Markets Day on Thursday. 28 September 2017
Biotechnology
Axovant Sciences saw around $1.8 billion wiped of its market cap on Tuesday, as the company announced its Alzheimer’s disease drug candidate intepirdine failed in a late-stage trial. 27 September 2017
Pharmaceutical
Families from across Europe are on Tuesday having their say on an epilepsy drug that raises the risk of birth defects. 26 September 2017
Pharmaceutical
News last week attracted a great deal of comment included Neos Therapeutics gaining US Food and Drug Administration for its attention deficit hyperactivity disorder (ADHD) drug Adzenys. Also garnering attention were: Ultragenyx’ rival bid to acquire Dimension Therapeutics; supplemental approval for Ipsen’s Somatuline Depot; an FDA safety alert on Intercept Pharmaceuticals’ Ocaliva; and a Phase III success for Nabriva’s lefamulin 23 September 2017
Pharmaceutical
Sales of migraine products are expected to grow to $8.7 billion by 2026, at a compound annual growth rate (CAGR) of 10.3% across the seven major markets (5EU (France, Germany, Italy, Spain, and the UK), and Japan; 7MM). 22 September 2017
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
Pharmaceutical
Life science investors can be divided into two groups: those who bought Novo Nordisk stock before GLP-1s hit the big time, and those who wish they had. 10 November 2024
Pharmaceutical
Jazz Pharmaceuticals has reported third-quarter revenue of $1 billion, a 9% increase over the prior year, fueled by strong performance in its key sleep and epilepsy portfolios. 7 November 2024
Biotechnology
US clinical-stage drug developer Acumen Pharmaceuticals has appointed Amy Schacterle as chief regulatory officer and head of quality, reporting to Jim Doherty, president and chief development officer at Acumen. 7 November 2024
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