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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
Pharmaceutical
Intra-Cellular Therapies has announced positive results from Study 304 evaluating the efficacy and safety of Caplyta (lumateperone) 42mg for the prevention of relapse in adult patients with schizophrenia. 6 November 2024
Pharmaceutical
CNS specialist Prilenia Therapeutics has announced the publication of additional analyses of pridopidine in Huntingdon’s disease. 18 December 2020
Biotechnology
French biotech firm AB Science yesterday announced that the Phase IIb/III study (AB09004 - NCT01872598) evaluating oral masitinib in patients with mild and moderate Alzheimer’s disease met its predefined primary endpoint. 17 December 2020
Biotechnology
California-based Neuron23, an early-stage biotech focused on developing precision medicines for genetically defined neurological and immunological diseases, has announced its launch backed by a combined $113.5 million Series A and B financing. 16 December 2020
Pharmaceutical
Danish diabetes care giant Novo Nordisk said today that it will enter Phase III development in Alzheimer’s disease with oral semaglutide, a once-daily oral formulation of the long-acting GLP-1 analogue semaglutide. 16 December 2020
Pharmaceutical
A veteran of both pharma and digital health has been named the chief executive of Cognito Therapeutics. 10 December 2020
Biotechnology
Following regulatory bids in Europe and Japan, aducanumab developers Biogen and Eisai have now formally submitted for approval in Japan. 10 December 2020
Biotechnology
Japanese drug major Chugai has obtained an import drug license from the Taiwan Food and Drug Administration (TFDA) for Enspryng (satralizumab) for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult and adolescent over 12 years old patients who are anti-aquaporin-4 (AQP4) antibody positive. 9 December 2020
Biotechnology
Shares in Tonix Pharmaceuticals were up by more than a third after 90 minutes of trading on Monday. 7 December 2020
Pharmaceutical
Johnson & Johnson’s pharma division, Janssen, has submitted for European approval to market PP6M - a formulation of paliperidone palmitate which can be administered every six months. 4 December 2020
Biotechnology
Last month’s licensing deal by Biogen with Sage Therapeutics to jointly develop and commercialize zuranolone (SAGE-217) and SAGE-324 did not immediately please the latter’s investors, despite being worth a potential $3 billion. 4 December 2020
Pharmaceutical
The US Food and Drug Administration has approved Hetlioz (tasimelteon) capsule and liquid formulations for the treatment of adults and children, respectively, with night-time sleep disturbances associated with Smith-Magenis syndrome (SMS). 3 December 2020
Pharmaceutical
The failure of the Phase III NEPTUNE clinical trial sent shares in New York-based rare disease specialist Ovid Therapeutics down by half on Wednesday. 3 December 2020
Biotechnology
Boosting its position as the leading developer of oral CGRP-receptor blockers, Biohaven Pharmaceutical has entered into a global collaboration and license deal with Japan’s Sosei Group. 1 December 2020
Pharmaceutical
The focus of last week’s major news was regulatory decisions, with Regeneron Pharmaceuticals receiving emergency use authorization from the US Food and Drug Administration for its COVID-19 antiviral cocktail REGEN-COV2. Also, US drug developer Reata Pharmaceuticals had another setback last week as the FDA called for some additional analysis on its Friedreich’s ataxia candidate omaveloxolone. And the FDA granted approval for Y-mAbs Therapeutics’ neuroblastoma drug Danyelza. On the research front, AstraZeneca and Oxford University released the latest data on their COVID-19 vaccine AZD1222. Meantime, biotech major Biogen acquired rights to Sage Therapeutics’ major depressive disorder drug zuranolone in a deal potentially worth $3 billion. 29 November 2020
Biotechnology
US CNS specialists Biogen and Sage Therapeutics have announced a global collaboration to develop and commercialize potential breakthrough therapies in depression and movement disorders. 27 November 2020
Generics
The European Commission has fined the pharmaceutical companies Israel-based Teva Pharmaceutical Industries 60.5 million euros ($72 million) for agreeing to delay for several years the market entry of a cheaper generic version of Cephalon's drug for sleep disorders, modafinil, after Cephalon's main patents had expired. 26 November 2020
Pharmaceutical
The UK Competition and Markets Authority (CMA) launched a competition law investigation into Essential Pharma last month because of suspicions that the firm may have abused its dominant position by proposing to withdraw the supply of bipolar drug, lithium-based Priadel, to UK patients. 26 November 2020
Biotechnology
The US Food and Drug Administration has granted accelerated approval for Danyelza (naxitamab) in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF). 26 November 2020
Biotechnology
The US Food and Drug Administration has completed its internal review of the Baseline-Controlled Study results of omaveloxolone for the treatment of patients with Friedreich’s ataxia (FA) and concluded that the results do not strengthen the results of Part 2 of the MOXIe study. 26 November 2020
Pharmaceutical
Opioid drug OxyContin manufacturer Purdue Pharma has pleaded guilty in federal court in Newark, New Jersey, to conspiracies to defraud the United States and violate the anti-kickback statute, the US Department of Justice announced yesterday. 25 November 2020
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