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Biotechnology
Japanese drugmaker Eisai today that the humanized antisoluble aggregated amyloid-beta (Aβ) monoclonal antibody Leqembi (lecanemab) has been launched in South Korea. 28 November 2024
Pharmaceutical
UK-based immunotherapy firm Centauri Therapeutics has secured a £1 million ($1.25 million) grant from PACE (Pathways to Antimicrobial Clinical Efficacy) to further develop its Alphamer technology. 25 November 2024
Biotechnology
Germany’s Evotec says it has taken notice of the statement made by Halozyme Therapeutics on November 22, stating that it has withdrawn its non-binding proposal to acquire Evotec for 11.00 euros per share in cash. 23 November 2024
Biotechnology
Colorado, USA-based OncoVerity announced the closing of a series A extension led by existing investors, argenX and RefinedScience. The value was not disclosed, but this extension follows a $30 million Series A fundraiser in March 2023. 22 November 2024
Biotechnology
Sweden-based BioArctic saw its fall 7.5% to 139.90 kronor on Friday, after its announced that its partner, Japan’s Eisa, has updated its revenue outlook for the Alzheimer’s treatment Leqembi (lecanemab) for the 2024 fiscal year (FY), which runs from April 2024 through March 2025. 11 November 2024
Biotechnology
Danish biotech Gubra announces that Germany’s Boehringer Ingelheim has decided to discontinue the development of the long-acting neuropeptide Y receptor type 2 (NPY2R) agonist BI 1820237 in obesity. 4 November 2024
Biotechnology
Japanese drugmaker Eisai has completed the rolling submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for lecanemab-irmb (US brand name Leqembi) subcutaneous autoinjector for weekly maintenance dosing after it was granted Fast Track designation by the FDA. 1 November 2024
Pharmaceutical
GSK has announced its largest US manufacturing investment to date, dedicated to producing medicines and vaccines. 25 October 2024
Pharmaceutical
Following a re-examination, the European Medicines Agency’s human health committee, CHMP confirmed its initial recommendation to refuse the granting of a conditional marketing authorization for Masitinib AB Science’s masitinib. 18 October 2024
Pharmaceutical
University Medical Center Groningen (UMCG) and SHINE Europe have secured a 10.5 million euro ($11 million) grant to advance European production of terbium isotopes for cancer treatments. 17 October 2024
Pharmaceutical
Danish dermatology focused LEO Pharma has announced the launch of Anzupgo (delgocitinib) cream in Germany for the treatment of adult patients with moderate to severe chronic hand eczema (CHE), for whom topical corticosteroids are inadequate or inappropriate. 15 October 2024
Pharmaceutical
French pharma major Sanofi revealed it has entered into negotiations with private equity firm Clayton Dubilier & Rice (CD&R) for the potential sale of a 50% controlling stake in Opella, its consumer healthcare business. 14 October 2024
Pharmaceutical
The UK’s new 2024 voluntary scheme for branded medicines pricing, access, and growth (VPAG) came into force at the beginning of January this year. 4 October 2024
Biotechnology
Sirnaomics, a firm specializing in RNAi therapeutics, has entered into a subscription agreement with biotech specialist Poon Hung Fai. 4 October 2024
Biotechnology
GigaGen has been awarded a contract by the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response (ASPR) within the US Department of Health and Human Services (HHS). 4 October 2024
Biotechnology
Oxford, UK-based Enara Bio today announces the closing of a $32.5 million Series B financing supported by a strong syndicate of new and existing biotech investors. 3 October 2024
Pharmaceutical
French drugmaker Mitem Pharmavhas the worldwide acquisition of Desferal (deferoxamine), a major MITM in hematology, from Swiss giant Novartis. 25 September 2024
article
The European Medicines Agency’s (EMA) Committee for Human Medicinal Products (CHMP) has elected Bruno Sepodes as its new chair. 19 September 2024
Pharmaceutical
The Austrian Academy of Sciences (OeAW) is further expanding its focus on life sciences by opening an institute for biomedical artificial intelligence (AI) based on a 150 million euros ($166.8 million) funding from the German non-profit Boehringer Ingelheim Foundation (BIS). 18 September 2024
Pharmaceutical
Italian drugmaker Alfasigma has signed an agreement to acquire the entire share capital of Sofar, a company with over half a century of operational history in the research, production and marketing of drugs, medical devices and food supplements. 18 August 2022
Biotechnology
US clinical-stage biotech firm Karuna Therapeutics recently announced positive top-line results from the Phase III EMERGENT-2 trial of KarXT (xanomeline + trospium chloride) in acutely psychotic hospitalized adult patients with schizophrenia. 18 August 2022
Biotechnology
Shares of China-based immuno-oncology-focussed biotech I-Mab plunged more than 13% to $6.90 yesterday, after the company revealed in a filing with the Securities and Exchange Commissions that AbbVie has discontinued a Phase I trial of I-Mab's anti-CD47 monoclonal antibody lemzoparlimab, which the US pharma major in-licensed for an upfront $180 million 2020. 18 August 2022
Biotechnology
The US Food and Drug Administration approved Zynteglo (betibeglogene autotemcel), also known as beti-cel, from bluebird bio the first cell-based gene therapy for the treatment of adult and pediatric patients with beta-thalassemia who require regular red blood cell transfusions. 18 August 2022
Pharmaceutical
Medicines Australia's national medicines policy (NMP) review, which was put on hold before the May federal election, has restarted. 18 August 2022
Pharmaceutical
Privately-held North Carolina, USA-based contract research organization BioAgilytix has named Linda Robbie its new chief operating officer. 17 August 2022
Biotechnology
Blueprint Medicines has announced positive top-line results from the registrational Part 2 of the PIONEER clinical trial of Ayvakit (avapritinib). 17 August 2022
Biotechnology
UK pharma major GSK announced today that the US Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for momelotinib for the potential treatment of myelofibrosis patients. 17 August 2022
Biotechnology
The contract development and manufacturing organization (CDMO) AGC Biologics and RoosterBio, a supplier of human mesenchymal stem/stromal cells (hMSCs), highly engineered media and bioprocess development services, have announced a strategic partnership. 17 August 2022
Pharmaceutical
The Project to Accelerate New Treatments for Tuberculosis (PAN-TB) collaboration today announced the execution of a joint development agreement (JDA) — among Johnson & Johnson unit Janssen Pharmaceutica, Japan’s Otsuka, TB Alliance and the Bill & Melinda Gates Medical Research Institute — supporting the progression of two investigational tuberculosis (TB) combination treatment regimens into Phase II clinical development. 17 August 2022
Pharmaceutical
In the UK, the National Institute for Health and Care Excellence (NICE) has given a positive reimbursement decision for AbbVie’s Rinvoq (upadacitinib). 17 August 2022
Biosimilars
The US Food and Drug Administration (FDA) has approved the citrate-free, high-concentration (100mg/mL) formulation of Hadlima (adalimumab-bwwd), a biosimilar referencing AbbVie’s mega-blockbuster Humira (adalimumab). 17 August 2022
Pharmaceutical
CNS specialist Lundbeck was trading 12% lower by mid-afternoon Wednesday after presenting its financial results for the first half of the year. 17 August 2022
Pharmaceutical
The UK government has initiated formal consultations with the European Union, with the aim of finalizing UK participation in EU science and research programs. This follows persistent delays by the EU in implementing the agreement reached under the Trade and Cooperation Agreement (TCA). 17 August 2022
Biotechnology
The European Investment Bank (EIB) is providing 22 million euros ($22.4 million; above 100 million polish zlotys) in financing to Ryvu Therapeutics, Poland’s largest biotech firm that is focusing on novel small molecule therapies that address unmet medical needs in oncology. 17 August 2022
Biotechnology
Ideaya Biosciences has announced its financials for second-quarter 2022, saying it has a strong balance sheet of ~$324 million cash, cash equivalents and marketable securities as of June 30, 2022, which is anticipated to fund planned operations into 2025. 17 August 2022
Pharmaceutical
Shares of French pharma major Sanofi were down 4.8% at 82.42 euros this morning, after it announced the discontinuation of the global clinical development program of amcenestrant, an investigational oral selective estrogen receptor degrader (SERD). 17 August 2022
Pharmaceutical
As President Joe Biden signs the Inflation Reduction Act into law, drugmakers in the USA are poring over the likely impact on drug prices, and how best to respond to its enactment. In this episode, we take a quick look at the Act’s provisions, and the likely impact on drugmakers, with Stephanie Kennan from political consultancy McGuireWoods. 17 August 2022
Biotechnology
US biotech Viridian Therapeutics has commenced an underwritten public offering of $175 million of shares of its common stock and series B preferred stock. 16 August 2022
Biotechnology
Big pharma has come knocking at the door of Orna Therapeutics, a biotech launched a few years ago by MIT alumni with the goal of developing a new kind of RNA therapeutic. 16 August 2022
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