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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Evotec says it has taken notice of the statement made by Halozyme Therapeutics on November 22, stating that it has withdrawn its non-binding proposal to acquire Evotec for 11.00 euros per share in cash. 23 November 2024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
Biosimilars
Poland-based drugmaker Polpharma Biologics today announced that the European Medicines Agency (EMA) has accepted the first-ever Marketing Authorization Application (MAA) for biosimilar natalizumab, a proposed biosimilar to branded multiple sclerosis treatment Tysabri. 15 July 2022
Generics
Following a public comment period, the USA’s Federal Trade Commission (FTC) has approved a final order settling charges that London-listed Jordanian drugmaker Hikma Pharmaceuticals’ $375 million acquisition of Custopharm likely would have harmed competition in the market for the corticosteroid drug triamcinolone acetonide, or TCA. 15 July 2022
Biotechnology
Chinese vaccine developer Sinovac Biotech announced that its COVID-19 vaccine (CoronaVac) has been approved by the Brazilian Health Regulatory Agency (Anvisa) for emergency use in children from three to five years old on July 13. 15 July 2022
Pharmaceutical
The US Food and Drug Administration yesterday issued a final guidance, “Instructions for Use – Patient Labeling for Human Prescription Drug and Biological Products – Content and Format.” 15 July 2022
Biotechnology
Sino-American biotech firm BeiGene today announced that the US Food and Drug Administration (FDA) has deferred action on the Biologics License Application (BLA) for tislelizumab as a second-line (2L) treatment for patients with unresectable or metastatic esophageal squamous cell carcinoma (ESCC). 14 July 2022
Biotechnology
The National Institute for Health and Care Excellence (NICE) has issued a Final Appraisal Document (FAD) recommending the combination of Opdivo (nivolumab) and Yervoy (ipilimumab) for the first-line treatment of adults with unresectable malignant pleural mesothelioma (MPM), in England and Wales. 14 July 2022
Biotechnology
Despite a very tardy authorization in the USA, the Novavax jab has the potential to be much more than just an also-ran in the COVID-19 vaccine market. 14 July 2022
Biotechnology
Swiss pharma giant Roche today announced new two-year data from the TENAYA and LUCERNE studies that reinforce the long-term efficacy, safety and durability of Vabysmo (faricimab) in neovascular or “wet” age-related macular degeneration (nAMD), a leading cause of vision loss. 14 July 2022
Biotechnology
Californian cytokine storm specialist Humanigen lost 80% of its market value on Wednesday based on the results of the National Institute of Allergy and Infectious Diseases’ (NIAID) ACTIV-5/BET-B trial. 14 July 2022
Pharmaceutical
Shares of US drug developer Theravance Biopharma were up more than 17% at $10.14 pre-market, following the announcement late Wednesday that it has entered into a definitive agreement to sell all of its units in Theravance Respiratory Company, representing its 85% economic interest in the sales-based royalty rights on worldwide net sales of UK pharma major GSK's (LSE: GSK) Trelegy (fluticasone furoate/ umeclidinium/vilanterol) Ellipta to Royalty Pharma. 14 July 2022
Biotechnology
A possible new indication for Sanofi’s IL-13 and IL-4 blocking antibody Dupixent (dupilumab) is on the cards, after a successful Phase III trial. 14 July 2022
Pharmaceutical
Family-owned drugmaker Grünenthal today announced an agreement with fellow Germany-based Bayer to acquire Nebido, a long-acting depot preparation of testosterone undecanoate and a well-known brand for the treatment of male hypogonadism, and its associated brands. 14 July 2022
Generics
India's Department for Promotion of Industry and Internal Trade (DPIIT) has been instructed by the Kerala High Court to consider compulsory licensing for the breast cancer drug ribociclib, marketed by Swiss pharma giant Novartis under the brand names Kisqali and Kryxana, reports The Pharma Letter’s local correspondent. 14 July 2022
Biotechnology
UK health technology assessor the National Institute for Health and Care Excellence (NICE) has recommended the use of Piqray (alpelisib) for use in combination with fulvestrant for the treatment of postmenopausal women, and men, with hormone receptor positive (HR+), human epidermal growth factor receptor 2 negative (HER2), locally advanced or metastatic breast cancer with a PIK3CA mutation after disease progression following endocrine-based therapy. 14 July 2022
Biotechnology
US biotech Gilead Sciences has announced that the National Institute for Health and Care Excellence (NICE) has recommended the use of Trodelvy (sacituzumab govitecan) in England within its marketing authorization. 14 July 2022
Pharmaceutical
SIGA Technologies saw its shares gain almost 8% to $14.05 today, after it announced around $28 million of procurement orders for oral TPOXX (tecovirimat). 13 July 2022
Pharmaceutical
South Korean firm SK bioscience has announced that SKYCovione, the Asian country’s first COVID-19 vaccine candidate adjuvanted with GSK’s pandemic adjuvant, has been authorized by the Korean Ministry of Food and Drug Safety. 13 July 2022
Biotechnology
Belgian biotech Agomab Therapeutics has extended its series B financing round with an additional close of $40.5 million, bringing the total to $114 million. 13 July 2022
Biotechnology
An expert review of data from 79 real-world studies showed that AstraZeneca’s COVID-19 vaccine, Vaxzevria (ChAdOx1-S [recombinant]) and the available mRNA COVID-19 vaccines provide equally effective protection against hospitalization and death from COVID-19 following two doses. 13 July 2022
Biotechnology
US biopharma company Greenwich LifeSciences , which is focused on the development of GLSI-100, announced that the Food and Drug Administration (FDA) has removed the clinical hold permitting the Flamingo-01 Phase III clinical trial to proceed. 13 July 2022
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