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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Evotec says it has taken notice of the statement made by Halozyme Therapeutics on November 22, stating that it has withdrawn its non-binding proposal to acquire Evotec for 11.00 euros per share in cash. 23 November 2024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
Biotechnology
Spanish dermatology specialist Almirall and Simcere Pharmaceutical Group have signed an exclusive licensing agreement for the Chinese firm’s IL-2 mutant fusion protein (IL-2 mu-Fc) autoimmune drug candidate, SIM0278. 29 September 2022
Pharmaceutical
Japanese drug major Sumitomo Pharma has filed an appeal with the US Court of Appeals for the Federal Circuit (CAFC) seeking revocation of the decision of the US Patent and Trademark Office (USPTO) relating to the proprietary atypical antipsychotic agent Latuda (lurasidone HCl tablets). 29 September 2022
Biotechnology
Continuing its impressive rise, Dupixent (dupilumab) has secured US Food and Drug Administration approval for prurigo nodularis, a debilitating skin condition. 29 September 2022
Generics
Private equity firm SK Capital Partners has entered into a deal to acquire Apotex Pharmaceutical Holdings, a Canada-based generic drugmaker with products across all major therapeutic areas for patients around the world. 29 September 2022
Pharmaceutical
Russia plans to accelerate the production of active pharmaceutical ingredients (APIs) for antibiotics, as well as to pay more attention to the development of drugs against chronic infections, as part of a new State Concept for the Development of Pharmaceutical industry in Russia that is designed until 2030, reports The Pharma Letter’s local correspondent. 29 September 2022
Biosimilars
Increasing access to capital has resulted in a surge of Indian biopharmaceutical companies focusing on research and development. A think-tank has advised the government that it is imperative to streamline regulatory approval procedures for the biotechnology industry and eliminate redundant steps so as to expedite the approval process, reports The Pharma Letter’s India correspondent. 28 September 2022
Pharmaceutical
Japanese drugmaker Shionogi closed 1% higher after Tokyo trading on Wednesday after reporting progress with its COVID-19 antiviral. 28 September 2022
Biotechnology
Elranatamab, an investigational B-cell maturation antigen (BCMA) CD3-targeted bispecific antibody in development for the treatment of multiple myeloma (MM) by US pharma giant Pfizer, has been granted an ‘Innovation Passport’ from the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA). 28 September 2022
Biotechnology
AstraZeneca has written to US healthcare professionals to notify them of the company’s volunatary withdrawal of an indication for Lynparza (olaparib). 28 September 2022
Pharmaceutical
Drugmakers in Europe are arguing for a new economic model for reimbursement of antibiotics, paving the way for a breakthrough in the fight against antimicrobial resistance. 28 September 2022
Biotechnology
Shares in Avidity Biosciences were down as much as 26% on the news that the US Food and Drug Administration (FDA) has placed a partial clinical hold on new participant enrollment in the Phase I/II MARINA clinical trial of AOC 1001 - an antibody-oligonucleotide conjugate (AOC) - in adults with myotonic dystrophy type 1 (DM1). 28 September 2022
Pharmaceutical
The Russian Parliament (State Duma) has said it will consider establishing the priority of using domestic reference materials in the pharmaceutical industry. 28 September 2022
Biotechnology
Japanese drugmaker Eisai’s shares gained more than 17% to 6,784 yen today, after it released top-line results from the Clarity AD Phase III clinical trial for lecanemab, an investigational anti-amyloid beta (Aβ) protofibril antibody for the potential treatment of early Alzheimer’s disease. 28 September 2022
Biotechnology
Japan’s Ministry of Health, Labor and Welfare (MHLW )has granted approval of the manufacturing and marketing application for Berinert SC Injection 2000 submitted by CSL Behring KK, a subsidiary of Australia’s CSL Limited. 28 September 2022
Biotechnology
A new UK-based antibody-drug conjugate (ADC) company, Pheon Therapeutics, has launched with $68 million in series A backing. 28 September 2022
Biotechnology
Californian genetic medicine company Scribe Therapeutics has scored a major strategic collaboration with French giant Sanofi. 27 September 2022
Biotechnology
Privately-held Arsenal Biosciences, a programmable cell therapy company engineering advanced CAR T therapies for solid tumors, has announced a multi-year collaboration with the Roche subsidiary Genentech. 27 September 2022
Biotechnology
North Carolina, USA-based 9 Meters Biopharma saw its shares rise nearly 22% to $0.25, after it announced positive final results from the Phase II study of vurolenatide and the outcome from its End-of-Phase II meeting with the US Food and Drug Administration (FDA). 27 September 2022
Biotechnology
Merck & Co has announced that its anti-PD-1 therapy Keytruda (pembrolizumab) has received four new approvals from Japan’s Ministry of Health, Labor and Welfare (MHLW). 27 September 2022
Biotechnology
Cambridge, USA-base immuno-oncology company DEM BioPharma has appointment of Nenad Grmusa as chief executive and Christophe Quéva, as chief scientific officer. 27 September 2022
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