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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Evotec says it has taken notice of the statement made by Halozyme Therapeutics on November 22, stating that it has withdrawn its non-binding proposal to acquire Evotec for 11.00 euros per share in cash. 23 November 2024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
The Russian drug market will reach a value of $35 billion by 2024, despite the ongoing military conflict between Russia and Ukraine and the ever-tightening sanctions pressure on Russia, according to calculations by experts from the Russian consulting company in the field of pharmaceuticals SBS Consulting, report The Pharma Letter’s local correspondent. 20 September 2022
Biotechnology
Danish diabetes care giant Novo Nordisk has entered into a definitive agreement to acquire Forma Therapeutics, a US clinical-stage biopharmaceutical company focused on transforming the lives of patients with sickle cell disease (SCD) and rare blood disorders, whose shares rocketed up 48% to $19.84 on the news. 19 September 2022
Biotechnology
US biotech bluebird bio has had a rocky ride in gaining US approval for its Skysona (elivaldogene autotemcel), but the US Food and Drug Administration (FDA), having earlier this year extended the review period for the product, on Friday granted authorization for the gene therapy. 19 September 2022
Biotechnology
Adding to approvals of Vabysmo (faricimab) in the major markets of the USA and Japan earlier this year, Swiss pharma giant Roche has now gained marketing clearance for the drug from the European Commission (EC) for the treatment of neovascular or ‘wet’ age-related macular degeneration (nAMD) and visual impairment due to diabetic macular edema (DME). 19 September 2022
Pharmaceutical
Ambitions are soaring for the UK’s pharma and biotech industry on the back of record investment but can it be sustained in the absence of workers with critical STEM skills? MHA’s Yogan Patel looks at strategies for attracting and retaining talent in an Expert View piece. 19 September 2022
Biotechnology
French biotech firm Genfit has entered into an exclusivity agreement to acquire Versantis, a private Swiss-based clinical stage biotechnology company focused on addressing the growing unmet medical needs in liver diseases. 19 September 2022
Biosimilars
Sandoz, the generic and biosimilar medicines unit of Novartis, which the Swiss pharma giant last month said it would hive off into a new publicly traded company, today announced further progress on its biosimilar pipeline, with the release of positive results from the integrated ROSALIA Phase I/III clinical trial study for its proposed biosimilar denosumab. 19 September 2022
Pharmaceutical
Pharma companies continue to evaluate novel ways to increase their return on investment and generate shareholder value, basic earnings per share (EPS), plus stock price. Historically, pharma has pursued mergers and acquisitions to undermine R&D and drive growth. 19 September 2022
Biotechnology
Last month, Belgo-Dutch autoimmune diseases specialist argenx announced the European Commission (EC) approval of Vyvgart (efgartigimod alfa-fcab) as an add-on to standard therapy for adults with generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody positive. 19 September 2022
Biotechnology
Significant news last week included US pharma major Bristol Myers Squibb gaining Food and Drug Administration approval for its TYK2 inhibitor Sotyktu (deucravacitinib) for the treatment of plaque psoriasis. Shares of US biotech Akero skyrocketed last Tuesday when it released very positive Phase IIb results for its efruxifermin in the treatment of non-alcoholic steatohepatitis (NASH). Also, US pharma giant Pfizer released impressive new Phase III data on its pentavalent vaccine for meningococcal disease. US biotech Gilead Sciences last week entered into a settlement with several generic drugmakers relating to copy versions of its HIV drugs Descovy and Odefsey. 18 September 2022
Biotechnology
Following approval from the US regulator in March this year, on Friday Bristol Myers Squibb revealed that the European Commission has also cleared its fixed-dose combination of Opdualag (nivolumab and relatlimab) for the first-line treatment of advanced (unresectable or metastatic) melanoma in adults and adolescents 12 years of age and older with tumor cell PD-L1 expression < 1%. 17 September 2022
Biotechnology
Intellia Therapeutics and Regeneron Pharmaceuticals presented positive interim results from a well-watched Phase I trial early Friday. 16 September 2022
Biotechnology
The European Medicines Agency’s (EMA) human medicines committee (CHMP) today released its list of recommended novel medicines and one biosimilar for approval following its September 2022 meeting. 16 September 2022
Biosimilars
The Initiative for Medicines, Access, and Knowledge (I-MAK), a campaign group seeking to drive down the cost of medicines, has taken aim at pharma firms’ protection of their patents. 16 September 2022
Biotechnology
Japanese medium-sized drugmaker Asahi Kasei Pharma yesterday revealed it has acquired the exclusive distribution rights in Japan for two products developed by Swedish Orphan Biovitrum. 16 September 2022
Biotechnology
Efforts on the part of New York pharma major Pfizer to become a vaccines giant took another step forward on Thursday, with positive results from a trial in meningitis. 16 September 2022
Biotechnology
Looking to cement its lead in the treatment of rare blood disorders, AstraZeneca has lifted the lid on positive results for a new add-on therapy for its blockbuster C5 inhibitor franchise. 16 September 2022
Pharmaceutical
The World Health Organization’s (WHO) Therapeutics and COVID-19: living guideline, which now conditionally recommends Veklury (remdesivir) for the treatment of patients with severe COVID-19, now continues to conditionally recommend Veklury in those with non-severe COVID-19 at the highest risk of hospitalization. 16 September 2022
Pharmaceutical
US agencies the Food and Drug Administration (FDA) and the National Institutes of Health (NIH) have announced the launch of the Critical Path for Rare Neurodegenerative Diseases (CP-RND). 16 September 2022
Pharmaceutical
A state-of-the-art research and development facility, using world-class medical research to find solutions for a range of serious illnesses, has opened in West Auckland. 16 September 2022
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