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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Evotec says it has taken notice of the statement made by Halozyme Therapeutics on November 22, stating that it has withdrawn its non-binding proposal to acquire Evotec for 11.00 euros per share in cash. 23 November 2024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
Bharat Biotech has recently completed the Phase III trials of its COVID-19 intranasal vaccine BBV154 and submitted the data to the Drug Controller General of India (DCGI) for approval both as a primary two-dose vaccine, and a heterologous booster dose. However, the company has not yet made clinical trial results publicly available. 25 August 2022
Biotechnology
Zelluna Immunotherapy, a Norwegian company developing allogeneic T Cell Receptor Natural Killer (TCR-NK) cells for the treatment of cancer, has announced an investment from Takeda Ventures. 25 August 2022
Biotechnology
On August 24, the US Food and Drug Administration announced it has approved Pharmacyclics application for Imbruvica (ibrutinib) for pediatric patients ≥ 1 year of age with chronic graft versus host disease (cGVHD) after failure of 1 or more lines of systemic therapy. Formulations include capsules, tablets, and oral suspension. 25 August 2022
Pharmaceutical
AstriVax, a start-up working to develop novel vaccines, has raised the largest amount of seed capital in the history of Belgium-based university KU Leuven spin-offs, totalling $30 million. 25 August 2022
Biotechnology
August is spinal muscular atrophy (SMA) awareness month – an opportunity to reflect on the current and future treatment landscape. 25 August 2022
Biotechnology
When it comes to lung diseases, asthma, chronic obstructive pulmonary disease (COPD), and cystic fibrosis might come to mind. 25 August 2022
Biotechnology
UK pharma major AstraZeneca this morning announced that it has received marketing approval from the Japanese Ministry of Health, Labor and Welfare (MHLW) for three of its pharmaceutical products, sending the firm’s shares edging up 1.3% to 11,497.12 pence. 25 August 2022
Biosimilars
Competition for AstraZeneca’s Soliris (eculizumab) is stepping closer to the market, with developer Amgen, a Californian biotech giant, announcing positive trial results. 24 August 2022
Biotechnology
US healthcare giant Johnson & Johnson subsidiary Janssen today revealed that the European Commission (EC) has granted conditional marketing authorization (CMA) of Tecvayli (teclistamab) as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma (RRMM). 24 August 2022
Biotechnology
Very young children can benefit from a high level of immunity to the novel coronavirus after receiving the Comirnaty vaccine, new research shows. 24 August 2022
Biotechnology
Privately-held Gensaic, a company that seeks to reimagine gene therapy, announced today that it has entered into a strategic collaboration agreement with US neurological diseases specialist Ovid Therapeutics. 24 August 2022
Generics
AMPAC Fine Chemicals (AFC), an SK pharmteco company, has opened its new Complex Molecule Chemistry & Engineering Center in Rancho Cordova, California. 24 August 2022
Pharmaceutical
The passing of the $740 billion Inflation Reduction Act, which aims to control and lower prescription drug costs, will be welcome news for patients feeling the repercussions of rising inflation and a cost-of-living crunch in the US. However, GlobalData predicts that few pharma companies will be left unaffected by its provisions, with its full effects only being felt in 2026. 24 August 2022
Biotechnology
US cancer-focused biotech Foghorn Therapeutics saw its shares plummet 25% to $11.00 by close of trading yesterday, after it announced that the US Food and Drug Administration (FDA) has placed a full clinical hold on the Phase I dose escalation study of FHD-286. 24 August 2022
Pharmaceutical
Based on an interim futility analysis of its global Phase III trial, REALM-DCM, US pharma giant Pfizer recently ceased clinical trial development of its therapy emprumapimod (PF-07265803). 24 August 2022
Pharmaceutical
US Department of Health and Human Services (HHS) Secretary Xavier Becerra has announced more than $20 million in funding to expand HIV prevention, testing, and treatment services at health centers nationwide. 24 August 2022
Biotechnology
US mRNA specialist biotech Moderna says that it has completed its submission to the US Food and Drug Administration (FDA) for emergency use authorization for its BA.4/BA.5 Omicron-targeting bivalent COVID-19 booster vaccine, mRNA-1273.222. 24 August 2022
Biotechnology
Japanese drugmaker Chugai Pharmaceutical today announced receipt of approval from the Ministry of Health, Labor and Welfare (MHLW) for the anticancer agent/antimicrotubule binding anti-CD79b monoclonal antibody Polivy intravenous infusion (polatuzumab vedotin (genetical recombination) for an additional indication of treatment of patients with previously untreated diffuse large B-cell lymphoma (DLBCL). 24 August 2022
Pharmaceutical
The face of the USA’s response to the coronavirus pandemic, Anthony Fauci, has announced he will step down from his role as Director of the National Institute of Allergy and Infectious Diseases (NIAID). 23 August 2022
Biotechnology
British biotech Mereo BioPharma has revealed its largest shareholder is agitating to purge certain board members as part of a plan to change the firm’s strategic direction. 23 August 2022
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