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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Evotec says it has taken notice of the statement made by Halozyme Therapeutics on November 22, stating that it has withdrawn its non-binding proposal to acquire Evotec for 11.00 euros per share in cash. 23 November 2024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
Zenas BioPharma announced the pricing of its upsized initial public offering of 13,235,294 shares of its common stock at an initial public offering price of $17.00 per share. 13 September 2024
Pharmaceutical
Despite positive top-line data, Syndax Pharmaceuticals stock has fallen more than a tenth, following an interim analysis from the AUGMENT-101 trial. 3 October 2023
Biotechnology
After 17 years at GSK, John Lepore’s departure from the UK pharma major was announced last week. 3 October 2023
Generics
US healthcare giant Johnson & Johnson has confirmed it will not enforce its patents for the multidrug-resistant tuberculosis med Sirturo (bedaquiline) in certain lower-income countries. 3 October 2023
Biotechnology
Privately-held Swiss dermatology company Galderma has announced some bad news relating to its pending Biologics License Application (BLA) for relabotulinumtoxinA (QM-1114) to the US Food and Drug Administration (FDA). 3 October 2023
Pharmaceutical
French pharma major Sanofi has signed a research collaboration with US healthcare giant Johnson & Johnson’s subsidiary Janssen Pharmaceuticals. 3 October 2023
Biotechnology
The US Food and Drug Administration (FDA) has issued a complete response letter for the lebrikizumab biologic license application (BLA) for the treatment of moderate-to-severe atopic dermatitis (eczema), the drug’s developer, US pharma major Eli Lilly, announced yesterday. 3 October 2023
Generics
The US Food and Drug Administration has revised its Manual of Policies and Procedures (MAPP), in relation to suitability petitions for generic drug regulatory submissions. 3 October 2023
Pharmaceutical
In the USA, British drugmaker AstraZeneca has brought to an end certain product liability lawsuits for the gastrointestinal meds Nexium (esomeprazole) and Prilosec (omeprazole). 3 October 2023
Biotechnology
Barcelona, Spain-based plasma-derived medicine specialist Grifols says that its biotech subsidiary GigaGen has signed an agreement with the National Cancer Institute (NCI), part of the USA’s National Institutes of Health (NIH), to advance development of the company’s differentiated anti-CTLA-4 antibody drug candidate for cancer treatment, GIGA-564. 3 October 2023
Pharmaceutical
The World Health Organization’s Strategic Advisory Group of Experts (SAGE) and the Malaria Policy Advisory Group (MPAG) have recommended for approval R21/Matrix-M malaria vaccine. 3 October 2023
Pharmaceutical
US pharma company PTC Therapeutics has announced a further strategic prioritization and associated reduction in its workforce. 2 October 2023
Biotechnology
Today, Boston, USA-based Clade Therapeutics announced the acquisition of Gadeta, a Netherlands-based cell therapy company developing innovative gamma/delta (g/d) T-cell receptor (TCR)-based immunotherapies for cancer patients. 2 October 2023
Pharmaceutical
Madrigal Pharmaceuticals, a US biopharma pursuing new therapeutics for non-alcoholic steatohepatitis (NASH), has announced the pricing of its underwritten public offering. 2 October 2023
Pharmaceutical
US health technology assessor the Institute for Clinical and Economic Review (ICER) today posted a Special Report evaluating the evidence on Eliquis (apixaban) and Xarelto (rivaroxaban) for the treatment of non-valvular atrial fibrillation (NVAF). 2 October 2023
Biosimilars
Medicines for Europe, the trade organization representing generics and biosimilars drugmakers, today highlighted the need for a security act for the European Union to provide health security. 2 October 2023
Pharmaceutical
Swiss pharma giant Novartis has announced positive top-line results from the pre-specified interim analysis of the Phase III APPLAUSE-IgAN study at nine months. 2 October 2023
Biotechnology
The Nobel Assembly at Karolinska Institutet has today decided to award the 2023 Nobel Prize in Physiology or Medicine jointly to Hungarian-born Katalin Kariko and Drew Weissman of the USA, for their discoveries on nucleoside base modifications that enabled the development of effective mRNA vaccines against COVID-19. 2 October 2023
Biotechnology
US pharma major AbbVie (NYSE: ABBV) saw its shares dip 2.1% to $149.06 on Friday after it announced disappointing data from its Phase III CANOVA study evaluating the safety and efficacy of Venclexta (venetoclax). 2 October 2023
Biosimilars
As Indian pharma majors take giant strides in biosimilars development, Indian policymakers are under pressure to contemplate a set of regulatory changes aimed at promoting their development. 2 October 2023
Pharmaceutical
ModeX Therapeutics, an OPKO Health company, has received a sizeable grant of up to $168 million from the Biomedical Advanced Research and Development Authority (BARDA), which is part of the Administration for Strategic Preparedness and Response at the US Department of Health and Human Services. 2 October 2023
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