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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
Biotechnology
US pharma major Eli Lilly and Egyptian firm EVA Pharma have entered into an agreement to expand access to Olumiant (baricitinib) to an estimated 20,000 people in 49 low- to middle-income countries in Africa by 2030. 6 September 2024
Pharmaceutical
Novartis is building two new radioligand therapy (RLT) manufacturing facilities in the USA to enhance its supply chain for cancer treatments. This move supports the growing use of RLTs, a form of precision medicine that targets tumors with radiation. 6 September 2024
Pharmaceutical
Belgium’s largest drugmaker UCB announced a strategic divestment deal in China, underscoring its strategic shift towards innovation and partnership in one of the world’s fastest-growing pharmaceutical markets. 27 August 2024
Biotechnology
Australia’s Therapeutic Goods Administration (TGA) yesterday revealed is has made the decision not to register Leqembi (lecanemab) for the treatment of patients with mild cognitive impairment (MCI) due to Alzheimer's disease and mild Alzheimer's dementia (early Alzheimer’s disease). 17 October 2024
Biotechnology
The chronic obstructive pulmonary disease (COPD) market in the seven major markets (7MM) is set to grow from $11.5 billion in 2023 to $30.8 billion in 2033, driven by the launch of the first biologic for COPD and other pioneering pipeline agents. 17 October 2024
Biotechnology
Shares of US protein-based vaccine maker Novavax closed down 19.4% at $10.15 yesterday having dropped as much as 24%, on the news of a setback for its investigational application for a covid vaccine. 17 October 2024
Biotechnology
A new clinical trial sponsored by the National Institutes of Health (NIH) has shown that the Jynneos (MVA-BN) vaccine is safe for adolescents and generates an antibody response similar to that in adults. 17 October 2024
Pharmaceutical
Shionogi has announced new data at IDWeek 2024 from PROVE (Retrospective Cefiderocol Chart Review), the largest global real-world evidence study of Fetroja/Fetcroja (cefiderocol), an innovative siderophore cephalosporin. 17 October 2024
Biotechnology
US RNA medicines biotech Wave Life Sciences yesterday announced positive proof-of-mechanism data from the ongoing Phase Ib/IIa RestorAATion-2 study of WVE-006 in alpha-1 antitrypsin deficiency (AATD) 17 October 2024
Generics
The US Food and Drug Administration (FDA) yesterday published the guidance for industry, “Requests for Reconsideration at the Division Level Under GDUFA.” 17 October 2024
Pharmaceutical
Sanofi has entered into an agreement with Orano Med, a subsidiary of the Orano Group, to advance the development of radioligand therapies for rare cancers. 17 October 2024
Biotechnology
UK-based Cellular Origins and Fresenius Kabi—an operating company of Germany’s Fresenius—have signed a development agreement to combine their expertise in cell and gene therapies (CGTs). 16 October 2024
Biotechnology
Where once the state of play in the cell and gene therapy space was mostly limited to hope and hype around what might be to come, this is increasingly being replaced by action, on-market therapies and genuine expectation of reaching patients—provided companies can avoid some of the sector’s notorious pitfalls. 16 October 2024
Pharmaceutical
ViiV Healthcare, the specialist HIV company majority owned by GSK, today announced the presentation of new real-world evidence and implementation data showing the effectiveness, adherence, and quality-of-life improvement of Apretude (cabotegravir long-acting (CAB LA)) for HIV pre-exposure prophylaxis (PrEP). 16 October 2024
Pharmaceutical
Jaguar Health today announced the US launch of Gelclair, the only Food and Drug Administration (FDA)-approved mucoadhesive on the market indicated for the management of pain caused by oral mucositis 16 October 2024
Pharmaceutical
Netherlands-based life sciences venture capital firm Forbion has raised more than 2 billion euros ($2.2 billion) across its two newest funds. 16 October 2024
Pharmaceutical
The American Lung Association Research Institute has announced a $22 million research investment in 2024, marking one of the largest lung health research programs in the USA. 16 October 2024
Pharmaceutical
US pharma major Eli Lilly has announced a strategic collaboration with two UK government departments and the devolved nations to tackle significant population health challenges, including exploring new models to better care for people living with obesity. 16 October 2024
Pharmaceutical
TenNor Therapeutics, a Suzhou-based clinical-stage biotech company, has announced the initial closing of a series E financing round, raising over 300 million yuan ($41 million). 16 October 2024
Biotechnology
Chinese biopharma Hutchmed was trading 5% higher at the mid-point of London’s trading day on Wednesday. 16 October 2024
Biotechnology
A staggering 800% increase in licensing agreement deal values for messenger ribonucleic acid (mRNA)-based innovator pharmaceuticals was recorded over 2019 to 2024 year-to-date (YTD), driven by the remarkable success of mRNA vaccines during the COVID-19 pandemic. 16 October 2024
Biotechnology
In Cambridge, UK, the protein specialist Nuclera has raised $75 million in a funding round led by Elevage Medical Technologies and backed by Patient Square Capital. 16 October 2024
Biotechnology
TRIANA Biomedicines has entered into a strategic collaboration and licensing agreement with US pharma giant Pfizer to discover novel molecular glue degraders for multiple targets in several disease areas, including oncology. 16 October 2024
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