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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Evotec says it has taken notice of the statement made by Halozyme Therapeutics on November 22, stating that it has withdrawn its non-binding proposal to acquire Evotec for 11.00 euros per share in cash. 23 November 2024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
Shares of Amylyx Pharmaceuticals rocketed up 74% in pre-market trading today on positive news from a regulatory advisory committee on its amyotrophic lateral sclerosis (ALS) drug candidate, having suffered earlier following the release of downbeat briefing papers from the US Food and Drug Administration’s (FDA) last Friday. 8 September 2022
Generics
Indian drugmaker Dr Reddy’s Laboratories has launched a generic version of Bristol Myers Squibb’s cancer drug Revlimid (lenalidomide). 8 September 2022
Biotechnology
Positive Phase III results have been presented on eplontersen, a ligand-conjugated antisense therapy from US RNA-targeted drug developer Ionis Pharmaceuticals and Anglo-Swedish pharma major AstraZeneca. 8 September 2022
Biotechnology
LifeArc revealed that its portfolio company Ducentis BioTherapeutics, a pre-clinical-stage UK biotechnology company focused on developing novel therapies for inflammation and autoimmune diseases, has been acquired by Arcutis Biotherapeutics. 8 September 2022
Biotechnology
Industry analyst GlobalData has presented context on recently-approved inhalable coronavirus vaccines, indicating that the method of administration could be key to combating the spread of infections. 8 September 2022
Biotechnology
Nodus Oncology has announced the completion of an asset purchase agreement (APA) for Basilea Pharmaceutica's novel poly (ADP-ribose) glycohydrolase (PARG) inhibitor discovery program. 8 September 2022
Biotechnology
Chinese biotech Hutchmed today announces summary results of the 691-patient, multi-regional clinical trial (MRCT) of fruquintinib. 8 September 2022
Pharmaceutical
India's drug regulator has stepped up efforts to stop the sale of unapproved antibiotic cocktail combinations over the counter. The regulator has warned that certain fixed-dose combinations (FDCs) will be banned unless scientific trials are conducted to verify their regularisation before they can be distributed, reports The Pharma Letter’s India correspondent. 8 September 2022
Biotechnology
Danish companies Zealand Pharma and Novo Nordisk have announced a deal. 7 September 2022
Pharmaceutical
It is no secret that last year was a generally a positive one for the world’s largest biopharmaceutical companies, particularly those with COVID-19 vaccines. 7 September 2022
Biotechnology
Health authorities in Europe have urged countries to use newly-authorized adapted COVID-19 vaccines as part of autumn and winter vaccination campaigns. 7 September 2022
Biotechnology
Privately-held Seattle, USA-based drug developer Good Therapeutics says it has entered into a definitive agreement to be acquired by Swiss pharma giant Roche. 7 September 2022
Biotechnology
California’s Arsenal Biosciences, a privately-held programmable cell therapy company engineering advanced CAR-T therapies for solid tumors, has closed a $220 million Series B financing. 7 September 2022
Biotechnology
Based in Cambridge, Massachusetts, USA, Orbital Therapeutics launched today with a vision of enhancing global health by unleashing the full potential of RNA medicines to treat human disease in ways that were not previously possible. 7 September 2022
Biotechnology
US biotech Rhythm Pharmaceuticals yesterday announced that the European Commission (EC) has expanded the marketing authorization for Imcivree (setmelanotide) to include the treatment of obesity and control of hunger associated with genetically confirmed Bardet-Biedl syndrome (BBS) in adult and pediatric patients six years of age and older. 7 September 2022
Biosimilars
Competition for one of the best-selling medicines of all time is gaining traction, with new three-year data for Hadlima (adalimumab-bwwd), a biosimilar of adalimumab developed by Samsung Bioepis. 7 September 2022
Biotechnology
Belgium’s largest pharma company UCB has announced new three-year results from the BE BRIGHT open-label extension study of bimekizumab. 7 September 2022
Biotechnology
The European Commission (EC) has approved CAR-T cell therapy Tecartus (brexucabtagene autoleucel) for the treatment of adult patients 26 years of age and above with relapsed or refractory (r/r) B-cell precursor acute lymphoblastic leukemia (ALL), developed by Kite, a part of Gilead Sciences. 7 September 2022
Biosimilars
Germany-headquartered drugmaker Fresenius Kabi says that the US Food and Drug Administration (FDA) has approved its biosimilar, Stimufend (pegfilgrastim-fpgk), for use in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia. 7 September 2022
Biotechnology
Results from the DESTINATION Phase III extension trial showed Tezspire (tezepelumab) demonstrated an overall long-term safety and efficacy profile consistent with the previous PATHWAY Phase II and NAVIGATOR Phase III trials, sustained over 104 weeks in a broad population of patients with severe asthma. 7 September 2022
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