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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Evotec says it has taken notice of the statement made by Halozyme Therapeutics on November 22, stating that it has withdrawn its non-binding proposal to acquire Evotec for 11.00 euros per share in cash. 23 November 2024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
Biotechnology
Outlook Therapeutics, a biopharmaceutical company working to develop and launch the first approved ophthalmic formulation of bevacizumab for use in retinal indications, has announced it has re-submitted its Biologics License Application (BLA) to the US Food and Drug Administration (FDA) for ONS-5010. 30 August 2022
Biotechnology
Sino-American RNAi therapeutics company Sirnaomics has announced that the cohort receiving the 180μg dose in its Phase II trial of STP705 (cotsiranib) for cutaneous basal cell carcinoma (BCC) achieved a 100% complete response (CR), indicating the promising viability of the treatment. 30 August 2022
Biotechnology
AcuraBio (formerly Luina Bio), an Australian biopharma contract development and manufacturing organization (CDMO), has been acquired by biotech investor Dr Glenn Haifer and Ampersand Capital Partners, a USA-based private equity firm. 30 August 2022
Biotechnology
A biotechnology company aimed at creating a new class of medicines that precisely target disease biology, Vilya, has announced its launch with $50 million in committed Series A financing led by ARCH Venture Partners. 30 August 2022
Pharmaceutical
London listed Jordanian drugmaker Hikma Pharmaceuticals and Indian drugmaker Glenmark Pharmaceuticals’ Glenmark Specialty subsidiary have announced the launch of Ryaltris olopatadine hydrochloride and mometasone furoate nasal spray) in the USA. 30 August 2022
article
US biopharma Chimerix has signed a multi-year contract with the Biomedical Advanced Research and Development Authority (BARDA) for the delivery of up to 1.7 million treatment courses of tablet and suspension formulations of Tembexa (brincidofovir) to the US government. 30 August 2022
Biotechnology
AstraZeneca's (LSE: AZN) Evusheld (tixagevimab and cilgavimab, formerly AZD7442), a long-acting antibody combination, has been approved in Japan for both prevention (pre-exposure prophylaxis) and treatment of symptomatic disease caused by SARS-CoV-2 infection. 30 August 2022
Biotechnology
The European Commission (EC) has approved Scemblix (asciminib) for the treatment of adult patients with Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase (Ph+ CML-CP), previously treated with two or more tyrosine kinase inhibitors (TKIs). 30 August 2022
Pharmaceutical
The European Commission (EC), the Heads of Medicines Agencies (HMA) and the European Medicines Agency (EMA) have published the 2022-2026 workplan of the initiative Accelerating Clinical Trials in the EU (ACT EU). 30 August 2022
Biotechnology
Shares of UK-based Diurnal shot up 134% to 26.35 pence this morning, after the company announced it has reached agreement on the terms of a recommended cash acquisition under which US neurology specialist Neurocrine Biosciences will acquire the entire issued and to be issued ordinary share capital of Diurnal. 30 August 2022
Biotechnology
The US Food and Drug Administration (FDA) has accepted for priority review the Biologics License Application (BLA) for efanesoctocog alfa (BIVV001) for the treatment of hemophilia A, a rare and life-threatening bleeding disorder. The target action date for the FDA decision is February 28, 2023. 30 August 2022
Generics
It was not so very long ago that Indian drugmakers were facing headwinds due to the spike in prices of active pharmaceutical ingredients (APIs) and intermediates being imported from China. From being dependent on China for APIs in the past, India has now swung to the opposite end of the spectrum and is imposing anti-dumping duties on several APIs and key starting materials that come from China, reports The Pharma Letter’s India correspondent. 30 August 2022
Biotechnology
French vaccines developer Valneva today reported further positive Phase III results for its inactivated, adjuvanted COVID-19 vaccine VLA2001, despite which the firm’s shares were down 3.4% at 9.28 euros by late afternoon trading. 29 August 2022
Biotechnology
The annual meeting of the European Society of Medical Oncology (ESMO) kicks off in Paris on September 9, and early indications are the event could be full of practice-changing data. In the runup to the event, The Pharma Letter spoke with medical oncologist and ESMO Council member Antonio Passaro for an inside look at some of the leading themes and key presentations at the event. 29 August 2022
Pharmaceutical
Late-breaking data presented today at the European Society of Cardiology Congress 2022 highlight the potential of German pharm major Bayer’s Kerendia (finerenone), compared to placebo, to significantly reduce the incidence of sudden cardiac death across a broad range of patients with early to late-stage chronic kidney disease (CKD) and type 2 diabetes (T2D). 29 August 2022
Biotechnology
US biotech giant Amgen today presented results from the FOURIER-OLE studies – the open-label extension studies of the Repatha FOURIER cardiovascular outcomes trial at the European Society of Cardiology (ESC) Annual Meeting being held in Barcelona, Spain. 29 August 2022
Pharmaceutical
Results from the Phase II AXIOMATIC-SSP dose-ranging study of the investigational oral factor XIa (FXIa) inhibitor, milvexian, were released on Sunday in a Hot Line session at the European Society of Cardiology (ESC) Congress 2022. 29 August 2022
Pharmaceutical
German drug major Bayer has announced the start of a Phase III clinical development program OCEANIC to investigate the efficacy and safety of asundexian, an oral Factor XIa (FXIa) inhibitor, as a potential new treatment in patients with atrial fibrillation and in patients with a non-cardioembolic ischemic stroke or high-risk transient ischemic attack. 29 August 2022
Biotechnology
Australian biotechnology company CSL Limited has announced positive top-line Phase III results for garadacimab (CSL312), the company’s investigational first-in-class monoclonal antibody inhibiting Factor XIIa being developed as a long-term preventive treatment for patients with hereditary angioedema (HAE). 29 August 2022
Biosimilars
Israeli generics giant Teva Pharmaceutical Industries announced that the European Commission (EC) has granted a Marketing Authorization for Ranivisio/FYB201 (ranibizumab), a biosimilar of the ophthalmology treatment Lucentis across all five indications in adults for which Lucentis is authorized. 29 August 2022
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