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
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
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
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
Japan’s Eisai and US biotech Biogen today revealed that the Ministry of Health and Prevention in the United Arab Emirates (UAE) has approved Leqembi (lecanemab) for the treatment of Alzheimer’s disease (AD). 14 August 2024
US clinical stage caner drug developer Theriva Biologics revealed that the US Food and Drug Administration (FDA) has granted Rare Pediatric Drug designation (RPDD) for VCN-01 for the treatment of retinoblastoma. 1 August 2024
Eisai and Biogen have announced that Israel has approved their Alzheimer's treatment, Leqembi (lecanemab), adding to nods in the USA, Japan, China, South Korea, and Hong Kong. 12 July 2024
Contract research and development organization (CDMO) Emergent BioSolutions has announced that Johnson & Johnson will pay $50 million to resolve claims linked to a terminated manufacturing deal for the latter’s COVID-19 vaccine. 11 July 2024
Japan’s Eisai and US biotech Biogen have announced that the Department of Health in Hong Kong has approved humanized anti-soluble aggregated amyloid-beta (Aβ) monoclonal antibody Leqembi (lecanemab) for treatment of Alzheimer’s disease (AD). 11 July 2024
PolTREG, a Polish biotech developing cell therapies for autoimmune diseases, has announced that its polyclonal Treg cell therapy PTG-007 demonstrated significant insulin secretion restoration in early-onset type-1 diabetes (T1D) patients, as well as a longer period of disease remission compared to a control group receiving standard-of-care. 24 June 2024
Indian drugmaker Cipla announced that its wholly-owned subsidiary in the UK, Cipla (EU) Limited, will invest an additional 3 million euros ($3.2 million) in Ethris GmbH, a German firm delivering mRNAs directly to the respiratory system. 19 June 2024
Dutch autoimmune diseases specialist Argenx announced that results from the Phase II ALPHA study of efgartigimod in post-COVID-19-mediated postural orthostatic tachycardia syndrome (PC-POTS) show that treated patients had no clinically meaningful improvement compared to placebo on the total Malmö POTS symptom (MaPS) score and COMPASS31. 17 June 2024
The US Food and Drug Administration (FDA) has accepted Eisai’s supplemental Biologics License Application (sBLA) for monthly Leqembi (lecanemab-irmb) intravenous (IV) maintenance dosing. 10 June 2024
The European Medicines Agency (EMA) has approved a Type II variation to the Summary of Product Characteristics (SmPC) for its approved Chimeric Antigen Receptor (CAR) T-cell therapies, Yescarta (axicabtagene ciloleucel) and Tecartus (brexucabtagene autoleucel) from Gilead Sciences’ Kite subsidiary. 6 June 2024
London-listed Finnish biotech firm Faron Pharmaceuticals today announces 12-month top-line overall survival results from its Phase I/II MATINS (Macrophage Antibody To INhibit immune Suppression) study investigating the safety and efficacy of bexmarilimab monotherapy (trade named Clevegen) in 10 different hard-to-treat metastatic or inoperable solid tumor cohorts. 15 June 2022
A key scientific panel of the US Food and Drug Administration has unanimously voted to recommend approval for Moderna’s COVID-19 vaccine in the age group six to 17. 15 June 2022
Family-owned German pharma major Boehringer Ingelheim late yesterday announced the signing of an option to acquire Trutino Biosciences, a privately-held San Diego-based biotech company. 15 June 2022
Lonza, a large Swiss contract development and manufacturing organization (CDMO), has agreed with French pharma group Pierre Fabre to produce its antibody candidate W0180. 15 June 2022
The first CAR-T cell therapy to treat cancers of the blood and lymphatic system is to be available in India early next year, offering hope to patients who can’t afford to travel abroad for the expensive treatment. 14 June 2022
Biotech BeiGene has announced that the US Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) goal date by three months to January 20, 2023 for the supplementary new drug application (sNDA) submitted for Brukinsa as a treatment for adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). 14 June 2022
RNAi therapeutics company Alnylam Pharmaceuticals today announced that the US Food and Drug Administration (FDA) approved Amvuttra (vutrisiran), an RNAi therapeutic administered via subcutaneous injection once every three months (quarterly) for the treatment of the polyneuropathy of hereditary transthyretin-mediated (hATTR) amyloidosis in adults. 14 June 2022
A major early-stage win in large B-cell lymphoma (LBCL) will take some pressure off the architects of AbbVie’s $750 million bet on Danish biotech Genmab. 14 June 2022
Shares of Valneva on Monday dropped by as much as 28%, after the specialty vaccine maker warned over prospects for its COVID-19 vaccine, VLA2001. 14 June 2022
German biotech Evotec today revealed it as entered a drug discovery collaboration with Janssen Pharmaceutica, a part of US healthcare giant Johnson & Johnson. 14 June 2022
French biotech ImCheck Therapeutics today announced the closing of a 96 million-euro ($103 million) financing, co-led by Earlybird and Andera Partners. 13 June 2022
Colorado-based data-driven proteomics technology company SomaLogic has signed a licensing agreement with precision oncology firm OncoHost. 13 June 2022
Massachusetts, USA-based biotech Selecta Biosciences, which is leveraging its clinically validated ImmTOR platform to develop tolerogenic therapies for autoimmune diseases, enhance gene therapies and mitigate unwanted immune responses to biologics, today announced several pipeline advancements and partnership updates. 13 June 2022
Swiss antibody-drug conjugate specialist ADC Therapeutics announced today it has appointed industry veteran David Gilman to the new role of chief business and strategy officer, reporting to chief executive Ameet Mallik effective July 1. 13 June 2022
Vertex Pharmaceuticals and CRISPR Therapeutics have presented new data on exa-cel at the European Hematology Association (EHA) annual meeting. 13 June 2022
The pandemic-induced bounty reaped by vaccine leaders Pfizer (NYSE: PFE) and BioNTech (Nasdaq: BNTX) may have passed, but two traditional players have not abandoned hope of making a contribution. 13 June 2022
Swiss pharma giant Novartis on Sunday announced long-term five-year follow-up results from the ELIANA pivotal clinical trial of Kymriah (tisagenlecleucel), the first-ever approved CAR-T cell therapy, in children and young adult patients with relapsed or refractory (r/r) B-cell acute lymphoblastic leukemia (ALL). 13 June 2022
Over the past few years, CAR T-cell therapies have also become transformative treatment options for patients with many forms of blood cancers, such as lymphoma and multiple myeloma. The treatment method involves taking a patient's T cells, "re-engineering" them to kill cancer cells, and infusing them back into the patient. 13 June 2022
Because of the critical roles of cytokines in cancer, there has been considerable interest in harnessing them for diagnosis and treatment over the past decades. Sherlyn Zhou, Product Manager for Sino Biological in the USA, tells The Pharma Letter about the role that they play in cancer and the opportunities and challenges in the field. 13 June 2022