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
Health Sciences Acquisitions Corp and Immunovant Sciences, a clinical-stage biopharmaceutical company focused on enabling normal lives for patients with autoimmune diseases and a member of Switzerland's Roivant family of companies, today announced that they have entered into a definitive share exchange agreement (SEA). 2 October 2019
Japanese drugmaker Asahi Kasei Pharma has filed a complaint requesting a preliminary injunction against Endo Ventures Limited and Endo Pharmaceuticals to require Ireland-incorporated Endo to continue to supply the company with Xiaflex (collagenase clostridium histolyticum), for the treatment of Dupuytren’s contracture. 2 October 2019
Tridek-One, a privately-held French biotech specializing in the development of products for the treatment of immune and inflammatory disorders, has named three new members of its executive team. 2 October 2019
Swiss pharma giant Novartis has presented additional data from the Phase III PREVENT trial on the use of Cosentyx (secukinumab) in non-radiographic axial spondyloarthritis (nr-axSpA). 2 October 2019
Cambridge, USA-based cell and gene therapy specialist ElevateBio has launched a new company, dubbed HighPassBio, dedicated to advancing novel T cell immunotherapies. 1 October 2019
Heron Therapeutics has resubmitted its New Drug Application (NDA) to the US Food and Drug Administration for HTX-011, an investigational agent for the management of postoperative pain. 1 October 2019
Canada’s ImmunoPrecise Antibodies, a provider of best-in-class therapeutic antibody discovery capabilities for the global industry, today announced the appointment of industry professional Dr Stefan Lang as chief business officer (CBO). 1 October 2019
Stockholm’s Calliditas Therapeutics has moved one step closer to securing European Medicines Agency (EMA) approval for its lead compound nefecon, the firm said in a statement on Monday. 1 October 2019
Switzerland-based biotech firm Numab Therapeutics and Japan’s Eisai have initiated a partnership, under a research and option agreement, to discover and develop novel multi-specific antibody immunotherapies for cancer, using Numab’s proprietary MATCH platform. 1 October 2019
Independent French company Servier has acquired Pixuvri (pixantrone), a drug approved in the European Union as monotherapy for multiply relapsed or refractory aggressive non-Hodgkin B-cell lymphoma, from USA-based CTI BioPharma. 1 October 2019
The Institute for Clinical and Economic Review (ICER) has posted a draft scoping document on its planned review of the cost-effectiveness offered by Vertex Pharmaceuticals’ (Nasdaq: VRTX) cystic fibrosis (CF) drugs in the USA. 1 October 2019
South Korean company Celltrion, which is best known as a biosimilars manufacturer, is about to launch its first innovative product in the USA. 1 October 2019
Sweden’s Moberg Pharma has entered into a license agreement granting Japan’s Taisho Pharmaceutical exclusive Japanese rights to MOB-015, a new topical treatment of onychomycosis based on Moberg's patented proprietary formulation of terbinafine. 1 October 2019
Swiss pharma giant Roche has officially announced localization of two of its innovative drugs in Russia at the facilities of its local partners, reports The Pharma Letter’s local correspondent. 30 September 2019
Positive top-line results from a second Phase III pivotal study evaluating the efficacy and safety of its investigational oral Janus kinase 1 (JAK1) inhibitor, abrocitinib, in patients aged 12 and older with moderate to severe atopic dermatitis (AD), were released on Friday by US pharma giant Pfizer. 30 September 2019
Hutchison China MediTech, also known as Chi-Med, has presented the results of the Phase III study of surufatinib in advanced neuroendocrine tumors – extra-pancreatic (SANET-ep) at the 2019 ESMO congress, which met the pre-defined primary endpoint of progression free survival (PFS) early. 30 September 2019
The US Food and Drug Administration has approved Rituxan (rituximab), in combination with glucocorticoids, for the treatment of granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA) in pediatric patients two years of age and older. 28 September 2019
US biotech G1 Therapeutics has presented preliminary overall survival (OS) data from its Phase II trial of trilaciclib in combination with chemotherapy for the treatment of metastatic triple-negative breast cancer. 28 September 2019