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
The USA’s Institute for Clinical and Economic Review (ICER) yesterday released a Draft Evidence Report assessing the clinical effectiveness and value of Spinraza (nusinersen) from Biogen and Zolgensma (onasemnogene abeparvovec), from Novartis and its subsidiary AveXis, for the treatment of spinal muscular atrophy (SMA). 21 December 2018
French biopharma company DBV Technologies announced after market close on Wednesday that, after discussions with the US Food and Drug Administration, its Biologics License Application (BLA 20 December 2018
The US Food and Drug Administration has granted Breakthrough Therapy Designation for the anti-interleukin-6 (IL-6) receptor humanized recycling antibody satralizumab, an investigational medicine for neuromyelitis optica and neuromyelitis optica spectrum disorders (NMO/NMOSD). 20 December 2018
Switzerland-based Roivant Sciences yesterday announced that it has entered into a collaboration with Daiichi Sankyo to facilitate the out-licensing of investigational medicines. 20 December 2018
In yet another licensing deal, Gilead Sciences has entered into a strategic collaboration with Scholar Rock Holding to discover and develop highly specific inhibitors of transforming growth factor beta (TGFβ) activation for the treatment of fibrotic diseases. 19 December 2018
Japan’s Chugai Pharmaceutical has announced positive results from the Phase III SAkuraStar Study of satralizumab, a candidate to treat neuromyelitis optica spectrum disorder (NMOSD). 19 December 2018
California-based Amgen and Swiss firm Molecular Partners have agreed terms for a collaboration and license deal related to MP0310 (FAP x 4-1BB). 19 December 2018
US biotech firm Semma Therapeutics today announced the appointments of: David Lebwohl as chief medical officer; David DiGiusto as chief technology officer; and Ann Darda as head of human resources. 19 December 2018
One of Russia’s largest pharma distributors has in-licensed trans-dermally delivered pDNA-based therapeutic HIV vaccine technology from Genetic Immunity, a clinical stage biotech company. 18 December 2018
Competition is tough in the new anti-calcitonin gene-related peptide (CGRP) class of migraine drugs, so Teva Pharmaceutical Industries will be pleased to present a large dose of data in support of its recently-approved entry into the space. 18 December 2018
US biotech firm Sophiris Bio has released mixed Phase IIb study results of topsalysin for localized prostate cancer, including top-line safety and biopsy results from the patients who received a second administration of study drug, which appeared to be safe and generally well-tolerated. 18 December 2018
Eli Lilly saw its shares close down 3.19% at $108.36 yesterday, despite releasing positive clinical trial results with its interleukin (IL)-17 inhibitor compared to the world’s best selling prescription drug Humira (adalimumab). 18 December 2018
Seattle-based Kineta Immuno-Oncology (KIO), a subsidiary of privately-held biotech firm Kineta Inc, has entered into a strategic research collaboration to develop RIG-I agonist immunotherapies for the treatment of cancer. 17 December 2018
Hong Kong’s Innovent Biologics, which has recently completed a $400 million-plus IPO, today said it had entered into a licensing deal for three clinical-stage compound for the Chinese market 17 December 2018
New Jersey’s Advaxis has suffered a near-40% blow to its share price after the firm revealed that Amgen was tearing up a half-billion dollar collaboration to develop ADX-NEO. 17 December 2018
The US Food and Drug Administration has approved the supplemental Biologics License Application (sBLA) for Nplate (romiplostim) for the treatment of pediatric patients one year of age and older with immune thrombocytopenia (ITP) for at least six months who have had an insufficient response to corticosteroids, immunoglobulins or splenectomy. 17 December 2018