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 pivotal Phase III clinical trial results announced today show Dupixent (dupilumab) combined with standard-of-care topical corticosteroids (TCS) in children aged six-11 years with uncontrolled severe atopic dermatitis significantly improved disease signs, symptoms and health-related quality of life. 3 April 2020
Closely-held US biotech firm Ridgeback Biotherapeutics yesterday announced that it has been awarded a contract for $10.9 million to support the development of ansuvimab (mAb114), an experimental Ebola treatment, through licensure with the US Food and Drug Administration. 3 April 2020
Privately-held drugmaker EUSA Pharma has announced initial preliminary findings from the SISCO study of siltuximab as a treatment for severe COVID-19. 2 April 2020
Austrian immuno-oncology firm Apeiron Biologics today announced that it has received regulatory approvals in Austria, Germany and Denmark to initiate a Phase II clinical trial of APN01 to treat COVID-19. 2 April 2020
The US Food and Drug Administration on Wednesday approved Sevenfact (coagulation factor VIIa [recombinant]-jncw) for the treatment and control of bleeding episodes occurring in adults and adolescents 12 years of age and older with hemophilia A or B with inhibitors (neutralizing antibodies). 2 April 2020
Gilead Sciences company Kite has entered into a license and collaboration agreement with Teneobio, gaining exclusive rights to certain anti-BCMA antibodies under development. 2 April 2020
A new strategic partnership aimed at scaling up COVID-19 antigen production has been formed between UK-based Native Antigen Company (NAC) and Oxford Genetics (OXGENE). 2 April 2020
Since the first reports of coronavirus (COVID-19) in Wuhan, China in December 2019 there have been more than 823,000 confirmed cases and over 45,000 deaths in 206 countries worldwide. 1 April 2020
Japanese companies Eisai and Seikagaku Corporation have entered into an agreement for the co-development and marketing alliance in China for SI-613 (diclofenac conjugated sodium hyaluronate). 1 April 2020
Japan’s Daiichi Sankyo has entered into a strategic partnership for the non-exclusive use of Ultragenyx Pharmaceutical’s proprietary adeno associated virus (AAV) based gene therapy manufacturing technology. 1 April 2020
Japan’s SanBio and Ocumension (Hong Kong) Ltd have entered into a business alliance for the research, development and commercialization of innovative stem cell therapies for ophthalmic diseases. 1 April 2020
Chicago, USA-based ophthalmic specialist Horizon Therapeutics has revealed positive data from a new pooled analysis of Tepezza (teprotumumab-trbw). 1 April 2020
US biotech Regenxbio announced a new exclusive, worldwide license agreement with Ultragenyx Pharmaceutical, extending the companies’ existing gene therapy partnership announced in October 2018. 1 April 2020
The US Food and Drug Administration has dropped an investigation into Novartis company AveXis, related to the novel spinal muscular atrophy (SMA) Zolgensma (onasemnogene abeparvovec-xioi). 1 April 2020
The share price of Californian biotech company Akero Therapeutics was 22% higher by lunchtime on Tuesday after its presentation of data from a NASH study. 31 March 2020
UK-based biopharmaceutical company Sitryx, focused on regulating cell metabolism to develop disease-modifying therapeutics in immuno-oncology and immuno-inflammation, has signed an exclusive global licensing and research collaboration with US pharma major Eli Lilly. 31 March 2020
A New Drug Application (NDA) has been submitted to Japan’s Ministry of Health, Labor and Welfare for the CAR-T therapy axicabtagene ciloleucel to treat relapsed/refractory diffuse large B-cell lymphoma (DLBCL) and related lymphomas. 31 March 2020
It is predominantly in the USA, Europe and parts of Asia, where advanced new treatments such as cell and gene therapies are being developed, offering hope for better outcomes for patients with diseases like cancer. 31 March 2020