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
Japanese drug major Shionogi has presented results from the Japanese Phase II/III clinical trial of S-268019, a recombinant protein-based vaccine for COVID-19, caused by the novel coronavirus (SARS-CoV-2), at the 96th Meeting of the Japanese Association for Infectious Diseases. 22 April 2022
Shares of Ampio Pharmaceuticals closed down 27% at $0.25 yesterday, as the US biopharma company announced the receipt of written responses from the US Food and Drug Administration regarding the AP-013 trial results, suggesting it will likely need to perform a further Phase III study. 22 April 2022
US biotech Terran Biosciences, which is focussed on therapeutics for neurological and psychiatric diseases, has entered into an agreement with French pharma major Sanofi for worldwide exclusive rights to develop and commercialize two late-stage CNS pipeline assets. 22 April 2022
US neurotology company Otonomy closed 6% higher on Wednesday after presenting positive top-line results from the Phase IIa clinical trial of OTO-413 in subjects with hearing loss. 21 April 2022
Top-line data for an mRNA-based COVID-19 vaccine from Arcturus Therapeutics have failed to impress investors, with the firm reporting 55% efficacy in the prevention of symptomatic disease. 21 April 2022
The New England Journal of Medicine has published detailed results from the PROVENT Phase III study of AstraZeneca’s coronavirus antibody therapy Evusheld (tixagevimab/cilgavimab). 21 April 2022
US biotech firm Tessera Therapeutics, which is pioneering a new approach in genetic medicine known as GENE WRITING technology, has raised over $300 million in Series C financing. 21 April 2022
Sweden’s BioArctic saw its shares fall 14.6% to 90.10 kronor today, after it revealed that US pharma major AbbVie has decided to terminate its collaboration on the portfolio of alpha-synuclein antibodies, including ABBV-0805. 20 April 2022
USA-based Satellite Bio has emerged from stealth to reveal its ‘Tissue Therapeutics’ that are bioengineered to repair, restore or replace critical organ or tissue function. 20 April 2022
Shares of USA-based AlloVir shot up more than 46% to $7.90 in mid-morning trading, after it announced that the US Food and Drug Administration has granted Regenerative Medicine Advanced Therapy (RMAT) designation to its lead investigational multi-virus-specific T cell therapy, posoleucel. 20 April 2022
At the same time as announcing strategic financing agreements worth $260 million, USA-based BioXcel Therapeutics has announced the formation of wholly-owned subsidiary OnkosXcel Therapeutics to develop transformative medicines in oncology. 20 April 2022
The Japanese business of Swiss biotech Idorsia has launched Pivlaz (clazosentan), a potent, selective endothelin A (ETA) receptor antagonist which targets the root cause of cerebral vasospasm. 20 April 2022
Cancer-focused cell therapy company ImmPACT Bio USA today announced the appointment of Venkata Yepuri as chief operating officer. In this role, Mr Yepuri will oversee business operations across the company. 20 April 2022
USA-based BioXcel Therapeutics, a biopharma using artificial intelligence to develop transformative medicines in neuroscience and immuno-oncology, has announced strategic financing agreements with funds managed by Oaktree Capital Management and Qatar Investment Authority (QIA). 19 April 2022
US biotech Regeneron Pharmaceuticals hit the M&A market today, announcing a definitive agreement to acquire Checkmate Pharmaceuticals at an all-cash price of $10.50 per share of Checkmate common stock. 19 April 2022
Japan’s largest drugmaker Takeda has received manufacturing and marketing approval from the Japan Ministry of Health, Labor and Welfare (MHLW) for Nuvaxovid intramuscular injection, a novel recombinant protein-based COVID-19 vaccine, for primary and booster immunization in individuals aged 18 and older. 19 April 2022