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
Sanofi Pasteur revealed today it plans to leverage previous development work for a SARS vaccine which may unlock a fast path forward for developing a novel coronavirus (COVID-19) vaccine. 18 February 2020
Government-funded non-profit CARB-X has taken a punt on another company that could help to tackle the emerging antimicrobial resistance crisis. 18 February 2020
Independent drugmaker Servier and fellow France-based biotech Oncodesign (Euronext: ALONC) late Monday announced reaching an important milestone in their strategic partnership on potential drug candidates for Parkinson’s disease, news of which sent Oncodesign’s shares leaping 17% to 11.70 euros in early trading this morning. 18 February 2020
The first patients in England have been treated with Novartis’ Luxturna (voretigene neparvovec), after the company reached a reimbursement deal in the UK in late 2019. 18 February 2020
Ahmedabad-based Zydus Cadila, a part of Cadila Healthcare, has launched an accelerated research program to develop a vaccine for the novel coronavirus, COVID-19. 17 February 2020
As has been widely expected following a positive advisory panel recommendation last December, the European Commission (EC) has now granted approval for Beovu (brolucizumab) injection for the treatment of wet age-related macular degeneration (AMD). 17 February 2020
Shares of UK-based ReNeuron Group rose as much as 4% in early trading, as the company announced the publication in a peer reviewed journal of positive clinical data from the PISCES II Phase IIa clinical trial of its CTX stem cell therapy candidate for disability resulting from stroke. 17 February 2020
The Chinese Communist Party has said that biotech companies located at the heart of the coronavirus outbreak can now return to work, reports GlobalData. 14 February 2020
Japanese drug major Chugai today said that polatuzumab vedotin in combination with bendamustine and rituximab (hereafter, BR therapy) had achieved the primary endpoint of complete response rate (CRR) by PET-CT at the timing of Primary Response Assessment (PRA) in the Japanese Phase II study (JO40762/P-DRIVE study). 14 February 2020
Continuing its progress in addressing different cancer types across different geographies, immuno-oncology blockbuster Tecentriq (atezolizumab) has secured Chinese approval in extensive-stage small cell lung cancer (ES-SCLC). 14 February 2020
As high drug prices continue to incite public outcry and US legislation, it is nonetheless possible that Regeneron Pharmaceuticals’ (Nasdaq: REGN) drug for a rare cholesterol condition could lock in as much as $500,000 annually. 14 February 2020
US clinical-stage synthetic biology company Codagenix has entered into a collaboration with the Serum Institute of India to rapidly co-develop a live-attenuated vaccine against the emergent coronavirus. 13 February 2020
US pharma major Bristol-Myers Squibb today announced that the US Food and Drug Administration has accepted for Priority Review its Biologics License Application (BLA) for lisocabtagene maraleucel (liso-cel). 13 February 2020
Tumor drug resistance specialist Deciphera Pharmaceuticals yesterday revealed that the US Food and Drug Administration has accepted for priority review its New Drug Application (NDA) seeking approval for ripretinib. 13 February 2020
Nordic biotech firm Swedish Orphan Biovitrum today announced its results for the fourth quarter and full-year 2019. Revenue growth for the full-year was 56% with sales of 14,248 million Swedish kronor ($1.48 billion). 13 February 2020
In early morning trading on Thursday, shares in Paris-based drugmaker Ipsen slumped nearly 6% following a results statement showing revenues of 2.57 billion euros ($2.8 billion) for full-year 2019, a little under the FT’s consensus estimate. 13 February 2020
Shares in US biotech CytoDon were 7% up after Wednesday morning's trading following news of a development and licensing deal for leronlimab in China. 13 February 2020
ElevateBio portfolio company AlloVir revealed today that the European Medicines Agency has granted PRIority MEdicines (PRIME) designation to Viralym-M (ALVR105). 12 February 2020