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
Shares of UK-based biotech Roquefort Therapeutics were up 9.3% at 8.88 pence by early afternoon, as it announced the successful development of new siRNA sequences and new patent filing for its family of novel anti-cancer siRNA therapeutics. 7 August 2023
US pharma major Eli Lilly on Friday announced top-line results from the LIBRETTO-431 study evaluating Retevmo (selpercatinib) versus platinum-based chemotherapy plus pemetrexed – with or without Merck & Co’s Keytruda. 7 August 2023
RNA refers to a large group of biomolecules that, following their success in Covid-19 vaccines, are believed to have great medical potential for prevention and therapy - and thus also significant economic importance. 7 August 2023
Friday produced a mixed decision from the US Food and Drug Administration (FDA) for biotechs Sage Therapeutics and its partner Biogen regarding their new type of antidepressant. 5 August 2023
Sino-American biotech specializing in liver disease and cancer Terns Pharmaceuticals has announced that Senthil Sundaram has resigned from his position as Terns’ chief executive for health reasons previously disclosed in January 2022. 5 August 2023
Australian regenerative medicine company Mesoblast saw its shares plunge almost 57% to A$0.47 after it revealed a second setback in the development of it remestemcel-L. 4 August 2023
Privately-held UK biotech Evox Therapeutics has announced a research collaboration and option agreement with the Icahn School of Medicine at Mount Sinai (Icahn Mount Sinai) in New York, USA. 4 August 2023
Ryvu Therapeutics has finalized two important agreements with Fortrea, with the news edging the Polish biotech’s shares up 1.7% to 60.00 zloty by mid-afternoon. 4 August 2023
Like other pharma majors that achieved huge sales and profits at the height of related to the COVID-19 pandemic, which has since subsided, pioneering US mRNA company Moderna reported a massive decline in second-quarter 2023 revenues. 4 August 2023
US biotech major Gilead Sciences late yesterday announced results of operations for the second quarter of 2023, reducing the range for its earnings outlook after posting mixed results for the three months, but its shares managed a small initial 1.2% rise. 4 August 2023
Agios Pharmaceuticals has signed exclusive worldwide license agreement with fellow USA-based Alnylam Pharmaceuticals to acquire the rights to develop and commercialize Alnylam’s novel pre-clinical siRNA targeting TMPRSS6, as a potential disease-modifying treatment for patients with polycythemia vera (PV). 4 August 2023
UK drugmaker GSK is suing Pfizer to add further intensity to the race to grab the lion’s share of the respiratory syncytial virus (RSV) vaccine market. 3 August 2023
US autoimmune drug developer Kyverna Therapeutics today announced the close of an oversubscribed $60 million Series B financing round extension, bringing the total Series B financing round to $145 million. 3 August 2023
German pharma major Bayer’s independently-operated subsidiary BlueRock Therapeutics has entered into a collaboration and option agreement with machine learning-powered bit.bio for the discovery and manufacture of iPSC-derived regulatory T cells (Tregs) for use in creating therapeutics. 3 August 2023
Privately-held USA-based CG Oncology, previously known as Cold Genesys, has announced the closing of an oversubscribed $105 million crossover financing round. 3 August 2023
Switzerland-based biologics contract development and manufacturing organization (CDMO), Celonic Group has appointed Dr Samantha Cimitan as chief executive. 3 August 2023
Japanese companies have been slow to progress COVID-19 vaccines, but today Daiichi Sankyo announced that it has received approval for the manufacturing and marketing of Daichirona for Intramuscular Injection (DS-5670). 2 August 2023
US biotech Seagen, the subject of a $43 billion takeover by US pharma giant Pfizer, today reported financial results for the second quarter ended June 30, 2023, highlighting record net product sales, with significant year-over-year growth of 26% to $544 million 2 August 2023