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
Japan’s Nxera Pharma has expanded its strategic R&D partnership with UK-based computational biology company PrecisionLife into autoimmune disorders with the potential to identify new drug targets for the treatment of complex, chronic conditions. 30 May 2024
The US Food and Drug Administration granted accelerated approval to Retevmo (selpercatinib) from US pharma major Eli Lilly for pediatric patients two years of age and older. 30 May 2024
Cell and gene therapy (CGT) manufacturing specialist Ori Biotech has introduced its IRO platform, aiming to streamline and scale the manufacturing process for CGTs. 30 May 2024
The US Food and Drug Administration (FDA) has accepted and granted Priority Review of the Biologics License Application (BLA) submitted by Jazz Pharmaceuticals for zanidatamab, the human epidermal growth factor receptor 2 (HER2)-targeted bispecific antibody. 30 May 2024
An Expert View from Danie du Plessis, executive vice president, pharmaceutical operations at Kyowa Kirin International, and chair of the Medical Affairs Professional Society (MAPS) board. 29 May 2024
Dublin, Ireland-headquartered protein specialist Prothena announced that US pharma major Bristol Myers Squibb has obtained the exclusive global license for PRX019. 29 May 2024
With the annual meeting of the American Society of Clinical Oncology (ASCO) now just days away, multiple large drugmakers have lifted the lid on data that they intend to present. 29 May 2024
Market and contract research organization IQVIA has published its Global Oncology Trends report for 2024, projecting a significant rise in cancer cases. 29 May 2024
The US Food and Drug Administration (FDA) has accepted the New Drug Application and granted Priority Review to inavolisib, an investigational, oral therapy, in combination with palbociclib (Ibrance) and fulvestrant, under development by Swiss pharma giant Roche. 29 May 2024
Less than two years after it was launched, San Francisco-based start-up Cartography Biosciences has announced a deal with nearby biotech major, Gilead Sciences. 29 May 2024
US biotech Insmed (Nasdaq: INSM) yesterday released positive top-line results from the ASPEN study, a global, randomized, double-blind, placebo-controlled Phase III trial to assess the efficacy, safety, and tolerability of brensocatib in patients with non-cystic fibrosis bronchiectasis. 29 May 2024
US healthcare giant Johnson & Johnson has acquired Yellow Jersey Therapeutics (YJT), a wholly-owned subsidiary of Swiss biotech Numab Therapeutics. 29 May 2024
Sapreme, a Dutch biotech developing next-generation RNA therapeutics for genetically-driven diseases, has appointed Marco Timmers as chief executive. 28 May 2024
Shares of Swedish biotech Calliditas Therapeutics shot up more than 78% to 202.60 kronor by late afternoon, on news of a takeover bid from Asahi Kasei. 28 May 2024
Australia’s Neuren Pharmaceuticals has announced top-line results from its Phase II trial of NNZ-2591 in children with Pitt Hopkins syndrome (PTHS). 28 May 2024
Privately-held Swiss drug firm Ewopharma it has entered into a strategic commercial collaboration with China’s CStone Pharmaceuticals to gain rights for sugemalimab in Switzerland and 18 Central Eastern European countries (CEE). 28 May 2024
The US Food and Drug Administration (FDA) has accepted for Priority Review the supplemental Biologics License Application (sBLA) for Sarclisa (isatuximab) alongside bortezomib, lenalidomide and dexamethasone (VRd) for transplant-ineligible newly diagnosed multiple myeloma (NDMM). 28 May 2024