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 US biotech Inovio were down almost 7% at $2.30, after the company disclosed it was halting development of two vaccine programs because of disappointing clinical trial results. 18 November 2022
UK health technology assessor the National Institute for Health and Care Excellence (NICE) has recommended Exkivity (mobocertinib) for treating EGFR Exon 20 insertion mutation-positive advanced non-small-cell lung cancer after platinum-based chemotherapy within a Final Appraisal Document (FAD). 18 November 2022
While excitement about the potential of CRISPR/Cas9 gene editing remains high, a setback for a leading company using this technique shows it is no golden ticket to success. 18 November 2022
The US Food and Drug Administration late yesterday approved Tzield (teplizumab-mzwv) injection to delay the onset of stage 3 type 1 diabetes in adults and pediatric patients eight years and older who currently have stage 2 type 1 diabetes. 18 November 2022
The European Commission today granted marketing authorization for Sino-American biotech BeiGene’s Brukinsa (zanubrutinib) for the treatment of adult patients with treatment-naïve or relapsed/refractory chronic lymphocytic leukemia (CLL), one of the most common types of leukemia in adults. 17 November 2022
Japanese drug major Takeda today revealed that the Phase III PhALLCON trial of Iclusig (ponatinib) for adult patients with newly-diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) met its primary efficacy endpoint in the frontline setting. 17 November 2022
French specialty vaccine company Valneva today announced the appointment of Dipal Patel as chief commercial officer (CCO) and management board member. 17 November 2022
Research from industry analyst GlobalData has identified challenges in the development of new CAR-T cell therapies for chronic lymphocytic leukemia (CLL). 17 November 2022
Japanese drug major Astellas Pharma today announced positive top-line results from the Phase III SPOTLIGHT clinical trial evaluating the efficacy and safety of zolbetuximab in combination with mFOLFOX6 (a combination regimen that includes oxaliplatin, leucovorin and fluorouracil). 17 November 2022
Germany’s Merck KGaA has announced an investment of more than 290 million euros ($302 million) in its biosafety testing capacity at Rockville, Maryland, USA. 16 November 2022
Marking a second M&A deal this year, USA-based gene therapy company Kriya Therapeutics today announced the acquisition of a privately held biotechnology company Redpin Therapeutics, which is developing regulatable gene therapies for intractable diseases of the nervous system. 16 November 2022
Bonum Therapeutics, a biopharma using allosteric regulation to create conditionally active and less toxic medicines, has announced a $93 million Series A financing. 16 November 2022
In a draft recommendation, the UK’s reimbursement agency has found in favor of three COVID-19 treatments, while sidelining several others. 16 November 2022
Positive top-line results from a trial in atopic dermatitis (AD) lifted shares in Californian biotech Arcutis Biotherapeutics around 4% on Tuesday. 16 November 2022
Swiss biotech Idorsia has entered into an exclusive licensing agreement with China’s Simcere Pharmaceutical for the commercialization of its dual orexin receptor antagonist daridorexant, a treatment for adult patients with insomnia, in China. 16 November 2022
Boston, USA-based biotech start-up Jnana Therapeutics, which is leveraging its next-gen chemoproteomics platform to discover medicines for challenging-to-drug targets, today announced two important milestones for the company. 15 November 2022
Moderna has announced that both of its bivalent Omicron-targeting booster candidates trigger a superior antibody response compared to a booster of mRNA-1273, the firm's prototype vaccine, against Omicron, in Phase II/III trials. 15 November 2022