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
South Korean contract development and manufacturing organization Samsung Biologics says that John Rim will become its president and chief executive, with immediate effect. 17 December 2020
Sio Gene Therapies has reported positive six-month follow-up data from the low-dose cohort of the company’s dose escalation study of AXO-AAV-GM1, its adeno-associated viral vector (AAV)9-based gene therapy for the treatment of GM1 gangliosidosis. 16 December 2020
California-based Neuron23, an early-stage biotech focused on developing precision medicines for genetically defined neurological and immunological diseases, has announced its launch backed by a combined $113.5 million Series A and B financing. 16 December 2020
A week on from its review of the Pfizer and BioNTech coronavirus vaccine, the US Food and Drug Administration’s (FDA) overworked Vaccines and Related Biological Products Advisory Committee will consider the case for approving another jab. 16 December 2020
Eli Lilly yesterday revealed that it has signed an agreement to acquire gene therapy company Prevail Therapeutics, with the news sending the latter’s shares roaring up 86% pre-market. 16 December 2020
Following a positive recommendation by the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) in October, the European Commission has now granted conditional marketing authorization for Tecartus (autologous, anti-CD19-transduced CD3+ cells; formerly KTE-X19). 16 December 2020
Shares in Australian biotech Mesoblast dropped by a fifth on Tuesday, after the firm announced the DREAM-HF Phase III trial missed its primary endpoint. 16 December 2020
News of a merger deal for Israel-headquartered pre-clinical biopharma firm Anchiano Therapeutics sent the firm’s shares up as much as 183% early yesterday, and still up 87% at $2.8 by close of trading. 16 December 2020
An amended collaboration agreement will see Gilead Sciences hand back certain rights to Jyseleca (filgotinib), following discouraging feedback from the US regulator. 16 December 2020
China and USA-based Harbour BioMed (HBM) and the Netherlands’ Utrecht University (UU) have licensed their fully human, SARS-CoV-2 neutralizing antibody, 47D11 program, to US pharma major AbbVie for the prevention and treatment of COVID-19 and related coronaviruses. 16 December 2020
The European Medicines Agency’s (EMA) human medicines committee (CHMP) has set a date to discuss BioNTech and Pfizer’s conditional marketing authorization (CMA) application for BNT162b2, a COVID‑19 mRNA vaccine. 15 December 2020
Swiss pharma giant Novartis has announced positive findings from the first interpretable results of the Phase III KESTREL study, assessing the efficacy and safety of Beovu (brolucizumab) 3mg and 6mg in diabetic macular edema (DME). 15 December 2020
Californian investment group Westlake Village BioPartners has launched two new funds totaling $500 million, with the goal of promoting promising firms with innovative technologies. 15 December 2020
Japanese firms Ono Pharmaceutical and Chordia Therapeutics have agreed a licensing deal on CTX-177, the latter company’s MALT1 inhibitor and its related compounds. 15 December 2020
Spanish pharma company Reig Jofre has reached an agreement with Janssen to execute the technology transfer to manufacture its investigational COVID-19 vaccine candidate, Ad26.COV2-S. 15 December 2020
Research from industry analyst GlobalData has found that established players in Japan’s immunology market have a dominant lead in the digital marketing space. 15 December 2020
The US Food and Drug Administration has approved a shorter two-hour infusion time for Ocrevus (ocrelizumab), dosed twice-yearly for those living with relapsing or primary progressive multiple sclerosis (MS) who have not experienced any prior serious infusion reactions (IRs). 15 December 2020
Shares of French metabolic diseases biotech company Poxel closed up 4.1% at 6.62 euros today, after it announced an update on results from the PXL770 Phase IIa STAMP-NAFLD trial in non-alcoholic steatohepatitis (NASH). 14 December 2020
A Phase III study of ruxolitinib in COVID-19 has missed its primary endpoint, with no statistically-significant reduction in severe cases of the disease. 14 December 2020