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 in Californian biotech MyoKardia slumped by 14% on Wednesday with the news that French pharma major Sanofi has pulled out of their collaboration in cardiovascular diseases. 3 January 2019
Chinese drug developer Connect Biopharmaceuticals has completed a $55 million Series B financing led by new investor Advantech Capital with participation by current investors Qiming Venture Partners, Northern Light Venture Capital, and Cowin Venture. CEC Capital acted as the exclusive financial advisor for the financing. 3 January 2019
Japanese conglomerate Itochu Corporation (TYO: 8001) has become the first lead investor in the Series D round of hepatology specialist Promethera Biosciences. 2 January 2019
Chinese biotech start-up Antengene Corp, a clinical stage therapeutics company focused on oncology, yesterday announced that it has completed a $120 million Series B financing. 2 January 2019
Patients with an advanced form of lung cancer will receive early access to Roche’s immunotherapy treatment Tecentriq (atezolizumab) in combination with chemotherapy and the Swiss company’s older oncology drug, Avastin (bevacizumab). 31 December 2018
Chinese regulator the National Medical Products Administration (NMPA) has approved Tyvyt (sintilimab) for the treatment of patients with classical Hodgkin's lymphoma (cHL) that has relapsed or refractory (r/r) after two or more lines of systemic chemotherapy (r/r cHL). 28 December 2018
BeiGene yesterday revealed that, on December 19, it received notice from Merck KGaA that the German firm was terminating for convenience the parties’ license agreement dated December 10, 2013, as amended, for the company’s investigational RAF dimer inhibitor lifirafenib (BGB-283) in the People’s Republic of China (PRC). 28 December 2018
Data from a planned interim analysis of the Phase III JAVELIN Ovarian 100 study of Bavencio (avelumab) did not support the study’s initial hypothesis, and therefore the developers made the decision to terminate the trial in alignment with the independent Data Monitoring Committee. 24 December 2018
US biotech Stemline Therapeutics has been granted US Food and Drug Administration approval of Elzonris (tagraxofusp-erzs; SL-401) for the treatment of blastic plasmacytoid dendritic cell neoplasm (BPDCN) in adult and pediatric patients two years and older, in both treatment-naïve and previously-treated populations. 22 December 2018
Actelion Pharmaceuticals UK & Ireland, a subsidiary of US healthcare giant Johnson & Johnson today announced that National Health Service (NHS) patients in England, who have a rare and devastating disease, pulmonary arterial hypertension (PAH) can now be treated with Uptravi (selexipag). 22 December 2018
The US Food and Drug Administration today approved Ultomiris (ravulizumab) injection for the treatment of adult patients with paroxysmal nocturnal hemoglobinuria (PNH), a rare and life-threatening blood disease. 21 December 2018
At a time when many big pharma companies are unreservedly buying into CAR-T therapies, Merck KGaA has taken a step away from the assets it has in the space. 21 December 2018
Not for the first time, US cost-effectiveness watchdog the Institute for Clinical and Economic Review’s (ICER) and the Institute for Patient Access (IfPA) are at loggerheads. 21 December 2018
China, with its reformed priority review and approval processes, is supporting biotech revolution in the country and thereby allowing domestic drug developers to compete with well-established multinational counterparts. 21 December 2018
US biotech firm Agenus leapt as much as 70% Thursday after announcing a deal with a biotech major, worth a potential $1.8 billion, and closed the day still up 23.38% at $2.48. 21 December 2018
Tokyo-based Chugai Pharmaceutical has won Japanese approval for additional dosing options for Hemlibra (emicizumab), a coagulation factor VIII substitute. 21 December 2018
The first quarter of 2019 will be an important one for Lundbeck as it moves on from the failure of its DAYBREAK trial of a schizophrenia drug with the launch of another medicine for the condition. 21 December 2018