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
UK biotechnology companies have already raised more than £1.5 billion ($1.97 billion) in 2018, surpassing the 2017 annual total of £1.2 billion. 28 September 2018
Carri Duncan has left her role as senior investor relations manager with German pharma major Bayer to join the CAR-T specialist Celyad. 27 September 2018
Cellular Biomedicine saw its shares rocket 16.6% to $23.55 in pre-market trading, after it revealed it had entered into a strategic licensing and collaboration agreement with Swiss pharma giant Novartis. 27 September 2018
Shares in US drugmaker Aldeyra Therapeutics closed 35% up on Wednesday due to positive results from its Phase IIb clinical trial of topical ocular reproxalap in patients with dry eye disease. 27 September 2018
Regulators and representatives from the UK biopharma industry met for the eighth annual joint conference in London, aimed at promoting the successful development of the sector. 27 September 2018
Texan drugmaker Lexicon Pharmaceuticals has announced details of clinical data for oral diabetes therapy sotagliflozin, to be presented at the upcoming annual meeting of the European Association for the Study of Diabetes (EASD). 27 September 2018
Adocia has announced details of five abstracts to be presented at the upcoming annual meeting of the European Association for the Study of Diabetes (EASD). 27 September 2018
It’s not often that the company announcing an acquisition sees a significant share price spurt, but this was certainly the case on Wednesday for Alexion Pharmaceuticals, which gained over 5.1% to $135.61. 27 September 2018
China’s WuXi Biologics and biotech firm I-Mab Biopharma have expanded their strategic collaboration and licensed proprietary WuXiBody Platform to develop three bispecific antibodies (Bsab). WuXi Biologics will also be the exclusive partner to develop and manufacture these bispecifics. 27 September 2018
In the context of a competitive, some say overheated, market for mergers and acquisitions, Johnson & Johnson’s $30 billion purchase of Swiss biotech Actelion could be seen as a value-destructive move for shareholders. 26 September 2018
Adding to a busy news week for Gilead Sciences, a court in Brazil has announced it will strip the Californian firm of its exclusivity patent for Sovaldi (sofosbuvir), at the request of presidential candidate Rolando Valcir Spanholo. 26 September 2018
The USA’s Institute for Clinical and Economic Review (ICER) has released a Draft Evidence Report assessing the clinical effectiveness and value of biologic treatments for asthma associated with Type 2 inflammation and/or allergic asthma. The draft report will be open to public comment until October 22, 2018. 26 September 2018
British drugmaker AstraZeneca has scored a significant trial hit, with positive data showing its immuno-oncology offering Imfinzi (durvalumab) delivered a near one-third reduction in risk of death for certain lung cancer patients. 26 September 2018
US biotech firm Cerecor has agreed to acquire Ichorion Therapeutics, a privately-held biopharmaceutical company focused on developing treatments and increasing awareness of inherited metabolic disorders known as Inborn Errors of Metabolism (IEMs). 26 September 2018
Germany’s Boehringer Ingelheim yesterday announced that the Phase III LUME-Meso trial did not meet its primary endpoint of progression-free survival (PFS) [NCT01907100]. 26 September 2018
The Japanese Ministry of Health, Labor and Welfare (MHLW) has granted marketing approval for Blincyto (blinatumomab) for the treatment of relapsed or refractory B-cell acute lymphoblastic leukemia (ALL). 26 September 2018
Detailed results from the IMpower133 study suggest Roche is poised to steal a march on immuno-oncology rivals in the relatively small population of small cell lung cancer patients. 25 September 2018
There was good news yesterday for Massachusetts, USA-based cancer specialist Verastem Oncology, vindicating the company’s faith in an in-licensed blood cancer drug that a former partner had ditched. 25 September 2018
Alexion Pharmaceuticals is in a strong position to push for a new approval with Soliris (eculizumab) after strong data in a rare complement-mediated disorder of the central nervous system. 25 September 2018
The European Commission has granted marketing authorization for Imfinzi (durvalumab) as monotherapy for the treatment of locally-advanced, unresectable non-small cell lung cancer (NSCLC) in adults whose tumors express PD-L1 on ≥1% of tumor cells and whose disease has not progressed following platinum-based chemotherapy and radiation therapy (CRT). 24 September 2018