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
California’s Amgen and Belgian biotech UCB have won approval in Europe for Evenity (romosozumab), as an option for severe osteoporosis in postmenopausal women at high risk of fracture. 12 December 2019
Ireland-incorporated superbug specialist Iterum Therapeutics has announced disappointing top-line results from the pivotal SURE 3 study of the novel antibiotic sulopenem. 12 December 2019
Gilead Science subsidiary Kite has submitted a Biologics License Application (BLA) to the US Food and Drug Administration (FDA) for the investigational chimeric antigen receptor (CAR) T cell therapy, KTE-X19, for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL). 12 December 2019
Ireland-incorporated biotech Alkermes saw its shares down almost 3% at $20.93 yesterday after it received a sharp rebuke from the US regulator over advertising of its opioid dependence drug. 12 December 2019
Privately-held US biotech NeoImmuneTech has joined the club of companies testing their therapeutic alongside Merck & Co’s blockbuster immuno-oncology drug Keytruda (pembrolizumab). 11 December 2019
US drugmaker Vertex Pharmaceuticals has announced that the European Commission has granted a label extension for Kalydeco (ivacaftor) to allow treatment of certain cystic fibrosis (CF) patients aged from six to 12 months. 11 December 2019
The US Food and Drug Administration has accepted the supplemental Biologics License Application (sBLA) for Xolair (omalizumab) for the treatment of nasal polyps in adult patients 18 years of age and older with inadequate response to intranasal corticosteroids. 11 December 2019
US pharma major Bristol-Myers Squibb presented data from multiple studies evaluating Reblozyl (luspatercept-aamt) in patients with anemia associated with multiple serious blood diseases at the 2019 American Society of Hematology (ASH) Annual Meeting in Orlando, Florida. 10 December 2019
Cambridge, UK-based artificial intelligence specialist Healx has launched a collaboration with Germany’s Boehringer Ingelheim to identify indications related to rare neurological diseases. 9 December 2019
US pharma major Bristol-Myers Squibb announced over the weekend that its Phase I study of lisocabtagene maraleucel (liso-cel) met its primary and secondary endpoints while demonstrating durable responses. 9 December 2019
US pharma major AbbVie and non-profit Scripps Research today announced a collaboration to develop new therapies for a range of diseases, including in the therapeutic areas of oncology, immunology, neurology and fibrosis. 9 December 2019
US biotech bluebird bio has presented new data from its Phase I/II HGB-206 study of its LentiGlobin gene therapy for sickle cell disease (SCD) at ASH. 9 December 2019
Genomic medicine company Sangamo Therapeutics and its pharma partner Pfizer have announced updated follow-up results from the Phase I/II Alta study on the SB-525 gene therapy in patients with severe hemophilia A. 9 December 2019
Newly-established FerGene has announced positive results from the pivotal Phase III clinical trial evaluating nadofaragene firadenovec (rAd-IFN/Syn3), an investigational gene therapy, for the treatment of high-grade, Bacillus Calmette-Guérin (BCG) unresponsive non-muscle invasive bladder cancer (NMIBC). 9 December 2019
At this year’s annual meeting of the American Society of Hematology (ASH), Johnson & Johnson has impressed with the first clinical data from its anti-BCMA CAR-T program, as rival candidates jostle for the lead in this area of innovation. 9 December 2019
Sanofi has entered into a definitive agreement under which it will acquire all of the outstanding shares of US clinical-stage biotech Synthorx for $68 per share in cash. 9 December 2019