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
When the UK’s National Institute for Health and Care Excellence (NICE) published a positive final appraisal determination (FAD) for Ocrevus (ocrelizumab) in relapsing-remitting multiple sclerosis (RRMS) last week, patient groups held back some praise for the decision. 29 June 2018
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended nine medicines for approval, including six orphan medicines, and two CAR-T therapies, at its June 2018 meeting. 29 June 2018
Results from a Phase III, randomized, double-blind, multi-center clinical study (MEDALIST) showed that luspatercept achieved a highly statistically-significant improvement in the primary endpoint of red blood cell (RBC) transfusion independence of at least 8 consecutive weeks during the first 24 weeks compared to placebo. 29 June 2018
Clinical stage biotech Arsanis lost 78% of its market value on Thursday amid news that it is to halt a Phase II trial of its pneumonia candidate, ASN100. 29 June 2018
The US Food and Drug Administration has awarded New York-based Pfizer Priority Review designation for glasdegib, an oral smoothened (SMO) inhibitor. 28 June 2018
US biotech Global Blood Therapeutics is pretty confident that it will have important regulatory news on its sickle cell disease (SCD) candidate voxelotor by Christmas. 28 June 2018
Development and commercialization partners AstraZeneca and Merck & Co have clocked up a potentially important milestone with Lynparza (olaparib) that could expand its reach considerably. 27 June 2018
Tilos Therapeutics, a biotech firm developing anti-LAP antibodies for the treatment of cancer, fibrosis and autoimmune diseases, today announced the appointment of Jessie English as chief scientific officer. 27 June 2018
Illinois-based pharma major AbbVie has renewed its partnership with Calico, the Alphabet subsidiary dedicated to combating the effects of aging. 27 June 2018
Privately-held UK biotech Plasticell is to lead a consortium seeking to develop advanced technologies for the manufacturing of ex vivo gene therapies. 26 June 2018
Cambridge, Massachusetts-based Skyhawk Therapeutics has entered into a global strategic collaboration with an affiliate of US biotech major Celgene to discover, develop and commercialize innovative small molecule treatment options for patients with neurological diseases based on Skyhawk's innovative STAR* technology platform. 26 June 2018
The death of a patient in a Phase IIb trial of topsalysin in localized prostate cancer caused shares in Sophiris Bio to close more than 40% down on Monday. 26 June 2018
US drugmaker AbbVie has announced a collaboration with Calibr, a non-profit drug discovery division of Scripps Research, focusing on switchable CAR-T therapies aimed primarily at solid tumors. 25 June 2018
Generally speaking, Roche’s immuno-oncology asset Tecentriq (atezolizumab) has struggled to keep up with the front-runners in the space in terms of trial results and approvals. 25 June 2018
The European Commission has granted marketing authorization for Biktarvy (bictegravir 50mg/emtricitabine 200mg/tenofovir alafenamide 25mg; BIC/FTC/TAF), a once-daily single tablet regimen (STR) for the treatment of HIV-1 infection. 25 June 2018
Amgen has announced new data that show Repatha (evolocumab) significantly reduced low-density lipoprotein cholesterol (LDL-C) and non-high density lipoprotein cholesterol (non-HDL-C) in patients with type 2 diabetes and hypercholesterolemia or mixed dyslipidemia, taking the maximum tolerated dose of moderate/high-intensity statin therapy. 25 June 2018
Claims by ViiV Healthcare’s chief executive Deborah Waterhouse that her company is doing more than just playing second fiddle to US biotech Gilead Science in the HIV space have been backed up by an analyst at GlobalData. 22 June 2018
Privately-held German pharma major Boehringer Ingelheim has announced its intention to invest 230 million euros into a new Biologics Development Center (BDC) at its existing research site in Biberach, Germany. 22 June 2018
Ireland-headquartered rare diseases specialist Shire today revealed results from a retrospective review of more than 2,500 patient records with metastatic adenocarcinoma of the pancreas (mPAC) from nine countries. 22 June 2018