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
The interleukin-23 (IL-23) inhibitor Skyrizi (risankizumab) has picked up its first approval, against plaque psoriasis, generalized pustular psoriasis, erythrodermic psoriasis and psoriatic arthritis, as a second-line option. 26 March 2019
In another high profile failure for the fatty liver disease sector, USA-based Conatus Pharmaceuticals has announced disappointing top-line results from the company’s Phase IIb ENCORE-NF clinical trial in patients with biopsy-confirmed non-alcoholic steatohepatitis (NASH) and liver fibrosis. 25 March 2019
Shortly after announcing its US filing for oral semaglutide, Danish diabetes giant Novo Nordisk has published positive Phase III data for the glucagon-like peptide-1 (GLP-1) analog in the Journal of the American Medical Association (JAMA). 25 March 2019
Continuing is recent flurry of licensing deals, Japan’s largest drugmaker Takeda has now entered into a research and licensing agreement with South Korea’s LegoChem Bioscience for the development of antibody-drug conjugates in immuno-oncology (I-O). 25 March 2019
US biotech firm bluebird bio on Friday officially opened its first wholly-owned manufacturing facility in Durham, North Carolina, that will produce lentiviral vector for the company’s investigational gene and cell therapies. 25 March 2019
Just a day after development partner Biogen revealed the Phase III failure of aducanumab, Japan’s Eisai has announced the start of late stage testing for another runner in the firms’ stable of Alzheimer’s candidates, BAN2401. 22 March 2019
Despite Brexit uncertainty, investment in the UK’s biotech sector has gone up 65% since 2016, with annual investment reaching £2.2 billion ($2.9 billion) in 2018. 22 March 2019
Janssen Pharmaceutica has submitted a Type II variation application to the European Medicines Agency (EMA) for a combination therapy for multiple myeloma. 22 March 2019
In the wake of the shocking failure of Biogen and Eisai’s aducanumab in Alzheimer’s, Canadian toxic oligomer specialist ProMIS Neurosciences has called for attention to be paid to its favored therapeutic approach. 22 March 2019
UK pharma major GlaxoSmithKline on Thursday announced further positive data from the DREAMM-1 study of patients with relapsed/refractory multiple myeloma who received GSK2857916, an investigational anti-B-cell maturation antigen (BCMA) antibody-drug conjugate. 22 March 2019
Canadian preclinical stage company Ovensa today announce that it has entered into a collaboration agreement with Japan’s Takeda Pharmaceutical (TYO: 4502) to evaluate Ovensa's proprietary nanomedicine platform called Triozan for the delivery of an antibody to the brain and evaluate its performance in a CNS disease model. 21 March 2019
Millions of people affected by Alzheimer’s disease were dealt a cruel blow on Thursday as the developers of aducanumab, a much-anticipated late stage candidate, announced the discontinuation of Phase III testing. 21 March 2019
In another move by big pharma into gene therapy, US giant Pfizer has acquired a 15% equity interest in privately-held French gene therapy biotech Vivet Therapeutics and secured an exclusive option to acquire all outstanding shares. 21 March 2019
Ireland-headquartered Jazz Pharmaceuticals has won US Food and Drug Administration (FDA) approval for Sunosi (solriamfetol) to improve wakefulness in adults with excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea (OSA). 21 March 2019
People with Alzheimer’s who use the antiepileptic drugs phenytoin, carbamazepine, valproic acid and pregabalin were associated with an increased risk of pneumonia. 21 March 2019
The purse strings remain loose for Boston, USA-based Alexion Pharmaceuticals, with the announcement of two new pipeline-boosting collaborations in Europe. 21 March 2019
US biotech major Celgene has become the latest drugmaker to team up with Exscientia, a privately-owned UK-based company that uses artificial intelligence (AI) in drug discovery. 21 March 2019
Danish diabetes giant Novo Nordisk has filed for US approval for oral semaglutide, a once-daily glucagon-like peptide-1 (GLP-1) analogue in a tablet. 20 March 2019
Japan’s largest drugmaker Takeda Pharmaceutical has out-licensed global development, manufacturing and commercialization rights to serabelisib and two additional PI3Kα-specific inhibitors to privately held Petra Pharma. 20 March 2019
Belgium’s PDC*line Pharma has signed an exclusive licensing and option agreement with LG Chem Life Sciences, the life sciences division of LG Chem. 20 March 2019