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
Germany’s Merck KGaA and US drug giant Pfizer have received US approval to market Bavencio (avelumab) for the maintenance treatment of locally-advanced or metastatic urothelial carcinoma (UC) that has not progressed with first-line platinum-containing chemotherapy. 1 July 2020
Swedish immuno-oncology firm BioInvent and New York pharma major Pfizer have extended their ongoing collaboration, through to the end of the year. 1 July 2020
In a therapy sector that has seen little success so far, Akero Therapeutics late yesterday announced results of a 16-week analysis of secondary and exploratory endpoints in its Phase IIa BALANCED study of efruxifermin (EFX), formerly known as AKR-001, in patients with non-alcoholic steatohepatitis (NASH). 1 July 2020
Ever deal-thirsty Japanese pharma giant Takeda has today entered into a collaboration with USA-based Carmine Therapeutics to discover, develop and commercialize transformative non-viral gene therapies for two rare disease targets using Carmine's REGENT technology, based on red blood cell extracellular vesicles. 30 June 2020
The long-running feud between US biopharma Vertex Pharmaceuticals and budget holders for the National Health Service (NHS) in England seems well and truly over. 30 June 2020
As Gilead Sciences revealed the price of remdesivir, its potential antiviral treatment for COVID-19, the US government announced that it has got its hands on another huge batch of the drug. 30 June 2020
Intercept Pharmaceuticals has received a complete response letter from the Food and Drug Administration regarding its New Drug Application (NDA) for obeticholic acid (OCA) for the treatment of fibrosis due to non-alcoholic steatohepatitis (NASH). 30 June 2020
A second patient in the ASPIRO clinical trial investigating AT132 (the investigational gene therapy product candidate) for X-linked myotubular myopathy (XLMTM) has tragically passed away, Audentes Therapeutics has revealed. 30 June 2020
Roche has been granted US approval for Phesgo (pertuzumab/trastuzumab/hyaluronidase) plus chemo, for the treatment of early and metastatic HER2-positive breast cancer. 30 June 2020
US biotech Heron Therapeutics was one of a number of companies to announce on Monday that it had received a complete response letter (CRL) from the US Food and Drug Administration (FDA). 30 June 2020
On Monday, the US Food and Drug Administration approved Keytruda (pembrolizumab) for intravenous injection for the first-line treatment of patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer. 30 June 2020
Efforts to broaden the use of IL-1 blocker rilonacept have been met with Phase III success, lifting shares in Bermuda-incorporated Californian firm Kiniksa Pharmaceuticals. 30 June 2020
Russian President Vladimir Putin has approved the proposal of the Ministry of Health to establish a special state fund that will focus on the purchases of some of the most expensive drugs for the needs of Russian patents, primarily children for years to come, according to recent statements by the press-service of the Russian Presidential Administration. 30 June 2020
Japan’s Ono Pharmaceutical has received a manufacturing and marketing approval of Ongentys (opicapone) Tablets 25mg, a catechol-O-methyltransferase (COMT) inhibitor (COMTi), in its home country. 29 June 2020
The new drug application for Enspryng (satralizumab) has been approved by Japan’s Ministry of Health, Labor and Welfare (MHLW) for the prevention of relapses of neuromyelitis optica spectrum disorder (NMOSD), including neuromyelitis optica). 29 June 2020
A private placement has raised $250 million for German precision medicines specialist BioNTech, a company focused on immunotherapies for cancer and infectious diseases. 29 June 2020
The European Commission (EC) on Friday approved Reblozyl (luspatercept), developed by Celgene, which is now part of US pharma major Bristol-Myers Squibb under a $74 billion buy-out that completed in November 2019, and Acceleron Pharma. 27 June 2020
Johnson & Johnson has axed its late-stage LOTUS study of Stelara (ustekinumab) in systemic lupus erythematosus (SLE), due to lack of efficacy. A second, China-based Phase III trial will now not go ahead. 26 June 2020