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
A change at the top is on the way at Cour Pharmaceuticals, a privately-held US biotech developing disease-modifying therapies designed to induce antigen-specific tolerance for immune-mediated diseases. 1 August 2024
UK health technology assessor the National Institute for Health and Care Excellence (NICE) has issued a final draft guidance (FDG) recommending Brukinsa for MZL. 1 August 2024
mRNA specialist Moderna (Nasdaq: MRNA) has reported a decline in revenues for the second quarter, taking in $241 million, down from $344 million in the same period last year. 1 August 2024
IDEAYA Biosciences has entered into an option and license agreement for a potential first-in-class B7H3/PTK7 BsADC program with Chinese biotech Biocytogen Pharmaceuticals. 1 August 2024
Boston, USA-based vaccines company HilleVax has attempted to stem the tide following its announcement of disastrous norovirus trial results last month. 1 August 2024
Tigermed (SZ: 300347), a global clinical research solution provider, has completed a move to boost capabilities in Japan and beyond, with the acquisition of the contract research organization (CRO) Medical Edge. 31 July 2024
The US Food and Drug Administration (FDA) has approved a new indication for Darzalex Faspro, (daratumumab and hyaluronidase-fih) from US healthcare giant Johnson & Johnson. 31 July 2024
Eisai (Tokyo: 4523) and Biogen (Nasdaq: BIIB) have shared new findings on Leqembi (lecanemab), the star of the show at the Alzheimer’s Association International Conference (AAIC) 2024. 31 July 2024
Osaka-based Ono Pharmaceutical (TYO: 4502) has added a new collab to a growing list of deals made in 2024, agreeing to work with Systasy Bioscience. 31 July 2024
Imunon has released data from the Phase II OVATION 2 study of its interleukin-12 (IL-12) immunotherapy called IMNN-001 in patients with advanced ovarian cancer. 30 July 2024
The month of July celebrated World Sjögren's Day, dedicated to Sjögren's syndrome (SS) – a condition affecting between 0.5% and 1% of the population.1 30 July 2024
The global market for biotech active pharmaceutical ingredient (API) manufacturing services is poised for significant growth, according to an analysis from Transparency Market Research (TMR). 30 July 2024
BioNTech released positive top-line data from the ongoing Phase II clinical trial in patients with unresectable stage III or IV melanoma whose disease had progressed following anti-PD-(L)1-containing treatment. 30 July 2024