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
Spanish skincare specialist Almirall has announced results from a new secondary analysis using data from the Phase III ADvocate and ADhere studies of lebrikizumab. 2 May 2023
Maze Therapeutics, a privately-held Californian company translating genetic insights into new precision medicines, has announced the signing of an exclusive worldwide license agreement with French pharma major Sanofi. 2 May 2023
Shares of New Jersey, USA-based biotech firm Iveric Bio closed up nearly 16% at $38.05 yesterday, on the news of an agreed takeover bid from Japanese pharma major Astellas Pharma, with the latter rising 2.2% to 2,093 yen. 2 May 2023
USA-based Nanoscope Therapeutics, a biotech developing gene therapies for retinal degenerative diseases, has presented results from the Phase IIb RESTORE trial of MCO-010 for the treatment of retinitis pigmentosa at the ARVO Annual Meeting. 2 May 2023
Swedish contract development and manufacturing organization (CDMO) today announced that its subsidiary, GenIbet Biopharmaceuticals, has been approved by the US Food and Drug Administration (FDA) as a manufacturing site of VOWST (fecal microbiota spores). 2 May 2023
Privately-held Australian biotech Cartherics has granted Shunxi Holding Group a license to develop, manufacture and commercialize its autologous CAR-T cell product, CTH-004, for multiple solid tumors including ovarian cancer in Greater China. 28 April 2023
Australian medicines regulator the Therapeutic Goods Administration (TGA) has approved the application from the local subsidiary of US mRNA vaccines specialist Moderna to transition its COVID-19 vaccine, Spikevax (elasomeran), from provisional to full registration. 28 April 2023
As with many biopharma firms, Gilead Sciences reported a drop in first-quarter revenue this year due to a decline in sales of a COVID-19 treatment. 28 April 2023
US muscle biology specialist Cytokinetics is set to wind down the Phase III trial of its amyotrophic lateral sclerosis (ALS) pipeline drug, reldesemtiv, as there is no evidence of an effect compared to placebo on primary or secondary endpoints. 28 April 2023
Californian biopharmaceutical firm Amgen as reported a 2% drop in revenues in the first quarter, to $6.1 billion, a reflection of falling sales from COVID-19 therapeutics. 28 April 2023
Nektar Therapeutics has announced that it will be regaining the full rights to rezpegaldesleukin (REZPEG; NKTR-358) from Eli Lilly (NYSE: LLY) which concludes the two companies’ collaboration that begun in 2017. 28 April 2023
Cambridge, USA-based Orbital Therapeutics, which debuted last September with the vision of enhancing global health by unleashing the full potential of RNA medicines to treat human disease in ways that were not previously possible, has now announced the successful closing of a $270 million Series A financing. 27 April 2023
In a first, more adult patients living with certain forms of blood cancer will now be able to access CAR T-cell therapy on the UK’s National Health Service (NHS). 27 April 2023
A new antibody therapy targeting coronavirus has “demonstrated benefit” in a Phase III trial, according to a statement from SAB Biotherapeutics, while markets reacted negatively to the top-line results. 27 April 2023
With another set of strong data under its belt, Swiss pharma giant Novartis is now looking to filing regulatory applications for its investigational oral monotherapy iptacopan. 26 April 2023
The US Food and Drug Administration (FDA) yesterday approved Qalsody (tofersen) to treat patients with amyotrophic lateral sclerosis (ALS) associated with a mutation in the superoxide dismutase 1 (SOD1) gene (SOD1-ALS). 26 April 2023
UK-based company Epsilogen is even more confident in its claim to be a global leader in the development of novel immunoglobulin E (IgE) antibodies to treat cancer following three new senior hires. 26 April 2023
Shares of Morphic Therapeutics experienced volatility yesterday, after the US biotech reported positive top-line data from the main cohort of the open-label EMERALD-1 Phase IIa study of MORF-057, an oral small molecule inhibitor of the α4β7 integrin, in adults with moderate to severe ulcerative colitis (UC). 26 April 2023
Post-marketing research into Vabysmo (faricimab) shows superior performance to aflibercept in wet age-related macular degeneration (nAMD). 26 April 2023
It has been a challenging first quarter for biotech financing, but a company founded by British clinical-stage biopharma firm PureTech Health has secured over $100 million for its work on the microbiome. 25 April 2023