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
Australia’s CSL Limited is active in multiple therapeutic areas and across different scientific platforms, from immunology to respiratory and from plasma fractionation to egg-based vaccines. 20 October 2020
Sacubitril-valsartan (trade name Entresto) has been proven to decrease hospitalization and reduce death due to heart failure with reduced ejection fraction (HFrEF) also known as systolic heart failure, according to a new study. 20 October 2020
Privately-held US biopharma company Synspira Therapeutics today announced that the Cystic Fibrosis Foundation has made equity and structured investments in the company of up to $14 million in additional funding. 20 October 2020
Aptinyx has announced positive results from the first Phase II study of its novel NMDA receptor modulator, NYX-783, in 153 patients with post-traumatic stress disorder (PTSD). 20 October 2020
The Institute for Clinical and Economic Review (ICER) has released an Evidence Report assessing the comparative clinical effectiveness and value of BioMarin Pharmaceutical’s Roctavian (valoctocogene roxaparvovec) and Roche’s Hemlibra (emicizumab) for the treatment of hemophilia A. 20 October 2020
ImmunoGen has announced an exclusive collaboration with Hangzhou Zhongmei Huadong Pharmaceutical to develop and commercialize mirvetuximab soravtansine in mainland China, Hong Kong, Macau, and Taiwan (Greater China). 20 October 2020
Contract development and manufacturing organization (CDMO) Akron Biotechnology has inked a deal with London-listed firm Synairgen, for the provision of SNG001. 19 October 2020
US cancer metabolism specialist Agios Pharmaceuticals late Friday announced the withdrawal of its European Marketing Authorization Application (MAA) for Tibsovo (ivosidenib tablets) for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with an isocitrate dehydrogenase-1 (IDH1) mutation. 19 October 2020
On Friday, Pfizer chairman and chief executive Albert Bourla issued an ‘open letter’ aiming to provide greater clarity around the development timelines for Pfizer and partner Germany’s BioNTech’s COVID-19 vaccine, known as BNT162b2, and when it might be submitted for review by the US Food and Drug Administration. 17 October 2020
US biotech major Gilead Sciences has announced findings from multiple studies in Asian population that evaluated the safety and efficacy of switching to once-daily, single tablet regimen, Biktarvy (bictegravir 50mg/emtricitabine 200mg/tenofovir alafenamide 25mg tablets, B/F/TAF) from baseline regimens. 16 October 2020
Chugai Pharmaceutical says it has filed a new drug application with the Ministry of Health, Labor and Welfare (MHLW) for risdiplam, an oral survival motor neuron-2 (SMN2) splicing modifier, for the treatment of spinal muscular atrophy (SMA). 16 October 2020
Belgium-based biotech Galapagos, along with partner French independent drugmaker Servier, reported that no signal of activity was observed in the top-line results in their ROCCELLA Phase II trial of GLPG1972/S20186. 16 October 2020
The US Food and Drug Administration (FDA) has approved an expanded label for Keytruda (pembrolizumab), Merck & Co’s anti-PD-1 therapy, as monotherapy for the treatment of adult patients with relapsed or refractory classical Hodgkin's lymphoma (cHL). 15 October 2020
Health Canada has approved Luxturna (voretigene neparvovec), a one-time gene therapy for the treatment of adult and pediatric patients with vision loss due to inherited retinal dystrophy caused by confirmed biallelic RPE65 mutations and who have sufficient viable retinal cells. 15 October 2020
With the objective of expanding its R&D efforts in pain and neurodegeneration, US pharma major Eli Lilly today announced that it acquiring privately-held US biotech Disarm Therapeutics, which is creating a new class of disease-modifying therapeutics for patients with axonal degeneration. 15 October 2020
Japanese drugmaker Otsuka and its member company Astex Pharmaceuticals have announced top-line results of the ASTRAL-2 and ASTRAL-3 clinical studies. 15 October 2020
US biopharma Vertex Pharmaceuticals has announced that the Phase II study of VX-814 in alpha-1 antitrypsin deficiency has been discontinued based upon safety and pharmacokinetic data. 15 October 2020
On Wednesday, the US Food and Drug Administration approved Inmazeb (atoltivimab, maftivimab, and odesivimab-ebgn; REGN-EB3), a mixture of three monoclonal antibodies, as the first FDA-cleared treatment for Zaire ebolavirus (Ebola virus) infection. 15 October 2020