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
Since the novel coronavirus pandemic outbreak, and with no available vaccines or treatment, many dozens of existing medicines have been trialled in the setting, so far with few successes. 29 July 2020
Shares of Belgium’s largest drugmaker UCB were barely moved in early trading, despite the announcement of a potentially massive licensing deal for its Alzheimer’s candidate. 29 July 2020
The Alliance for Regenerative Medicine (ARM) has called for pan-European action to fast-track the use of real world evidence (RWE) for advanced therapy medicinal products (ATMPs) to help ensure patient access to transformative therapies. 29 July 2020
Infectious diseases specialist Nabriva Therapeutics has won European approval for Xenleta (lefamulin), for the treatment of community-acquired pneumonia (CAP) in adults. 29 July 2020
US biotech giant Amgen late Tuesday announced financial results for the second quarter of 2020, which, although better than analysts’ expectations, pushed the firm’s shares down 1.5% to $251.50 in after-hours trading. 29 July 2020
Cancer Research UK, the University of Southampton and London-based biotech Touchlight Genetics, today (July 29) announced a new clinical development partnership to progress a therapeutic DNA vaccine, TGL-100, into an early phase clinical trial targeting head and neck squamous cell carcinoma (HNSCC). 29 July 2020
AbbVie’s aspiring blockbuster Rinvoq (upadacitinib) is on course for a second indication following the presentation of pivotal Phase III results in atopic dermatitis (AD). 28 July 2020
Oral peptide specialist Chiasma has announced positive data from the Phase III CHIASMA OPTIMAL open-label extension (OLE) study of Mycapssa (octreotide). 28 July 2020
The US Department of Health and Human Services has reserved the available advanced manufacturing capability and capacities of the Center for Innovation in Advanced Development and Manufacturing (CIADM) at the Texas A&M University System for use in manufacturing COVID-19 vaccines. 28 July 2020
BioNTech and Pfizer have revealed the start of a global (except for China) Phase II/III safety and efficacy clinical study to evaluate a single nucleoside-modified messenger RNA (modRNA) candidate from their BNT162 mRNA-based vaccine program, against SARS-CoV-2. 28 July 2020
Swiss giant Roche has exercised an option to increase the scope and value of a research project with UK-based immunodiagnostics firm Oncimmune Holdings. 27 July 2020
Japanese drugmaker Daiichi Sankyo (TYO: 4568) saw its shares rise more than 4% to 8.712 yen, after it revealed another multi-billion licensing deal, potentially worth $6 billion. 27 July 2020
The US Food and Drug Administration has granted accelerated approval to Tecartus (brexucabtagene autoleucel, formerly KTE-X19), the first and only approved chimeric antigen receptor (CAR) T cell therapy for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL). 27 July 2020
mRNA therapeutics and vaccines specialist Moderna Therapeutics has secured an additional $472 million from the US authorities for late-stage development of mRNA-1273. 27 July 2020
North Carolina, USA-based oncology specialist G1 Therapeutics has signed a license agreement for lerociclib to EQRx, a biopharmaceutical company focused on making innovative medicines at dramatically lower prices for the benefit of people and society. 24 July 2020
Chinese publication Science and Technology Daily has analyzed the progress of the AstraZeneca and University of Oxford coronavirus vaccine alongside a competitor from China. 24 July 2020
UCB today announced positive results from the Phase IIIb BE RADIANT study, a direct comparison of the investigational interleukin (IL)-17A and IL-17F inhibitor, bimekizumab, to the IL-17A inhibitor, Novartis’ (NOVN: VX) Cosentyx (secukinumab) in the treatment of adult patients with moderate-to-severe plaque psoriasis. 24 July 2020
After a run of positive announcements on the clinical side, mRNA therapeutics and vaccines developer Moderna Therapeutics has been struck with a patent blow, knocking 10% off its share price. 24 July 2020
Shares in CymaBay Therapeutics have been lifted by a quarter after the liver disease specialist announced multiple clinical holds for seladelpar had been lifted. 24 July 2020