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
The European Medicines Agency’s (EMA) safety committee (PRAC) is assessing further data on the risk of myocarditis and pericarditis following vaccination with mRNA COVID-19 vaccines. 29 October 2021
US biotech Gilead Sciences has entered into a clinical trial collaboration and supply agreement with Merck & Co to evaluate the efficacy of Gilead’s Trop-2 targeting antibody-drug conjugate Trodelvy (sacituzumab govitecan-hziy) in combination with Merck’s mega-blockbuster anti-PD-1 therapy, Keytruda (pembrolizumab), as a first-line treatment for patients with locally advanced or metastatic triple-negative breast cancer (TNBC). 29 October 2021
US drugmaker AbbVie has announced better than expected financial results for the third quarter of 2021, pushing the firm’s shares up 2.9% to $112.60 before the opening bell this morning. 29 October 2021
US biotech major Gilead Sciences late yesterday announced third quarter 2021 financial results that well beat analysts’ forecasts, but its shares dipped 2.3% to $65.82 in after-hours trading. 29 October 2021
US biotech Alnylam Pharmaceuticals has announced new data from the HELIOS-A Phase III study of vutrisiran, an investigational RNAi therapeutic in development for the polyneuropathy associated with hereditary transthyretin-mediated (hATTR) amyloidosis. 28 October 2021
Belgian biotech Agomab Therapeutics is to acquire Origo Biopharma, a Spanish firm developing organ-restricted small molecule drug candidates targeting the transforming growth factor beta (TGF-β) pathway for the treatment of fibrosis-related disorders. 28 October 2021
Following the announcement that its Phase III TRYbeCA-1 clinical trials of eryaspase in 512 second-line patients with metastatic pancreatic cancer failed to meet its primary endpoint, shares of Lyon, France-based biotech firm Erytech Pharma plummeted as much as 40%. 28 October 2021
Shares of US pharma major Bristol Myers Squibb closed down 3% at $56.49 yesterday, after the company reported results for the third quarter of 2021, which it said reflect solid sales, strong commercial execution and continued progress of the company’s pipeline. 28 October 2021
Japan’s leading drugmaker Takeda Pharmaceutical today said it is exercising its option to acquire UK-based GammaDelta Therapeutics, an Abingworth portfolio company, focused on exploiting the unique properties of gamma delta (γδ) T cells for immunotherapy. 27 October 2021
Privately-held German pharma major Boehringer Ingelheim and Austria’s Thoeris have announced a collaboration and license deal aimed at investigating new first-in-class therapies for patients with urea cycle disorders (UCDs). 27 October 2021
The US Food and Drug Administration’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) has voted 17 to 0, with 1 abstention, to recommend that the FDA grant Emergency Use Authorization (EUA) for Comirnaty, the COVID-19 vaccine from Pfizer and BioNTech, in children five to 27 October 2021
Having risen nearly 50% over the last six month to $57.68, US biotech Cortexyme saw its shares tank 72% to $16.18 in after-hours trading yesterday, after it revealed that its investigational oral Alzheimer’s candidate failed to achieve a clinical goal. 27 October 2021
Sanofi and Regeneron have shared results from a second Phase III trial assessing the investigational use of Dupixent (dupilumab) in patients 12 years and older with eosinophilic esophagitis (EoE). 26 October 2021
Now three years since its founding, US biotech Mammoth Biosciences, which is building the next generation of CRISPR products to cure and detect disease, has signed its first major R&D deal. 26 October 2021
US a multi-asset longevity biotech Cambrian Biopharma today announced the closing of an oversubscribed Series C financing, which raised $100 million. 26 October 2021
UK-based biotech Bicycle Therapeutics today announced that Swiss pharma giant Roche’s subsidiary Genentech has exercised an option to initiate a new program, expanding the exclusive strategic collaboration agreement with Bicycle to discover, develop and commercialize novel Bicycle-based immuno-oncology therapies. 26 October 2021
US mRNA specialist Moderna has announced positive interim data from a Phase II/III study of the company’s vaccine against COVID-19, in children aged six to under 12 years of age. 26 October 2021
The US Food and Drug Administration has released a briefing document ahead of a planned committee meeting on Tuesday, which will consider authorization of Pfizer (NYSE: PFE) and BioNTech’s (Nasdaq: BNTX) coronavirus vaccine in younger children. 25 October 2021
Shares of Novartis dipped around 1% this morning as it revealed that its cancer drug canakinumab had disappointed in another lung cancer study. 25 October 2021