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
Japanese biotech PeptiDream has entered into a license and collaboration agreement with US RNAi therapeutics company Alnylam Pharmaceuticals to discover and develop peptide-siRNA conjugates to create multiple opportunities to deliver RNAi therapeutics to tissues outside the liver. 31 July 2021
US drugmaker AbbVie announced financial results for the second quarter of 2021, showing that revenues were up 33.9% on a reported basis at $13.959 billion, beating the expectations of analysts polled by FactSet of $13.63 billion. 30 July 2021
US pharma major Eli Lilly’s Loxo Oncology unit has signed a multi-year collaboration with San Diego-based Kumquat Biosciences on the discovery, development and commercialization of potential novel small molecule that stimulate tumor-specific immune responses. 30 July 2021
The UK genomics sector has released a report detailing the strength of research in this area, highlighting what it sees as a broad range of investment opportunities. 30 July 2021
The US Food and Drug Administration has approved Nucala (mepolizumab), a monoclonal antibody that targets interleukin-5 (IL-5), as a treatment for patients with chronic rhinosinusitis with nasal polyps (CRSwNP). 30 July 2021
Johnson & Johnson’s partner for manufacturing its coronavirus vaccine, Emergent BioSolutions, has announced it will be able to resume operations at its plant in Bayview, USA. 30 July 2021
US biotech major Gilead Sciences yesterday posting financials for second-quarter 2021, showing that revenues of $6.2 billion increased 21% compared to the same period in 2020. 30 July 2021
US biotech Arrowhead Pharmaceuticals today announced that it was granted Breakthrough Therapy designation (BTD) by the US Food and Drug Administration for ARO-AAT, also known as TAK-999, the company’s second-generation investigational RNA interference (RNAi) therapeutic. 29 July 2021
The US Food and Drug Administration has revised the Emergency Use Authorization (EUA) for baricitinib, sold under the brand name Olumiant by Eli Lilly’s), now authorizing baricitinib alone for the treatment of COVID-19 in hospitalized adults and pediatric patients. 29 July 2021
The US Food and Drug Administration has accepted Roche’s Biologics License Application (BLA), under Priority Review, for faricimab for the treatment of neovascular or “wet” age-related macular degeneration (nAMD) and diabetic macular edema (DME). The FDA has also accepted the Swiss pharma giant’s submission for diabetic retinopathy. 29 July 2021
US biotech bluebird bio edged up 2% in early trading yesterday, after it announced an agreement with National Resilience to accelerate the early research, development, and delivery of next-generation cell therapies. 29 July 2021
On the same day that New York’s Pfizer released stellar second-quarter financials, the company also made public less encouraging news on the vaccine front. 29 July 2021
The US Food and Drug Administration today alerted patients and health care professionals that a clinical trial (OCEAN, Study OP-103) evaluating Pepaxto (melphalan flufenamide) with dexamethasone to treat patients with multiple myeloma showed an increased risk of death. 28 July 2021
Pfizer’s investment in developing a novel coronavirus vaccine has paid off, and then some, the firm’s second-quarter results statement reveals. 28 July 2021
The Japanese pairing of PeptiDream and Takeda have announced an expansion of their research collaboration and exclusive license agreement to create peptide-drug conjugates (PDCs) for several central nervous system (CNS) targets. 28 July 2021
For the second time since its initiation in 2014, a research partnership between AbbVie and Calico Life Sciences has been extended, bringing the total investment to over $3 billion. 28 July 2021
The USA’s largest biotech Amgen has announced its third acquisition this year, saying yesterday that it is to buy Teneobio, a California-based privately held, clinical stage biotechnology company developing a new class of biologics called human heavy-chain antibodies. 28 July 2021
Evidence from a large real-world study suggests that rare blood clotting disorders, previously associated with viral vector-based coronavirus vaccines, could also affect mRNA-based options. 28 July 2021
Marking a second licensing deal this month, French drugmaker Ipsen has signed an exclusive worldwide collaboration agreement with US biotech BAKX Therapeutics to research, develop, manufacture and commercialize BKX-001 as a potential treatment for leukemia, lymphoma and solid tumors. 28 July 2021