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
Eli Lilly has announced that the US Food and Drug Administration (FDA) has approved Omvoh (mirikizumab-mrkz) infusion (300mg/15 mL)/injection (100mg/mL), the first and only interleukin-23p19 (IL-23p19) antagonist for moderately to severely active ulcerative colitis (UC) in adults. 27 October 2023
French venture capital firm Sofinnova Partners has announced the closing of a $200 million fund, spearheaded by partners Edward Kliphuis and Simon Turner. 27 October 2023
Swiss pharma giant Roche has announced that the US Food and Drug Administration (FDA) has approved Vabysmo (faricimab) for the treatment of macular edema following retinal vein occlusion (RVO). 27 October 2023
The UK’s National Institute for Health and Care Excellence (NICE) has issued final draft guidance, recommending the use of Cosentyx (secukinumab) as a treatment option for adults in England and Wales with active moderate to severe hidradenitis suppurativa (HS). 27 October 2023
Gene editing company Verve Therapeutics has been cleared by the US regulator to go ahead with what will be the first in-human base editing study in the country, 26 October 2023
Eisai and Biogen have announced the presentation of new data for their Alzheimer’s drug Leqembi (lecanemab-irmb) 100mg/mL injection for intravenous (IV) use. 26 October 2023
Privately-held Italian drugmaker Dompé has announced the appointment of Shannon Sullivan as is chief commercial officer (CCO), with immediate effect. 26 October 2023
Independent data monitors have recommended that French microbiome specialist MaaT Pharma continues its Phase III ARES study without modification. 26 October 2023
UK-based Revolo Biotherapeutics, which is developing therapies that reset the immune system to achieve superior long-term remission for patients with autoimmune and allergic diseases, has announced top-line data from its allergen challenge mapping study. 25 October 2023
The US Centers for Disease Control and Prevention (CDC) is issuing an alert to provide options for clinicians to protect infants from respiratory syncytial virus (RSV) in the context of a limited supply of nirsevimab. 25 October 2023
Fibrocor Therapeutics, a privately-held Canadian developer of therapeutics to treat fibrosis, has named William Newsome III as president and chief executive and Piet Wigerinck as chief scientific advisor.
William Newsome III was one of the co-founders of Fibrocor when he was with German drug discovery firm Evotec (ETR: EVT) and he has remained closely involved with the company as a non-executive director since 2018. 25 October 2023
Boston, USA-based biotech Elektrofi has entered a multi-target research collaboration and license agreement with US pharma major Eli Lilly to develop next-generation medicines that can be delivered subcutaneously. 25 October 2023
Norway’s clinical-stage biopharmaceutical company Nykode Therapeutics today announced that its private placement has been successfully placed, raising around 505 million Norwegian kroner (~$45 million) in gross proceeds through the allocation of 29,549,400 new shares at a subscription price of 17.10 kroner per share. 25 October 2023
At the annual meeting of the American College of Gastroenterology (ACG), Johnson & Johnson has presented data from the Phase III QUASAR trial. 25 October 2023
American critical care specialist Citius Pharma is to list its oncology subsidiary on the Nasdaq exchange, via merger with a special purpose acquisition company (SPAC). 25 October 2023
Shares of Sino-American biotech LianBio shot up 120% to $3.06 in early US trading today, on the news of an agreement with US pharm major Bristol Myers Squibb. 24 October 2023
In the world of outsourced clinical research, ICON is a big fish in a pond full of other increasingly big fish. In this episode of the podcast, we chat with the company’s CCO, George McMillan. 24 October 2023
San Francisco, USA-based biotech start-up Aiolos Bio has today emerged out of stealth, backed by an oversubscribed $245 million Series A investment. 24 October 2023
Germany’s BioNTech has presented positive Phase I/II on its CAR-T cell therapy candidate BNT211 in advanced solid tumors at the European Society of Medical Oncology (ESMO) Congress 2023. 24 October 2023
At the 2023 annual congress of the European Society of Medical Oncology (ESMO), Johnson & Johnson has presented important new data for Rybrevant (amivantamab-vmjw). 24 October 2023