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
In San Francisco, a new company focused on using artificial intelligence to power drug discovery has launched with more than $1 billion of committed capital. 24 April 2024
Norway-based clinical-stage immunologics company Calluna Pharma today announced the appointment of Margrethe Sørgaard to the position of senior vice president of clinical operations and pharmacovigilance. 24 April 2024
Swedish biopharma Calliditas Therapeutics today announced positive global open-label extension (OLE) Phase III NefIgArd study results in IgA nephropathy (IgAN) patients treated with Nefecon/Tarpeyo (budesonide). 24 April 2024
The US Food and Drug Administration has approved Lutathera (lutetium Lu 177 dotatate, from Advanced Accelerator Applications USA, a Novartis company). 24 April 2024
In a bid to expand its portfolio of immunology products, US biotech Incyte today announced it plans to acquire privately-held Escient Pharmaceuticals. 23 April 2024
US biopharma Abeona Therapeutics was trading nearly 50% lower in Tuesday morning’s trading after announcing a regulatory update for prademagene zamikeracel (pz-cel). 23 April 2024
Following an earlier snub, the US Food and Drug Administration has now approved Anktiva (N-803, or nogapendekin alfa inbakicept-pmln) plus Bacillus Calmette-Guérin (BCG). 23 April 2024
Long-term partners BioArctic and Eisai have announced a new research agreement regarding BAN2802, a potential treatment combining the former company’s proprietary BrainTransporter technology with an undisclosed Alzheimer drug candidate. 23 April 2024
Cash-laden Vertex Pharmaceuticals has followed up this month’s news of its $4.9 billion buy of US biotech company Alpine Immune Sciences with an announcement of an in-licensing deal. 23 April 2024
French drugmaker Ipsen says it has signed an exclusive worldwide collaboration with privately-held US biotech Skyhawk Therapeutics to discover and develop novel small molecules that modulate RNA for rare neurological diseases. 23 April 2024
A first-in-class treatment for paroxysmal nocturnal hemoglobinuria (PNH), Voydeya (danicopan), has been granted marketing authorization in Europe. 23 April 2024
Oxford, UK-based start-up Ochre Bio, an innovator in chronic liver disease drug development, today announced a partnership with family-owned German pharma major Boehringer Ingelheim. 22 April 2024
While there are currently no marketed disease-modifying therapies (DMTs) for Parkinson’s disease (PD), hope is on the horizon in the shape of prasinezumab (PRX-002), Roche’s monoclonal antibody. 22 April 2024
The European Commission (EC) has granted marketing authorization for the interleukin (IL)-17A and IL-17F inhibitor Bimzelx (bimekizumab), from Belgian drugmaker UCB's, for the treatment of active moderate to severe hidradenitis suppurativa (HS) in adults with an inadequate response to conventional systemic HS therapy. 22 April 2024