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
US drugmaker AbbVie and I-Mab signed a broad, global agreement for the development and commercialization of lemzoparlimab, an innovative anti-CD47 monoclonal antibody internally discovered and developed by the Chinese biopharma for the treatment of multiple cancers. 4 September 2020
Kite today announced that it has submitted a supplemental Biologics License Application (sBLA) to the US Food and Drug Administration for Yescarta (axicabtagene ciloleucel). 4 September 2020
US authorities have been urged to review whether Moderna Therapeutics has been upfront about public sources of funding for some of its work. 4 September 2020
RedHill Biopharma announced that opaganib (trade name Yeliva) has been selected for $300,000 grant funding from the Pennsylvania state COVID-19 Vaccines, Treatments and Therapies (CV-VTT) program, which will support the rapid further development of novel COVID-19 therapies. 4 September 2020
Californian monoclonal antibody (Mab) specialist Xencor has entered a strategic collaboration with the University of Texas MD Anderson Cancer Center to study investigational treatments for patients with a variety of cancer types. 4 September 2020
Chinese biotech InxMed (Nanjing) says that it has completed its Series A+ financing of 130 million renminbi (~$19 million), which was led by Ennovation Ventures and China Growth Capital and followed by InnoMed Capital and Grand Yangtze Capital 4 September 2020
Gilead Sciences’ CAR-T subsidiary Kite and HiFiBiO Therapeutics have entered into a two-year research collaboration and license agreement in acute myeloid leukemia (AML). 3 September 2020
Janssen says it is disappointed with the UK’s medicines cost-effectiveness body the National Institute for Health and Care Excellence (NICE) second draft guidance published today, that does not recommend Spravato (esketamine) nasal spray. 3 September 2020
Days after the US Food and Drug Administration issued an emergency use authorization (EUA) for the use of convalescent plasma in COVID-19, a key advisory panel has warned of a lack of evidence. 3 September 2020
A new analysis from professional services firm BDO shows that demands for innovation have caused research and development (R&D) spend to outpace revenue growth from 2016 to 2019. 3 September 2020
Shares of UK biotech Allergy Therapeutics jumped 7.8% to 19.40 pence in early trading after it revealed a further investment in virus-like particle (VLP) technology for applications beyond the allergy immunotherapy field. 3 September 2020
Shares of US drugmaker AbbVie closed down 3.4% at $92.24 yesterday, after it was revealed that US House Committee on Oversight and Government Reform chairwoman Carolyn Maloney intends to subpoena AbbVie for documents related to the committee's investigation into how big-name drugmakers price some of the world's best-selling drugs. 2 September 2020
A new agreement between Santhera Pharmaceuticals and fellow Swiss firm Idorsia, plus USA-based ReveraGen BioPharma, will make Santhera a direct license holder of vamorolone. 2 September 2020
Swedish rare disease specialist Hansa Biopharma has provided updated guidance regarding its ongoing and planned clinical trial program. 2 September 2020
The US Food and Drug Administration (FDA) has approved Onureg (azacitidine 300mg tablets, CC-486) for the continued treatment of adult patients with acute myeloid leukemia (AML). 2 September 2020
Bristol Myers Squibb has announced interim results from the Phase III open-label extension trial DAYBREAK, demonstrating the long-term efficacy and safety profile of Zeposia (ozanimod) in relapsing forms of multiple sclerosis. 1 September 2020
US clinical-stage biotech Jounce Therapeutics’ shares ratcheted up nearly 49% to $7.19 in mid-morning trading, having soared as much as 97% pre-market, after it announced a lucrative out-licensing deal for its JTX-1811 immunotherapy program. 1 September 2020
Anglo-Swedish pharma major AstraZeneca (LSE: AZN) says that development of its COVID-19 vaccine candidate ZD1222 has expanded into a Phase III clinical trial in the USA to assess its safety, efficacy and immunogenicity. 1 September 2020
Strasbourg-based G Protein-Coupled Receptors (GPCR) pioneer Domain Therapeutics has expanded a research collaboration with New York’s Pfizer. 1 September 2020