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
A novel gene therapy program developed at University College London (UCL), the first project to be supported by Apollo Therapeutics, has been licensed to healthcare investment firm Deerfield. 21 July 2020
US clinical-stage biotech Pieris Pharmaceuticals has announced that its Phase I studies of PRS-343 have been placed on partial clinical hold by the US Food and Drug Administration 21 July 2020
There was nothing to deter investors, governments and populations in a set of interim results from the ongoing Phase I/II COV001 trial of AZD1222, a COVID-19 vaccine candidate being developed by AstraZeneca and the University of Oxford. 20 July 2020
Having already signed up to receive 100 million of AstraZeneca and the University of Oxford’s investigational COVID-19 vaccine, the UK government has now gambled on two further candidates. 20 July 2020
PTC Therapeutics today announced an agreement to monetize a portion of the risdiplam royalty stream for $650 million from Royalty Pharma, with the news bringing the firm’s shares down 2.5% to $54.29 in early trading. 20 July 2020
The report by the Courier Mail and other Australia media agencies on Saturday that an agreement has been struck to specifically secure supply, when a vaccine is available, for Queensland, is incorrect, says the country’s leading pharma company CSL Limited. 20 July 2020
Clinical-stage German biotech CureVac has signed a strategic collaboration with UK pharma major GlaxoSmithKline on mRNA vaccine and monoclonal antibody (MAb) research. 20 July 2020
US pharma major Bristol-Myers Squibb today announced that the European Medicines Agency has validated its Marketing Authorization Application (MAA) for lisocabtagene maraleucel (liso-cel). 17 July 2020
Eli Lilly today announced that its mirikizumab, an investigational monoclonal antibody that binds to the p19-subunit of interleukin (IL)23, met the primary and all key secondary endpoints versus placebo at Week 16 (superiority) and all key secondary endpoints versus Cosentyx (secukinumab) at Week 16 (non-inferiority) and Week 52 (superiority) in the OASIS-2 study. 17 July 2020
Nerlynx, (neratinib), a new breast cancer drug shown to significantly reduce the risk of cancer recurrence, is now approved for use in Malaysia. 17 July 2020
US biotech Tricida opened more than a third lower on Thursday after announcing a setback relating to veverimer, the company’s orally-administered polymer designed to treat metabolic acidosis in patients with chronic kidney disease (CKD). 16 July 2020
UK novel RNA therapeutics firm Silence Therapeutics says Mallinckrodt has exercised the option, under the collaboration forged in July 2019, to obtain exclusive worldwide licenses for two additional complement-targeted RNAi assets from Silence. 16 July 2020
The Japan-based Sosei Group today announced the successful completion of an international offering of new shares and euro-yen denominated convertible bonds due 2025 that has raised a total of approximately $200 million. 16 July 2020
Guangzhou, China-based LintonPharm is launching a Phase III trial program for catumaxomab in peritoneal carcinomatosis, a form of advanced gastric cancer. 16 July 2020
The European Commission has approved an additional indication for nintedanib in adults for the treatment of other chronic fibrosing interstitial lung diseases (ILDs) with a progressive phenotype beyond idiopathic pulmonary fibrosis (IPF). 16 July 2020