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 health technology assessor the Institute for Clinical and Economic Review (ICER) has released a Final Evidence Report assessing the comparative clinical effectiveness and value of three new treatments targeting the B-cell maturation antigen (BCMA) for heavily pre-treated patients with triple class refractory multiple myeloma (TCRMM) who have cycled through numerous previous lines of therapy: 12 May 2021
MiNA Therapeutics has today announced a global research collaboration with US pharma major Eli Lilly to develop novel drug candidates using MiNA’s proprietary small activating RNA (saRNA) technology platform. 11 May 2021
Shares US drug developer Organicell Regenerative Medicine were up a massive 29% at $0.36 by mid-morning, after it announced that its Zofin therapy has been approved by Pakistani regulators to be used for a COVID-19 patient on compassionate grounds. 11 May 2021
US biotech Inovio might be behind competitors in the development of a COVID-19 vaccine, but the company has provided a reminder that it is still in the game. 11 May 2021
The US Food and Drug Administration has expanded the emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 Vaccine for the prevention of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) to include adolescents through 15 years of age. 11 May 2021
Slow progress in preparing regulatory submissions will see US vaccines developer Novavax send its COVID-19 vaccine, NVX-CoV2373, for approval in the third quarter at the earliest. 11 May 2021
Eli Lilly has inked royalty-free, non-exclusive voluntary licenses to established Indian pharmaceutical manufacturers of generic medicines, Cipla, Lupin and Sun Pharmaceutical Industries, to expedite availability of its arthritis drug baricitinib for the treatment of COVID-19 patients in India. 10 May 2021
Mainz, Germany-based BioNTech has announced plans to expand its global footprint to Asia with the establishment of a new regional headquarters in Singapore. 10 May 2021
Chugai Pharmaceutical has reached agreement with the Japanese government regarding the antibody cocktail casirivimab and imdevimab (formerly known as REGN-COV2), which is being investigated as a potential treatment for COVID-19. 10 May 2021
Belgium-based biotech Galapagos has announced operational highlights and plans for refocussing of its clinical pipeline, along with its first-quarter 2021 financial results. 10 May 2021
The PARP inhibitor pamiparib has received conditional approval from the China National Medical Products Administration (NMPA) for the treatment of patients with germline BRC (gBRCA) mutation-associated recurrent advanced ovarian, fallopian tube, or primary peritoneal cancer who have been treated with two or more lines of chemotherapy. 8 May 2021
AstraZeneca’s Tagrisso (osimertinib) is the beneficiary of the UK’s Medicines and Healthcare products Regulatory Agency’s (MHRA) first authorization under Project Orbis, a global program designed to deliver faster patient access to innovative cancer drugs. 7 May 2021
US pharma giant Pfizer and German partner BioNTech have announced the initiation of a Biologics License Application (BLA) with the US Food and Drug Administration for approval of their mRNA vaccine to prevent COVID-19 – called Comirnaty or BNT162b2 - in individuals 16 years of age and older. 7 May 2021
Minutes from the May meeting of the European Medicines Agency’s safety committee show the panel has reaffirmed the positive benefit-risk ratio of approved coronavirus vaccines. 7 May 2021
The European Medicines Agency (EMA) has started a rolling review of data on sotrovimab (previously VIR-7831), an investigational dual-action SARS-CoV-2 monoclonal antibody, for the treatment of adults and adolescents (aged 12 years and over and weighing at least 40 kg) with coronavirus disease 2019 (COVID-19) who do not require oxygen supplementation and who are at risk of progressing to severe COVID-19. 7 May 2021
An estimate-beating first quarter performance lifted shares in New York’s Regeneron Pharmaceuticals over 3% on Thursday, with revenues up 38% at $2.5 billion. 7 May 2021
Swiss–American biotechnology CRISPR Therapeutics and Nkarta, a biopharmaceutical company developing engineered NK cell therapies to treat cancer, have entered a strategic partnership to research, develop, and commercialize CRISPR/Cas9 gene-edited cell therapies for cancer. 7 May 2021