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
Anglo-Swedish pharma major AstraZeneca has reached an agreement to collaborate with VaxEquity for the discovery, development and commercialization of the proprietary self-amplifying RNA (saRNA) therapeutics platform developed at Imperial College London. 23 September 2021
The HER2+ breast cancer market is expected to experience low growth from $10.4 billion in 2020 to $12.1 billion in 2030 across the eight major markets (8MM: the USA, France, Germany, Italy, Spain, UK, China and Japan) at a compound annual growth rate (CAGR) of 1.5%. 23 September 2021
US biotech Gilead Sciences (Nasdaq: GILD) has released positive results from a Phase III randomized, double-blind, placebo-controlled trial to evaluate the efficacy and safety of a three-day course of Veklury (remdesivir) for intravenous (IV) use for the treatment of COVID-19 in non-hospitalized patients at high risk for disease progression. 23 September 2021
The Retinal Degeneration Fund (RD Fund), the venture arm of the Foundation Fighting Blindness, today announced the launch of Opus Genetics, a patient-focused gene therapy company efficiently developing therapies for orphan inherited retinal diseases, based in Raleigh, North Carolina, USA. 22 September 2021
US pharma giant Pfizer and German partner BioNTech have reached agreement with the US government to provide an additional 500 million doses of their COVID-19 vaccine – trade-named Comirnaty - at a not-for-profit price for donation to low- and lower-middle-income countries and the organizations that support them 22 September 2021
Announcing a second Asian out-licensing deal for its rare liver disease drug candidate, US biotech Mirum Pharmaceuticals has now granted exclusive rights to market maralixibat in Japan to Takeda Pharmaceutical. 22 September 2021
A combination of Phase III data and real-world evidence show the safety and efficacy of offering a booster shot of Johnson & Johnson’s coronavirus vaccine. 22 September 2021
Canada’s AbCellera (Nasdaq: ABCL) today announced the European Commission (EC) and Eli Lilly (NYSE: LLY) have entered into a joint procurement agreement to supply up to 220,000 doses of bamlanivimab together with etesevimab to treat confirmed COVID-19 in patients aged 12 years and older that do not require supplemental oxygen for COVID-19 and who are at increased risk of progressing to severe COVID-19. 22 September 2021
US biotech bluebird bio says it has completed the rolling submission of its Biologics License Application (BLA) to the US Food and Drug Administration for betibeglogene autotemcel (beti-cel) gene therapy in adult, adolescent and pediatric patients with β-thalassemia who require regular red blood cell (RBC) transfusions, across all genotypes. 22 September 2021
Pharma giant Novartis today announced that it has acquired fellow Switzerland-based Arctos Medical, adding a pre-clinical optogenetics-based AAV gene therapy program and Arctos’ proprietary technology to its ophthalmology portfolio. 22 September 2021
The US Food and Drug Administration has approved Cabometyx (cabozantinib) for the additional indication of the treatment of adult and pediatric patients 12 years of age and older with locally advanced or metastatic differentiated thyroid cancer (DTC) that has progressed following prior vascular endothelial growth factor receptor (VEGFR)-targeted therapy and who are radioactive iodine-refractory or ineligible. 21 September 2021
Privately-held US immune-oncology firm Vigeo Therapeutics today announced completion of the Phase I/II dose expansion studies evaluating its lead asset VT1021 in recurrent glioblastoma (rGBM) and pancreatic cancer. 21 September 2021
German family-owned drugmaker Boehringer Ingelheim says it has acquired Abexxa Biologics, a biopharmaceutical company taking a new approach in the fields of immuno-oncology (I-O) and oncology research to develop the next generation of precision medicines designed to revolutionize cancer treatments. 21 September 2021
US cancer specialist Verastem Oncology saw its shares briefly spike by as much as 29% Monday morning, after announcing a clinical collaboration agreement with biotech major Amgen to evaluate the combination of VS-6766, Verastem’s investigational dual RAF/MEK inhibitor, with Amgen’s KRAS G12C inhibitor Lumakras (sotorasib) in KRAS G12C-mutant non-small cell lung cancer (NSCLC). 21 September 2021
Data from the Phase III IMpower010 trial testing Tecentriq (atezolizumab) after surgery and chemo in lung cancer show a 34% reduction in the risk of disease recurrence or death. 21 September 2021
The US Food and Drug Administration has accepted for priority review the Biologics License Application (BLA) submitted by US pharma major Bristol Myers Squibb for the LAG-3-blocking antibody relatlimab and Opdivo (nivolumab) fixed-dose combination. 21 September 2021
The US Food and Drug Administration has granted accelerated approval to Tivdak IV (tisotumab vedotin-tftv), the first and only approved antibody-drug conjugate (ADC) for the treatment of adult patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy. 21 September 2021
Bristol Myers Squibb’s immuno-oncology combination of Opdivo (nivolumab) and Yervoy (ipilimumab) continues to deliver mixed results, according to data shared at the European Society for Medical Oncology (ESMO) Congress 2021. 20 September 2021
US clinical-stage targeted oncology company Mirati Therapeutics today announced the appointment of industry veteran David Meek as chief executive (CEO), effective immediately. 20 September 2021