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
The US Food and Drug Administration (FDA) has scheduled a public meeting of key scientific advisors to discuss the use of predictive biomarkers for immune checkpoint inhibitors. 23 August 2024
Next-gen RNA-focused biotech Borealis Biosciences has emerged from stealth with $150 million in combined Series A financing from founding investor Versant Ventures and Swiss pharma giant Novartis. 23 August 2024
US pharma major AbbVie today revealed that the UK’s National Institute for Health and Care Excellence (NICE) had accepted the firms Skyrizi (risankizumab) for adults with modera 22 August 2024
China's National Medical Products Administration (NMPA) has approved domestic biopharma firm Innovent Biologics’ Dupert (fulzerasib) for the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) harboring KRAS G12C mutation who have received at least one systemic therapy. 22 August 2024
Stockholm-based biotechnology firm Oblique Therapeutics has announced an expanded research collaboration with US pharma giant Eli Lilly (NYSE: LLY). 22 August 2024
BridgeBio Pharma (Nasdaq: BBIO) has announced the formation of a new joint venture, GondolaBio, in collaboration with a syndicate of prominent investors. 22 August 2024
Texas, USA-based Coya Therapeutics announced that Arun Swaminathan has been promoted to the role of chief executive (CEO) effective November 1, 2024. 22 August 2024
BioMarin Pharmaceutical (Nasdaq: BMRN) has announced key leadership changes, appointing Greg Friberg as chief research and development officer, and James Sabry as chief business officer. 21 August 2024
The US Food and Drug Administration (FDA) has issued a complete response letter (CRL) for the biologics license application (BLA) for linvoseltamab.. 21 August 2024
Shares of US clinical-stage biotech Kymera Therapeutics, Inc. declined 5% to $42.05 after it announced a public offering of $200 million in common stock and pre-funded warrants. 21 August 2024
FUJIFILM Diosynth Biotechnologies has hosted a celebration for the opening of its microbial fermentation manufacturing facility in Billingham, UK. 21 August 2024
Swiss mitochondrial therapeutics developer Vandria today announced the second closing of its Series A financing, bringing the final amount raised to date to $30.7 million (28.3 million francs). 21 August 2024
GSK (LSE: GSK) has received Breakthrough Therapy designation from the US Food and Drug Administration for GSK'227, an investigational B7-H3-targeted antibody-drug conjugate (ADC). 20 August 2024
AstraZeneca (LSE: AZN) has announced that Fasenra (benralizumab) has picked up a new approval from China's National Medical Products Administration (NMPA). 20 August 2024
Danish biotech Adcendo has signed a licensing agreement with Multitude Therapeutics for the global development and commercialization of ADCE-T02. 20 August 2024