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
Provention Bio has revealed that the US Food and Drug Administration has granted coveted Breakthrough Therapy designation (BTD) to teplizumab (PRV-031) for the prevention or delay of clinical type 1 diabetes (T1D) in individuals at-risk of developing the disease. 5 August 2019
Immunotherapeutics developer Imcyse today announced the appointment of seasoned biotech expert Thomas Taapken as executive chairman and chairman of the board. 5 August 2019
Sosei Group has entered into a strategic multi-target partnership with fellow Japan-based Takeda Pharmaceutical to discover, develop and commercialize novel molecules, including small molecules and biologics, that modulate G protein-coupled receptor (GPCR) targets. 5 August 2019
One of Roche’s star cancer meds, Tecentriq (atezolizumab) has garnered further Phase III trial success, with the Phase III IMvigor130 study meeting its primary endpoint of progression-free survival (PFS). 5 August 2019
The Phase III Rivipansel (GMI-1070) Evaluating Safety, Efficacy and Time to Discharge (RESET) pivotal study did not meet its primary or key secondary efficacy endpoints. 5 August 2019
Late on Friday, the US Food and Drug Administration announced it has granted approval to Turalio (pexidartinib) capsules for the treatment of adult patients with symptomatic tenosynovial giant cell tumor (TGCT) associated with severe morbidity or functional limitations and not responsive to improvement with surgery. 3 August 2019
A month after announcing that Adrian Rawcliffe is to succeed the retiring James Noble as chief executive in September, Adaptimmune has revealed further management changes. 2 August 2019
The European Commission has granted marketing authorization for Maviret (glecaprevir/pibrentasvir) to shorten once-daily treatment duration from 12 to eight weeks in treatment-naïve, compensated cirrhotic, chronic hepatitis C (HCV) patients with genotype (GT)1, 2, 4, 5, and 6 infection. 2 August 2019
French biotech company Transgene today announced that the independent Data Monitoring Committee (IDMC) of the PHOCUS study of Pexa-Vec in liver cancer has completed a planned interim futility analysis. 2 August 2019
In Japan, a new filing for marketing approval for the monoclonal antibody tildrakizumab-asmn has been lodged, for the treatment of moderate-to-severe psoriasis and psoriatic arthritis. 2 August 2019
Ireland-incorporated Horizon Therapeutics yesterday announced the availability of an expanded access program for its investigational medicine teprotumumab. 2 August 2019
UK and USA-based clinical-stage biotech Orchard Therapeutics has received a Regenerative Medicine Advanced Therapy (RMAT) designation for OTL-103, a gene therapy for the treatment of Wiskott-Aldrich Syndrome (WAS). 1 August 2019
USA’s AVEO Oncology's 2006 license agreement with Kyowa Kirin has been amended to allow the latter to buy back the non-oncology rights of tivozanib (trade name Fotivda) in AVEO territories, which includes the USA and European Union. 1 August 2019
The US Food and Drug Administration has granted Breakthrough Therapy designation (BTD) for investigational agent bempegaldesleukin (NKTR-214), from Nektar Therapeutics, in combination with Bristol-Myers Squibb's Opdivo (nivolumab) for the treatment of patients with previously untreated unresectable or metastatic melanoma. 1 August 2019
Hotly-tipped Hong Kong-based biotech Chi-Med has said it expects to file for a new cancer drug this year, the second after its approved therapy Elunate (fruquintinib). 31 July 2019
Johnson & Johnson Rx pharma unit Janssen Biotech has returned worldwide rights to develop and commercialize the CD40 agonistic antibody, ADC-1013 (JNJ-64457107), to Sweden-based biotech firm Alligator Bioscience. 31 July 2019