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 inclusion and wording of a black box warning for thrombosis and embolism risk in the label for upadacitinib are now likely to be applied across all JAK inhibitors used for autoimmune diseases, according to SVB Leerink Research analyst Pasha Sarraf, referring to last Friday’s approval of AbbVie’s Rinvoq (upadacitinib) by the US Food and Drug Administration. 20 August 2019
Canada-headquartered Generex Biotechnology saw its shares rise 3.9% to $2.13 by mid-morning today, after it said that it has acquired an additional 38% of Olaregen Therapeutix for a total Generex ownership of approximately 99% after the share exchange at $2.50 a share for GNBT stock, in a cashless transaction. 18 August 2019
Discovered and developed by AbbVie Rinvoq (upadacitinib) marks the second US Food and Drug Administration approval of a targeted immunomodulator (TIM) therapy for the company this year. 17 August 2019
Celgene Corp today announced the US Food and Drug Administration has approved Inrebic (fedratinib) for the treatment of adult patients with intermediate-2 or high-risk primary or secondary (post-polycythemia vera or post-essential thrombocythemia) myelofibrosis. 16 August 2019
The Institute for Clinical and Economic Review (ICER) could scarcely have been more damning of two companies behind treatments for Duchenne muscular dystrophy (DMD), the most common fatal genetic disease diagnosed in childhood. 16 August 2019
Ultra-rare disease specialist Ultragenyx Pharmaceutical has inked a deal with GeneTx Biotherapeutics in relation to the antisense oligonucleotide GTX-102. 16 August 2019
GeneCentric Therapeutics has acquired the data analysis and biomarker development firm Select ImmunoGenomics. Both companies are based in North Carolina, USA. 16 August 2019
The US Food and Drug Administration has granted accelerated approval for Rozlytrek (entrectinib) for the treatment of adults with ROS1-positive, metastatic non-small cell lung cancer (NSCLC). 16 August 2019
Eli Lilly has released data showing that its Taltz (ixekizumab) met the primary and all major secondary endpoints up to week 12 in the Phase IV IXORA-R study, which evaluated the efficacy and safety of Taltz versus rival drug Tremfya (guselkumab) in people living with moderate to severe plaque psoriasis (PsO). 15 August 2019
Two senior executives at Novartis' AveXis unit are being shown the door as the firm faces accusations from the US regulator it was aware of data manipulation before it filed for gene therapy Zolgensma (onasemnogene abeparvovec-xioi). 15 August 2019
Australian biotech CSL Limited saw its shares rise 6.6% to A$234.00 today, after it posted revenue of $8,539 million, up 7.9%, for the 12 months ended June 30, 2019. CSL is Australia largest health business specializing in immunotherapies and vaccines for life-threatening diseases. 14 August 2019
A week after presenting compelling Lynparza (olaparib) results in prostate cancer, AstraZeneca and Merck & Co have completed the data set in support of its use across advanced ovarian cancer disease maintenance settings. 14 August 2019
Adding to good previous earlier-stage clinical data, Regeneron Pharmaceuticals today announced positive pivotal Phase III results for evinacumab, an investigational angiopoietin-like 3 (ANGPTL3) antibody, in patients with homozygous familial hypercholesterolemia (HoFH). 14 August 2019
Danish dermatology specialist LEO Pharma says it has acquired the exclusive rights to develop and market brodalumab (marketed as Kyntheum in the European Union and Siliq in other regions) for the treatment of moderate-to-severe psoriasis outside of Europe through a new sub-licensing agreement with Bausch Health. 14 August 2019
If the accusation of withholding information over Zolgensma (onasemnogene abeparvovec-xioi) is the first major test for Novartis chief executive Vasant Narasimhan, then it is increasingly looking like a big one. 14 August 2019
The US Food and Drug Administration has granted Breakthrough Therapy designation (BTD) for Calquence (acalabrutinib) as a monotherapy treatment for adult patients with chronic lymphocytic leukemia (CLL), one of the most common types of leukemia in adults. 14 August 2019
China’s medicines regulator has called for greater implementation of the Vaccine Administration Law, urging drug regulatory departments to put promoting awareness of the law “at the top of their agenda.” 13 August 2019
A resounding success in the Phase III INVICTUS study sent shares in East Coast, USA-based Deciphera Pharmaceuticals climbing around 80% on Tuesday. 13 August 2019
The Janssen and AbbVie partnered drug Imbruvica (ibrutinib) has now nabbed five European Commission (EC) approvals in as many years, as its use was broadened in two indications. 13 August 2019
Positive growth from tablet products propelled allergy immunotherapy specialist ALK Abello to a strong performance in the second quarter of 2019, with total revenues up 9% at 785 million Danish kroner ($117 million). 13 August 2019