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 biotech Neurocrine Biosciences and Canada’s Xenon Pharmaceuticals today announced a license and collaboration agreement to develop first-in-class treatments for epilepsy. 2 December 2019
Wuxi Biologics’ vaccine arm WuXi Vaccines (WV) expects to become a giant global vaccine supplier with its $240 million investment in the vaccine facility in Ireland last week, said the WuXi Vaccines chairman Chris Chen at a press meeting held on November 29 in Shanghai. 2 December 2019
Cambridge Innovation Capital (CIC), the UK venture capital investor enabling visionaries to build global, category-leading companies in the Cambridge ecosystem, has provided an update on its performance for the six months ended September 30, 2019, showing it has attracted £1 billion ($1.29 billion) of investments into Cambridge companies. 2 December 2019
The Australian subsidiary of AbbVie has announced the federal government’s decision to list Skyrizi (risankizumab), a new treatment option for adults living with severe chronic plaque psoriasis, which eligible Australian patients will be able to access from December 1, 2019 on the Pharmaceutical Benefits Scheme (PBS). 2 December 2019
AstraZeneca and US partner Merck & Co on Friday announced the recommendation of Lynparza (olaparib) by UK health technology assessor the National Institute for Health and Care Excellence (NICE) for maintenance treatment of relapsed, platinum-sensitive ovarian cancer in adults with a BRCA-mutation and who have had two or more courses of platinum-based chemotherapy. 30 November 2019
The US Food and Drug Administration has accepted a supplemental Biologics License Application (sBLA) and granted Priority Review for Imfinzi (durvalumab) for the treatment of patients with previously untreated extensive-stage small cell lung cancer (SCLC). 29 November 2019
Positive news results of the SAkuraSky Study, a global Phase III clinical study of satralizumab (development code: SA237) have published in the online version of The New England Journal of Medicine (NEJM). 29 November 2019
Vancouver, Canada-based regenerative medicine company NervGen Pharma announced the appointment of Paul Brennan as president and chief executive effective immediately. 28 November 2019
Nantes, France-based biotech OSE Immunotherapeutics has agreed a deal with immuno-oncology diagnostic firm HalioDx, to conduct a translational investigation of immune biomarkers. 28 November 2019
The US Food and Drug Administration has accepted for Priority Review the New Drug Application (NDA) for pemigatinib, a selective fibroblast growth factor receptor (FGFR) inhibitor, as a treatment for patients with previously treated, locally-advanced or metastatic cholangiocarcinoma with FGFR2 fusions or rearrangements. 28 November 2019
Researchers from Queen Mary University of London and Zhengzhou University, China, have developed a personalized vaccine system that could ultimately delay the onset of pancreatic cancer, they believe. 27 November 2019
Singapore-based TauRx has announced the publication of unexpected results of its drug hydromethylthionine, or LMTM, in patients with mild-to-moderate Alzheimer's disease. 27 November 2019
US drugmaker AbbVie frequently comes under fire for the money – well in excess of $100 billion – that it has earned from its mega blockbuster arthritis drug Humira (adalimumab). 27 November 2019
The Roche majority-owned Chugai has launched the 840mg intravenous infusion of Tecentriq (atezollizumab) in Japan for the treatment of PD-L1-positive triple-negative breast cancer (TNBC). 27 November 2019
Switzerland-based companies Lonza and DiNAQOR, a global gene therapy platform firm, have announced a strategic collaboration to advance the latter’s pre-clinical programs for the treatment of cardiac myosin-binding protein-C (MYBPC3) cardiomyopathies, a genetic condition that can result in heart failure. 27 November 2019
US biotech firm Evofem Biosciences announced the resubmission of its New Drug Application to the US Food and Drug Administration for its lead candidate Amphora (L-lactic acid, citric acid and potassium bitartrate) for the prevention of pregnancy. 26 November 2019
Shares in CymaBay Therapeutics closed 76% down on Monday after the company announced it was terminating its Phase IIb study of seladelpar in non-alcoholic steatohepatitis (NASH) and its recently initiated Phase II study of seladelpar in primary sclerosing cholangitis (PSC). 26 November 2019
The US Food and Drug Administration (FDA) has granted accelerated approval to Oxbryta (voxelotor) tablets for the treatment of sickle cell disease (SCD) in adults and children 12 years of age and older. 26 November 2019
Canadian immuno-oncology specialist Medicenna Therapeutics has presented positive data from its Phase IIb trial of MDNA55 in people with recurrent glioblastoma (rGBM). 26 November 2019
Privately-held Swiss drugmaker Ferring Pharmaceuticals has launched a new gene therapy company, FerGene, together with Blackstone Life Sciences. 25 November 2019