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
Biocon has received the Drugs Controller General of India’s (DCGI) approval to market Alzumab (itolizumab) injection 25mg/5mL solution for emergency use in India for the treatment of cytokine release syndrome (CRS) in moderate to severe ARDS (acute respiratory distress syndrome) patients due to COVID-19. 13 July 2020
Swiss pharma giant Novartis has noted the publication of full results from the Phase III IRIDIUM study in The Lancet Respiratory Medicine, reminding physicians of the data supporting Enerzair Breezhaler (indacaterol acetate, glycopyrronium bromide and mometasone furoate) in uncontrolled asthma. 10 July 2020
GlobalData expects the Hodgkin’s lymphoma market to grow from $1.2 billion in 2019 to $2.1 billion in 2029 across the eight major markets (8MM) at a moderate compound annual growth rate (CAGR) of 5.5%. 9 July 2020
Spanish company Grifols has begun European delivery of Tavlesse (fostamatinib) to treat chronic immune thrombocytopenia (ITP) in adult patients refractory to other treatments. 9 July 2020
US biotech Kymera Therapeutics has entered into a multi-program strategic collaboration with Sanofi to develop and commercialize first-in-class protein degrader therapies targeting IRAK4 in patients with immune-inflammatory diseases. 9 July 2020
The National Institute for Health and Care Excellence (NICE) has recommended Adcetris (brentuximab vedotin) with cyclophosphamide, doxorubicin and prednisone (CHP), for untreated systemic anaplastic large cell lymphoma (sALCL) in adults, within a final appraisal document (FAD). 9 July 2020
Wisconsin, USA-based diagnostics company Promega is launching a new test for microsatellite instability (MSI) in the UK, which could help identify candidates for cancer immunotherapy. 9 July 2020
US cancer-focused biotech start-up Foghorn Therapeutics, formed in 2016, has announced it first major collaboration, signing a deal with US giant pharma Merck & Co. 9 July 2020
Canadian biotech firm Zymeworks saw its share gain 5% in after-hours trading yesterday, after announcing it has signed a new license deal with long-time partner, Merck & Co to develop additional multispecific antibody therapeutic candidates using Zymeworks’ Azymetric and EFECT platforms. 9 July 2020
In a rare setback for immuno-oncology leader Keytruda (pembrolizumab), the US regulator on Wednesday rejected a bid for accelerated approval in liver cancer. 8 July 2020
Evive Biotech, a Shanghai-based biologics firm formerly known as Generon Biomed, has announced positive Phase III results for F-627 (efbemalenograstim alpha) to treat chemotherapy-induced neutropenia (CIN) in breast cancer patients. 8 July 2020
Medicines regulator Health Canada has approved Sarclisa (isatuximab for injection) in combination with pomalidomide and dexamethasone for the treatment of adults with relapsed and refractory multiple myeloma (RRMM) who have received at least two prior therapies including lenalidomide and a proteasome inhibitor. 8 July 2020
Belgian drugmaker UCB and privately-held Swiss firm Ferring have signed a co-promotion agreement to commercialize the prefilled syringe formulation of Cimzia (certolizumab pegol) in the USA for the treatment of Crohn's disease (CD). 8 July 2020
Dutch biopharma Kiadis Pharma's shares kick off today, leaping 58% to 2.22 euros by early afternoon, after it announced an exclusive license deal for its previously undisclosed K-NK004 program with French pharma major Sanofi. 8 July 2020
Anglo-Swedish drugmaker AstraZeneca and US pharma giant Merck & Co have announced that Lynparza (olaparib) has been approved in the European Union (EU) for germline BRCA-mutated (gBRCAm) metastatic pancreatic cancer. 8 July 2020