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
Emerging US biotech Tyme Technologies saw its shares leap 13.6% to $1.75 in unusually heavy volume, on news of a potential $40 million deal with Eagle Pharmaceuticals focused on the co-promotion of Tyme's lead CMBT candidate oral SM-88 in advanced cancers. 8 January 2020
Adding to the list of marketing clearances for the drug, now Health Canada has approved Rinvoq (upadacitinib) for the treatment of adults with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to methotrexate (MTX). 7 January 2020
Shares of US biotech Protagonist Therapeutics gained more than 4% to $6.96 by mid-morning, after it revealed a milestone payment under its 2017 collaboration with Johnson & Johnson unit Janssen Biotech. 7 January 2020
Velabs Therapeutics and fellow German firm Alytas Therapeutics have agreed a licensing deal for the development and commercialization of certain of the latter’s antibodies. 7 January 2020
The former executive team of Swiss biotech Therachon has founded a new company, VectivBio, with $35 million in financing to target serious rare diseases. 7 January 2020
CNS specialist AlzeCure Pharma has exclusively in-licensed a vanilloid receptor subtype 1 (VR1) project targeting neuropathic pain from fellow Swedish company Acturum Life. 7 January 2020
US biotech firm FibroGen has appointed Enrique Conterno as the company’s chief executive and a member of the board of directors, effective immediately. 7 January 2020
Keytruda (pembrolizumab) is already approved in five lung cancer indications, but the Merck & Co drug does not have the market entirely cornered, new data shows. 7 January 2020
Dutch antibody-drug conjugate (ADC) specialist Synaffix and Shanghai Miracogen have expanded an existing collaboration with an agreement to develop and commercialize a second product candidate. 7 January 2020
A subsidiary of Japanese group Kyorin Holdings has acquired an exclusive license to develop and commercialize a candidate for interstitial lung diseases in Japan from California’s aTyr Pharma. 7 January 2020
US clinical-stage biopharma firm Pulmatrix today announced that it has entered into a research collaboration with fellow USA-based Nocion Therapeutics to explore new technologies to enable and improve inhaled drug delivery. 6 January 2020
There was good news for Germany’s Merck KGaA and US partner Pfizer today as they announced the Phase III JAVELIN Bladder 100 study with their PD-L1 antibody Bavencio (avelumab) met its primary endpoint of overall survival (OS) at the planned interim analysis. 6 January 2020
The National Institute of Health and Care Excellence (NICE) has issued draft guidance not recommending Waylivra (volanesorsen) as a treatment for familial chylomicronaemia syndrome (FCS) on the National Health Service (NHS) in England. 3 January 2020
US drugmaker Incyte Corporation looked set to open Friday’s trading more than 11% down after taking an after-hours pummelling in the stock market. 3 January 2020
Californian biotech Durect Corporation lost almost a third of its value in the stock market on Thursday after the company announced disappointing results from its study of DUR-928 in mild to moderate plaque psoriasis. 3 January 2020