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 Russian Direct Investment Fund (RDIF) has bolstered manufacturing capacity for the supply of Sputnik V, Russia’s home-grown coronavirus vaccine. 27 November 2020
The US Food and Drug has approved Imcivree (setmelanotide) for chronic weight management in adult and pediatric patients six years of age and older with obesity due to proopiomelanocortin (POMC), proprotein convertase subtilisin/kexin type 1 (PCSK1) or leptin receptor (LEPR) deficiency confirmed by genetic testing. 27 November 2020
It has been a long and confusing week for investors and patients trying to work out what is going on with the COVID-19 vaccine being developed by the University of Oxford and Anglo-Swedish drugmaker AstraZeneca. 27 November 2020
Germany’s Merck KGaA has announced that the European Medicines Agency (EMA) has validated for review, the application for tepotinib for the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) harboring mesenchymal-epithelial transition factor gene (MET) exon 14 (METex14) skipping alterations. 26 November 2020
Israel’s RedHill Biopharma yesterday announced partnerships with two leading, USA-based manufacturers for large-scale manufacturing of opaganib (trade name Yeliva). 26 November 2020
The US Food and Drug Administration has granted accelerated approval for Danyelza (naxitamab) in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF). 26 November 2020
The US Food and Drug Administration has completed its internal review of the Baseline-Controlled Study results of omaveloxolone for the treatment of patients with Friedreich’s ataxia (FA) and concluded that the results do not strengthen the results of Part 2 of the MOXIe study. 26 November 2020
British artificial intelligence specialist InstaDeep and German biotech firm BioNTech have deepened ties, embarking on a multi-year project to develop new technologies. 25 November 2020
Messenger RNA specialist Moderna has agreed to supply 80 million doses of its COVID-19 vaccine to the European Commission, with an option for a further 80 million. 25 November 2020
Privately-held Chinese company Gmax Biopharm has announced that the first patient has received its humanized monoclonal antibody, GMA301, as part of investigations around the drug’s efficacy for the treatment of pulmonary arterial hypertension (PAH). 24 November 2020
Danish biotech Genmab’s shares were down 2.9% to 2,210 Danish kroner by close of trading today, after it revealed that it will not advance the development of a cancer drug candidate. 24 November 2020
Roche subsidiary Genentech has successfully broadened the US label for Xofluza (baloxavir marboxil), to include treatment to prevent influenza after contact with an infected person. 24 November 2020
Swiss drug developer Idorsia has announced positive top-line results of the Japanese registration program investigating clazosentan in adult Japanese patients post-aneurysmal subarachnoid hemorrhage (aSAH). 24 November 2020
The US Food and Drug Administration has approved Oxlumo (lumasiran) as the first treatment for primary hyperoxaluria type 1 (PH1), a rare genetic disorder. 24 November 2020
German drugmaker Bayer has generally preferred in-licensing deals and other collaborations to multi-billion dollar acquisitions, so executives must have been highly impressed by what they saw of Asklepios BioPharmaceutical (AskBio) to spend $2 billion upfront on buying the US biotech, along with up to $2 billion more depending on certain milestones. 23 November 2020
UK-based rare diseases specialist Mereo BioPharma today announced the appointment of Dr Suba Krishnan as senior vice president of clinical development, effective December 7, 2020. 23 November 2020
Safe and effective vaccines for the novel coronavirus seem to be like buses: after a long, anxious period of waiting, finally three come along at once. 23 November 2020