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
Beating many analysts’ expectations for the final quarter, Bristol Myers Squibb reported sales of $11.1 billion in its annual results statement, yielding full-year revenues of $42.5 billion. 4 February 2021
The China National Medical Products Administration (NMPA) has granted conditional approval to Xospata (gilteritinib) for the treatment of adult patients who have relapsed (disease that has returned) or refractory (resistant to treatment) acute myeloid leukemia (AML) with a FLT3 mutation (FLT3mut+) detected by a fully validated test. 4 February 2021
A scientific panel of the European Medicines Agency has kicked off a rolling review of NVX-CoV2373, a COVID‑19 vaccine being developed by US biotech Novavax. 4 February 2021
Swiss pharma giant Roche this morning announced 2020 financial results, showing that group sales increased 1% to 58.32 billion Swiss francs ($65.43 billion) at constant exchange rates (CER), but a 5% decline in Swiss francs, as a result of continued appreciation of the Swiss franc against most currencies, as well as biosimilars competition. 4 February 2021
The US Food and Drug Administration late yesterday granted accelerated approval to Tepmetko (tepotinib), from EMD Serono, the US healthcare business of Germany’s Merck KGaA for adult patients with metastatic non-small cell lung cancer (NSCLC) harboring mesenchymal-epithelial transition (MET) exon 14 skipping alterations. 4 February 2021
Setting the scene for an active M&A year for the biopharma sector, US biotech firm Jazz Pharmaceuticals today announced the biggest takeover deal so far this year. 3 February 2021
AbbVie, which has recently completed its $63 billion acquisition of Allergan, today announced financial results for the fourth quarter and full year ended December 31, 2020, that beat Wall Street forecasts, and pushing the firm’s shares 1.8% higher to $105.33 by mid-morning. 3 February 2021
For the fourth quarter of 2020, Biogen has reported revenues of $2.8 billion, hitting most analysts’ forecasts on the nose and bringing the total for the year to $13.4 billion. 3 February 2021
UK pharma major GlaxoSmithKline and German biotech firm CureVac today announced a new 150 million-euro ($180.5 million) collaboration, building on their existing relationship, to jointly develop next generation mRNA vaccines for COVID-19 with the potential for a multi-valent approach to address multiple emerging variants in one vaccine. 3 February 2021
New York-based biopharma Immunovant lost 42% of its value in Tuesday’s trading after announcing a voluntary pause of dosing in its ongoing clinical trials for IMVT-1401. 3 February 2021
UK health technology assessor the National Institute for Health and Care Excellence (NICE) has issued final guidance recommending Beovu (brolucizumab) as an option in the National Health Service (NHS) for the treatment of neovascular (wet) age-related macular degeneration (AMD) in adults. 3 February 2021
A primary analysis of Phase III clinical trials indicates that COVID-19 Vaccine AstraZeneca - formerly known as AZD1222 - is safe and effective more than 22 days after the first dose. 3 February 2021
Feeling the effects of the coronavirus pandemic, Californian biotech Amgen reported mixed results for the final quarter of 2020, with rising revenues but declining profits. 3 February 2021
Life sciences investment group Abingworth has announced the final closing of its latest transatlantic venture fund, Abingworth Bioventures 8 (ABV 8) at $465 million. 3 February 2021
In a second research collaboration this year, privately-held US DNA-encoding specialist X-Chem has entered into a research collaboration and license agreement with Swiss pharma giant Roche’s subsidiary Genentech. 3 February 2021
French vaccines developer Valneva today reported that the UK government has exercised its option to order a further 40 million doses of its inactivated, adjuvanted COVID-19 vaccine candidate, VLA2001, for supply in 2022. 2 February 2021
Japan’s Ono Pharmaceutical has entered into a license agreement with US clinical-stage oncology company Ribon Therapeutics for RBN-2397, Ribon’s PARP7 (Poly ADP-ribose polymerase 7) inhibitor in Phase I clinical development for the treatment of cancer. 2 February 2021
China’s Clover Biopharmaceuticals is to begin a global Phase II/III trial of its protein-based S-Trimer COVID-19 vaccine candidate adjuvanted with Dynavax’s CpG 1018 plus alum. 2 February 2021
Coherus BioSciences’ shares gained 12% yesterday, after it announced a collaboration with Shanghai Junshi Biosciences for the development and commercialization of toripalimab, the Chinese firm’s anti-PD-1 antibody, in the USA and Canada, which could be worth as much as $1.1billion to the latter. 2 February 2021