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
Danish biotech Genmab has announced topline results from the Phase III MAIA study of daratumumab in combination with lenalidomide and dexamethasone (DRd) versus the latter two alone, in front-line multiple myeloma. 30 October 2018
UCB has sustained its stable rate of growth and remains on target to meet its 2018 expectations, according to its results from the first nine months of the year. 30 October 2018
AMO Pharma has announced an update on results of the recently-completed TIDE study of AMO-02 (tideglusib) in treatment of autism spectrum disorder (ASD) at the 65th Annual Meeting of the American Academy of Child and Adolescent Psychiatry in Seattle, Washington, USA. 30 October 2018
Japanese drugmaker Kissei Pharmaceutical has acquired exclusive rights to develop and commercialize Tavalisse (fostamatinib disodium) in all current and potential indications in Japan, China, Taiwan and the Republic of Korea. 29 October 2018
Two major new listings on the Australian Pharmaceutical Benefits Scheme (PBS) have the potential to extend the lives of Australians with advanced lung cancer and those at risk of a heart attack, saving patients up to nearly A$190,000 ($135,714) a year. 29 October 2018
Swiss pharma giant Novartis has announced additional brolucizumab Phase III results from year two that reaffirmed its positive year one findings. 29 October 2018
Additional data from a Phase II trial on a drug being developed by Japan's Eisai and US biotech Biogen has failed to win over doubters that this could be the long-awaited answer for a step forward in Alzheimer’s. 26 October 2018
US biopharma firm AbbVie will assume full development and commercial responsibility for its collaboration with Belgo-Dutch biotech Galapagos to discover and develop new therapies to treat cystic fibrosis (CF). 26 October 2018
Regeneron Pharmaceuticals announced positive Phase III trial news on its ophthalmology drug Eylea (aflibercept) in diabetic eye disease on Thursday. 26 October 2018
Sales recorded by US biotech giant Gilead Sciences in the third quarter beat analysts’ expectations but were still down on the same period of 2017. 26 October 2018
Melbourne, Australia-headquartered Cancer Therapeutics CRC (CTx) has announced a two-year research collaboration and a license agreement with Pfizer. 26 October 2018
US biotech major Celgene today posted third-quarter 2018 financials, showing that total revenues leapt 18.4% to $3.89 billion, so beating analysts’ estimates of $3.85 billion. 25 October 2018
Amgen said yesterday that it is making its PCSK-9 inhibitor Repatha (evolocumab), an innovative biologic medicine for people with high cholesterol who are at risk for heart attacks and strokes, available at a reduced list price. 25 October 2018
New Jersey, USA-based Merck & Co has announced strong third quarter financial results, with global revenues up 5% on the same period last year, at $10.8 billion, in line with analysts’ expectations. 25 October 2018
Ireland-based rare diseases specialist Shire has filed its second submission to the US Food and Drug Administration for its new plasma manufacturing facility near Covington, Georgia. 25 October 2018
Danish biopharma Forward Pharma says it is considering its options after the US Court of Appeals for the Federal Circuit denied the company rights to royalties relating to the blockbuster multiple sclerosis drug Tecfidera (dimethyl fumarate). 25 October 2018