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
French pre-clinical biotech Mablink Biosciences has confirmed earlier rumors that it has agreed to a takeover bid from acquisition-hungry US pharma major Eli Lilly. 19 October 2023
Japanese drugmaker Daiichi Sankyo revealed that it has been ordered by a Texas district court to pay royalties on its antibody-drug conjugate (ADC) to US biotech Seagen. 19 October 2023
Californian advanced therapy company Nkarta moving forward with plans to leverage the potential of natural killer (NK) cell-based treatments outside of oncology. 19 October 2023
The European Commission (EC) has now approved Adcetris (brentuximab vedotin) in combination with doxorubicin, vinblastine and dacarbazine (AVD) to treat adult patients with previously untreated CD30+ Stage III Hodgkin lymphoma. 19 October 2023
After scientific advisors recommended that the US regulator not approve a new amyotrophic lateral sclerosis (ALS) therapy, developer BrainStorm Cell Therapeutics has opted to withdraw its submission. 19 October 2023
Elevar Therapeutics and Hengrui Pharma have agreed to a global licensing deal giving the former rights to commercialize and develop the checkpoint blocker camrelizumab. 18 October 2023
Sino-American biotech BeiGene became the first Chinese-origin pharma company to market a programmed cell death protein 1 (PD1) therapy for oncology indications in various global markets, beginning with the European Union. 18 October 2023
UCB has won two approvals from the US Food and Drug Administration, one for a new first-in-class rare disease med and another, for Bimzelx (bimekizumab-bkzx), bringing a new option for Americans with plaque psoriasis. 18 October 2023
Sanofi has presented new data from its Phase III program for Tzield (teplizumab-mzwv) at the 49th Annual ISPAD Conference, in The Netherlands. 18 October 2023
Shares USA-based clinical-stage biotech Evelo Biosciences plummeted 59% to $1.20 yesterday, as it announced disappointing top-line results from its Phase II clinical study with EDP2939 in moderate psoriasis. 18 October 2023
The US Food and Drug Administration (FDA) has approved US pharma giant Merck & Co’s leading checkpoint blocker Keytruda (pembrolizumab) for the treatment of patients with resectable non-small cell lung cancer (NSCLC). 18 October 2023
US antiviral-focused biotech Assembly Biosciences saw its share price rocket nearly 95% to $1.42, on news of a research collaboration with Gilead Sciences. 17 October 2023
Spanish genetic medicines company SpliceBio has signed an exclusive collaboration and licensing agreement with Spark Therapeutics, which was acquired by Swiss pharma giant Roche in a $4.8 billion deal in 2020, to utilize SpliceBio’s proprietary Protein Splicing platform to develop a gene therapy for an undisclosed inherited retinal disease. 17 October 2023
In what the company said was a big day for Monte Rosa Therapeutics, a clinical-stage biotech company developing novel molecular glue degrader (MGD)-based medicines, the company announced two major milestones. 17 October 2023
Chicago, USA-based artificial intelligence and antibody specialist SparX Biopharmaceutical is to embark on a new strategic collaboration with Arovella Therapeutics. 17 October 2023
Israeli drugmaker Teva Pharmaceutical Industries has announced that data from the UNITE study presented at the World Congress of Neurology in Montreal, Canada, show that Ajovy (fremanezumab) reduced migraine attacks and depression symptoms in migraine patients with major depressive disorder. 17 October 2023
Seattle, USA-based biotech Omeros Corporation saw its shares plummet as much as 58% to an all-time low of $0.92 yesterday, after it said it will discontinue development of an experimental therapy to treat a type of kidney disease after a late-stage study failure. 17 October 2023