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
Israel’s largest drugmaker Teva Pharmaceutical Industries has announced further positive data from the pan-European PEARL study investigating the impact of Ajovy (fremanezumab) on the prevention of migraine in a real-world setting, due to be completed in 2024. 1 July 2023
Gaining US Food and Drug Administration (FDA) approval for its news generalized myasthenia gravis (gMG) drug was positive news for Belgium’s largest drug maker UCB, but the company will face challenges 1 July 2023
French clinical-stage developer of immunotherapies Exeliom Biosciences today announced the completion of its 24 million-euro ($26 million) Series A financing to progress the clinical development of its therapeutic pipeline. 30 June 2023
US biotech BioMarin Pharmaceutical has won US approval for Roctavian (valoctocogene roxaparvovec-rvox) gene therapy for the treatment of severe hemophilia A without antibodies to adeno-associated virus serotype 5. 30 June 2023
Dublin, Ireland-headquartered protein specialist Prothena has published results from the Phase III VITAL trial in a journal of the American Society of Hematology (ASH). 30 June 2023
Cancer giant Bristol Myers Squibb has secured a new European approval for its checkpoint blocker Opdivo (nivolumab), in non-small cell lung cancer (NSCLC). 30 June 2023
The US Food and Drug Administration yesterday approved Lantidra (donislecel), the first allogeneic (donor) pancreatic islet cellular therapy made from deceased donor pancreatic cells for the treatment of type 1 diabetes. 30 June 2023
US pharma major Eli Lilly is to acquire Sigilon Therapeutics, a biopharma company seeking to develop functional cures for patients with a range of acute and chronic diseases. 29 June 2023
Lars Petersen has been named as the new president and chief executive officer (CEO) of FUJIFILM Diosynth Biotechnologies, a Japanese contract development and manufacturing organization (CDMO), and subsidiary of FUJIFILM Corp, effective immediately. 29 June 2023
French pharma major Sanofi hosted a Vaccines Investor Event today, when it reaffirmed its ambition to deliver more than 10 billion euros ($10.9 billion) in annual vaccines sales by 2030, driven by core franchises of influenza, meningitis, and pediatric vaccines, with the addition of RSV. 29 June 2023
San Diego, USA-based biotech AvantGen has appointed of Jordon Wang as its new chief operating officer (COO) and senior vice president of technology development. 29 June 2023
BlueRock Therapeutics, a wholly-owned subsidiary of German life sciences company Bayer, can boast that bemdaneprocel, its neuronal stem cell therapy for Parkinson’s disease, is the first to show positive results in a Phase I study. 28 June 2023
US drug major Bristol Myers Squibb’s Sotyktu (deucravacitinib), a once-daily oral tablet, has been recommended for use on the National Health Service (NHS) in England as an option for treating certain adults with moderate to severe plaque psoriasis. 28 June 2023
The US Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) for the Biologics License Application (BLA) for aflibercept 8mg for the treatment of patients with wet age-related macular degeneration (wAMD), diabetic macular edema (DME) and diabetic retinopathy (DR), solely due to an ongoing review of inspection findings at a third-party filler. 28 June 2023
German biotech TME Pharma saw its shares rise more than 7% to 1.44 euros in early trading today, as it announced a positive clinical update on the survival of first-line glioblastoma patients in the GLORIA expansion arm evaluating NOX-A12, TME Pharma's CXCL12 inhibitor, in combination with standard of care radiotherapy and anti-VEGF, bevacizumab. 28 June 2023
Top-line Phase III data from Bavarian Nordic reflect the difficulties of targeting COVID-19, with a constantly mutating viral threat and an equally changeable regulatory landscape. 28 June 2023
The Russian biotech company Biocad has begun a Phase III of clinical trial of its new, original drug for the treatment of melanoma, bringing it a step closer to launching a second product for this disease. 28 June 2023
The US Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) for fidanacogene elaparvovec for the treatment of adults with hemophilia B, said US pharma giant Pfizer. 27 June 2023
A new Pompe disease therapy has been approved by the European Medicines Agency, with Amicus Therapeutics picking up authorization for the enzyme stabilizer Opfolda (miglustat). 27 June 2023