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
Positive high-level results from the FoCus Phase III trial in Wilson disease showed ALXN1840 met the primary endpoint with a statistically-significant improvement in daily mean copper mobilization from tissues, demonstrating superiority compared with standard-of-care (SoC) treatments 26 August 2021
A Texan biotech company focused on Alzheimer’s disease saw its share price slip by 24% during Wednesday morning’s trading after claims were posted about the firm’s scientific integrity online on Tuesday after market hours. 25 August 2021
The European Commission (EC) has approved Rinvoq (upadacitinib), an oral, selective and reversible JAK inhibitor from US pharma major AbbVie, for the treatment of moderate to severe atopic dermatitis in adults and adolescents 12 years and older who are candidates for systemic therapy. 25 August 2021
The International Vaccine Institute (IVI) has announced the first participant received Bharat Biotech International Ltd’s (BBIL) Chikungunya vaccine candidate (BBV87) in a Phase II/III clinical trial in Costa Rica. 25 August 2021
For spinal muscular atrophy (SMA) Awareness Month, we take a look at advances in the pharmacological treatment of this rare hereditary disease. 25 August 2021
Approval has been granted for the combination of Opdivo (nivolumab) intravenous infusion and Cabometyx (cabozantinib s-malate) tablets in Japan for the treatment of unresectable or metastatic renal cell carcinoma (RCC), for a partial change in approved items of the manufacturing and marketing approval. 25 August 2021
UK-based T cell receptor (TCR) biotech firm Immunocore yesterday announced that regulators in the USA and European Union have each accepted applications for the approval of tebentafusp (IMCgp100) for the treatment of HLA-A*02:01-positive adult patients with metastatic uveal melanoma (mUM). 25 August 2021
Children in England are set to be the first in the world to be offered direct acting antiviral (DAA) tablets for hepatitis C, as part of National Health Service (NHS) plans to eradicate the disease entirely. 24 August 2021
A host of companies have signed up to take part in Inno4Vac, a newly-established European public-private partnership to innovate vaccine development. 24 August 2021
Shares of Denmark’s biopharma company Orphazyme rose 12.4% to $5.63 on Monday, as it announced that positive results from a Phase II/III trial of arimoclomol, an investigational heat-shock protein amplifier, in Niemann-Pick disease type C (NPC) have been published in the peer-reviewed Journal of Inherited Metabolic Disease (JIMD). 24 August 2021
The European Medicines Agency’s human medicines committee (CHMP) has adopted recommendations that will increase manufacturing capacity and supply of two COVID-19 vaccines in the European Union. 24 August 2021
The UK government has agreed to purchase 35 million more doses of the Pfize/BioNTech COVID-19 vaccine, to be delivered from the second half of next year. 24 August 2021
Shares in Swiss pharma company Novartis were 1% lower by lunchtime on Tuesday following news of a setback for Kymriah (tisagenlecleucel), the first approved CAR-T cell therapy. 24 August 2021
Australia’s Therapeutic Goods Administration (TGA) has granted provisional determination to the local subsidiary of Swiss pharma giant Roche in relation to the combination therapy casirivimab + imdevimab, now trade-named Ronapreve. 24 August 2021
Norwegian clinical-stage biotech BerGenBio has announced the appointment of Martin Olin as its new chief executive, effective September 8, 2021. 24 August 2021
More than eight months after first being granted emergency use authorization (EUA), the COVID-19 vaccine from Pfizer and BioNTech has received full approval from the US Food and Drug Administration (FDA). 23 August 2021
French biotech Valneva has started rolling submission for initial approval of its COVID-19 vaccine candidate, VLA2001, with the UK’s Medicines and Healthcare products Regulatory Agency (MHRA). 23 August 2021
Sino-America biotech firm BeiGene today said that the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) has accepted a supplemental Biologics License Application (sBLA) for its anti-PD-1 antibody tislelizumab in combination with chemotherapy as a first-line treatment for patients with recurrent or metastatic nasopharyngeal cancer (NPC). 23 August 2021
Shares of Canadian immuno-oncology drug developer Trillium Therapeutics skyrocketed 193% to $17.8 pre-market today, after it was revealed that its board has accepted a takeover bid from US pharma giant Pfizer. 23 August 2021