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
Autogene cevumeran, an innovative cancer vaccine which could pave the way for a new class of oncology treatment, has entered into Phase II testing. 1 October 2021
Following French pharma major Sanofi’s decision this week to drop out of the race to develop coronavirus vaccines because it admits to being a late comer, the charity Médecins Sans Frontières (MSF) is urging the company to transfer the technology and know-how for the vaccine to the World Health Organization (WHO)-led COVID-19 mRNA vaccine technology transfer hub in South Africa. 1 October 2021
Rumors that US pharma giant Merck & Co was interested in acquiring Acceleron Pharma proved to be well-founded after an $11.5 billion deal was confirmed today. 30 September 2021
Danish dermatology specialist LEO Pharma today announced results showing that after two years of continuous treatment with Adtralza (tralokinumab), adult patients with moderate-to-severe atopic dermatitis maintained improvements in signs and symptoms, itch severity and sleep interference. 30 September 2021
Positive results from a Phase IIa study evaluating the safety and efficacy of amlitelimab (formerly KY1005), a human monoclonal antibody targeting key immune system regulator OX40-Ligand, were presented as a late-breaker today at the European Academy of Dermatology and Venerology (EADV) 2021 Virtual Congress. 30 September 2021
US biotech Amicus Therapeutics is to create a new genetic medicine company called Caritas Therapeutics as part of a deal that will see its gene therapy business acquired by ARYA Sciences Acquisition Corp IV (Nasdaq: ARYD), a special purpose acquisition company (SPAC). 30 September 2021
Mirum Pharmaceuticals, a leader in rare liver disease, says that the US Food and Drug Administration has approved Livmarli (maralixibat) oral solution for the treatment of cholestatic pruritus in patients with Alagille syndrome (ALGS) one year of age and older. 30 September 2021
Cuba is keen to forge joint ventures (JVs) with Indian companies for manufacturing biotech drugs and vaccines. A new joint venture established in Cuba is offering opportunities to Indian pharma and biotech companies for investments and partnerships. 29 September 2021
Chicago-based drugmaker AbbVie has had another calcitonin gene-related peptide (CGRP) receptor antagonist approved in the migraine space by the US Food and Drug Administration (FDA). 29 September 2021
Spanish plasma-derived medicines company Grifols has announced that Tavlesse (fostamatinib), used to treat chronic immune thrombocytopenia (ITP) in adult patients refractory to other treatments, is now available in France, Italy and Spain and reimbursable from their respective health systems. 29 September 2021
A new analysis of five-year data for the gene therapy PTC-AADC shows “profound improvements” in children with aromatic L-Amino acid decarboxylase (AADC) deficiency. 29 September 2021
Swiss independent dermatology specialist Galderma today announced the presentation of new Phase II data supporting the efficacy of its investigational monoclonal antibody, nemolizumab, at the virtual 30th EADV congress now taking place. 29 September 2021
In the UK, Advanced Accelerator Applications (AAA) has been granted a Promising Innovative Medicine (PIM) designation for 177Lu-PSMA-617, an investigational radioligand therapy. 29 September 2021
Of the five late-stage pipeline products expected to be licensed in the seven major pharma markets for cystic fibrosis (CF) between 2020 and 2030, four will be CF transmembrane conductance regulator (CFTR) modulators, according to GlobalData. 29 September 2021
Anglo-Swedish pharma major AstraZeneca’s recently-acquired Alexion rare diseases unit has exercised its option to acquire all remaining equity in Caelum Biosciences. 29 September 2021
US neurodegenerative diseases focussed biotech Denali Therapeutics has appointed Katie Peng to the newly created role of chief commercial officer (COO). 29 September 2021
Sino-American company Brii Biosciences today announced the appointment of Coy Stout as senior vice president and head of US market access and patient advocacy. 28 September 2021
Japanese drug major Eisai said today that it has initiated a rolling submission to the US Food and Drug Administration of a Biologics License Application (BLA) for lecanemab (BAN2401), the company’s investigational anti-amyloid beta (Aβ) protofibril antibody, for the treatment of early Alzheimer’s disease (early AD). 28 September 2021
Shares of Syndax Pharmaceuticals closed up more than 5% yesterday after the company announced a licensing deal with fellow USA-based biotech Incyte to develop and commercialize axatilimab, Syndax’s anti-CSF-1R monoclonal antibody. 28 September 2021