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
US biotech Ikena Oncology and the Vall d’Hebron Institute of Oncology (VHIO) yesterday announced an alliance to enable generation and exploration of tumor and biomarker-specific data derived from specific patient populations. 3 May 2022
The Food and Drug Administration (FDA) has approved Rinvoq (upadacitinib; 15mg, once daily) for the treatment of adults with active ankylosing spondylitis (AS) who have had an inadequate response or intolerance to one or more tumor necrosis factor (TNF) blockers, marking the fourth approval for the drug in the past five months alone. 3 May 2022
An Expert View from Neelam Patel, chief executive of MedCity, a not-for-profit that serves as the life sciences cluster organization for London. 2 May 2022
Fibrodysplasia ossificans progressiva (FOP) is a rare connective tissue disease characterized by heterotopic ossification, where bone growth occurs in areas where bone typically should not be present.1 30 April 2022
Outpacing analysts' expectations, New York–based cancer giant Bristol Myers Squibb has reported first quarter 2022 revenues of $11.6 billion, a 5% increase from the $11 billion achieved in the same period of 2021. 29 April 2022
Shares US pharma major AbbVie were down 9% at $142.08 in early trading, as the company announced financial results for the first quarter ended March 31, 2022, which missed Wall Street estimates for first-quarter sales. 29 April 2022
Canada-based biotech Zymeworks late yesterday confirmed it has received an unsolicited, non-binding proposal from All Blue Falcons FZE (ABF) and its affiliates to purchase the company for $10.50 per share in cash, or some $773 million in total. 29 April 2022
Gilead Sciences increased its quarterly revenue by 3% compared to the first quarter of 2021, the company announced in presenting its latest financial results. 29 April 2022
People with Duchenne muscular dystrophy (DMD) have been given renewed hope that an investigational gene therapy under development by Pfizer may yield results. 29 April 2022
RNAi therapeutics company Alnylam Pharmaceuticals today reported its consolidated financial results for the first quarter ended March 31, 2022. 28 April 2022
US messenger RNA (mRNA) therapeutics and vaccines specialist Moderna has announced that Arpa Garay will join the firm as chief commercial officer (CCO), effective Monday, May 31, 2022. She 28 April 2022
Now the first and only long-acting C5 complement inhibitor in gMG, Ultomiris (ravulizumab-cwvz), has gained an additional approval in the USA. 28 April 2022
Shares of US biotech giant Amgen were down almost 6% at $233.98 in pre-market trading today, following the company’s release of positive first-quarter 2022 results, but with a sting in the tail relating to back taxes, after markets closed on Wednesday. 28 April 2022
Outlook Therapeutics recently submitted a Biologics License Application to the US Food and Drug Administration for ONS-5010 (bevacizumab-vikg) for the treatment of wet age-related macular degeneration (wAMD). 28 April 2022
The European Medicines Agency (EMA) has granted access to the Priority Medicines (PRIME) scheme for BCX9250, a novel, oral activin receptor-like kinase-2 (ALK-2) inhibitor discovered and developed by BioCryst Pharmaceuticals for the treatment of fibrodysplasia ossificans progressiva (FOP). 27 April 2022
Pfizer and BioNTech have submitted an application to the US Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) of a 10-µg booster dose of their COVID-19 jab for children aged five to 11 years of age. 27 April 2022
The stock market provided a telling assessment of Protagonist Therapeutics’ presentation of its top-line results from the Phase II IDEAL study evaluating PN-943 in ulcerative colitis (UC). 27 April 2022
Chinese start-up Xbiome, an AI-based microbiome drug development company, has acquired the clinical-stage M201 program from Californian firm Assembly Biosciences. 27 April 2022
Swiss pharma giant Novartis today announced positive top-line results from an interim analysis of the Phase III RATIONALE 306 study, which showed anti-PD-1 immune checkpoint inhibitor tislelizumab plus chemotherapy significantly improved overall survival (OS) compared to chemotherapy in patients with previously untreated unresectable, locally advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC), regardless of PD-L1 expression. 27 April 2022