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
The China National Drug Administration (CNDA) has approved Genvoya (elvitegravir 150mg/cobicistat 150mg/emtricitabine 200mg/tenofovir alafenamide 10mg or E/C/F/TAF) for the treatment of HIV-1 infection. 6 August 2018
Oxford Biomedica released a statement on Monday announcing that it had partnered with Boehringer Ingelheim, Imperial Innovations and the UK Cystic Fibrosis Gene Therapy Consortium, to find a genetic therapy for cystic fibrosis. 6 August 2018
The USA’s Institute for Clinical and Economic Review (ICER) on Friday released a Final Condition Update report and Report-at-a-Glance on targeted immunomodulators for the treatment of moderate-to-severe plaque psoriasis. 6 August 2018
The British Medicines and Healthcare Products Regulatory Agency (MHRA) has given the thumbs-up to Alnylam's experimental RNAi therapy patisiran. 3 August 2018
CAR-T therapy company Cellectis announced on Friday that Stefan Scherer, vice president and global lead for early development and innovation at Novartis, would join the company in a leadership role. 3 August 2018
A new report from Future Market Insights (FMI) suggests that the global enzyme replacement therapy market is likely to to expand by 6.5% compound annual growth until over the next 10 years. 3 August 2018
US biotech Epizyme lost 24% of its market value on Thursday after announcing a partial clinical hold impacting its lead candidate, tazemetostat. 3 August 2018
The US Institute for Clinical and Economic Review (ICER) has announced plans to develop a report assessing the comparative clinical effectiveness and value of Novartis’ AVXS-101 and Biogen’s Spinraza (nusinersen) for treatment of spinal muscular atrophy (SMA). 3 August 2018
PTC Therapeutics and Akcea Therapeutics today announced a collaboration under which PTC will commercialize two of Akcea's rare disease drugs in Latin America: Tegsedi (inotersen) and Waylivra (volanesorsen). 2 August 2018
US biotech Regeneron Pharmaceuticals posted second-quarter 2018 financials before the market opened, showing that total revenues increased 9% to $1.61 billion. 2 August 2018
A new study published in Ophthalmology Retina evaluated diabetic retinopathy (DR) outcomes with Lucentis (ranibizumab) treatment in patients with DR and diabetic macular edema (DME) at high risk of progression to proliferative disease. 2 August 2018
Privately-owned UK biotech Cell Medica has named Chris Nowers its new chief executive after its founder and former leader Gregg Sando stepped down. 1 August 2018
UK-based antiviral drug discovery and development company ReViral today announced the successful completion of a $55 million Series B financing. 1 August 2018
Merck & Co’s Keytruda (pembrolizumab) might have overtaken Opdivo (nivolumab) in the last quarter to become the top-selling cancer immunotherapy and has the most US approvals, but the Bristol-Myers Squibb drug is ahead in terms of approved indications in the European Union (EU). 31 July 2018
Novartis announced on Tuesday the approval of its game-changing migraine prevention therapy Aimovig (erenumab) by the European Medicines Agency (EMA). 31 July 2018
Shares in Californian dermatology specialist Sienna Biopharmaceuticals closed down around 5% on Monday, after the firm announced two key trials had failed to meet their primary endpoints. 31 July 2018
Sanofi and Regeneron intend to sidestep the pressures of the crowded PD-1 field by aiming for a first cemplimab approval in cutaneous squamous cell carcinoma (CSCC), which does not yet have any marketed checkpoint inhibitors, says life sciences analytics company GlobalData. 31 July 2018
Multinational biotech firm HiFiBiO Therapeutics has agreed a multi-target deal with Japan’s Takeda Pharmaceutical to try to discover breakthrough antibody therapies in gastroenterology and oncology. 30 July 2018
Gastrointestinal drug developer RedHill Biopharma today announced positive top-line safety and efficacy results from the first Phase III study with RHB-104 for Crohn's disease (the MAP US study). 30 July 2018
Shares of Japanese pharma major Daiichi Sankyo fell 2.18% to 4,574 yen today after it announced a second licensing accord with privately-held German biotech firm Glycotope. 30 July 2018