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
French clinical-stage drug developer Acticor Biotech announced late Thursday that it has received "PRIority Medicines" status from the European Medicines Agency (EMA) for its drug candidate, glenzocimab, for the treatment of patients with stroke. 22 July 2022
Cancer Research UK and Sosei Heptares have agreed a deal to bring the Japanese drugmaker’s cancer immunotherapy drug candidate into a first-in-human trial. 21 July 2022
CAMP4 Therapeutics, a biotech promising to harness the power of RNA to restore healthy protein expression, has announced the close of a $100 million Series B financing round, led by Enavate Sciences. 21 July 2022
Avista Therapeutics, which recently launched as a spin-out of the University of Pittsburgh Medical Center (UPMC), aims to develop innovative gene therapies for rare ophthalmic conditions. The new company today announced a partnership with Swiss pharma giant Roche to develop novel AAV gene therapy vectors for the eyes. 21 July 2022
People with head and neck cancer did not receive a statistically-significant benefit from treatment with Merck & Co’s Keytruda (pembrolizumab) in the KEYNOTE-412 trial. 21 July 2022
Shares of Innate Pharma shot up as much as 10% in an initial reaction to its announcement that French pharma major Sanofi has made the decision to progress IPH6401/SAR’514 into investigational new drug (IND)-enabling studies, triggering a 3 million-euro ($3.1 million) milestone payment. 21 July 2022
The UK’s R&D tax relief regime will continue to support innovative life sciences and biotech companies to conduct essential clinical trials and some pre-clinical work overseas following the publication of new draft legislation. 21 July 2022
US clinical-stage immuno-oncology company Portage Biotech says it has acquired the outstanding ownership interest (approximately 22%) of its invariant natural killer T cell (iNKT agonist) platform and now fully owns the worldwide rights to its small molecule iNKT agonists, including lead programs PORT-2 and PORT-3. 21 July 2022
New Jersey, USA-based rare disease drug developer PTC Therapeutics today announced that Upstaza (eladocagene exuparvovec) was granted marketing authorization by the European Commission. 20 July 2022
Unofficial American cost-effectiveness watchdog the Institute for Clinical and Economic Review (ICER) has published a Final Evidence Report on betibeglogene autotemcel for the treatment of beta thalassemia. 20 July 2022
Versanis Bio, a privately-held biotech advancing novel therapeutics for cardiometabolic diseases, has announced the appointment of Mark Pruzanski as chairman and chief executive 20 July 2022
The US Food and Drug Administration (FDA) has approved Opzelura (ruxolitinib) cream 1.5% for the topical treatment of nonsegmental vitiligo in adult and pediatric patients 12 years of age and older, the drug’s developer, Incyte, announced late Monday, when the firms share closed up 3.2% at $81.36. 20 July 2022
Cell therapies are among the most researched treatment types for blood cancer and the product pipeline is oversaturated, with over 800 products currently in development for just five major blood cancers. 20 July 2022
Chinese contract research, development and manufacturing organization (CRDMO) WuXi Biologics has announced a 10-year, $1.4 billion investment plan to expand its research, development, and large-scale drug substance and drug product manufacturing capacity and capabilities in Singapore. 19 July 2022