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
In a filing with the US Securities and Exchange Commission (SEC), Boundless Bio has revealed its intention for an initial public offering (IPO). 7 March 2024
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has today approved Rystiggo (rozanolixizumab), from Belgium’s largest drug maker UCB. 7 March 2024
UK-based Ellipses Pharma has received Fast Track designation from the US Food and Drug Administration (FDA) for its selective RET inhibitor EP0031/A400 for the potential treatment of RET-fusion positive non-small cell lung cancer (NSCLC). 7 March 2024
UK pharma major GSK today announced positive headline results from an interim analysis of the DREAMM-8 Phase III head-to-head trial evaluating Blenrep (belantamab mafodotin). 7 March 2024
Israeli company BiomX has entered into a definitive merger agreement with Adaptive Phage Therapeutics, a USA-based, privately-held, biotech developing phage-based therapies to combat bacterial infections. 6 March 2024
US antiviral drug specialist Gilead Sciences has entered into a research collaboration, option and license agreement with Dutch biotech Merus to discover novel dual tumor-associated antigens (TAA) targeting trispecific antibodies. 6 March 2024
A bold move to rip up intellectual property protections for COVID-19 vaccines appears to have been quietly dropped, after the World Trade Organization (WTO) opted not to extend the measure. 6 March 2024
Early data from the AFFINITY DUCHENNE trial of a new gene therapy, RGX-202, raise hopes for a breakthrough in Duchenne muscular dystrophy (DMD). 6 March 2024
Today Boston, USA-based Sionna Therapeutics announced it closed a $182 million Series C financing, one of the largest late-stage rounds in biotech so far this year. 6 March 2024
Marking a fourth deal this year, Japanese drugmaker Ono Pharmaceutical today announced that it has entered into a license agreement with pre-clinical stage Korean biotechnology NEX-I for NXI-101. 6 March 2024
Progress is happening in the cell and gene therapies (CGT) space—but that does not mean that the challenges that have held it back are about to disappear. 6 March 2024
A pair of big pharma companies have become the latest drugmakers to take aim at the National Institute for Health and Care Excellence (NICE), the cost-effectiveness watchdog for England and Wales. 5 March 2024
A preliminary report from the US Food and Drug Administration could raise concerns about the safety of new vaccines for respiratory syncytial virus (RSV). 5 March 2024
The UK's National Institute for Health and Care Excellence (NICE) has decided not to recommend Xenpozyme (olipudase alfa) as a treatment for acid sphingomyelinase deficiency (ASMD; Niemann-Pick Disease) in people with type AB or type B. 5 March 2024
The Phase II KARDIA-2 study of zilebesiran, an investigational RNAi therapeutic in development for the treatment of hypertension (high blood pressure) - the leading cause of cardiovascular disease worldwide - met its primary endpoint. 5 March 2024
Beacon Therapeutics’ gene therapy AGTC-501 (laruparetigene zovaparvovec) is in the spotlight with encouraging interim results from SKYLINE trial in the retinitis pigmentosa (retinitis) market. 5 March 2024
UK health technology assessor the National Institute for for Health and Care Excellence (NICE) today issued a final draft guidance recommending UK pharma major GSK’s Jemperli (dostarlimab) for a new indication. 5 March 2024
Danish CNS specialist Lundbeck will release clinical data from the AMULET Phase II, double-blind, randomized trial of Lu AF82422 in multiple system atrophy (MSA) at the InternaPional Conference on Alzheimer's and Parkinson's Diseases and related neurological disorders (AD/PD 2024). 5 March 2024