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
After two previous setbacks, US pharma giant Pfizer yesterday released disappointing new data for its Duchenne muscular dystrophy (DMD) gene therapy candidate. 13 June 2024
Belgium’s UCB is sharing results from three studies supporting the value of Cimzia (certolizumab pegol) for women of childbearing age living with chronic immune-mediated diseases and people with rheumatoid arthritis (RA) and high rheumatoid factor (RF) levels. 13 June 2024
One of the most important medical meetings in rheumatology is underway in Vienna, Austria, and leading drugmakers in the field have lifted the lid on data they intend to present. 12 June 2024
US gene therapy company Regenxbio has announced that co-founder Kenneth Mills is to step down as president and chief executive following 15 years of leadership at the company. 12 June 2024
Bright Peak Therapeutics yesterday announced that it raised $90 million in a Series C financing, as the privately-held biotech looks to make a name for itself in the immunoconjugate space. 12 June 2024
Belgian biotech UCB has presented promising two-year data from Phase III studies on Bimzelx (bimekizumab) at the European Congress of Rheumatology, EULAR 2024. 12 June 2024
Shares of Germany drug discovery company Evotec were up 2.2% at 9.06 euros as it announced it has reached important scientific progress within its neuroscience collaboration with Bristol Myers Squibb . 12 June 2024
The Center for Drug Evaluations of the National Medical Products Administration (NMPA) in China has accepted the biologics license application (BLA) for zanidatamab for second-line treatment of HER2-positive biliary tract cancer (BTC). 11 June 2024
Shares of Skye Bioscience fell as much as 25% in pre-market activity on Monday, after it revealed that its Phase IIa clinical trial of SBI-100 ophthalmic emulsion (OE) did not meet its primary endpoint for lowering intraocular pressure (IOP). 11 June 2024
Privately-held Spanish CNS specialist Minoryx Therapeutics today announced encouraging results from a compassionate use study of leriglitazone for treatment of progressive cerebral adrenoleukodystrophy (cALD) in adult male patients, which are published in the peer-reviewed journal Brain. 11 June 2024
UK pharma major GSK and US biotech SpringWorks Therapeutics are to end their collaboration combining Blenrep (belantamab mafodotin) and Ogsiveo (nirogacestat). 11 June 2024
The US Food and Drug Administration’s (FDA) Peripheral and Central Nervous System Drugs Advisory Committee yesterday unanimously voted that donanemab shows clinical benefit for the treatment of early Alzheimer’s disease. 11 June 2024
Japanese drugmaker Kyowa Kirin yesterday revealed it is establishing a new, state-of-the-art manufacturing facility in Sanford, North Carolina, in the USA. 11 June 2024
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has approved Bimzelx (bimekizumab) for the treatment of active moderate to severe hidradenitis suppurativa (HS) in adults with an inadequate response to conventional systemic HS therapy. 10 June 2024