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
Swiss pharma giant Roche edged 1.02% higher to 252.15 Swiss francs this morning, after it was revealed it is seeking a position in the hot area of liver disease. 28 November 2018
New York-based cell and gene therapy specialist Axovant Sciences has agreed a new strategic partnership with Yposkesi, a Contract Development & Manufacturing Organization (CDMO) specializing in gene therapy vector manufacturing. 28 November 2018
The first children in the UK to receive a game-changing personalized therapy for cancer will start treatment at Great Ormond Street Hospital in London this week, NHS England announced yesterday. 28 November 2018
Canada-based Zymeworks and China’s BeiGene have entered into a strategic collaboration for the clinical development and commercialization of Zymeworks’ investigational ZW25 and ZW49 HER2-targeted bispecific antibodies. 27 November 2018
Shares in New York-based drugmaker Bristol-Myers Squibb are faring poorly in pre-market trading, after the firm announced a Phase III trial flop for its combination Opdivo (nivolumab) plus Yervoy (ipilimumab) therapy. 27 November 2018
Israel and USA-based biotech Anchiano Therapeutics today announced the appointment of David Kerstein, as the company’s new chief medical officer (CMO). 27 November 2018
The Ireland Strategic Investment Fund (ISIF), an Irish sovereign development fund, WuXi NextCODE, the emerging global standard platform for genomics, and Irish life sciences company Genomics Medicine Ireland (GMI), today announce details of a $400 million investment program aimed at making Ireland an important hub for genomics research and development of new disease treatments and cures. 27 November 2018
US biotech suffered another setback in drug development yesterday, as the US regulator put a clinical hold on its investigational drug ZGN-1061. 27 November 2018
Switzerland’s Roivant Sciences has launched a new biotech startup, in collaboration with the Cincinnati Children's Hospital Medical Center, called Aruvant Sciences. 27 November 2018
Just over 140 years ago, the world’s first industrial-sized research and development laboratory opened. As someone who’s devoted his working life to finding new research and development (R&D) breakthroughs, I’m envious of the explosion of activity that made the lab’s owner, Thomas Edison, one of history’s most remarkable inventors. But it’s his process of innovation that inspires me, as much as his life-changing creations. 27 November 2018
Greg MacMichael, the former global head of cell and gene therapy technical development and manufacturing at Swiss pharma giant Novartis, is one of five new recruits to join Axovant Sciences. 26 November 2018
It’s been a busy year for Promore Pharma (Nasdaq: PROMO), a Swedish developer of therapeutic peptides, which has made good progress in its two clinical assets, making the investment case more attractive to investors, noted Klas Palin, analyst at Sweden’s Redeye Equity Research. 26 November 2018
The European Commission has granted a marketing authorization to Poteligeo (mogamulizumab), a humanized monoclonal antibody (MAb) directed against CC chemokine receptor 4 (CCR4), for the treatment of adult patients with mycosis fungoides (MF) or Sézary syndrome (SS) who have received at least one prior systemic therapy. 26 November 2018
The European Court of Justice will not stand in the way of Roche’s cancer drug Avastin (bevacizumab) being prescribed for an unlicensed indication. 23 November 2018
In recent decades, the pharmaceutical industry has developed next-generation treatments for cystic fibrosis (CF) that have a real impact on patients’ lives and extend life expectancy considerably. 23 November 2018
Switzerland-based Novartis has won European approval for the one-time gene therapy Luxturna (voretigene neparvovec). The treatment was approved in the USA in late December 2017. 23 November 2018
The UK government-backed Cell and Gene Therapy Catapult (CGT Catapult) has launched a new apprenticeship program aimed at supporting the development of Advanced Therapy Medicinal Products (ATMP). 23 November 2018