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
Ireland-incorporated rare diseases giant Shire announced on Friday that it had receieved approval from the US Food and Drug Administration on its first submission for a new plasma manufacturing center in the state of Georgia. 22 June 2018
English patients who have not responded to at least one other systemic therapy will soon be able to receive routine National Health Service prescriptions for a targeted biologic for moderate to severe atopic dermatitis, the most common type of eczema. 22 June 2018
USA-based biotech firm Heron Therapeutics saw its share rocket 30.13% to $39.95 after its revealed clinical data promising high hopes for its post-surgery pain treatment, as well as a coveted designation from the US regulars. 22 June 2018
The first ever application for a combination of two immuno-oncology (I-O) drugs in lung cancer has been accepted by the US Food and Drug Administration (FDA). 22 June 2018
The UK's Medicines and Healthcare products Regulatory Agency has renewed the Early Access to Medicines Scheme scientific opinion for Raxone (idebenone) for patients with Duchenne muscular dystrophy in respiratory function decline who are not taking glucocorticoids. 22 June 2018
At its 2018 Investor and Analyst Event, Incyte's (Nasdaq: INCY) recent suffering continued with the announcement that it planned to scrap one of its clinical trials. 21 June 2018
Lonsurf (trifluridine and tipiracil) leads to significant improvement in overall survival (OS) in patients with refractory metastatic gastric cancer, according to Phase III data. 21 June 2018
The US Food and Drug Administration (FDA) has added restrictions to the labels of two immunotherapy drugs for locally advanced or metastatic urothelial cancer patients who are not eligible for cisplatin-containing therapy. 21 June 2018
NeuroVive Pharmaceutical has entered into an exclusive licensing agreement with USA-based biotech BridgeBio Pharma for a subset of succinate prodrug chemistry under NeuroVive's NVP015 program. 21 June 2018
iTeos Therapeutics, a biotech developing novel cancer immunotherapies, has announced the completion of an oversubscribed $75 million Series B financing in the latest example of major investment in immuno-oncology (I-O). 20 June 2018
Proving their commercial viability is arguably the biggest barrier that gene therapies have to overcome, with the growing body of evidence and regulatory approvals showing that they are winning the battle to prove efficacy and safety. 20 June 2018
Independent mitochondrial DNA specialist Stealth BioTherapeutics has raised $100 million from Nan Fung Technology’s Pivotal Beta and other new and existing investors. 20 June 2018
US development stage company TG Therapeutics and privately-held Swiss firm Novimmune have entered into an exclusive global agreement to collaborate on the development and commercialization of Novimmune’s novel first-in-class anti-CD47/anti-CD19 bispecific antibody known as TG-1801 (previously NI-1701). 20 June 2018
The international medical humanitarian organization Médecins Sans Frontières (MSF) has filed a legal patent challenge at China’s State Intellectual Property Office (SIPO), requesting the invalidation of the patent granted to US pharmaceutical corporation Gilead Sciences (Nasdaq: GILD) for the oral hepatitis C medicine velpatasvir. 20 June 2018
Less than a week after setting up two new companies with a $35 million investment, life sciences trust Syncona is making more waves in gene therapy by contributing £85 million ($112 million) to Freeline Therapeutics' Series B funding campaign. 20 June 2018
US biotech major Amgen yesterday announced that the European Commission (EC) has granted a full marketing authorization for Blincyto (blinatumomab) based on the overall survival (OS) data from the Phase III TOWER study. 20 June 2018
Israel-based Galmed Pharmaceuticals has priced its previously announced underwritten public offering of 5,000,000 ordinary shares, at a public offering price of $15.00 per share. 20 June 2018
Sarepta Therapeutics saw its share price rocket following positive trial results for its lead gene therapy, targeting Duchenne muscular dystrophy (DMD). 19 June 2018
PTC Therapeutics saw its share price rise sharply over the weekend, following the revealing of encouraging data regarding the company's spinal muscular atrophy (SMA) treatment risdiplam. 19 June 2018
Novo Nordisk has announced a collaboration with Kallyope, a privately-held New York biotechnology platform developer, with the aim of developing novel therapies for diabetes and obesity. 19 June 2018