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
South Korean firm Kolon Life Science has agreed a deal to sell cell and gene therapy Invossa (TissueGene-C) in parts of China, pending regulatory approval. 24 July 2018
Shares of UK-based Avacta Group soared nearly 58% to 45.00 pence this morning, after it revealed a major co-development partnership with a US business. 24 July 2018
In its attempts to show the effectiveness of using two drug combinations in HIV, ViiV Healthcare has added more data to its evidence base. 24 July 2018
Shares in East Coast, USA-based Biogen were up 6% just ahead of the opening bell in New York, after the firm released positive second quarter results on Tuesday. 24 July 2018
China’s BeiGene says that its investigational BTK inhibitor zanubrutinib has been granted Fast Track designation by the US Food and Drug Administration for the treatment of patients with Waldenström macroglobulinemia (WM). 24 July 2018
A new GlobalData report suggests that China, already the second-largest market in the acute ischemic stroke (AIS) market, is set to grow even further due to the aging population, giving stem cell therapies a chance to penetrate in the region. 24 July 2018
Changsheng Biotechnology is the subject of an ongoing controversy this week, after an inspection in mid-July found the company had fabricated production and inspection documents related to the production of 250,000 faulty rabies vaccines. 23 July 2018
US pharma major Eli Lilly has entered into a multi-million dollar agreement for the discovery and development of translation inhibitors for several target proteins. 22 July 2018
Swedish Orphan Biovitrium (Sobi) announced on Friday that it had reached an exclusive licensing deal with Novimmune for rights to emapalumab. 20 July 2018
Roche has entered into a multiyear collaboration with PureTech Health to advance the latter’s milk-derived exosome platform technology for the oral administration of the Swiss pharma giant’s antisense oligonucleotide platform. 20 July 2018
Kite, a Gilead Sciences subsidiary, and privately-held Dutch firm Gadeta have entered into a strategic collaboration to develop novel gamma delta T cell receptor (TCR) therapies in various cancers. 20 July 2018
It’s been a rapid journey for the biopharma industry over the last few years. We’ve seen the industry stagger to its feet – surpassing notable early setbacks caused by lack of control over hyperallergenic drugs. 20 July 2018
Bristol-Myers Squibb has entered into a clinical trial collaboration immuno-oncology firm Gritstone Oncology to evaluate the safety and tolerability of Gritstone’s personalized neoantigen immunotherapy, GRANITE-001. 19 July 2018
Swiss pharma giant Novartishas entered into an exclusive license agreement with two biotech companies – Belgo-Dutch Galapagos and Germany’s MorphoSys - regarding their atopic dermatitis compound MOR106. 19 July 2018
Swiss pharma giant Roche has been awarded a Breakthrough Therapy badge for a combination of Tecentriq (atezolizumab) and Avastin (bevacizumab) against hepatocellular carcinoma (HCC) in the first-line setting. 19 July 2018
The US Food and Drug Administration today approved Kisqali (ribociclib) in combination with an aromatase inhibitor for the treatment of pre/perimenopausal or postmenopausal women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer, as initial endocrine-based therapy. 19 July 2018
A 16-week Phase III study in patients with osteoarthritis (OA) pain evaluating subcutaneous administration of tanezumab, an investigational humanized monoclonal antibody, met all three co-primary endpoints. 19 July 2018
The Australian government will provide A$50 million (S37 million) to support some of Australia’s sickest patients, battling the most aggressive and deadliest cancers, to access potentially life-saving medical treatment, Health Minister Greg Hunt revealed today. 18 July 2018