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
Ionis Pharmaceuticals rallied 4% pre-market today, after is announced a new collaboration to develop IONIS-FB-LRx for the treatment of complement-mediated diseases, which could earn the company nearly $760 million. 10 October 2018
At the upcoming congress of the European Society for Medical Oncology (ESMO), Eli Lilly will present a range of new data, including on the investigational compound pegilodecakin. 10 October 2018
The National Institute for Health and Care Excellence (NICE) has issued final guidance recommending Crysvita (burosumab) within its marketing authorization, for treating X-linked hypophosphatemia (XLH) in children and young people with growing bones in England and Wales. 10 October 2018
New data showing treatment with a single intravenous (IV) dose of Stelara (ustekinumab) induces clinical remission and response in adults with moderate to severe ulcerative colitis (UC) who previously experienced an inadequate response or were intolerant to conventional or biologic therapies are being presented today at the American College of Gastroenterology (ACG) Scientific Meeting 2018. 9 October 2018
Swiss rare diseases focused biotech Therachon today announced the acquisition of Canada-based GLyPharma Therapeutic for an undisclosed amount. 9 October 2018
Results from the Phase III STYLE study show that Otezla (apremilast) 30mg twice daily achieved a highly statistically-significant improvement in the primary endpoint of the Scalp Physician’s Global Assessment (ScPGA) response [defined as ScPGA score of clear (0) or almost clear (1) with at least a 2-point reduction from baseline] at week 16 compared with placebo. 9 October 2018
Dublin-headquartered Californian firm Theravance Biopharma has announced positive new data from multiple studies of Vibativ (telavancin) at IDWeek 2018. 8 October 2018
Shares of US biotech firm Akcea Therapeutics gained 4.39% to $31.85 by close of trading and a further 2.04% to $32.50 in after-hours on Friday, after the company revealed that the US Food and Drug Administration had approved Tegsedi (inotersen) for the treatment of the polyneuropathy of hereditary transthyretin (hATTR) amyloidosis in adults. 8 October 2018
Sitryx, a new, Oxford, UK-based biopharmaceutical company focused on regulating cell metabolism to develop disease-modifying therapeutics in immuno-oncology and immuno-inflammation, today announces it has closed its Series A financing round. 8 October 2018
A month after the UK's National Health Service (NHS) agreed a deal to make Novartis’ Kymriah (axicabtagene ciloleucel) available to children and young people with a rare form of leukemia, a deal has been announced to bring another CAR-T therapy to English patients. 5 October 2018
US biotech bluebird bio has had its marketing authorization application accepted by the European Medicines Agency for its investigational LentiGlobin gene therapy for treatment of adults and adolescents with transfusion-dependent β-thalassemia (TDT) and a non-β0/β0 genotype. 5 October 2018
There was good news for Roche with the coveted wider indication for its hemophilia drug in the USA, so increasing its focus on diseases beyond cancer to help replace revenue from older products that have, or will soon, lost patent exclusivity. 5 October 2018
Belgian clinical-stage biotech firm Celyad has entered into an exclusive agreement with the UK’s Horizon Discovery for the use of its shRNA technology to generate Celyad’s second non-gene-edited allogeneic platform. 5 October 2018
Arrowhead Pharmaceuticals saw its shares surge 19% to a high of $20.31 pre-market but plunge 15.7% to $16.04 by late morning New York trading, despite announcing a licensing deal that could earn it as much as $3.7 billion. 4 October 2018
UK-based biotech firm Orchard Therapeutics has been awarded the fast track PRIME Designation from the European regulator for its investigational gene therapy OTL-300. 4 October 2018
OxStem, an Oxford University spin-out developing regenerative medicine-based therapies, is launching two subsidiary companies to develop regenerative treatments for diabetes and chronic inflammation and wound healing. 4 October 2018
In a second major deal signed this year, biotech firm HiFiBiO Therapeutics has entered into a research collaboration and license agreement with Gilead Sciences company Kite, to develop technology supporting the discovery of neoantigen-reactive T cell receptors (TCRs) for the potential treatment of various cancers, including solid tumors. 4 October 2018
The Australian government has announced that it will make a drug for severe inflammatory spinal arthritis more affordable when it is listed on the Pharmaceutical Benefits Scheme (PBS), saving patients more than A$15,000 ($10,870) a year. 4 October 2018