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
A report has predicted a significant growth in the Pompe disease market size due to growing general physician awareness and improvement in diagnosis models, according to GlobalData, a leading data and analytics company. 14 December 2018
Swiss cell and gene therapy specialist Axovant Sciences has licensed exclusive worldwide rights for the development and commercialization of two novel gene therapy programs to address GM1 gangliosidosis and GM2 gangliosidosis (also known as Tay-Sachs and Sandhoff diseases) from the University of Massachusetts (UMass) Medical School. 14 December 2018
AstraZeneca and its global biologics research and development arm MedImmune, have presented overall survival (OS) and progression-free survival (PFS) data from the Phase III MYSTIC trial at the European Society for Medical Oncology (ESMO) Immuno-Oncology 2018 Congress in Geneva, Switzerland. 14 December 2018
Shares in Applied Genetic Technologies plummeted almost 50% on Thursday, after the firm revealed biotech major Biogen was tearing up a 2015 deal that could have been worth a billion dollars. 14 December 2018
Having taken an exclusive option to acquire US biotech firm Potenza Therapeutics back in 2015, as part of a research collaboration, Japanese pharma major Astellas Pharma yesterday closed the transaction. 14 December 2018
CTI BioPharma saw its shares fall 7.77% to $1.36 yesterday, after it announced a restructuring plan to improve efficiencies and reduce costs within the organization. 14 December 2018
UK and USA-based clinical-stage biotech Orchard Therapeutics has signed a long-term lease agreement to build-out a gene therapy manufacturing facility in Fremont, California. 13 December 2018
GenSight Biologics has seen its share price nearly triple since late October as expectations rise on its lead product candidate, and the company kept the good data coming with a presentation on Wednesday. 13 December 2018
Johnson & Johnson has announced positive data from the Phase III ECLIPSE study showing that Tremfya (guselkumab) was superior to Novartis’ Cosentyx (secukinumab) in moderate to severe plaque psoriasis. 13 December 2018
US pharma giant Merck & Co and Instituto Butantan, Sao Paulo, Brazil, a non-profit producer of immunobiologic products for Brazil have entered into a collaboration agreement to develop vaccines to protect against dengue virus disease, the mosquito-borne infection. 13 December 2018
The European Commission (EC) has approved Xolair (omalizumab) prefilled syringe (PFS) for self-administration, allowing patients with severe allergic asthma (SAA) and chronic spontaneous urticaria (CSU) to administer their own treatment. 13 December 2018
Japanese biotech firm Sosei Group today announced that its board of directors, at a meeting held on December 11, 2018, approved a change in its president and chief executive (CEO). 12 December 2018
UK biotech firm Circassia Pharmaceuticals today announced that it is exercising its option to acquire the full US commercial rights to Tudorza (aclidinium) from AstraZeneca. 11 December 2018
Astellas Pharma today announced that Xospata (gilteritinib) is now available for prescription in the USA for the treatment of adult patients who have relapsed or refractory (resistant to treatment) acute myeloid leukemia (AML) with a FLT3 mutation as detected by a Food and Drug Administration-approved test. 11 December 2018
Australia has become the first country anywhere to grant regulatory approval to a cancer drug originally found in a marine microorganism. 11 December 2018
USA-based HiFiBiO Therapeutics has today announced the formation of Victa Biotherapeutics, a joint venture with Vikas Sukhatme, Robert W Woodruff Professor of Medicine and Dean of Emory University School of Medicine. 11 December 2018
Chinese biotech firm HitGen has entered into a drug discovery research collaboration with Japanese drugmaker Mitsubishi Tanabe Pharma to identify novel small molecule leads for targets of interest. 11 December 2018
A trial of a treatment for REM sleep behavior disorder failed to meet its main goal, said Switzerland-based biotech firm Axovant Sciences. 11 December 2018
New research predicts that the atopic dermatitis market will grow from $6.4 billion in 2017 to $18.3 billion in 2027 across the seven major markets (7MM = USA, France, Germany, Italy, Spain, the UK, and Japan), expanding at a compound annual growth rate (CAGR) of 11.1%. 11 December 2018