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
Shares of Canadian immuno-oncology drug developer Trillium Therapeutics skyrocketed 193% to $17.8 pre-market today, after it was revealed that its board has accepted a takeover bid from US pharma giant Pfizer. 23 August 2021
The US Food and Drug Administration (FDA) has approved Opdivo (nivolumab) 240mg every two weeks or 480 mg every four weeks for the adjuvant treatment of urothelial carcinoma (UC) patients at high risk of recurrence after radical resection, regardless of prior neoadjuvant chemotherapy, nodal involvement or PD-L1 status. 23 August 2021
Positive 12-week results from the Phase III ADVANCE trial evaluating atogepant for the preventive treatment of migraine in adults who meet criteria for episodic migraine have been published in the prestigious New England Journal of Medicine (NEJM). 21 August 2021
AstraZeneca has announced positive top-line results from a key Phase III trial of its injectable antibody therapy for COVID-19, AZD7442. 21 August 2021
Months after the USA granted approval to Roche and Regneron’s antibody cocktail for COVID-19 disease, the UK’s medicines regulator has followed suit. 21 August 2021
UK-based flu specialist Seqirus, a business unit of Australia’s CSL Limited, today announced plans to accelerate the development of its next generation of messenger RNA (mRNA) vaccine technology, self-amplifying messenger RNA (sa-mRNA), with the creation of a dedicated sa-mRNA program and senior leadership appointment. 20 August 2021
Australia’s Therapeutic Goods Administration (TGA) today granted provisional approval to the local subsidiary of UK pharma major GlaxoSmithKline for its COVID-19 treatment - sotrovimab (trade name Xevudy) - making it the second COVID-19 treatment to receive regulatory approval in Australia. 20 August 2021
Gilead Sciences has announced that the company’s Marketing Authorization Application (MAA) for lenacapavir, a long-acting HIV-1 capsid inhibitor, has been fully validated and is now being evaluated by the European Medicines Agency (EMA). 20 August 2021
US drugmaker Alexion Pharmaceuticals revealed today that it is discontinuing CHAMPION-ALS, the global Phase III clinical trial of Ultomiris (ravulizumab) in adults with amyotrophic lateral sclerosis (ALS). 20 August 2021
Comirnaty, the COVID-19 vaccine from Pfizer and BioNTech, is 86% effective in preventing infection among those aged 60 and older after a third dose, according to an Israeli study. 19 August 2021
Adding to US regulatory clearance in March this year, US pharma major Bristol Myers Squibb has now won conditional approval for its a first-in-class B-cell maturation antigen (BCMA)-directed chimeric antigen receptor (CAR) T cell immunotherapy Abecma (idecabtagene vicleucel; ide-cel) from the European Commission. 19 August 2021
Research from industry analyst GlobalData shows that domestic drug developers in China are leading the way in CAR-T cell therapy trials, with 337 company-sponsored studies underway. 19 August 2021
Shares of China-headquartered Adagene were down 3.9% at $17.10 in early trading, despite the company today announcing that it has entered into a third clinical trial collaboration and supply agreement with US pharma giant Merck & Co 19 August 2021
While people in many parts of the world wait in the hope of receiving their first shot of a COVID-19 vaccine, Americans are to be offered their third dose in an attempt to boost immunity to the virus. 19 August 2021
US clinical-stage biotech AzurRx BioPharma saw its shares rocket almost 32% to $0.69 yesterday, after it reported some positive mid-stage trials results for its cystic fibrosis candidate MS1819. 19 August 2021
Privately-held Irish-American company Shorla Pharma has announced a partnership with Eversana to support the launch and commercialization of its oncology portfolio. 18 August 2021
The China National Medical Products Administration (NMPA) has granted Qarziba (dinutuximab beta) conditional approval for the treatment of high-risk neuroblastoma in patients aged 12 months and above, said the drug’s developers, UK-based EUSA Pharma and China’s BeiGene, whose shares rose 1.8% to $286.64 on the news. 18 August 2021
US biotech Qualigen Therapeutic' shares tumbled more than 22% to $1.30 yesterday, after it announced its intention to prioritize its focus to its oncology pipeline that includes QN-247 and RAS-F. 18 August 2021