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
Today, Swiss pharma giant Novartis (NOVN: VX) announced results from the Phase III RATIONALE 306 trial showing tislelizumab plus chemotherapy significantly improved overall survival (OS) as a first-line treatment for adult patients with unresectable, locally advanced or metastatic esophageal squamous cell carcinoma (ESCC), regardless of PD-L1 status. 30 June 2022
Chicago-based ARCH Venture Partners has announced the closing of a $2.975 billion fund to invest in the creation, development and funding of early-stage biotech companies. 30 June 2022
US pharma giant Pfizer and German partner BioNTech announced a new vaccine supply agreement with the US government to support the continued fight against COVID-19. 30 June 2022
Privately-held US biotech Generian Pharmaceuticals has entered into a collaboration and exclusive license agreement with Japanese drug major Astellas Pharma’s Mitobridge unit, to discover and develop novel small molecules for undruggable therapeutic targets by using a proprietary drug discovery platform for diseases that have limited treatment options. 29 June 2022
UK health technology assessor the National Institute for Health and Care Excellence (NICE) has issued a Final Appraisal Document recommending Rinvoq (upadacitinib), from US drugmaker AbbVie, as a treatment of moderate to severe atopic dermatitis (AD) for adults and young people aged 12 and over. 29 June 2022
Coronavirus vaccine developers have been busy updating their jabs in time for cold weather booster campaigns, but a panel of US Food and Drug Administration scientists has just thrown a wrench into the works. 29 June 2022
NewAmsterdam Pharma, a Dutch clinical-stage company focused on the research and development of transformative therapies for cardio-metabolic diseases, and privately-held Italian Menarini Group have announced an exclusive license agreement for the commercialization of obicetrapib. 29 June 2022
MiroBio, which is developing checkpoint agonists to treat autoimmune diseases, today announced the completion of a $97million (£80 million) Series B financing led by Medicxi. 29 June 2022
Switzerland-based Roivant Sciences, which has a long history of creating new companies, has now unveiled Priovant Therapeutics, this time in collaboration with US pharma giant Pfizer, dedicated to developing and commercializing novel therapies for autoimmune diseases with the greatest morbidity and mortality. 28 June 2022
Japanese pharma major Astellas Pharma today announced a worldwide, strategic collaboration and licensing agreement with USA-based drug developer Sutro Biopharma, focused on the discovery and development of novel immunostimulatory antibody-drug conjugates (iADCs). 28 June 2022
The European Commission (EC) has approved Sanofi’s Xenpozyme (olipudase alfa) as the first and only enzyme replacement therapy to treat non-central nervous system (CNS) manifestations of acid sphingomyelinase deficiency (ASMD) in pediatric and adult patients with ASMD type A/B or ASMD type B. 28 June 2022
The US Food and Drug Administration (FDA) has placed a partial clinical hold on US biotech firm Nuvation Bio’s Phase I dose escalation study of NUV-422 in solid tumors, including high grade glioma, HR+/HER2- advanced breast cancer and metastatic castration resistant prostate cancer. 28 June 2022
The European Commission (EC) has approved its CAR-T cell therapy Yescarta (axicabtagene ciloleucel) for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) after three or more lines of systemic therapy. 28 June 2022
Japanese drugmaker Ono Pharmaceutical and US biotech Fate Therapeutics have boosted their collaboration, adding the discovery of CAR-NK cell therapies to an existing agreement. 28 June 2022
The European Commission has granted marketing authorization for Nexviadyme (avalglucosidase alfa), an enzyme replacement therapy (ERT) for the long-term treatment of both late-onset and infantile-onset Pompe disease, a rare, progressive and debilitating muscle disorder, from French pharma major Sanofi. 28 June 2022
Shares of Swiss biotech Basilea Pharmaceutica gained more than 3% to 38.45 francs yesterday, after it announced an update on the progress made in the implementation of its strategic focus on anti-infectives. 28 June 2022
The US Food and Drug Administration (FDA) has placed a clinical hold on the FORTIS PhI/II trial following a serious adverse event (SAE) of peripheral sensory neuropathy in one of the trial participants. 27 June 2022