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
In just three months, Henlius’ heavily invested PD1 blockbuster Hansizhuang (serplulimab) rewarded the company with nearly 80 million renminbi ($11.6 million) since its launch in March 2022 in China to treat microsatellite instability-high (MSI-H). 27 August 2022
Delaware, USA-based Incyte has announced that the US Food and Drug Administration (FDA) has approved Pemazyre (pemigatinib), a selective fibroblast growth factor receptor (FGFR) inhibitor, to treat adults with relapsed or refractory myeloid/lymphoid neoplasms (MLNs) with FGFR1 rearrangement. 26 August 2022
Threatening to upset Pfizer’s dominance of the multi-billion dollar coronavirus vaccine market, Moderna is today starting legal action against the firm, claiming patent infringement. 26 August 2022
Finch Therapeutics yesterday announced that it will regain full development and commercial rights to FIN-524 (previously known as TAK-524) and FIN-525 from Japanese pharma major Takeda Pharmaceutical. 26 August 2022
The UK’s Medicines and Healthcare Regulatory Agency (MHRA) has approved Sunlenca (lenacapavir) injection and tablets, in combination with other antiretrovirals, in adults with multi-drug resistant HIV infection for whom it is otherwise not possible to construct a suppressive anti-viral regimen. 26 August 2022
Shares in liver and cardio-metabolic specialist 89bio were up 5% ahead of the opening bell on Friday, following positive Phase II results from the ENTRIGUE study. 26 August 2022
Nuvaxovid, the COVID-19 vaccine developed by US vaccines specialist Novavax (Nasdaq: NVAX), has today been granted an extension to its existing UK approval, for 12- to 17-year-olds. This extension has been authorized by the Medicines and Healthcare products Regulatory Agency (MHRA). 26 August 2022
Celsius Therapeutics, a privately-held biotech developing precision medicines for cancer and autoimmune disease through single-cell RNA sequencing, has named Sarah Grant its chief medical officer (CMO). 26 August 2022
Moving ahead in the race to develop a jab for respiratory syncytial virus (RSV), a market that analysts estimate will generate up to $10 billion of annual sales, yesterday US pharma giant Pfizer announced positive top-line data from the Phase III clinical trial (NCT05035212) RENOIR (RSV vaccine Efficacy study iNOlder. 26 August 2022
US biotech BioMarin Pharmaceutical yesterday announced that the European Commission (EC) has granted conditional marketing authorization (CMA) to Roctavian (valoctocogene roxaparvovec) gene therapy for the treatment of severe hemophilia A (congenital Factor VIII deficiency) in adult patients without a history of Factor VIII inhibitors and without detectable antibodies to adeno-associated virus serotype 5 (AAV5). 25 August 2022
Zelluna Immunotherapy, a Norwegian company developing allogeneic T Cell Receptor Natural Killer (TCR-NK) cells for the treatment of cancer, has announced an investment from Takeda Ventures. 25 August 2022
On August 24, the US Food and Drug Administration announced it has approved Pharmacyclics application for Imbruvica (ibrutinib) for pediatric patients ≥ 1 year of age with chronic graft versus host disease (cGVHD) after failure of 1 or more lines of systemic therapy. Formulations include capsules, tablets, and oral suspension. 25 August 2022
UK pharma major AstraZeneca this morning announced that it has received marketing approval from the Japanese Ministry of Health, Labor and Welfare (MHLW) for three of its pharmaceutical products, sending the firm’s shares edging up 1.3% to 11,497.12 pence. 25 August 2022
US healthcare giant Johnson & Johnson subsidiary Janssen today revealed that the European Commission (EC) has granted conditional marketing authorization (CMA) of Tecvayli (teclistamab) as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma (RRMM). 24 August 2022
Very young children can benefit from a high level of immunity to the novel coronavirus after receiving the Comirnaty vaccine, new research shows. 24 August 2022
Privately-held Gensaic, a company that seeks to reimagine gene therapy, announced today that it has entered into a strategic collaboration agreement with US neurological diseases specialist Ovid Therapeutics. 24 August 2022
US cancer-focused biotech Foghorn Therapeutics saw its shares plummet 25% to $11.00 by close of trading yesterday, after it announced that the US Food and Drug Administration (FDA) has placed a full clinical hold on the Phase I dose escalation study of FHD-286. 24 August 2022