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 deeper look at late-stage research conducted by Biogen suggests a more positive outlook for its amyotrophic lateral sclerosis (ALS) candidate tofersen. 23 September 2022
Despite trying to put a positive spin on another regulatory setback for French biopharma company DBV Technologies’ peanut allergy candidate, battered investors sent the firm’s stock down 12% to less than $2 in pre-market trading. 23 September 2022
Inventiva, which is making solid progress with its candidate for the highly challenging non-alcoholic steatohepatitis (NASH) indication, saw its shares shoot up more than 25% to 5.06 euros yesterday, after the French biotech announced a lucrative licensing deal for its drug lanifibranor in China. 23 September 2022
Shares of US pharma major Eli Lilly edged up 1.4% to $300.68 pre-market today, on the news that its RET kinase inhibitor Retevmo (selpercatinib) had received a second approval in the USA. 22 September 2022
Investors are jittery after the sudden departure of French drugmaker Servier from a collaboration in oncology with San Francisco’s Allogene Therapeutics. 22 September 2022
Shares of US biotech Sesen Bio (Nasdaq: SESN) tumbled nearly 33% to $0.45 by close of trading yesterday, after it revealed a plan to merge with privately-held Carisma Therapeutics. 22 September 2022
Coeptis Therapeutics has raided the nearby University of Pittsburgh in the latest step towards realizing the company’s aim of disrupting conventional treatment paradigms. 21 September 2022
A drug candidate that Japan’s largest drugmaker Takeda Pharmaceutical pretty much decided to discontinue back in 2015, has now been out-licensed in a deal that could earn the firm nearly $300 million should it prove successful, albeit with a modest upfront payment. 21 September 2022
Aiming to delve further into the use of poly ADP-ribose polymerase inhibitor, German life sciences major Merck KGaA has linked up with a leading Italian oncology discovery organization. 21 September 2022
Shares in US biopharma Spectrum Pharmaceuticals dropped by a massive 37% on Tuesday while those in Swedish biotech Oncopeptides closed 25% lower. 21 September 2022
Nine months after gaining its first approval in the USA, AstraZeneca’s Tezspire (tezepelumab) has now been approved in the European Union (EU). 21 September 2022
UK health technology assessor the National Institute for Health and Care Excellence (NICE) has issued a final appraisal document (FAD) recommending Brukinsa (zanubrutinib). 21 September 2022
Driven by the launch of longer-acting anti-vascular endothelial growth factor (VEGF) therapies among other pioneering pipeline therapies, the diabetic macular edema market is expected to more than double over the next decade. 21 September 2022
Belgium’s NeuVasQ Biotechnologies, a Université Libre de Bruxelles (ULB) spin-off developing pharmaceuticals to restore blood-brain barrier function, has named Emmanuel Lacroix chief executive and company director. 20 September 2022
German biotech Evotec has been awarded a contract valued at up to $49.9 million by the US Department of Defense (DOD) for the rapid development of monoclonal antibody (MAb)-based drug product prototypes targeting plague. 20 September 2022
ViroCell Biologics, a UK contract development and manufacturing organization (CDMO), has announced the appointment of Susan Nichols to its senior management team as chief business officer (CBO). 20 September 2022