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
On Friday, the US Food and Drug Administration (FDA) announced its final decision to withdraw the marketing authorization of Swedish biotech Oncopeptides’ Pepaxto (melphalan flufenamide). 24 February 2024
South Korean vaccine developer SK bioscience revealed on Friday that it has obtained prequalification (PQ) certification from the World Health Organization (WHO) for its typhoid conjugate vaccine (TCV), SKYTyphoid (project name NBP618). 24 February 2024
The European Medicines Agency’s (EMA) human medicines committee (CHMP) recommended seven novel medicines and one biosimilar for approval at its February 2024 meeting. 23 February 2024
Japan’s largest drugmaker Takeda decided to discontinue the development programs of its four oncology assets - Phase III asset modakafusp alfa (TAK-573) and three Phase I chimeric antigen receptor (CAR-T) assets: TAK-102, TAK-103 and TAK-940 - as part of a plan to align its focus on advancing allogeneic cell therapies. 23 February 2024
Ophthalmology company Ocular Therapeutix has named what it describes as a ‘retina dream team’ alongside its announcement of a $325 million financing. 23 February 2024
US pharma major AbbVie revealed yesterday that it has linked up with San Diago, USA-based start-up Tentarix Biotherapeutics on the discovery and development of conditionally-active, multi-specific biologic candidates in oncology and immunology. 23 February 2024
US protein-based vaccine developer Novavax and Gavi, the Vaccine Alliance (Gavi) today announced they have reached a settlement related to the 2021 Advance Purchase Agreement (APA) for Novavax's prototype COVID-19 vaccine (NVX-CoV2373). 23 February 2024
Privately-held immuno-oncology company Immune-Onc Therapeutics has announced a Phase Ib/II trial collaboration with Swiss pharma giant Roche. 22 February 2024
US biotech Rigel Pharmaceuticals today announced that it has entered into a definitive agreement to acquire the US rights to cancer drug Gavreto (pralsetinib) from Blueprint Medicines 22 February 2024
USA-based biotech Emergent BioSolutions has appointed Joseph Papa as president and chief executive (CEO), effective February 21, 2024. 22 February 2024
As sales for Daiichi Sankyo and AstraZeneca’s HER2+-targeting antibody-drug conjugate (ADC) Enhertu (trastuzumab deruxtecan) continue to skyrocket, the companies are poised for yet another anticipated ADC blockbuster with DS-1062, or datopotamab deruxtecan. 22 February 2024
UK health technology assessor the National Institute for Health and Care Excellence (NICE) has published Final Draft Guidance which recommends US pharma giant Pfizer’s Litfulo (ritlecitinib). 22 February 2024
Shares of US clinical-stage biotech Coya Therapeutics leapt almost 10% to $8.82 in morning trading, after releasing a letter to stockholders from its chief executive and chairman, Dr Howard Berman. 21 February 2024
The US Food and Drug Administration (FDA) has accepted for Priority Review the Biologics License Application (BLA) submitted by US biotech Regeneron. 21 February 2024
PolTREG, a Polish biotech developing cell therapies for autoimmune diseases, has named Daniel Shelly its chief business development officer. 21 February 2024
The US Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for Tecvayli (teclistamab-cqyv) for a reduced dosing frequency of 1.5 mg/kg every two weeks in relapsed or refractory multiple myeloma (RRMM) patients who have achieved and maintained a complete response or better for a minimum of six months. 21 February 2024