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
Citing “an abundance of caution,” Novartis has paused production of its cancer med Luthera (lutetium Lu 177 dotatate), as well as newly-approved prostate cancer therapy Pluvicto (lutetium Lu 177 vipivotide tetraxetan). 6 May 2022
Vertex Pharmaceuticals has reported product revenues of $2.1 billion for the first quarter, towards the high end of most analysts’ expectations, and a 22% increase on the same period of 2021. 6 May 2022
Just a week on from the US Food and Drug Administration (FDA) granting approval for Ultomiris (ravulizumab-cwvz) in generalized myasthenia gravis (gMG), the long-acting C5 complement inhibitor has shown its promise in another potential indication. 5 May 2022
In a striking vote of confidence from big pharma, British targeted protein degradation (TPD) specialist Amphista Therapeutics has inked two strategic collaborations with major drug developers. 5 May 2022
The antibody-drug conjugate (ADC) Enhertu (trastuzumab deruxtecan) has been approved in the USA, for the treatment of certain adults with unresectable or metastatic HER2-positive breast cancer. 5 May 2022
US vaccines specialist Novavax has applied to the Medicines and Healthcare products Regulatory Agency (MHRA) in Great Britain to expand the authorization of Nuvaxovid (NVX-CoV2373) COVID-19 Vaccine (recombinant, adjuvanted), to adolescents aged 12 through 17 years. 5 May 2022
Privately-held Dutch biotech Byondis has entered into a license and collaboration and a supply agreement with medac GmbH, a privately owned pharmaceutical company based in Germany. 5 May 2022
Swiss pharma giant Novartis says that the European Commission (EC) has approved Kymriah (tisagenlecleucel), a CAR-T cell therapy, for the treatment of adult patients with relapsed or refractory (r/r) follicular lymphoma (FL) after two or more lines of systemic therapy. 5 May 2022
COVID-19 vaccine developer Moderna has reported first quarter revenues of $6.1 billion, more than triple the $1.7 billion for the same period of 2021, handily outpacing analysts’ expectations. 4 May 2022
The atopic dermatitis (AD) market is expected to grow from a value of $6.4 billion in 2020 to $16.8 billion in 2030 in the seven major markets at a compound annual growth rate (CAGR) of 10.1%, according to GlobalData. 4 May 2022
US biotech Regeneron Pharmaceuticals today announced financial results for the first quarter of 2022, showing that total revenues increased by 17% to $2.965 billion compared to $2.529 billion in the first quarter of 2021. 4 May 2022
Tubulis, a Munich-based biotech company in the antibody drug conjugate (ADC) space, has announced the successful closing of a 60 million euros ($63 million) series B financing round. 4 May 2022
Shares of clinical-stage drug developer Kezar Life Sciences plunged more than 24% to $9.35 in after-hours trading on Tuesday as the company announced mixed top-line results from the PRESIDIO Phase II clinical trial of zetomipzomib (formerly KZR-616) in patients with dermatomyositis (DM) and polymyositis (PM). 4 May 2022
Singapore-based Juniper Biologics and privately-held Swiss drugmaker Helsinn Group have signed an exclusive license agreement to develop and commercialize infigratinib (INN) in Australia, New Zealand, Southeast Asia and certain markets in the Middle East and Africa . 4 May 2022
The sceptre of failure from the infamous Alzheimer’s drug Aduhelm (aducanumab) loomed large over the first-quarter financial results presentation of US biotech Biogen on Tuesday. 3 May 2022
The European Commission (EC) has approved the use of Cabometyx (cabozantinib) as a monotherapy for adults with locally advanced or metastatic differentiated thyroid carcinoma (DTC), refractory or not eligible to radioactive iodine who have progressed during or after prior systemic therapy. 3 May 2022
The European Commission (EC) has granted marketing authorization for Quviviq (daridorexant) for the treatment of adult patients with insomnia characterized by symptoms present for at least three months and considerable impact on daytime functioning. 3 May 2022
US biotech companies Dragonfly Therapeutics and Gilead Sciences have announced a collaboration designed to advance a number of Dragonfly's novel natural killer (NK) cell engager-based immunotherapies for oncology and inflammation indications. 3 May 2022
Coming out of stealth since its founding in 2019, US biotech Dianthus Therapeutics today announced the completion of its $100 million Series A financing led by 5AM Ventures, Avidity Partners, and Fidelity Management & Research Company. 3 May 2022