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
TG Therapeutics has announced the completion of the rolling submission of a New Drug Application (NDA) to the US Food and Drug Administration requesting accelerated approval for umbralisib as a treatment for patients with previously-treated marginal zone lymphoma (MZL) and follicular lymphoma (FL). 18 June 2020
Californian company Ideaya Biosciences has agreed a strategic partnership with UK pharma major GlaxoSmithKline in synthetic lethality, an emerging field in oncology. 17 June 2020
US clinical-stage immunotherapy firm PDS Biotechnology saw its shares soar 12% pre-market today, after announcing a co-development agreement with Brazil-based Farmacore Biotechnology for Versamune CoV-2FC, a Versamune -based vaccine aimed at preventing COVID-19 infection. 17 June 2020
Latest research findings show Emgality (galcanezumab-gnlm), which received regulatory approval in the USA and Europe in 2018, reduces total pain burden in a recent analysis of patients with episodic and chronic migraine. 17 June 2020
The US Food and Drug Administration granted accelerated approval for an additional indication for Keytruda (pembrolizumab), Merck & Co’s best-selling drug with 2019 sales of $11.08 billion, and already approved for a number of cancer indications. 17 June 2020
Cosentyx (secukinumab), the only fully-human biologic directly targeting IL-17A, has picked up a new approval for a fourth indication in the USA. 17 June 2020
Eli Lilly yesterday announced that Verzenio (abemaciclib) in combination with standard adjuvant endocrine therapy (ET) has met the primary endpoint of invasive disease-free survival (IDFS), significantly decreasing the risk of breast cancer recurrence or death compared to standard adjuvant ET alone. 17 June 2020
The first ever therapy for active and adult-onset Still’s disease (AOSD) has been approved in the USA, providing hope for people with the rare autoinflammatory condition. 17 June 2020
London-listed biotech firm PureTech Health’s founded entity, Akili Interactive, has gained US Food and Drug Administration clearance for EndeavorRx (AKL-T01) as a prescription treatment for children with attention-deficit/hyperactivity disorder (ADHD). 16 June 2020
US RNA (mRNA) therapeutics and vaccines specialist Moderna today announced that Ray Jordan has joined the firm as chief corporate affairs officer, effective Monday, June 15, 2020. 16 June 2020
Detailed data for bimekizumab show strong efficacy in psoriasis, raising the prospect that UCB’s dual IL-17 blocker could make a bigger splash in the market than had been expected. 16 June 2020
The US Food and Drug Administration (FDA) has approved Zepzelca (lurbinectedin) to treat metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy. 16 June 2020
Having risen a percentage point rise in earlier trading, Japanese drugmaker Kyowa Kirin’s shares closed down almost 2% at 2,725 yen, despite announcing the roll-out of its rare blood cancer diseases drug Poteligeo (mogamulizumab) in Europe. 15 June 2020
UK drugmaker AstraZeneca has announced progress lining up manufacturing capacity in Europe for its investigational COVID-19 vaccine, AZD1222. 15 June 2020
Janssen has announced new long-term plaque psoriasis data for Tremfya (guselkumab), a first-in-class treatment showing consistent, high levels of skin clearance at week 100 and week 204 (four years) in adult patients with moderate to severe plaque psoriasis. 15 June 2020
UK health technology assessor the National Institute for Health and Care Excellence (NICE) has granted a positive final appraisal document (FAD) for the use of Rozlytrek (entrectinib) in adults with ROS1-positive non-small cell lung cancer (NSCLC) not previously treated with ROS1 inhibitors. 15 June 2020
The US Food and Drug Administration on Thursday approved Uplizna (inebilizumab-cdon) injection for intravenous use for the treatment of neuromyelitis optica spectrum disorder (NMOSD), also called Sjögren’s syndrome, in adult patients with a particular antibody (patients who are anti-aquaporin-4 or AQP4 antibody positive). 12 June 2020