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
Shares in Apellis Pharmaceuticals soared 30.2% to close at $40.04 yesterday after it provided more information regarding the safety of its eye disease product. 24 August 2023
Less than six months after raising $100 million in a Series A financing, neuromedicines company Rapport Therapeutics has added another $150 million to its coffers. 24 August 2023
Swedish contract development and manufacturing organization (CDMO) NorthX Biologics has appointed Janet Hoogstraate as its new chief executive. 24 August 2023
Swiss cancer giant Roche has been forced to put out a statement addressing an “inadvertent” release of data related to its highly-anticipated anti-TIGIT candidate tiragolumab. 24 August 2023
Seattle, USA-based Alpine Immune Sciences, an immunotherapy company developing innovative treatments for autoimmune and inflammatory diseases, has named Christina Yi its new chief technology officer. 24 August 2023
Japanese mid-size drugmaker Kyowa Kirin says it has received approval from the Ministry of Health, Labor and Welfare (MHLW) for partial change of approved indication of Lumicef (brodalumab [genetical recombination]) for the treatment of palmoplantar pustulosis (PPP) that respond inadequately to existing therapies. 24 August 2023
In the latest reminder about the lingering presence of COVID-19, the US Department of Health and Human Services (HHS) has awarded more than $1.4 billion for Project NextGen to support the development of new tools and technologies to protect against the virus. 23 August 2023
The US Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) will review data supporting Amgen’s supplemental New Drug Application (sNDA) for the full approval of Lumakras (sotorasib). 23 August 2023
August is Spinal Muscular Atrophy (SMA) Awareness Month – an opportune time to explore pharmacological advances in the treatment of this autosomal-recessive, progressive neuromuscular disease.1 23 August 2023
While Geron had hoped for a Priority Review for its rare blood cancer candidate imetelstat, the US regulator has confirmed a standard review will now take place, with a decision due by mid-June next year. 23 August 2023
Oxford, UK-based techbio innovator Etcembly is coming out of stealth mode, kickstarting the next generation of immunotherapies with a pipeline of best-in-class T cell receptor (TCR) therapeutics designed using generative AI. 23 August 2023
US pharma giant Pfizer’s Abrysvo has won US approval for use in pregnant women to prevent lower respiratory tract disease (LRTD) and severe LRTD caused by respiratory syncytial virus (RSV) in infants from birth through six months of age. 22 August 2023
The European Commission (EC) has granted conditional marketing authorization (CMA) of Talvey (talquetamab), developed by Janssen Pharmaceuticals. 22 August 2023
California-based Genesis Therapeutics, a company seeking to use artificial intelligence (AI) to create medicines, has closed an oversubscribed $200 million round of Series B financing. 22 August 2023
US mRNA specialist Moderna saw its shares close up 9.3% at $111.08 on Monday after the announcement of a collaboration agreement to investigate Shanghai, China-based CARsgen Therapeutics’ investigational Claudin18.2 CAR T-cell product candidate (CT041) in combination with Moderna’s investigational Claudin18.2 mRNA cancer vaccine. 22 August 2023