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
Swedish biotech Lokon Pharma, currently developing LOAd703, a potent double-armed (TMZ-CD40L/4-1BBL) oncolytic adenovirus for solid tumors, has announced a collaboration with Swiss pharma giant, Roche. 3 July 2019
The total spinal muscular atrophy (SMA) market was estimated to be worth $1.5 billion across the seven major markets (7MM: the USA, France, Germany, Italy, Spain, UK and Japan) in 2018. 3 July 2019
Belgium’s Confo Therapeutics has signed a drug discovery deal with Dresden, Germany-based DyNAbind, focused on an undisclosed G-protein coupled receptor (GPCR). 3 July 2019
US biotech Amicus Therapeutics has entered into a strategic manufacturing agreement with Paragon Gene Therapy, a unit of Catalent Biologics. 2 July 2019
US biotech Incyte and China and USA-based Zai Lab have entered into a collaboration and license agreement for the development and commercialization of INCMGA0012, an investigational anti-PD-1 monoclonal antibody, in Greater China. 2 July 2019
Nicox has entered into an exclusive license agreement with China’s Ocumension Therapeutics for the development and commercialization of Nicox’ product candidate, NCX 4251. 2 July 2019
Israel’s leading drugmaker Teva Pharmaceutical has presented data from exploratory endpoints from the Phase IIIb FOCUS trial of Ajovy (fremanezumab), at the annual congress of the European Academy of Neurology (EAN). 2 July 2019
National Health Service patients in the UK will be the first to gain access in Europe to new skin cancer treatment, Libtayo (cemiplimab), through the Cancer Drugs Fund (CDF), it was revealed today, just a day after the drug won conditional regulatory approval from the European Commission. 2 July 2019
The precision medicine hypothesis that the genetics of a patient’s cancer will determine their response to a treatment has been thrown into doubt by new research by the UK’s Institute of Cancer Research (ICR). 1 July 2019
Libtayo (cemiplimab) has been granted conditional approval for the treatment of certain adults with metastatic or locally advanced cutaneous squamous cell carcinoma (CSCC), one of the most commonly diagnosed skin cancers worldwide. 1 July 2019
Germany’s Boehringer Ingelheim today announced a collaboration and license agreement for the development of a first-in-class dual agonist for the treatment of non-alcoholic steatohepatitis (NASH) and related liver diseases that combines GLP-1 and FGF21 activity in one molecule. 1 July 2019
Novartis has grabbed many of the recent headlines in the field of spinal muscular atrophy (SMA), a leading genetic cause of infant mortality. 1 July 2019
Opthalmology specialist Ocular Therapeutix has launched its lead product in the USA for the treatment of ocular inflammation and pain following ophthalmic surgery. 1 July 2019
Sun Pharmaceutical Industries has entered into a licensing agreement with a subsidiary of China Medical System Holdings (CMS) for the development and commercialization of tildrakizumab in Greater China. 1 July 2019
Despite competition in the anti-CGRP migraine therapy space, Swiss pharma giant Novartis’ Aimovig (erenumab) has become the most-prescribed in the since its launch last year. 1 July 2019
French nanomedicine company Nanobiotix today announced organizational changes to align with strategic priorities post European market approval for Hensify (NBTXR3), which was cleared for marketing in April. 1 July 2019
Privately-held Danish vaccines specialist AJ Vaccines has won approval in Denmark for its adjuvanted IPV vaccine, after positive results from clinical trials involving almost 3,000 infants. 28 June 2019
Danish drugmaker Genmab has won US approval for Darzalex (daratumumab), in combination with lenalidomide and dexamethasone (Rd) to treat people with multiple myeloma who are ineligible for autologous stem cell transplant (ASCT). 28 June 2019