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
Imperial Innovations Group portfolio company Crescendo Biologics says that it has achieved another technical milestone in its collaboration with a Japanese pharma major. 16 August 2018
Australia’s biggest biotech, CSL Limited, has announced a net profit after tax of $1.73 billion for the year ending June 30, an impressive 29% rise on the previous 12 months. 15 August 2018
UK biopharma firm PureTech Health has announced the appointment of Dr Steven Paul, as chief executive of its affiliate, Karuna Pharmaceuticals. 15 August 2018
Shares in SalvaRx Group soared as much as 40.65 pence to 85.25 pence on Tuesday after the company said it has entered into a sale agreement for the disposal of its 94.2% stake in SalvaRx Limited to Canada-based Portage Biotech. 15 August 2018
The cost regulator for England and Wales has not recommending paying for Biogen’s Spinraza (nusinersen) on the National Health Service (NHS) in draft guidance published on Tuesday. 15 August 2018
USA-based Mustang Bio has entered into a partnership and exclusive license deal with St Jude Children’s Research Hospital for the development of a first-in-class ex vivo lentiviral gene therapy for children with X-linked severe combined immunodeficiency (X-SCID), or bubble boy disease. 15 August 2018
A trial failure for the UK-based biopharmaceutical firm Realm Therapeutics (LSE: RLM) has led to its share price dropping to less than half of the level that it started the week at. 15 August 2018
Following the resignation of Dr Andrew Cheng, chief medical officer of US biotech major Gilead Sciences, the company has announced two promotions. 15 August 2018
Paragon Biosciences’ portfolio company Emalex Biosciences has acquired fellow USA-based Psyadon Pharmaceuticals, a biopharmaceutical company dedicated to the development of new treatments for rare and orphan neurological conditions. 14 August 2018
Vienna, Austria-based biotech firm Haplogen has entered into a multi-year drug discovery and development collaboration with German pharma major Bayer to identify new therapeutics with applications in pulmonary diseases such as chronic obstructive pulmonary disease (COPD). 14 August 2018
Shares in rare disease specialist Amicus Therapeutics unsurprisingly closed up on Friday following the approval of its Fabry disease drug Galafold (migalastat), but it was a different story on Monday. 14 August 2018
An established allergy drug has now been granted Breakthrough Therapy designation (BTD), aimed at expediting the development and approval process, by the US Food and Drug Administration in the food allergy space. 14 August 2018
News of challenges to US biotech giant Gilead Sciences’ intellectual property in overseas markets is commonplace, with the company conceding patents relating to its hepatitis C drugs in China this week. 14 August 2018
The USA-based non-profit campaigner on patents, I-MAK, has claimed a significant victory in its bid to bring hepatitis C treatments that were previously protected by patents to the world’s largest patient population. 14 August 2018
Namir Hassan has been named chief scientific officer of Zelluna Immunotherapy, a privately-held Norwegian biotech specializing in T-cell receptor (TCR) immunotherapies. 13 August 2018
Due to ongoing labeling discussions, the US Food and Drug Administration has issued a complete response letter (CRL) regarding the supplemental Biologics License Application (sBLA) for Eylea (aflibercept) Injection in patients with wet age-related macular degeneration (wet AMD). 13 August 2018
Accelerator Life Science Partners and the University of Texas MD Anderson Cancer Center have announced the launch of Magnolia Neurosciences, a drug discovery and development company focused on creating a novel class of neurological therapies. 13 August 2018
There has been a steady drumbeat of failure in the race to develop a third-generation EGFR inhibitor to compete with Tagrisso (osimertinib) from AstraZeneca in an around $5 billion market. 13 August 2018
The US Food and Drug Administration has approved Onpattro (patisiran) lipid complex injection, a first-of-its-kind RNA interference (RNAi) therapeutic, for the treatment of the polyneuropathy of hereditary transthyretin-mediated (hATTR) amyloidosis in adults. 11 August 2018
The US Food and Drug Administration on Friday granted accelerated approval for Galafold (migalastat), the first oral medication for the treatment of adults with Fabry disease. 11 August 2018