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
The UK's National Institute for Health and Care Excellence (NICE) has recommended Omvoh (mirikizumab) for the treatment of eligible adults in England and Wales with moderately to severely active ulcerative colitis. 22 September 2023
US biotech Seagen and Japanese partner Astellas Pharma today announced positive top-line results from the much awaited Phase III EV-302 clinical trial (also known as KEYNOTE-A39). 22 September 2023
The National Institute for Health and Care Excellence (NICE) has recommended Darzalex (daratumumab) alongside lenalidomide and dexamethasone (DLd) for untreated multiple myeloma (MM) for routine use in England and Wales. 22 September 2023
Australian allogenic cellular medicines developer Mesoblast closed down 3.4% at A$1.265 yesterday, after it provided an update on the path to approval for its lead-product candidate Ryoncil. 22 September 2023
The US Court of Appeals for the Federal Circuit has quashed an appeal from the Takeda unit Baxalta in relation to Roche’s hemophilia treatment Hemlibra (emicizumab). 22 September 2023
It may feel like groundhog day for the beleaguered backers of a novel drug-device product developed by biotech unicorn Intarcia Therapeutics. 22 September 2023
California, USA-based clinical-stage biopharmaceutical company 89bioe edged up 2% to $15.37 in morning trading, after it revealed that the US Food and Drug Administration (FDA) granted Breakthrough Therapy designation (BTD) to pegozafermin in patients with non-alcoholic steatohepatitis (NASH). 21 September 2023
A new collaboration will see Californian biotech Kezar Life Sciences and China’s Everest Medicines working together on an immunoproteasome blocker, zetomipzomib. 21 September 2023
Cambridge, UK-based biotech Maxion Therapeutics has announced the appointment of senior industry leader Eva-Lotta Allan as chairwoman of its board of directors. 21 September 2023
UK-based Oxford Biomedica, a contract development and manufacturing organization (CDMO), is in talks to buy ABL Europe from family-owned French holding company Institut Mérieux in an all-share transaction. 21 September 2023
Precision medicine specialist Rezo Therapeutics has appointed Nadir Mahmood as chief executive officer, replacing co-founder Nevan Krogan, who has held the role on an interim basis. 20 September 2023
According to a statement from China’s National Health Commission (NHC), mpox will now be treated under a higher level of threat protocol, after hundreds of new cases were detected in the country. 20 September 2023
The past year has been one of ups and downs for Blueprint Medicines Corporation, a US precision medicines company developing therapies for people with cancer and blood disorders. 20 September 2023
Japanese biopharma firm PeptiDream saw its share rise almost 5% to 1,714 yen, after it revealed a potentially lucrative licensing deal with US biotech Genentech. 20 September 2023
Gene therapy company Orchard Therapeutics has announced that the US Food and Drug Administration (FDA) has accepted the filing of its Biologics License Application (BLA) for OTL-200 in metachromatic leukodystrophy (MLD) under Priority Review. 20 September 2023
Belgian drugmaker UCB is not expecting a decision from the US Food and Drug Administration (FDA) any time soon on its Biologics License Application (BLA) for Bimzelx (bimekizumab) for the treatment of adults with moderate to severe plaque psoriasis. 20 September 2023
The UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) has granted marketing authorization for Adtralza (tralokinumab) in a new pre-filled pen, developed by privately-held Danish dermatology specialist LEO Pharma. 20 September 2023