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
China-based biotech start-up I-Mab Biopharma today announces that it has entered into a memorandum of understanding (MoU) with Hong Kong-based Bio-Cancer Treatment International (BCT) to jointly explore and investigate new therapeutic potentials for BCT's arginine depletion therapy in autoimmune diseases and cancers. 1 February 2019
Danish biotech Genmabrevealed on Thursday that the patent infringement lawsuit launched by Germany-based MorphoSys relating to Darzalex (daratumumab) is finally over. 1 February 2019
Novartis’ CAR-T therapy Kymriah (tisagenlecleucel) has been approved by the UK’s cost-effectiveness watchdog the National Institute for Health and Care Excellence (NICE) for diffuse large B-cell lymphoma (DLBCL). 1 February 2019
Group sales climbed 7% to 56.8 billion Swiss francs ($57.2 billion) in full-year 2018, Swiss pharma giant Roche announced this morning. 31 January 2019
A report from industry analyst GlobalData suggests that AbbVie’s strong immunology pipeline will protect its grip on the plaque psoriasis and rheumatoid arthritis markets, while the workhorse Humira (adalimumab) loses ground to competition in Europe. 30 January 2019
Describing it as “an incomplete and poorly conceived report from the controversial Institute for Clinical and Economic Review,” the Institute for Patient Access (IfPA) says the ICER has set its sights on a most unbecoming target: infants with a degenerative, life-threatening neurological condition. 30 January 2019
US pharma majors Pfizer and Eli Lilly yesterday announced positive top-line results from a Phase III study evaluating tanezumab 2.5mg or 5mg in patients with moderate-to-severe osteoarthritis (OA) pain. 30 January 2019
Neurocrine Biosciences has entered a strategic collaboration focused on the development and commercialization of Voyager Therapeutics’ gene therapy programs. 30 January 2019
Shares of US biotech major Amgen dipped 2.43% to $187.45 in after-hours trading yesterday, when the company released its financial results for 2018. 30 January 2019
Shares in Japan’s SanBio are down a quarter after the firm announced that a US-based Phase IIb study of the investigational cell and gene therapy candidate SB623 has flopped. 30 January 2019
US biotech Biogen today posted full-year and fourth-quarter financial results for 2018. Full year total revenues were $13.5 billion, a 10% increase versus the prior year. 29 January 2019
Canada-based Triphase Accelerator, together with its majority shareholder FACIT, today announced a new strategic collaboration with US biotech major Celgene for a first-in-class preclinical therapeutic targeting the WDR5 protein for the treatment of blood cancers including leukemia. 29 January 2019
US drugmaker Alexion Pharmaceuticals announced that the Phase III study of Ultomiris (ravulizumab-cwvz), the company’s long-acting C5 complement inhibitor, met its primary objective in complement inhibitor-naïve patients with atypical hemolytic uremic syndrome (aHUS). 29 January 2019
Imbruvica (ibrutinib) clocked up a third US Food and Drug Administration (FDA) approval in first-line chronic lymphocytic leukemia (CLL) on Monday, this time in combination with Gazyva (obinutuzumab). 28 January 2019
Results from a pooled analysis of four Phase III clinical trials demonstrating patients with moderate-to-severe plaque psoriasis (PsO) treated with Cosentyx (secukinumab) 300mg reported improvements in mobility, self-care, and usual activities components of the EQ-5D-3L questionnaire as early as Week 4 when compared to placebo in patients who reported problems at baseline. 28 January 2019
The Australian government said on Friday that it will make two new medicines for the treatment of the skin condition psoriasis more affordable, saving patients up to A$32,600 ($23.453) per year. 28 January 2019
The migraine market has seen a game-change with the approvals and launches of a new and much-anticipated class of therapy, calcitonin gene-related peptide (CGRP) inhibitors. 28 January 2019