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
Janssen has received European Commission (EC) marketing authorization for Darzalex (daratumumab) in combination with lenalidomide and dexamethasone (DRd) for the treatment of newly diagnosed multiple myeloma patients who are ineligible for autologous stem cell transplant (ASCT). 20 November 2019
US pharma major Bristol-Myers Squibb has announced that its combination of Opdivo (nivolumab) and Yervoy (ipilimumab) has failed to meet a primary endpoint in the CheckMate -915 Phase III melanoma trial. 20 November 2019
Australians living with non-small cell lung cancer and early stage acute lymphoblastic leukemia will be able to access better treatment options with new listings on the Pharmaceutical Benefits Scheme (PBS) coming into effect on December 1, 2019. 20 November 2019
Shares in CRISPR Therapeutics and Vertex Pharmaceuticals closed up by 17% and 2% respectively on Tuesday after they presented data from an ongoing Phase I/II study. 20 November 2019
Shares in The Medicines Company have been boosted by reports that Swiss drugmaker Novartis (NOVN: VX) is considering making a bid on the firm. 20 November 2019
Shares of US biotech CNS Pharmaceuticals gained 4.1% to $4.33 yesterday, after revealing that it has completed an agreement with Houston Pharmaceuticals Inc (HPI) to obtain the rights to a worldwide, exclusive royalty-bearing, license for the chemical compound commonly known as berubicin. 20 November 2019
Industry analyst GlobalData has highlighted the significance of the POSEIDON study for AstraZeneca’s hopes in non-small-cell lung carcinoma (NSCLC). 19 November 2019
Ireland-incorporated biotech Alkermes has filed a New Drug Application (NDA) to the US Food and Drug Administration seeking approval of ALKS 3831 (olanzapine/samidorphan) for the treatment of schizophrenia and for the treatment of bipolar I disorder. 19 November 2019
The PD-1 inhibitors space has become extremely competitive, but the latest data show that there is now an out-right winner in terms of revenue generation. 19 November 2019
Israeli drugmaker Protalix BioTherapeutics closed 40% up on Monday amid good news for pegunigalsidase alfa, the Fabry disease candidate that it is advancing alongside its development and commercialization partner, Chiesi Farmaceutici. 18 November 2019
In what is its first outright M&A deal in two decades, Ireland-incorporated biotech firm Alkermes has entered into a definitive agreement to acquire Rodin Therapeutics, a privately held biopharmaceutical company focused on developing novel, small molecule therapeutics for synaptopathies 18 November 2019
Shares in Boston biotech resTORbio were worth 86% less by Friday’s close after the announcement of top-line data from the Phase III study on the company’s lead candidate. 18 November 2019
East Coast, USA-based drug developer Dicerna Pharmaceuticals has inked an agreement with Denmark’s Novo Nordisk (NOV: N) to discover and develop novel therapies for liver-related cardio-metabolic diseases. 18 November 2019
With the US Centers for Disease Control and Prevention (CDC) report on antimicrobial resistance (AMR) stating that it is a much larger and more severe public health threat than previously thought, the AstraZeneca spin-out Entasis Therapeutics (Nasdaq: ETTX) has called for policy change. 18 November 2019
The US Food and Drug Administration on Friday approved Adakveo (crizanlizumab-tmca), a treatment to reduce the frequency of vaso-occlusive crisis – a common and painful complication of sickle cell disease that occurs when blood circulation is obstructed by sickled red blood cells – for patients aged 16 years and older. 18 November 2019
Weeks after presenting positive Phase III trial results on the company’s key pipeline candidate, bimekizumab, UCB has proven that the first study was no fluke. 15 November 2019
The importance of the year ahead for US biopharma BioMarin Pharmaceutical was made abundantly clear at the company’s R&D Day in New York on Thursday. 15 November 2019