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
Californian biotech XOMA Corporation has acquired a royalty interest in six clinical-stage assets targeting the adenosine pathway for $10 million from privately-held Spanish firm Palobiofarma. 27 September 2019
German pharma and sciences firm Merck KGaA says that Erbitux (cetuximab) has been granted approval by China’s National Medical Products Administration (NMPA) for the first-line treatment for patients with RAS wild-type (wt) metastatic colorectal cancer (mCRC) in combination with FOLFOX or FOLFIRI, or in combination with irinotecan in patients who are refractory to irinotecan-based chemotherapy. 27 September 2019
Following the publication of new Phase II data for Japanese pharma major Takeda’s TAK-620 (maribavir) as a treatment for cytomegalovirus (CMV) infections in recipients of hematopoietic cell or solid organ transplant, GlobalData’s senior pharma analyst Paul Jeng has offered his perspective on the candidate. 27 September 2019
The UK government-backed Cell and Gene Therapy Catapult (CGT Catapult) has announced that its chief executive, Keith Thompson, is to retire from April 2020. 26 September 2019
The cost-effectiveness watchdog for England and Wales has ruled that Novartis’ anti-CGRP migraine therapy is too expensive at its current price to be provided on the National Health Service (NHS). 26 September 2019
US Venture capital-backed biotech Blade Therapeutics, which is focused on novel anti-fibrotic therapies, today announced the acquisition of ATXCo Inc, including its core asset, PAT-409, a Phase I-ready autotaxin inhibitor for patients with fibrotic diseases. 26 September 2019
US biotech Omeros Corp has announced study results showing that inhibition of mannan-binding lectin-associated serine protease-2 (MASP-2) protects against renal injury caused by proteinuria (ie, high levels of plasma proteins in the urine) and inflammation. 26 September 2019
The New England Journal of Medicine (NEJM) on Thursday will publish important results online from the VARSITY study, the first head-to-head clinical trial in ulcerative colitis. 25 September 2019
Swiss pharma giant Novartis has responded to the US Food and Drug Administration’s (FDA) issuing of a Form 483 relating to allegations of data manipulation on Zolgensma (onasemnogene abeparvovec-xioi). 25 September 2019
The US Food and Drug Administration yesterday announced the approval of Jynneos smallpox and monkeypox vaccine, live, on-replicating, for the prevention of smallpox and monkeypox disease in adults 18 years of age and older determined to be at high risk for smallpox or monkeypox infection. 25 September 2019
Urovant Sciences has reported positive Phase III results for its investigational drug candidate vibegron, a next-generation, once‐daily oral beta‐three adrenergic agonist in development for the treatment of overactive bladder. 25 September 2019
The Cell and Gene Therapy (CGT) Catapult, a UK government-backed agency, has doubled the capacity of its manufacturing center in Stevenage, Hertfordshire. 24 September 2019
Shares of clinical-stage US biotech Provention Bio rose 6% in pre-market trading in reaction to reiteration of its registration plan for its Breakthrough Therapy-designated teplizumab (PRV-031) for the prevention or delay of clinical type 1 diabetes in at-risk people 24 September 2019
In Cambridge, USA, just around the corner from fellow gene therapy specialist bluebird bio, a less well-known biotech startup could be about to shake up the market for certain rare disease therapies. 24 September 2019
UK-headquartered DNA Damage Response (DDR) company Artios Pharma today announces the appointment of Tania Dimitrova as chief business officer and its expanded presence in the USA. 24 September 2019
French biotech Deinove saw its shares rise more than 5% to 0.79 euros by mid-morning, as the company said it has expanded its technology platform with an advanced genetic too, the CRISSPR-cas9 system, to enhance its ability to optimize various microorganisms. 24 September 2019