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
Shares in Akebia Therapeutics finished the day around 6% up on Tuesday, after the firm announced the first ever filing for vadadustat, an investigational oral treatment for anemia due to chronic kidney disease (CKD). 24 July 2019
In a major fillip for cancer biotech Jounce Therapeutics, Celgene has opted to license worldwide rights to JTX-8064, an antibody targeting the LILRB2 receptor on macrophages. 24 July 2019
A set of quarterly financial results that exceeded expectations and led to improved full-year guidance prompted shares in Biogen increasing by 5% in Tuesday morning’s trading. 23 July 2019
A company that calls itself the world-leading AI-driven drug discovery company has entered into a collaboration with Rallybio, a privately-held development-stage biotechnology company focused on rare diseases. 23 July 2019
Germany’s Bayer is voluntarily recalling two lots of Kogenate FS antihemophilic factor (recombinant) 2000 IU vials in the USA to the patient level. Certain vials from these two lots that were labeled as Kogenate FS actually contain the FVIII hemophilia A treatment, Jivi, antihemophilic factor (recombinant) PEGylated-aucl 3000 IU. 23 July 2019
Japanese drugmaker Shionogi has entered into an out-licensing agreement on COT-143, a humanized monoclonal antibody targeting the PcrV protein of Pseudomonas aeruginosa, with the UK’s AMR Centre, based in Alderley Park, Cheshire. 23 July 2019
Acadia Pharmaceuticals saw its shares fall 16% to $21.62 in after-hours trading on Monday, after it released disappointing top-line results from its Phase III ENHANCE study. 23 July 2019
A new combination therapy for liver cancer has been granted Breakthrough Therapy Designation (BTD) by the US Food and Drug Administration, unlocking expedited development and review by the US regulator. 23 July 2019
As the global medical lead of the Adcetris (brentuximab vedotin) program for Japanese pharma major Takeda, Thanos Zomas’ job was made easier by Phase III trial results that he describes as “almost unprecedented.” 22 July 2019
Israeli biotech firm Intec Pharma (Nasdaq: NTEC) saw its market capitalization plummet after it announced top-line data from the company's pivotal Phase III trial (the ACCORDANCE trial). 22 July 2019
Shares of US biotech firm Durect were up as much as 39% in light pre-market volume today, as it announced a significant collaboration with Gilead Sciences. 22 July 2019
Belgium’s UCB has won approval from China’s National Medical Product Administration (NMPA) for Cimzia (certolizumab pegol), to treat moderate-to-severe rheumatoid arthritis. 22 July 2019
Takeda Pharmaceutical today announced top-line results from the VISIBLE 2 clinical trial evaluating the efficacy and safety of an investigational subcutaneous (SC) formulation of the gut-selective biologic Entyvio (vedolizumab). 22 July 2019
The US Food and Drug Administration (FDA) has approved Otezla (apremilast) 30mg twice daily (BID) for the treatment of adult patients with oral ulcers associated with Behçet’s disease. 20 July 2019
Johnson & Johnson’s pharma business Janssen has submitted to broaden the European label for Darzalex (daratumumab), for subcutaneous treatment of multiple myeloma. 19 July 2019
Gilead Sciences (Nasdaq: GILD) today announced today that it has licensed three pre-clinical antiviral programs, including investigational agents with the potential to treat human rhinovirus, influenza and herpes viruses. 19 July 2019
Cynata Therapeutics has revealed that it has received an indicative, non-binding and conditional proposal from Japan’s Sumitomo Dainippon Pharma regarding a possible acquisition. 19 July 2019
European life sciences investment firm Medicxi today announces the closing of Medicxi III, a new 400 million-euro ($488 million) fund. This brings the total amount raised by Medicxi in the last three years to over $1 billion. 19 July 2019
The US Food and Drug Administration has granted rare pediatric disease designation to LM-030, an investigational therapy licensed from Novartis last year and ready to enter into pivotal clinical trials for the treatment of Netherton syndrome by privately-held rare diseases specialist LifeMax Laboratories. 19 July 2019
USA-based biotech firm MacroGenics has announced that French privately held drugmaker Servier will terminate their collaboration and license agreement entered into seven years ago, with an effective date of January 15, 2020, unless sooner agreed to by the parties. 18 July 2019