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
A stern letter has been written to the US Food and Drug Administration (FDA) by the chairs of two US congressional committees, demanding answers in relation to the approval of Biogen and Eisai’s Alzheimer’s drug, Aduhelm (aducanumab). 3 September 2021
Today the European Union and AstraZeneca reached an agreement which will secure the delivery of the remaining COVID-19 vaccine doses to member states under the terms of the Advance Purchase Agreement concluded on August 27, 2020 with UK pharm major AstraZeneca. 3 September 2021
Kees Melief, chief scientific officer of ISA Pharmaceuticals, provides an Expert View on why therapeutic cancer vaccines will be a success following many years of being out of favor. 3 September 2021
Shares of Swedish Orphan Biovitrum, also known as Sobi, jumped as much as 23.6% to 235 Swedish kronor early today, after the company revealed it has received a takeover bid. 3 September 2021
Ultomiris (ravulizumab) has now been approved in the European Union for expanded use to include children (with a body weight of 10 kg or above) and adolescents with paroxysmal nocturnal hemoglobinuria (PNH). 3 September 2021
Swedish biotech pairing Alligator Bioscience and Scandion Oncology have concluded a research collaboration, describing its outcome as positive. 2 September 2021
A US Food and Drug Administration (FDA) review of a large clinical trial has led the agency to conclude that JAK inhibitors lead to an increased risk of serious heart-related events such as heart attack or stroke, cancer, blood clots, and death. 2 September 2021
Precision BioSciences and UK biotech Tiziana Life Sciences have entered an exclusive license agreement to explore Tiziana's foralumab, a fully human anti-CD3 monoclonal antibody (MAb), as an agent to induce tolerance of allogeneic CAR T-cells to potentially improve the clinical outcome of CAR-T cell therapy. 2 September 2021
Brukinsa (zanubrutinib) has received approval from the US Food and Drug Administration (FDA) for the treatment of adult patients with Waldenström’s macroglobulinemia (WM). 2 September 2021
Another coronavirus vaccine is moving towards the finishing line, as South Korean firm SK Bioscience announced the initiation of Phase III tests for its candidate, GBP510. 1 September 2021
GlaxoSmithKline has launched its shingles vaccine, Shingrix (zoster vaccine recombinant), in the UK. The vaccine will be available to purchase from pharmacies and private healthcare practices, as well as through a national immunization program for people in their seventies. 1 September 2021
Merck & Co has announced a label update for Keytruda (pembrolizumab), the US pharma giant’s blockbuster anti-PD-1 therapy, for its indication in first-line advanced urothelial carcinoma (bladder cancer) in the USA. 1 September 2021
All signs point to an M&A boom in late 2021 and throughout 2022. In this episode, Lance Minor, principal and national co-leader of the life sciences practice at BDO, provides valuable insight into current and emerging trends in the biotech investing landscape. 1 September 2021
Japanese pharma major Astellas Pharma has voluntarily paused screening and dosing of additional participants in its ASPIRO clinical trial evaluating AT132 in patients with X-linked myotubular myopathy (XLMTM). 1 September 2021
Swiss pharma giant Novartis has reached a commercial agreement with the National Health Service (NHS) in England as part of a collaboration to pioneer a first-of-its-kind population health management approach to address elevated "bad" low-density lipoprotein (LDL)-cholesterol in eligible patients with atherosclerotic cardiovascular disease (ASCVD) across England. 1 September 2021
The US Centers for Disease Control and Prevention (CDC) has officially endorsed the recommendation for use of tozinameran, the coronavirus vaccine produced by Pfizer and BioNTech. 31 August 2021
Shares in AC Immune were up on Tuesday, after the firm announced encouraging results from a Phase II trial of its Alzheimer’s disease (AD) candidate. 31 August 2021
Chinese biopharma firm Innovent Biologics and US biotech Bolt Biotherapeutics have announced a drug research and development collaboration to develop three new anti-cancer therapeutic immune-stimulating antibody conjugate (ISAC) candidates. 31 August 2021