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
Slightly more than a month after the US Food and Drug Administration approved the product, the European Commission (EC) has also granted marketing authorization for Darzalex (daratumumab) subcutaneous (SC) formulation for the treatment of adult patients with multiple myeloma (MM), says US healthcare giant Johnson & Johnson. 5 June 2020
Privately-held German firm Immatics Biotechnologies today announced that Cedrik Britten has been appointed as chief medical officer (CMO) effective June 1, 2020. 4 June 2020
South Korean LegoChem Biosciences has entered a worldwide license agreement with Newcastle, UK-based Iksuda Therapeutics for the development and commercialization of LCB73, a CD19-targeted ADC candidate for hematological tumors. 4 June 2020
Canada-based biotech FSD Pharma saw its shares skyrocket 127% to C$9.65 by close of trading Wednesday, after it revealed that the US Food and Drug Administration had given the company permission to submit an Investigational New Drug Application (IND) for the use of its lead candidate FSD-201 (ultramicronized palmitoylethanolamide, or ultramicronized PEA) to treat COVID-19, the disease caused by the SARS-CoV-2 virus. 4 June 2020
The European Commission (EC) has approved Braftovi (encorafenib) in combination with cetuximab for the treatment of adult patients with BRAFV600E-mutant metastatic colorectal cancer (mCRC) who have received prior systemic therapy, says privately-held French drugmaker Pierre Fabre. 4 June 2020
Pharma giant Novartis has announced full positive results from the Phase III PREVENT trial of Cosentyx (secukinumab) in axial spondyloarthritis. 4 June 2020
Life sciences venture capital firm Forbion says that its newest portfolio company, Prilenia Therapeutics, a Naarden, Netherlands- and Herzliya, Israel-based clinical stage biotech company, has raised $62.5 million in a Series A financing round. 4 June 2020
Of around 50 biopharma companies and contract manufacturing organizations that took advantage of a US government $659 billion loan program, five are working on COVID-19 therapies. 3 June 2020
Interleukin (IL)-17A antagonist Taltz (ixekizumab) demonstrated consistent efficacy and long-term potential to help patients with psoriatic arthritis (PsA) in new data to be presented virtually on June 5 at the European Congress of Rheumatology 2020 (EULAR). 3 June 2020
US pharma major Bristol-Myers Squibb today announced results from the open-label switch period of Early AMPLE, a Phase IV exploratory biomarker study assessing the differences by which Orencia (abatacept) and another treatment, adalimumab, interfere with disease progression in moderate-to-severe early rheumatoid arthritis (RA) patients who tested positive (seropositive) for certain autoantibodies. 3 June 2020
China-based biotech BeiGene today revealed that its BTK inhibitor Brukinsa(zanubrutinib) has received approval from the China National Medical Products Administration (NMPA) in two indications. 3 June 2020
US biotech Regeneron Pharmaceuticals has failed to invalidate a fifth Kymab patent, covering genetically-modified mice used to produce human antibody therapeutics. 3 June 2020
Novo Ventures, part of Denmark’s Novo Holdings, today announced that it has led the $55 million Series B financing in UK and USA-based biotech NodThera, which is developing a new class of medicines to treat diseases driven by chronic inflammation. Nanna Lüneborg, a partner at Novo Ventures, will join the NodThera board. 3 June 2020
Swiss biotech Relief Therapeutics and its US partner, NeuroRx, have announced the start of treatment of patients with RLF-100 at the University of Miami Miller School of Medicine. 3 June 2020
Pfizer, at a time when the COVID-19 pandemic is disrupting drugmakers clinical trials activities, on Tuesday announced the establishment of the Pfizer Breakthrough Growth Initiative, through which the US pharma giant will invest up to $500 million in biotechnology companies to help provide funding and access to Pfizer’s scientific expertise to ensure continuity of the biotechnology companies’ most promising clinical development programs. 3 June 2020
Danish dermatology specialist LEO Pharma has promised a plethora of data from Phase III trials in atopic dermatitis (AD) and psoriasis at this year’s American Academy of Dermatology (AAD) virtual meeting later this month. 2 June 2020
The European Commission (EC) has approved Sarclisa (isatuximab) in combination with pomalidomide and dexamethasone (pom-dex) for the treatment of adult patients with relapsed and refractory multiple myeloma (MM) who have received at least two prior therapies including lenalidomide and a proteasome inhibitor and have demonstrated disease progression on the last therapy. 2 June 2020
The US Department of Health and Human Services (HHS) has added $628 million to its contract with Emergent BioSolutions to advance manufacturing capabilities and capacity for a potential COVID-19 vaccine as well as therapeutics. 2 June 2020