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
US biotech major Regeneron has shown that the addition of its investigational LAG-3 inhibitor fianlimab to its PD-1 inhibitor Libtayo (cemiplimab) offers impressive results in advanced melanoma. 17 September 2024
A cancer drug in-licensed by German biotech major BioNTech from China-based Biotheus could be a good one, if mid-stage results shared at the European Society for Medical Oncology (ESMO) are anything to go by. 17 September 2024
Cambridge, USA-based Korro Bio has entered a collaboration with Denmark’s Novo Nordisk to advance the discovery and development of new genetic medicines, with the initial target to treat cardiometabolic diseases. 17 September 2024
Danish biotechnology company MinervaX has announced a collaboration with Wacker Biotech, a subsidiary of Wacker Chemie, to manufacture active protein ingredients. 17 September 2024
US pharma major Bristol Myers Squibb has decided to end its collaboration with Germany-based Immatics for the co-development of IMA401. 17 September 2024
Californian biopharma 89bio, a company focused on the development and commercialization of innovative therapies for the treatment of liver and cardiometabolic diseases, has announced an important appointment. 17 September 2024
Bicara Therapeutics, a biotech focused on developing bifunctional therapies for solid tumors, has closed its initial public offering, raising approximately $362 million. 17 September 2024
British biotech IMU Biosciences has announced key changes to its leadership team as it looks to grow in the field of precision medicine. 17 September 2024
French pharma major Sanofi today revealed it is shipping Beyfortus (nirsevimab-alip) 50mg and 100mg Injection doses in the USA to private healthcare providers and to the Centers for Disease Control and Prevention. 17 September 2024
Eisai and Merck & Co have announced positive data for their combination therapy of Lenvima (lenvatinib) and Keytruda (pembrolizumab) in liver cancer. 17 September 2024
Following its $2.7 billion acquisition of Carmot Therapeutics, Roche is intensifying its focus on obesity treatments, details of which have been set out at an investor event. 17 September 2024
Swiss pharma giant has shared a well-timed updated analysis from the pivotal Phase III NATALEE trial at the European Society for Medical Oncology (ESMO) Congress 2024 16 September 2024
The US Food and Drug Administration (FDA) has approved Ocrevus Zunovo (ocrelizumab and hyaluronidase-ocsq) for the treatment of relapsing multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS), from Swiss pharma giant Roche. 16 September 2024
Ohio, USA-based Trailhead Biosystems has appointed Josh Snow as its new chief commercial officer, as the company moves to expand its presence in the commercial market with its iPSC-derived human cell products. 16 September 2024
As ever, US pharma giant Merck & Co has been sharing plenty of data on its blockbuster anti-PD-1 therapy Keytruda (pembrolizumab) at this year’s meeting of the European Society for Medical Oncology (ESMO). 16 September 2024
Positive results from the NIAGARA Phase III trial showed that UK pharma major AstraZeneca’s (LSE: AZN) Imfinzi (durvalumab) in combination with chemotherapy demonstrated a statistically-significant and clinically-meaningful improvement in the primary endpoint of event-free survival (EFS) and the key secondary endpoint of overall survival (OS) versus neoadjuvant chemotherapy for patients with muscle-invasive bladder cancer (MIBC). 16 September 2024
The Phase II study of ponsegromab, a monoclonal antibody directed against growth differentiation factor-15 (GDF-15), met its primary endpoint of change from baseline in body weight compared to placebo in people with cancer cachexia and elevated levels of GDF-15, said US pharma giant Pfizer. 16 September 2024