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 of Dutch biotech LAVA Therapeutics shot up 43% to $2.23 by close of trading on Thursday, after it revealed a clinical trial collaboration and supply agreement with US pharma giant Merck & Co. 26 January 2024
Products from biotech major Gilead Sciences appear twice on a US Food and Drug Administration (FDA) list of six cell therapies that are to carry black box warnings about the risk of T-cell malignancies. 25 January 2024
Cellular Origins, a part of TTP Company, focused on enabling scalable, cost-effective, and efficient manufacture of cell and gene therapies, today announced the appointment of Peter Crossley as chief operating officer (COO). 25 January 2024
Korean immuno-oncology company CanariaBio has taken a stock market battering following the failure of its Phase III trial of oregovomab, an antibody targeting CA125, for ovarian cancer patients. 25 January 2024
Belgian cell therapy biotech BioSenic will, for the first time, share post hoc data on its late-clinical asset JTA-004 at the Osteoarthritis Research Society International (OARSI) World Congress 2024. 25 January 2024
The US Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) in response to the supplemental Biologics License Application (sBLA) for the F8 formulation of tesamorelin, submitted by Montreal, Canada-based Theratechnologies . 25 January 2024
San Diego, USA-based precision cancer medicines developer Kura Oncology saw its shares rocket more than 46% to $19.62 yesterday it announced a $150 million oversubscribed private placement. 25 January 2024
Earlier this week, ArriVent Biopharma filed for an IPO, following several other young biotechs giving notice they planned to take the plunge in 2024. 25 January 2024
Unnatural Products (UNP), a biotech company pairing AI with chemistry to enable the next generation of molecularly targeted therapeutics, has announced a collaboration with US pharma giant Merck & Co. 24 January 2024
Scientists advising the US medicines regulator will convene to discuss a submission to move Carvykti (ciltacabtagene autoleucel) into an earlier line of treatment. 24 January 2024
Akouos, which Eli Lilly acquired in 2022, has released positive initial clinical results from the Phase I/II AK-OTOF-101 study, testing a gene therapy for the restoration of hearing loss. 24 January 2024
Privately-held Boston, USA-based biotech Vivtex Corporation has entered a research collaboration with Japanese drug major Astellas Pharma. 23 January 2024
German pharma major Bayer’s independently operated company BlueRock Therapeutics today revealed it has exercised its option to exclusively license OpCT-001 under a 2021 deal with FUJIFILM Cellular Dynamics and Opsis Therapeutics. 23 January 2024
US genetic medicines developer GenEdit today revealed a multiyear collaboration and license agreement with Genentech as well as a $24 million Series A1 financing round. 23 January 2024
Small biotechs continue to show more interest in a public listing in 2024, with ArriVent Biopharma the latest to opt for an initial public offering (IPO) in the USA. 23 January 2024