US biotech Scynexis has submitted a New Drug Application to the US Food and Drug Administration for oral ibrexafungerp for the treatment of vulvovaginal candidiasis, also known as vaginal yeast infection. 14 October 2020
Age-related macular degeneration (AMD) is the leading cause of blindness in older adults across western countries. It damages the retina but its exact causes are not fully understood, according to a new report from Edison Investment Research. 14 October 2020
US pharma giant Pfizer and partner Germany’s BioNTech have entered into an agreement with the New Zealand government to supply 1.5 million doses of their potential COVID-19 vaccine, according to local media reports. 13 October 2020
Privately-held UK-based company Oxular has announced that it has received both Rare Pediatric Disease and Orphan Drug designations from the US Food and Drug Administration (FDA) for OXU-003, the firm’s proprietary drug in development for the treatment of retinoblastoma. 12 October 2020
The Canadian subsidiary Pfizer and Germany BioNTech have announced the initiation of a rolling submission to Health Canada for BNT162b2, their lead candidate from the companies' vaccine development program against COVID-19. 10 October 2020
Bristol Myers Squibb today announced that Health Canada has approved Zeposia (ozanimod) for the treatment of patients with relapsing remitting multiple sclerosis (RRMS) to decrease the frequency of clinical exacerbations. 7 October 2020
Zejula (niraparib) is now approved in Canada for the monotherapy maintenance treatment of women with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to first-line platinum-based chemotherapy. 6 October 2020
Hot on the heels of a planned rolling review of AstraZeneca’s COVID-19 vaccine candidate AZD1222 by the European Medicines Agency, medicines regulator Health Canada says it has received a submission from the UK-based drug major’s product being developed in partnership with the University of Oxford. 2 October 2020
Myovant Sciences’ relugolix failed to achieve statistical superiority for castration resistance-free survival compared to leuprolide acetate in men with metastatic prostate cancer through 48 weeks. 30 September 2020
Today the Food and Drug Administration has approved SIMPONI ARIA (golimumab), from Johnson & Johnson subsidiary Janssen, for patients two years of age and older for the treatment of active pJIA and has extended the PsA indication for this same patient population. 30 September 2020
Swedish biotech firm Alligator Bioscience today announced the appointment of Gayle Mills as chief business officer to lead the company´s business development activities. 28 September 2020
Dutch biopharma company Khondrion says it received a rare pediatric disease (RPD) designation from the US Food and Drug Administration for sonlicromanol for the treatment of patients with MELAS syndrome. 28 September 2020
Privately-held Canadian firm AbCellera and Californian biotech IGM Biosciences have entered into a multi-year, multi-target strategic research collaboration and license agreement to facilitate the discovery and development of IgM antibodies. 25 September 2020
Japan’s Chugai Pharmaceutical has received approval for an additional indication of Tecentriq (atezolizumab) and Avastin (bevacizumab) for the treatment of unresectable hepatocellular carcinoma (HCC) from the Ministry of Health, Labor and Welfare (MHLW). 25 September 2020
Novo Ventures, the ventures arm of Novo Holdings, today announced that it has co-led the oversubscribed $83 million Series C financing in LAVA Therapeutics, a Dutch and US biotech company pioneering the development of bispecific antibodies to engage gamma-delta T cells for cancer therapies. 17 September 2020
Adding BB Pureos Bioventures to its list of investors, France’s ImCheck Therapeutics has boosted its series B financing to 54 million euros ($64 million). 16 September 2020
Gilead Sciences today announced that the US Food and Drug Administration has granted Breakthrough Therapy designation for magrolimab, a first-in-class, investigational anti-CD47 monoclonal antibody for the treatment of newly-diagnosed myelodysplastic syndrome (MDS). 15 September 2020
Italian pharma major Recordati saw its shares rise more than 5% to 52.00 euros in early trading, as it announced a deal to expand its portfolio of marketed rare disease medicines. 4 October 2024
Paris-based asset manager Kurma Partners has raised 140 million euros ($154 million), successfully completing the first closing of Biofund IV 4 October 2024
Bristol Myers Squibb has received a new approval from the US Food and Drug Administration for its blockbuster checkpoint blocker, Opdivo (nivolumab). 4 October 2024
Singapore’s Agency for Science, Technology and Research (A*STAR) and US biotech incubator Flagship Pioneering have agree to collaborate on advancing health and sustainability outcomes in Singapore and the broader Asia Pacific region. 4 October 2024
The US Food and Drug Administration (FDA) has removed the partial clinical hold on delpacibart etedesiran (del-desiran/AOC 1001), an investigational treatment designed to address the root cause of myotonic dystrophy type 1 (DM1), under development by US biotech Avidity Biosciences . 4 October 2024
The US Food and Drug Administration (FDA) has granted the Gilead Sciences subsidiary Kite a Regenerative Medicine Advanced Therapy Designation (RMAT) for Yescarta (axicabtagene ciloleucel) for adults with newly-diagnosed, high-risk large B-cell lymphoma (LBCL). 3 October 2024
Kedrion Biopharma has finalized an agreement with Germany-based Biotest for the long-term commercialization and distribution of Yimmugo (immune globulin) in the USA. 3 October 2024
US clinical-stage biotech Arcus Biosciences has entered into a clinical trial collaboration with AstraZeneca on renal cancer treatments. 3 October 2024
PeptiDream says that its wholly-owned PDRadiopharma subsidiary has entered into a strategic partnership with French nuclear medicines firm Curium. 3 October 2024
Privately-held Ferring Pharmaceuticals has announced the opening of a global manufacturing hub in Finland for the drug substance of its intravesical non-replicating gene therapy Adstiladrin (nadofaragene firadenovec-vncg). 3 October 2024
Shares of UK drug developer Hemogenyx Pharmaceuticals rose as much as 9% and closed up 5.9% at 1.70 pence yesterday on the news of a further investment from Prevail Partners. 3 October 2024
UK-based biotech Resolution Therapeutics has announced the completion of a £63.5 million ($76.8 million) series B financing round led by Syncona. 3 October 2024
The BioIndustry Association (BIA), in collaboration with the Centre for Process Innovation (CPI), has published a new report on the UK’s mRNA sector. 2 October 2024
Aspen Neuroscience, a private biotechnology company specializing in autologous cell therapies, has announced the opening of a major new facility near its headquarters in San Diego. 2 October 2024
Privately-held UK biotech Curve Therapeutics today announced the further strengthening of its leadership team with the appointments of Andre Hoekema as chairman of the board and Cora Griffin as head of business development. 2 October 2024
NK:IO, a London startup developing a cell therapy for treating solid tumors, has announced the appointment of a permant chief executive and the finalization of a seed funding round. 2 October 2024