3 October 2024 F2G’s September $100m funding round provides the company with crucial funds to
renavigate approval of its lead drug, olorofim. The substantial financing also
highlights the paucity of novel antifungal products in the clinic.
Massachusetts, USA-based biotech incubator Flagship Pioneering and US pharma giant Pfizer have announced a novel agreement to create a new pipeline of innovative medicines. 19 July 2023
UK biotech start-up Bloomsbury Genetic Therapies says that the US Food and Drug Administration (FDA) has granted Rare Pediatric Disease designation (RPDD) for BGT-OTCD, the company’s investigational liver-targeted gene therapy for the treatment of Ornithine transcarbamylase deficiency (OTCD). 19 July 2023
Boston, USA-based clinical-stage biotech Pieris Pharmaceuticals saw its shares surge as much as 70%, and still up 27% at $0.24 mid-morning, after it provided a strategic update following recent events that have impacted its inhaled respiratory franchise. 18 July 2023
Privately held, venture-funded biotech Revolo Biotherapeutics today announced additional data from its proof of concept, two-week, three-dose, Phase IIa clinical trial evaluating the efficacy, safety, and tolerability of the company’s immune-resetting drug, ‘1104, in adults with active eosinophilic esophagitis (EoE). 18 July 2023
The US Food and Drug Administration (FDA) has approved Beyfortus (nirsevimab-alip) for the prevention of RSV lower respiratory tract disease in neonates and infants. 18 July 2023
Shares of Swedish Orphan Biovitrum, also known as Sobi, edged up 3% to 212.00 kronor today, after it posted financial results for the second quarter of 2023. 18 July 2023
The European Medicines Agency (EMA) has accepted for review the marketing authorization application for bimekizumab, an interleukin (IL)-17A and IL-17F inhibitor, for the treatment of adults with moderate to severe hidradenitis suppurativa (HS), submitted by Belgium’s largest pharma company UCB. 18 July 2023
Over the last few days, attendees of the ongoing annual meeting of the Alzheimer’s Association have been arriving in Amsterdam for what has turned out to be a particularly exciting congress. 18 July 2023
UK-based CAR-T therapies specialist Leucid Bio today announced the appointment of Filippo Petti as its chief executive (CEO), with immediate effect. 18 July 2023
While targeted protein-busting antibodies are revolutionizing the treatment of Alzheimer’s disease, a damaging side effect - amyloid-related imaging abnormalities (ARIA) - has emerged as a differentiator among the growing number of options. 17 July 2023
Belgo-Dutch autoimmune diseases specialist argenx has announced positive top-line results from the ADHERE study evaluating Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) in chronic inflammatory demyelinating polyneuropathy (CIDP). 17 July 2023
DTx Pharma, a San Diego, USA-based pre-clinical stage biotechnology company, today announced that it has been acquired by Swiss pharm giant Novartis. 17 July 2023
Venture capital firm Westlake Village BioPartners has announced the launch of its third fund of $450 million to incubate and grow early-stage biotech companies in the Los Angeles area and further afield. 17 July 2023
Market reaction to genetic medicines developer Sangamo Therapeutics announcement of an evaluation and option agreement with Prevail Therapeutics, a wholly-owned subsidiary of Eli Lilly, was positive pre-market, with its shares rising 9.2% to $1.41. 17 July 2023
At the AAIC in Amsterdam, we’re speaking with two key figures from Lilly's development program for donanemab, as the company presents new data that could help it to push ahead in the treatment of early Alzheimer's. 17 July 2023
Fragile X syndrome (FXS) is an X-linked dominant disorder characterized by a broad range of clinical manifestations, including intellectual disability, autism spectrum disorder, language deficits, macroorchidism, seizures, and anxiety. 17 July 2023
Important regulatory news last week included French pharma major Sanofi gaining approval from the US Food and Drug Administration (FDA) and the Chinese medicines authority for its blockbuster drug Dupixent as the first biologic for chronic obstructive pulmonary disease (COPD). Spanish epigenetics firm Oryzon Genomics announced that, with FDA feedback, it is preparing for a Phase III trial of its CNS drug candidate vafidemstat. Also, the FDA authorized Bristol Myers Squibb’s blockbuster drug Opdivo in a new lung cancer indication for patients with specific mutations such as EGFR or ALK. On the deal-making front, US biotech Arcus Biosciences has entered a collaboration with AstraZeneca to evaluate its casdatifan with the UK pharma major’s volrustomig in renal cell cancer. 6 October 2024
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
Sign up to receive email updates Join industry leaders for a daily roundup of biotech & pharma news
Company Spotlight
A pre-clinical stage biopharmaceutical group developing new medicines and treatments to treat blood and autoimmune disease and to bring the curative power of bone marrow transplantation to a greater number of patients suffering from otherwise incurable life-threatening diseases.