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.
Overall survival (OS) results from the Phase II MagnetisMM-3 study of Pfizer’s Elrexfio (elranatamab-bcmm) in patients with heavily pre-treated relapsed or refractory multiple myeloma (RRMM), demonstrated a median OS of 24.6 (95% CI, 13.4, NE) months in cohort A (n=123) of the pivotal single arm trial. 14 June 2024
The European Commission (EC) has accused privately-held API manufacturer Alchem International of breaching European Union antitrust rules by participating in a long-lasting cartel concerning an important pharmaceutical product. 14 June 2024
China’s Innovent Biologics recently presented Phase I study results of its first-in-class anti-CLDN18.2/CD3 bispecific antibody (IBI389) for the treatment of advanced pancreatic cancer. 14 June 2024
Bladder cancer specialist UroGen Pharma saw its shares close up nearly 38% at $17.50 yesterday, after it shared positive trial results on its lead pipeline candidate UGN-102, an innovative formulation of mitomycin. 14 June 2024
Kite, a Gilead Sciences company, has unveiled new analyses for Yescarta (axicabtagene ciloleucel) in relapsed/refractory large B-cell lymphoma (LBCL). 14 June 2024
South Korea’s Samsung Bioepis today presented the post-hoc analysis of the Phase III clinical study results for Epysqli (SB12), a biosimilar to AstraZeneca’s Soliris (eculizumab), at the EHA Congress. 14 June 2024
First launched in 2022, US precision immunology company Santa Ana Bio yesterday emerged from stealth with $168 million in combined Series A and B funding. 14 June 2024
The market for amyotrophic lateral sclerosis (ALS) products across mature markets could reach $1.3 billion by 2029, up from $317 million in 2019, according to GlobalData. 13 June 2024
As the UK heads for a general election next month, the Association of the British Pharmaceutical Industry (ABPI) today assessed the Labour Party manifesto, having yesterday appraised the UK Conservative pledges. 13 June 2024
Alzheon, a clinical-stage biopharma company, has secured $100 million in a series E funding round led by Alerce Medical Technology Partners. 13 June 2024
Johnson & Johnson says it has “grave concern” for the availability of future innovative mental health treatments in England, following a decision by National Institute for Health and Care Excellence (NICE) to not re-appraise Spravato (esketamine nasal spray) for treatment-resistant depression in England 13 June 2024
US drugmaker AbbVie and China’s FutureGen Biopharmaceutical have announced a license agreement to develop FG-M701, a next generation TL1A antibody for the treatment of inflammatory bowel disease (IBD), currently in preclinical development. 13 June 2024
AstraZeneca’s Farxiga (dapagliflozin) has received approval from the US Food and Drug Administration to improve glycemic control in children with type-2 diabetes (T2D). 13 June 2024
Aardvark Therapeutics might not have scored the biggest venture haul in May, but its $85 million Series C round will further strengthen rumors that the California-based company is gearing up for an IPO this summer, which could come as soon as late July. 13 June 2024
After two previous setbacks, US pharma giant Pfizer yesterday released disappointing new data for its Duchenne muscular dystrophy (DMD) gene therapy candidate. 13 June 2024
Trevi Therapeutics has announced significant milestones in its clinical programs for Haduvio (nalbuphine), an investigational therapy aimed at treating chronic cough in idiopathic pulmonary fibrosis (IPF) and refractory chronic cough (RCC). 4 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
The European Medicines Agency’s pharmacovigilance committee, PRAC, has started a review of medicines containing finasteride and dutasteride following concerns regarding suicidal ideation (suicidal thoughts) and behaviors. 4 October 2024
Opioid Use Disorder (OUD) is a chronic neurological disorder that is described as the consequences associated with repeated, compulsive use of opioid drugs and prolonged self-administration of opioid drugs. 4 October 2024
Proposals from the National Health Service (NHS) England have been set out for a phased launch of Eli Lilly’s obesity injection Mounjaro/Zepbound (tirzepatide) at the start of a consultation. 4 October 2024
Aspire Pharma, a UK-based niche generics business, has announced the acquisition of all assets from Canute Pharma, further expanding its product range. 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
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. 3 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
The US Food and Drug Administration (FDA) has determined the shortage of tirzepatide injection, a glucagon-like peptide 1 (GLP-1) medication, has been resolved. 3 October 2024
Israel’s Teva Pharmaceutical Industries and mAbxience, a Fresenius Kabi majority-owned group with partial ownership from Insud Pharma, have announced a global licensing deal for the development of an anti PD-1 oncology biosimilar candidate. 3 October 2024
Caliway Biopharmaceuticals has successfully completed its initial public offering, raising NT$6.4 billion ($206 million), the largest IPO in Taiwan's biotech industry to date. 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
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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.