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.
The annual meeting of the American Society of Clinical Oncology (ASCO) is set to commence on 2 June in Chicago, with the highly anticipated plenary session taking place on the Sunday. 22 May 2024
Swiss generic and biosimilar medicines company Sandoz today announced that the European Commission (EC) has granted marketing authorization for Wyost (denosumab) and Jubbonti (denosumab), the first and only biosimilar versions of reference medicines Xgeva and Prolia in Europe. 22 May 2024
UK pharma major GSK yesterday announced positive results from trials of depemokimab, an "ultra-long-acting biologic" that could simplify treatment options for patients with severe asthma. 22 May 2024
Rhythm Pharmaceuticals, a US biopharma specializing in rare neuroendocrine diseases, has announced that its drug Imcivree (setmelanotide) is expected to be funded and available for use in England and Wales within three months through the National Health Service (NHS) in specialist centers. 22 May 2024
Executives at cash-strapped biotech Lyra Therapeutics are hoping a drastic reduction in headcount will help keep the lights on, alongside other cost-cutting measures. 22 May 2024
The Russian government is considering tightening domestic patent legislation, in a move to respond to numerous calls of global drugmakers, which are unhappy with the level of protection of their original drugs in the local market, reports The Pharma Letter’s local correspondent. 22 May 2024
The Journal of Clinical Psychopharmacology has published a post hoc analysis of data from the Phase III KINECT-4 study of Ingrezza (valbenazine). 22 May 2024
A new subcutaneous version of the checkpoint blocker Opdivo (nivolumab) could be approved earlier than expected, after the US regulator brought forward the date for a decision. 22 May 2024
UK pharma major AstraZeneca’s Fasenra (benralizumab) recently received Food and Drug Administration (FDA) approval for severe asthma in children aged six to 11, specifically for the eosinophilic phenotype, in over 80 countries, including the USA, European Union, and Japan. 22 May 2024
Taking another step into the sector, US pharma major Eli Lilly has signed an agreement with Boston, USA-based biotech firm Aktis Oncology, to generate anticancer radiopharmaceuticals using the latter’s novel miniprotein technology platform. 21 May 2024
Data have been presented from the NOTUS Phase III study on the use of Dupixent (dupilumab) as an add-on maintenance treatment in adults with uncontrolled COPD on maximal standard-of-care inhaled therapy and evidence of type 2 inflammation. 21 May 2024
Given that the USA’s House Committee on Oversight and Accountability held a markup meeting last week on the legislation, it is likely that the USA will pass the BIOSECURE Act (the Act) in December this year. 21 May 2024
Israeli dermatology company Sol-Gel Technologies has signed an agreement with Beimei Pharma for the commercialization of Twyneo (tretinoin/benzoyl peroxide) in China, Hong Kong, Macau, Taiwan and Israel. 21 May 2024
UK antibody-drug conjugate (ADC) company Pheon Therapeutics today announced the completion of a $120 million Series B financing to fund the development of its pipeline of differentiated ADCs. 21 May 2024
US healthcare giant Johnson & Johnson has announced that the Tremfya (guselkumab) QUASAR maintenance study in ulcerative colitis (UC) met its primary endpoint and all major secondary endpoints, including highly statistically significant rates of endoscopic remission. 21 May 2024
Massachusetts-USA-based biotech-Progentos Therapeutics has announced its launch and the closing of a $65 million Series A round of financing. 21 May 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.