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 recent approval by the US Food and Drug Administration (FDA) of Moderna’s (Nasdaq: MRNA) respiratory syncytial virus (RSV) vaccine mRESVIA represents a significant development in the field and will likely encourage the use of mRNA technology across other disciplines. 7 June 2024
The US Food and Drug Administration (FDA) late Thursday announced the approved of Geron Corporation’s Rytelo (imetelstat), an oligonucleotide telomerase inhibitor. 7 June 2024
Moderna has announced that the US Food and Drug Administration has selected mRNA-3705 for the Support for Clinical Trials Advancing Rare Disease Therapeutics (START) pilot program. 6 June 2024
UK-based AI-driven precision medicines company Exscientia today announced the appointment of two technology and clinical development leaders to senior roles. 6 June 2024
Italy's Competition Authority (AGCM) is investigating four pharmaceutical companies over what it called coordination of their commercial strategies, allegedly delaying access to a biosimilar eye-disease treatment in the country. 6 June 2024
Aurobindo Pharma's wholly-owned subsidiary, TheraNym Biologics Private, has signed a Master Service Agreement (MSA) with Merck Sharpe & Dohme (MSD). 6 June 2024
Gilead Sciences has announced data from the Phase IIb MYR204 open-label study assessing the first-in-class entry inhibitor bulevirtide as monotherapy and in combination with pegylated interferon alfa-2a (PegIFN), in compensated chronic hepatitis delta virus (HDV) infection. 6 June 2024
Singaporean speciality pharma company Hyphens Pharma International has entered into an exclusive license, development and commercialization agreement with Japanese drugmaker Maruho. 6 June 2024
A report from industry analyst GlobalData finds that reforms to the European Union's general pharmaceutical legislation have become a pivotal policy development for the pharma industry. 6 June 2024
Isotope Technologies Munich (ITM) has announced an equity investment of 188 million euros ($204 million) led by Temasek with participation from funds managed by BlackRock, Qatar Investment Authority, ATHOS and Carbyne. 6 June 2024
Australian radiopharma developer Telix Pharmaceuticals has announced the launch of its initial public offering in the USA of 17,000,000 American Depositary Shares (ADSs), each representing one ordinary share in Telix. 6 June 2024
The race to secure market share for GLP-1 agonists continues to develop, with Eli Lilly revealing more promising results for its option, tirzepatide. 6 June 2024
USA-based ArriVent BioPharma has entered into a collaboration agreement with a unit of Chinese biotech Alphamab Oncology, to discover, develop and commercialize novel antibody-drug conjugates (ADCs) for the treatment of cancers. 6 June 2024
Ireland-headquartered Mallinckrodt has released new data on Terlivaz (terlipressin) for injection in patients with hepatorenal syndrome (HRS) with rapid reduction in kidney function. 6 June 2024
Top-line data from the randomized, placebo-controlled Phase III MITIGATE study demonstrated Uplizna (inebilizumab) met all primary and key secondary endpoints in treating immunoglobulin G4-related disease (IgG4-RD), US biotech major Amgen announced. 5 June 2024
Privately-held US biotech Bluejay Therapeutics today announced positive preliminary data from the Phase II study of BJT-778, at the European Association for the Study of the Liver (EASL) Congress 2024. 5 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.