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 global recombinant proteins market is projected to grow from $132 billion in 2023 to $203 billion by 2029, according to a recent BCC Research study. 4 July 2024
Chinese biopharma Hutchmed today announced that the New Drug Application (NDA) for tazemetostat for the treatment of adult patients with relapsed or refractory (R/R ) follicular lymphoma (FL) has been accepted for review and granted Priority Review in China. 4 July 2024
US biotech Moderna has received a project award of $176 million through the Rapid Response Partnership Vehicle (RRPV) to accelerate the development of mRNA-based pandemic influenza vaccines. 4 July 2024
British drugmaker GSK (LSE: GSK) and Germany's CureVac (Nasdaq: CVAC) have announced a restructuring of their collaboration into a new licensing agreement. 4 July 2024
UK pharma major AstraZeneca is defending a patent for its diabetes drug Forxiga (dapagliflozin) in Russia, as part of the recent decision taken by the Russian Supreme Court, reports The Pharma Letter’s local correspondent. 4 July 2024
A survey of British voters ahead of Thursday’s general election has revealed just how much importance they attach to the issue of access to medicines. 3 July 2024
Viatris has announced that the antitrust division of the US Department of Justice (DOJ) has concluded its investigation into Mylan and its former president, Rajiv Malik. 3 July 2024
LenioBio, a German biotech company focused on cell-free protein production, and UK-based enzymatic DNA production Touchlight have announced a supply agreement. 3 July 2024
UK life science incubator Syncona says it has committed $42.5 million (£33.5 million) to a $170 million (£134 million) Series B financing of its portfolio company Beacon Therapeutics 3 July 2024
The US Food and Drug Administration (FDA) approved Eli Lilly’s Kisunla (donanemab-azbt), once-monthly injection for IV infusion), Alzheimer's treatment . 3 July 2024
The European Medicines Agency (EMA) has approved Dupixent (dupilumab) as an add-on maintenance treatment for certain adults with uncontrolled chronic obstructive pulmonary disease (COPD). 3 July 2024
US healthcare giant Johnson & Johnson (NYSE: JNJ) yesterday released encouraging new data on the overall survival benefit of its Carvykti (ciltacabtagene autoleucel; cilta-cel). 3 July 2024
Cartesian Therapeutics, a biotech seeking to develop mRNA cell therapies for autoimmune diseases, was trading nearly 20% lower early in Tuesday’s trading. 3 July 2024
Annovis Bio (NYSE: ANVS), a late-stage drug developer, has announced new data from its Phase III study of Parkinson’s candidate buntanetap. 3 July 2024
Oxford, UK-based ThirtyFiveBio, a company specializing in GPR35 inhibitors for gastrointestinal diseases, has announced receipt of a grant from Innovate UK. 2 July 2024
Cambridge, UK-based Mission Therapeutics, a clinical-stage biotech, has received $5.2 million in funding from The Michael J. Fox Foundation for Parkinson's Research and Parkinson's UK. 2 July 2024
China’s Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) has approved Japanese pharma major Astellas’ Xtandi (enzalutamide) for the treatment of patients with metastatic hormone-sensitive prostate cancer (mHSPC). 2 July 2024
Swedish Orphan Biovitrum, also known as Sobi, today announced the initiation of a rolling Biologics License Application (BLA) to the US Food and Drug Administration (FDA) for SEL-212. 2 July 2024
The UK Bioindustry Association (BIA) has joined the European Biosolutions Coalition, an initiative established by several industry organisations to elevate the prominence of biosolutions on Europe’s agenda. 2 July 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.