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
Abivax ABVX) today announced the results of an interim efficacy and safety analysis of an open-label maintenance (OLM) study that enrolled patients with ulcerative colitis (UC). 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
AstraZeneca’s supplemental New Drug Application (sNDA) for Calquence (acalabrutinib) has been accepted and granted Priority Review in the USA for the treatment of adults with previously untreated mantle cell lymphoma (MCL). 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
The US Department of Health and Human Services (HHS) has released final guidance for the second cycle of Medicare drug price negotiations. 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
Liquidia Corporation and Pharmosa Biopharm have amended the current exclusive licensing agreement for the development and commercialization of L606. 3 October 2024
The European Medicines Agency (EMA) and the European medicines regulatory network are working to speed up the approval of new medicines. 3 October 2024
Timing can be crucial in biotech, and any company that can help optimize radiopharmaceuticals to fight cancer is likely to a hot property right now, given the recent popularity of the field among investors and drugmakers. 2 October 2024
Eli Lilly today announced a $4.5 billion investment to create the Lilly Medicine Foundry, a new center for advanced manufacturing and drug development. 2 October 2024
Novartis has discontinued an early Phase II trial of LTP001 in idiopathic pulmonary fibrosis (IPF). The company confirmed that the decision was not related to safety, with no issues emerging in the study. 15 October 2024
Eli Lilly has released new data demonstrating more patients with moderately to severely active Crohn's disease treated with mirikizumab – Johnson & Johnson’s (NYSE: JNJ) Stelara -achieved histologic response at Week 52 compared to ustekinumab, regardless of prior biologic experience. 15 October 2024
US pharma major Eli Lilly has announced plans to invest around 1.5 billion yuan ($206 million) into expanding its manufacturing facility in Suzhou, China. 15 October 2024
In Hong Kong, Akeso Biopharma has successfully raised $250 million through a share placement, marking its second major fundraising effort of 2024. 15 October 2024
Spanish dermatology specialist Almirall (BME: ALM) has announced the successful completion of the decentralized regulatory procedure in Europe for efinaconazole. 15 October 2024
French biopharma company Inventiva has announced financing of immediately 94.1 million euros ($103 million) and up to 348 million euros, subject to satisfaction of specified conditions. 15 October 2024
Antibody-drug conjugates (ADCs) represent a transformative class of cancer therapy that combine the targeting ability of antibodies with the cell-killing potential of cytotoxic drugs. 15 October 2024
Celltrion today announced two-year results of subcutaneous infliximab (CT-P13 SC) dose escalation therapy at United European Gastroenterology (UEG) Week 2024 in Vienna, Austria. 15 October 2024
At last month’s European Academy of Dermatology and Venereology (EADV) congress in Amsterdam, Novartis presented new early and long-term Phase III data for remibrutinib in chronic spontaneous urticaria (CSU). 14 October 2024
A recent study published in The New England Journal of Medicine has detailed seven cases of blood cancer in patients treated with the gene therapy Skysona (elivaldogene autotemcel). 14 October 2024
UK pharma major AstraZeneca and Japanese drugmaker Daiichi Sankyo’s Enhertu (trastuzumab deruxtecan) has won conditional approval in China. 14 October 2024
French biotech Innate Pharma has appointed Jonathan Dickinson as its new chief executive (CEO) and chairman of the executive board, effective November 1, 2024. 14 October 2024
Roche has presented positive two-year data from the ongoing RAINBOWFISH study assessing the efficacy and safety of Evrysdi (risdiplam) in children with spinal muscular atrophy (SMA) who were treated pre-symptomatically as infants before six weeks of age. 14 October 2024
India's Central Drugs Standard Control Organization (CDSCO) has provided a favorable recommendation for its novel antibiotic Miqnaf (nafithromycin) discovered and developed for the treatment of community-acquired bacterial pneumonia (CABP) in adults. 14 October 2024
Stealth BioTherapeutics has received a favorable vote from a US Food and Drug Administration advisory committee regarding its lead product, elamipretide. 14 October 2024
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Company Spotlight
Stealth Biotherapeutics is an American biotech with a focus on mitochondrial therapies, in fields as diverse as metabolics, neurology and musculoskeletal.