Advanz Pharma Ltd. has won a stay on the withdrawal of its primary biliary cholangitis (PBC) drug, Ocaliva (obeticholic acid), after the European Commission (EC) said on Sept. 3 that the conditional marketing approval should be revoked. Following that, London-based Advanz launched a legal challenge, announcing on Sept 5 that the General Court of the EU has temporarily suspended the EC’s decision. As a result, the conditional marketing authorization for Ocaliva remains in place until further notice from the court, and the 7,000 existing patients – and new ones – will still have access to the farnesoid X receptor agonist. Read More
With Novo Nordisk A/S hobbled by a complete response letter, Eli Lilly and Co. has forged ahead in developing a once-weekly type 2 diabetes treatment. Top-line data from Lilly’s phase III Qwint-1 and Qwint-3 studies of efsitora alfa showed noninferior average levels of blood glucose, A1C, compared to those using another daily basal insulin treatment. Read More
Cytokinetics Inc. CEO Robert Blum said his firm chalked “a watershed moment” during last weekend’s congress of European Society of Cardiology (ESC) in London, where further mid- and late-stage data were disclosed with the heart drug aficamten, a myosin inhibitor. South San Francisco-based Cytokinetics rolled out six presentations, including two late breakers, with four concurrent publications in medical journals. Read More
On news that drove shares up by 36% on Sept. 3, San Carlos, Calif.-based Vaxcyte Inc. priced a $1.3 billion follow-on offering a day later. It is the fourth highest amount raised through a follow-on offering of shares in BioWorld’s records, as well as the second largest financing of all types for 2024, behind New York-based Pfizer Inc.’s $3.1 billion global sale of shares in March. Read More
After receiving a complete response letter from the U.S. FDA more than three years ago and conducting another phase III trial, Iterum Therapeutics plc is preparing to make its case before an advisory committee Sept. 9 for sulopenem etzadroxil/probenecid as an oral treatment option for women with uncomplicated urinary tract infections caused by specific microorganisms. Read More
South Korean artificial intelligence-based drug developer Pharos Ibio Co. Ltd. said that the Ministry of Food and Drug Safety (MFDS) granted an orphan drug designation for PHI-101, a second-line therapy for acute myeloid leukemia (AML). Read More
Glenmark Pharmaceuticals Inc. USA agreed Sept. 4 to pay $25 million, based on its ability to pay, to resolve the Department of Justice’s civil allegations that it conspired to fix the U.S. price of pravastatin, a generic drug used to treat high cholesterol. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Aelis, Athira, Biogen, Genentech, Jnana, Telix, Tris, Vesper. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Acepodia, Collegium, Eli Lilly, Eva, Forus, Genprex, Incyte, Ironshore, Oncopeptides, Pharmaessentia, Slavpharma, Veld. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Actimed, Axsome, Cel-Sci, Innovent, Synthekine, Yoltech. Read More
