Clinical updates, including trial initiations, enrollment status and data readouts and publications: Actinogen, Allakos, Alligator, Argenx, Annexon, Arrowhead, Camurus, Encell, Huadong, Intellia, Lyell, Savara, Vega.
New single-step genome editing techniques that enable the insertion, inversion or deletion of long DNA sequences at specified genome positions have been demonstrated in bacteria.
The U.S. FDA granted approval of Verona Pharma plc’s ensifentrine on its PDUFA date of June 26, giving the chronic obstructive pulmonary disease (COPD) community its first new mechanistic option in a decade. The drug, branded Ohtuvayre, is also the first inhaled nonsteroidal therapy to treat a respiratory disease that combines both a bronchodilator and anti-inflammatory mechanism into one molecule. It is indicated for the maintenance treatment of COPD, which Verona said allows for broad use.
Partners Daiichi Sankyo Co. Ltd. and Merck & Co. Inc. received a complete response letter (CRL) from the U.S. FDA for their first-in-class HER3-directed antibody-drug conjugate HER3-DXd (patritumab deruxtecan) to treat patients with locally advanced or metastatic EGFR-mutated non-small-cell lung cancer.
Merck Sharp & Dohme Corp. (MSD), known as Merck & Co. Inc. in the U.S. and Canada, terminated its potential $1.86 billion deal with San Diego-based Artiva Biotherapeutics Inc. for novel chimeric antigen receptor-natural killer cell therapies. GC Cell disclosed news of the terminated deal on the Korea Exchange near market close of June 25, saying it was notified by Artiva after the decision was reached by MSD’s internal decision makers.
In reviving another case involving drug label carveouts, the U.S. Court of Appeals for the Federal Circuit insisted that its June 25 decision in Amarin Pharma Inc. v. Hikma Pharmaceuticals plc will not kill so-called skinny labels that allow generics to come to market when some of the brand’s indications still have patent protection.
Radiopharm Theranostics Ltd. announced a AU$70 million (US$46.69 million) institutional placement, and as part of that capital raise, radiopharma company Lantheus Holdings, Inc., has agreed to make an initial equity investment of AU$7.5 million.
A patient death and cases of pneumonitis overshadowed positive signs of efficacy for South San Francisco-based Lyell Immunopharma Inc.’s ROR1 CAR T-cell candidate, LYL-797, which is treating triple-negative breast cancer and non-small-cell lung cancer in a phase I trial.
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