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. Read More
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. Read More
Positive top-line results from Calcimedica Inc.’s placebo-controlled phase IIb of Auxora in acute pancreatitis couldn’t support the stock for the day. The selective small-molecule inhibitor of Orai1-containing calcium release-activated calcium (CRAC) channels hit the randomized, double-blind, dose-ranging Carpo study’s primary endpoint, the median time it took to tolerate solid food, as patients who received Auxora had a statistically significant dose response compared to those who received placebo. Read More
In a 5-4 decision June 27, the U.S. Supreme Court scuttled a Purdue Pharma LP’s bankruptcy plan that would have discharged any claims against the Sackler family, which owned and controlled the company that made billions of dollars from its sales of Oxycontin (oxycodone). Read More
The obesity market is hot with Novo Nordisk A/S generating $6.3 billion in sales from its semaglutide-containing drugs, Ozempic, Saxenda, Rybelsus and Wegovy, in the first quarter of 2024 and Eli Lilly and Co. bringing in $2.3 billion for its tirzepatide-containing drugs, Zepbound and Mounjaro, in the same quarter. It appears unlikely the market will be a two-horse race for much longer though. Read More
South Korea’s SK Bioscience Co. Ltd. has entered a cross-shareholding acquisition deal with Germany’s Klocke Pharma-Service GmbH to acquire its contract development and manufacturing organization (CDMO), IDT Biologika Corp. Read More
The U.S. FDA reissued a 2022 draft guidance for clinical trial diversity at the behest of legislation from Congress, ballooning the previous nine-page draft to 23 pages. Read More
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. Read More
New hires and promotions in the biopharma industry, including: Anima, CN Bio, Iomx, Neurona, Parallel Biosystems, Sensorion, Tourmaline, Valneva. Read More
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. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Agile, Diamedica, Eli Lilly, Exeltis, Hyundai Bioscience, Immuno Cure, Insud, OpenAI. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Antengene, Astrazeneca, Bavarian Nordic, Brainstorm Cell, Simcere, Vir. Read More
