Neither the primary endpoint of overall response rate nor the key secondary endpoint of progression free survival achieved statistical significance in Isofol Medical AB’s phase III Agent study of arfolitixorin in combination with 5 fluorouracil, oxaliplatin and bevacizumab in metastatic colorectal cancer (mCRC), licensee Solasia Pharma KK reported.
Kringle Pharma Inc.’s phase II trial evaluating its recombinant human hepatocyte growth factor ligand, oremepermin alfa, failed to meet both primary and secondary endpoints in a study of its potential to help people with amyotrophic lateral sclerosis (ALS).
Women now have a new treatment option for dealing with the pain associated with endometriosis with U.S. FDA approval of Myfembree (relugolix/estradiol/norethindrone acetate) for managing moderate to severe pain associated with endometriosis in premenopausal women.
Neither the primary endpoint of overall response rate nor the key secondary endpoint of progression free survival achieved statistical significance in Isofol Medical AB’s phase III Agent study of arfolitixorin in combination with 5 fluorouracil, oxaliplatin and bevacizumab in metastatic colorectal cancer (mCRC), licensee Solasia Pharma KK reported.
Shionogi & Co. Ltd. has in-licensed Japan rights to Grunenthal GmbH’s intra-articular injectable, resiniferatoxin, for the treatment of pain associated with osteoarthritis of the knee. Currently in phase III trials, RTX is a transient receptor potential vanilloid 1 agonist, which can reversibly desensitize TRPV1-expressing nociceptors. This mechanism may result in long-lasting pain relief.
The U.S. FDA has approved Daiichi Sankyo Co. Ltd. and Astrazeneca plc’s Enhertu (fam-trastuzumab deruxtecan) as the first HER2-directed therapy for patients with HER2-low metastatic breast cancer.
Following the readout of a phase II trial evaluating its COVID-19 oral antiviral Pentarlandir (SNB-01), Taiwan’s Syneurx International Corp. said it expects to launch a phase III test of the candidate in the next few months.
Researchers are closer to better diagnosing and treating age-related macular degeneration (AMD) after discovering new genetic signatures of the disease by reprogramming stem cells to generate high-resolution disease models.
The FDA granted Adherium Ltd. 510(k) clearance for its next-generation Hailie sensor that connects with Glaxosmithkline plc’s Ellipta inhaler to enable monitoring of medication use for asthma and chronic obstructive pulmonary disorder (COPD).
Shionogi & Co. Ltd. has in-licensed Japan rights to Grunenthal GmbH’s intra-articular injectable, resiniferatoxin, for the treatment of pain associated with osteoarthritis of the knee. Currently in phase III trials, RTX is a transient receptor potential vanilloid 1 agonist, which can reversibly desensitize TRPV1-expressing nociceptors. This mechanism may result in long-lasting pain relief.
