As of Aug. 13, more than 90,000 patients hospitalized in the U.S. with COVID-19 already had been given access to convalescent plasma through a national expanded use protocol (EAP) sponsored by the Mayo Clinic. The FDA’s decision Sunday to grant emergency use authorization (EUA) for the potential therapy will further expand access to convalescent plasma for hospitalized patients throughout the country at a time when fully approved COVID-19 treatments are nonexistent and even EUAs are few and far between. Read More
A phase III study evaluating a combination of a Novartis AG anti-PD-1 candidate with the well-established BRAF/MEK inhibitor combo in first-line unresectable or metastatic BRAF V600 mutant melanoma missed its primary endpoint of progression-free survival. Read More
Through the use of sequencing data, researchers in Hong Kong presented a case study providing the strongest evidence yet that individuals can become reinfected with SARS-CoV-2 after clearing a first infection. Read More
Adverse events (AEs) took the shine off Odonate Therapeutics Inc.’s long-awaited top-line data from the phase III trial called Contessa testing the oral taxane chemotherapy tesetaxel in metastatic breast cancer (MBC), and shares of the San Diego-based firm (NASDAQ:ODT) closed at $18.33, down $15.21, or 45%. Read More
DUBLIN – Adrenomed AG has reported encouraging, albeit limited, data for its antibody adrecizumab in eight COVID-19 patients in Germany with life-threatening acute respiratory distress syndrome (ARDS). The drug was made available on a named-patient basis to critically ill patients undergoing mechanical ventilation. Read More
Onconova Therapeutics Inc.’s lead candidate in myelodysplastic syndromes took a major hit Monday as the small molecule I.V. rigosertib failed to meet the primary endpoint of significantly improved survival vs. best supportive care in higher-risk patients. Read More
Tricida Inc. executives were not surprised when the FDA issued a complete response letter for veverimer to treat chronic metabolic acidosis. Despite an Aug. 22 PDUFA date, the company had received an FDA notification on July 16 that there were deficiencies that would preclude discussion of labeling and postmarketing requirements and commitments. Read More
HONG KONG –Stempeutics Research Pvt Ltd. received the green light from the Drug Controller General of India (DCGI) to launch its Stempeucel therapy to treat critical limb ischemia (CLI) due to Buerger’s disease and atherosclerotic peripheral arterial disease. Read More
HONG KONG – Last week was a busy one for Harbour Biomed Therapeutics Ltd., seeing the company sign a COVID-19 research collaboration with several Dutch institutions as well as lodge an application to list on the Hong Kong Stock Exchange. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Adrenomed, Aslan, Celldex, Cohbar, Cynata, Geovax, Mitsubishi Tanabe, Novartis, Novavax, Odonate, Onconova, Protalix, PTC, Reithera, Trevena. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Aligos, Editas, Exelixis, HHS, Kazia, Merck, Turning Point. Read More
