LONDON – Results from two non-randomized phase I/II trials of the Russian COVID-19 vaccine Sputnik V that recently received conditional regulatory approval show both a frozen and a freeze-dried formulation of the two-shot vaccine had a good safety profile and induced antibody responses in all 76 participants within 21 days.
While the volume of clinical data in July dipped below previous pandemic months, the amount of news focused on therapeutics or vaccines for COVID-19 is climbing, representing about 16% of BioWorld’s database entries during the month.
As society continues to re-open and biopharma companies move back toward a business-as-usual approach, the number of clinical trials affected by the COVID-19 pandemic has plummeted with only 12 reporting delays or disruptions in the month of June. This compares to 171 in April and 71 in May.
A number of clinical trials hit primary endpoints in May, despite the COVID-19 pandemic, which still accounted for about 30% of the phase I through phase III news flow during the month.
Proteus Digital Health Inc.’s digital medicine program, Digimeds, achieved 95% adherence in patients with hepatitis C virus (HCV) who typically would not be offered direct-acting antivirals because of their high risk for nonadherence as a result of mental illness, transportation issues or previous evidence of nonadherence.
SAO PAULO, Brazil – Latin America is rife with opportunities to undertake clinical trials, but regulatory adjustments are needed for companies to fully take advantage of them. As the largest market in the region, Brazil, for one, is in dire need of those adjustments, said experts gathered in Sao Paolo last week for the annual BIO Latin America conference.
Francis Collins, director of the U.S. NIH, said in a public forum that the agency is "really bullish" about precision medicine. However, while precision medicine requires mounds of data, which soon may be available, Collins said the NIH All of Us research program has drawn the interest of more than 300,000 willing participants to date, adding that the target enrollment of 1 million should be accomplished before the end of 2022.
The failure of Novartis AG's Entresto in a phase III clinical trial staggered the stock (NASDAQ:NVS) somewhat Monday, down just 1.14%, but the real trauma may well be the loss of roughly $2.5 billion in anticipated sales.
HONG KONG – China has approved the fourth homegrown CD47 antibody to start clinical trials, intensifying the local CD47 race. Chinese biologics developer I-Mab Biopharma (Shanghai) Co. Ltd. said it received the go-ahead for the clinical study of TJC-4, its differentiated fully human CD47 monoclonal antibody for treating advanced malignant tumors.
DUBLIN – Shares in Polyphor AG dropped as much as 21% Wednesday as the company shut down two phase III trials of its lead drug candidate, murepavadin, a first-in-class intravenous antibiotic in development for hospital-acquired and ventilator-associated bacterial pneumonia (HABP/VABP).
