Gilead Sciences Inc. ended the speculation Monday when it announced its no-bargaining price for remdesivir for all governments of developed countries where the drug is approved or authorized as a treatment for COVID-19. Read More
LONDON – Scientists investigating the impact of SARS-CoV-19 on protein expression in human cells have shown that infected cells develop virus-laden membrane protrusions, or filopodia, which may explain the rapidity of viral spread through the body. Read More
Multiple sessions at the American Association for Cancer Research Virtual Annual Meeting II covered how COVID-19 is affecting cancer patients, from how clinical trials needed to be modified during the pandemic to how real-world evidence can play a role now and in the future. Read More
Toss a complete response letter (CRL) onto two missed PDUFA dates and a few adcoms that were discussed but never actualized to get an idea of where Intercept Pharmaceuticals Inc. now stands with its NDA for obeticholic acid (OCA) to treat fibrosis due to nonalcoholic steatohepatitis (NASH). Read More
Shares of Heron Therapeutics Inc. sank 27% in morning trading, after the San Diego-based firm disclosed a second complete response letter (CRL) for HTX-011 in postoperative pain. The CRL, received from the FDA on June 26, the anticipated PDUFA date, stated the agency was unable to approve the NDA in its present form and called for additional nonclinical information. Read More
BEIJING – Beijing-based cellular immunotherapy firm Immunotech Biopharm Ltd. said June 28 that it intends to raise up to HK$1.1 billion (US$141.9 million) on the Hong Kong Stock Exchange (HKEX) on July 10, with shares priced between HK$10.5 and HK$11 apiece. Read More
Shares of Kiniksa Pharmaceuticals Ltd. hit a 52-week high on June 29 as pivotal phase III results showed that Arcalyst (rilonacept), a medicine it licensed from Regeneron Pharmaceuticals Inc., led to a 96% reduction in risk of recurrent pericarditis events among 61 people not helped by standard-of-care treatments. Read More
PERTH, Australia – Melbourne-based Neuren Pharmaceuticals Ltd. will be able to progress NNZ-2591 to the clinic for three orphan indications after raising AU$20 million (US$13.75 million) in a placement to institutional and sophisticated investors in Australia, New Zealand, Hong Kong and the U.K. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: 9 Meters, Achieve, Aileron, Biocardia, Cytodyn, Immutep, Immunovant, Intra-Cellular, Iterum, Kiniksa, KPB, Medicure, Revimmune, TFF, Tonix. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Alexion, Aptose, Aquestive, Cancer Prevention, Cytocom, Emmaus, Genentech, Goliver, Heron, Incyte, Intercept, Merz, Nordic Nanovector, Novartis, PTC, Rakuten, Roche, Rocket, SFA, Teijin. Read More
