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Sponsors of drug trials should determine what effect the use of acid-reducing agents (ARA), such as antacids, proton pump inhibitors and histamine blockers, could have on the solubility of an orally administered drug, according to a new FDA draft guidance released Monday. Read More
The UK’s RECOVERY trial, which is evaluating multiple treatments for COVID-19, will add the inexpensive anti-inflammatory drug colchicine to the list of therapies being tested in hospitalized patients. Read More
Moderna on Monday submitted a request for FDA Emergency Use Authorization (EUA) for its coronavirus vaccine, mRNA-1273, making it just the second company to date that’s taken a candidate far enough to file an application for emergency clearance. Read More
AstraZeneca’s COVID-19 vaccine candidate is facing another potential delay as the company plans to undertake a new global clinical trial to confirm the vaccine’s 90 percent efficacy based on a one-and-a-half-dose regimen. Read More
German drugmaker BioNTech and China’s Fosun Pharmaceutical Group have announced that the Pfizer/BioNTech COVID-19 vaccine candidate, BNT162b2, will be evaluated in a phase 2 study in China, building on an agreement the companies signed in March. Read More
It seems like every week another large biopharmaceutical company announces a new relationship with a cell and gene therapy (CGT)-focused company, if not an outright acquisition — often for stunning amounts. Read More
AstraZeneca’s COVID-19 vaccine candidate will undergo increased scrutiny by regulators because of the promising but confusing interim analysis results from a late-stage trial that found a one-and-a- half-dose regimen — given by mistake — was significantly more effective than a full double dose. Read More
The FDA yesterday issued a final guidance outlining the process for sponsors and researchers to submit plans for new drug development tools (DDT) to the agency for approval. Read More
AstraZeneca’s (AZ) and the University of Oxford’s COVID-19 vaccine candidate — which has been shown to be 90 percent effective at a one-and-a-half-dose level — could be a godsend for low- and middle-income nations due to its relative ease of distribution, high manufacturing capacity and the not-for-profit price the drugmaker has vowed to offer developing countries “in perpetuity.” Read More