Russia Denies Pause in COVID-19 Vaccine Trial
Russia’s Gamaleya Research Institute has reportedly resumed dosing in a phase 3 trial evaluating its COVID-19 vaccine, Sputnik V., but a Russian government spokesperson denies that the study was ever…
Agios Withdraws European Tibsovo AML Submission
Agios has withdrawn its EU marketing authorization application to the European Medicines Agency for Tibsovo (ivosidenib) for the treatment of adults with relapsed or refractory acute myeloid leukemia (AML) featuring…
Endo Gains Control of Two Collagenase Therapies in BioSpecifics Purchase
Endo International announced that it will purchase the biopharmaceutical company BioSpecifics Technologies for approximately $540 million giving the company complete control over two promising collagenase-based therapies. Source: Drug Industry Daily
UK Authorizes COVID-19 Human Challenge Trial
The British government has entered into a contract to conduct human challenge trials in which participants will be deliberately infected with COVID-19 to bolster development of a vaccine. Source: Drug…
Sinopharm to Supply 1 Billion COVID-19 Vaccine Doses Next Year
China’s state-owned pharmaceutical company Sinopharm is gearing up to manufacture 1 billion doses of its two potential coronavirus vaccines in 2021. Source: Drug Industry Daily
Moderna Could Earn EUA for COVID-19 Vaccine in December, CEO Says
Moderna CEO Stéphane Bancel said that the drugmaker’s COVID-19 vaccine candidate could receive an Emergency Use Authorization (EUA) in December if all goes according to plan, with interim data expected…
FDA Cites Nutravail for Data Integrity, Supplier Validation
Following an inspection of its Chantilly, Va., plant, the FDA cited Nutravail for failing to ensure data integrity at the facility or to validate reports from a component supplier. Source:…
Administration to Finalize Rule to Allow Drug Imports From Canada
Despite industry resistance and reluctance from state legislatures, the Trump administration is gearing up to issue a final rule allowing states to import prescription drugs from Canada as part of…
Merck’s Keytruda Improves Survival for Esophageal Cancer Patients
Merck said its blockbuster cancer drug Keytruda (pembrolizumab) in combination with chemotherapy significantly improved survival in patients with locally advanced or first-line metastatic esophageal cancer in a phase 3 clinical…
Pfizer-BioNTech COVID-19 Vaccine Moves Into Pivotal Trial
Pfizer’s and BioNTech’s experimental COVID-19 vaccine BNT162b2 has been chosen for a phase 2/3 efficacy study of 9,000 participants following its success in a phase 1 trial. Source: Drug Industry…
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