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French drugmaker Servier is expanding its reach into cancer drugs by acquiring Agios Pharmaceutical’s oncology business in a deal valued at up to $2 billion. Read More
The FDA has placed a clinical hold on uniQure’s entire clinical development program for its investigational gene therapy for hemophilia B after a patient participating in a pivotal phase 3 clinical trial was given a preliminary diagnosis of liver cancer, the company announced Monday. The serious adverse event was included in a mid-December safety report on the trial as being possibly related to the patient’s treatment with the investigational gene therapy, etranacogene dezaparvovec (AMT-061) in October 2019. Read More
CanSino Biologics has enrolled more than 20,000 participants in a global phase 3 study of its COVID-19 vaccine candidate, Ad5-nCoV, co-developed with a research arm of the Chinese military. Read More
The House Select Subcommittee on the Coronavirus Crisis issued subpoenas on Monday to the chiefs of HHS and the Centers for Disease Control and Prevention (CDC), demanding documents relating to the Democrats’ investigation of alleged political tampering with coronavirus response efforts. Read More
Ending months of haggling between lawmakers, Congress passed an omnibus appropriations bill and COVID-19 relief package late Monday with a seven-day continuing resolution in place to keep the government funded at fiscal 2020 levels until the legislation is signed into law as expected. Read More
Vaccinations using Pfizer/BioNTech’s COVID-19 vaccine are set to begin Sunday throughout Europe, following the European Commission’s landmark authorization of its first coronavirus vaccine. Read More
Novartis has received a Complete Response Letter (CRL) from the FDA regarding a new drug application (NDA) for its cholesterol-lowering drug Leqvio (inclisiran). Read More