Europe’s medicines regulator added a rare nerve-degenerating disorder, Guillain-Barré syndrome, as a possible rare side effect from Johnson & Johnson’s Covid-19 vaccine after the European Medicines Agency reviewed 108 cases reported worldwide.
Novartis aims to help manufacture more than 50 million doses of BioNTech’s Covid-19 vaccine in 2021 at the Swiss drugmaker’s Stein, Switzerland fill-and-finish facility after the European Union’s drug regulator approved the bottling plant.
Europe’s health regulator started a real-time review of Johnson & Johnson’s Covid-19 vaccine candidate after preliminary results showed that the shot triggered the production of antibodies and immune cells against the virus.
Junshi Biosciences, based in Shanghai, China, announced that an Independent Monitoring Committee (IDMC) decided the company’s Phase III JUPITER-02 trial had met the pre-specified primary endpoint at the interim analysis.
The U.S. Food and Drug Administration approved Bristol Myers Squibb’s Onureg (azacitidine 300 mg tablets, CC-486) for the continued treatment of adult patients with acute myeloid leukemia (AML) who achieved first complete remission or CR with incomplete blood count recovery following intensive induction chemotherapy and who are not able to complete intensive curative therapy.
As pharma companies bolster their pipelines via multibillion-dollar acquisitions, drug manufacturers continue to heavily invest in the oncology space.
Shionogi & Co. Ltd. announced results from APEKS-NP, an international, double-blind, randomized Phase III clinical trial evaluating the efficacy and safety of the investigational antibiotic cefiderocol in patients with nosocomial pneumonia (NP).
Celgene Corporation announced that the company submitted a New Drug Application to the U.S. FDA for ozanimod for the treatment of adults with relapsing forms of multiple sclerosis (RMS).
The EMA’s risk assessment committee recommended restrictions on the use of the broad-spectrum antibiotics.
Novartis received European approval for Kymriah, the Swiss drugmaker’s gene-modifying therapy for blood cancer.