The U.S. Food and Drug Administration’s Oncologic Drugs Advisory Committee did not agree in a meeting to maintain the accelerated approval of Bristol Myers Squibb’s Opdivo (nivolumab) as a second-line treatment of hepatocellular carcinoma.
The European Medicines Agency will conduct an accelerated review of Eli Lilly and Co.’s rheumatoid arthritis drug Olumiant for hospitalized Covid-19 patients getting oxygen, the EU agency said on April 29, as the search for treatment options continues.
BioNTech expects results by September from trials testing the Covid-19 vaccine developed with Pfizer in babies as young as 6 months old, German magazine Spiegel cited the company’s CEO as saying.
Takeda’s non-small cell lung cancer (NSCLC) treatment Mobocertinib (TAK-788) is leading closer to regulatory approval after the U.S. Food and Drug Administration granted priority review to the New Drug Application.
ERT, a global leader in clinical endpoint data solutions, on April 28 announced the close of the company’s merger with Bioclinica, a technological and scientific leader in clinical imaging.
Placebo response is one of the most significant challenges faced by drug developers who are investigating new pain medications. According to a review of published chronic neuropathic pain trials, placebo responses have increased in magnitude over time, making it even more difficult to definitively demonstrate treatment advantage. Research has also shown that up to 60 percent of study participants may experience placebo-related analgesic responses and that these responses may be persistent.
Eli Lilly released the company’s first-quarter 2021 financial report and is abandoning plans to submit mirikizumab to health regulators for psoriasis.
Novartis said on Tuesday that a large British study of the Swiss drugmaker’s cholesterol-lowering medicine Leqvio is not expected to be completed until 2026, a year later than expected, as Covid-19 infections made participant recruitment difficult.
Shares of uniQure NV climbed after the company announced the clinical hold on its hemophilia B gene therapy was lifted by the U.S. Food and Drug Administration.
Sanofi will use the company’s manufacturing capabilities to support the development of 200 million doses of the Moderna Covid-19 vaccine beginning in September. Sanofi is boosting the number of authorized vaccines while researching the development of its own preventative medicines.