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Shionogi’s investigative COVID-19 therapy is showing some promise in early laboratory studies, rapidly clearing viral levels and decreasing the period of active shedding, the company reported at the European Congress of Clinical Microbiology and Infectious Diseases. Read More
A large postmarket study suggests that some patients with multiple sclerosis (MS) who are stable on Biogen’s Tysabri (natalizumab) can safely extend their dosing interval from four to six weeks. Read More
The five members are asking for disclosure regarding the price of the vaccine’s unit, advance payments, donations, liability and indemnification. Read More
The European Medicines Agency (EMA) has issued a final guidance for drug developers on the quality data needed to support applications to its Priority Medicines (PRIME) program and other unmet medical need review pathways. Read More
India is making moves to reduce its dependence on countries like China for sourcing active pharmaceutical ingredients (API) used in manufacturing regulated medicines. Read More
The FDA has expanded its approval of Gilead Sciences’ Veklury (remdesivir) for pediatric patients 28 days and older weighing at least 6.6 pounds who have tested positive for COVID-19 and are either hospitalized or are at high risk of developing severe COVID-19. Read More
Ardelyx said the FDA will convene an advisory committee meeting to review the company’s Xphozah (tenapanor) as a treatment for the control of serum phosphorus in adults suffering from chronic kidney disease who are on dialysis. Read More
Roche’s breast cancer drug candidate giredestrant, an oral selective estrogen receptor degrader (SERD), didn’t meets its primary endpoint of progression-free survival in a phase 2 trial of patients with an advanced form of breast cancer, said the company in an Securities and Exchange Commission (SEC) filing yesterday. Read More
Axsome Therapeutics said it anticipates the FDA will decline to approve its experimental drug AXS-07 for the acute treatment of migraines because of problems related to its chemistry, manufacturing and controls (CMC) processes. Read More