Archive for April 2022

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. Source: Drug Industry Daily

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. Source: Drug Industry Daily

India is making moves to reduce its dependence on countries like China for sourcing active pharmaceutical ingredients (API) used in manufacturing regulated medicines. Source: Drug Industry Daily

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. Source: Drug Industry Daily

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. Source: Drug Industry Daily

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. Source: Drug Industry Daily

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. Source: Drug Industry Daily

The European Medicines Agency’s (EMA) human safety medicines committee signed off on four new drugs during its monthly meeting held from April 19 to 22, including Novartis’ (capmatinib) for treating advanced nonsmall-cell lung cancer. Source: Drug Industry Daily

Abaco Partners, operating as Surefil, has received a seven-observation Form 483 from the FDA after a November 2021 inspection of the company’s Grand Rapids, Mich., manufacturing facility turned up observations of testing and other quality lapses. Source: Drug Industry Daily

The FDA announced Friday that it’s working on a project to identify and prioritize pharmaceutical quality (PQ) and chemistry and manufacturing and controls (CMC) information that would benefit from a structured submission approach. Source: Drug Industry Daily